PastProg - Excel by xCVbF9L

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									Session
   #               Status      Primary Theme                Session Title
       6   Accepted                               Helping the
                            Formulation Design & DevelopmentMedicine Go Down -Pediatric Medicines: Formulation, M
      10   Accepted                               Lipid-based
                            Formulation Design & DevelopmentDrug Delivery Systems
      12   Accepted                               Dissolution Testing: Relevance in a Quality by Design Approach to D
                            Analysis and Pharmaceutical Quality
      13   Accepted                               ICH Guidelines
                            Analysis and Pharmaceutical Quality Q8, Q9 and Q10, Q11: How Do They all Fit Together
      15   Accepted                               Predicting Clinical Outcome
                            Clinical Pharmacology and Translational Research Events Using Biomarkers for Drug Deve
      18   Accepted                               Placental ABC Transporters -Impact on Drug/xenobiotic Disposition
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
      26   Accepted                               Bioanalytical
                            Analysis and Pharmaceutical QualityProcedures and Regulation: Towards Global Harmoniz
      28   Accepted                               In-Vitro Release of Drugs from Non-Oral Dosage Forms
                            Analysis and Pharmaceutical Quality
      29   Accepted                               Quality Assurance of Medicines: the Detection of Counterfeits and A
                            Analysis and Pharmaceutical Quality
      31   Accepted                               Natural Products: Interface
                            Medicinal Chemistry, Drug Design and Discovery Between Science and Practice
      35   Accepted                                & Engineering
                            Manufacturing Science Nutraceuticals -Quality by Design
      52   Accepted                               Affinity-Based
                            Analysis and Pharmaceutical Quality Media: Analytical Aspects and Applications
      54   Accepted                                & Engineering
                            Manufacturing Science Sharing Global Best Practices in Educating Pharmaceutical Scientist
      56   Accepted                               Analytical Instrument Qualification: Towards Globalization
                            Analysis and Pharmaceutical Quality
      62   Accepted                               High Quality
                            Analysis and PharmaceuticalPh Mobile Phase (Lc-Ms/ms) to Optimize Analytical Sensitivity
      66   Accepted                               Traditional and Discovery
                            Medicinal Chemistry, Drug Design Medicines in a New Paradigm of Global Health
      81   Accepted                               Delivery of Poorly
                            Physical Pharmacy & Biopharmaceutics Soluble Drugs: Evolving Science and Technology
      82   Accepted                               Implementation
                            Analysis and Pharmaceutical Quality of Dried Blood Spot (Dbs) Sampling In Regulated Bi
      88   Accepted                               Computer-Aided
                            Physical Pharmacy & Biopharmaceutics Drug Development: a Rational Approach to Improve
      93   Accepted         Biotechnology         The Revival of Synthetic Peptides and Small Proteins in Biopharmac
      94   Accepted                               Mechanistic PK-PD Modelling
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
      95   Accepted                               Ppk: Bottom-Up, Top-Down, or Both?
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
      96   Accepted                               Pharmacogenetics -Found
                            Clinical Pharmacology and Translational Research in Translation?
      97   Accepted         Biotechnology         Customized Vaccines for the Future
      98   Accepted         Regulatory Sciences Risk Management Planning: an Essential Component of Pharmacov
      99   Accepted                               Novel Drug Delivery Systems: Definition of New Excipients
                            Formulation Design & Development
     108   Accepted         Regulatory Sciences The Globalization of Pharmaceutical Regulation?
     115   Accepted                               New Molecular Targets for Drug Discovery
                            Pharmacology and Biochemistry
     117   Accepted                               Stability Testing
                            Analysis and Pharmaceutical Quality in Pharmaceutical Development
     120   Accepted                                & Engineering
                            Manufacturing Science Continuous Manufacturing: Benefits and Challenges
     123   Accepted         Biotechnology         A Close Look at Subvisible Particles in Protein Therapeutics
     126   Accepted         Biotechnology         Neutralizing Antibodies: Alternatives to Cell-Based Assays
     128   Accepted                               The Gut Wall as a Metabolic Barrier to Drug Development
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
     134   Accepted                               Can Nanoparticles
                            Physical Pharmacy & Biopharmaceutics Be Simultaneously Used for Multimodality Imagin
     137   Accepted                               Genomics Issues and Solutions in Oncology, Drug Discovery and De
                            Clinical Pharmacology and Translational Research
     140   Accepted                               Individualizing (Small Molecule) Drugs: from Subtype Specificity to M
                            Medicinal Chemistry, Drug Design and Discovery
     141   Accepted         Safety Sciences       Systems Approaches to Adverse Drug Reactions
     143   Accepted         Safety Sciences       Safety Sciences -Education and Training
     149   Accepted         Biotechnology         PEGylated Proteins: Analytical and Pharmacokinetic Issues
     155   Accepted                               Pharmacogenetics -a Testing Issue
                            Clinical Pharmacology and Translational Research
     170   Accepted                               Pharmacogenetics: Translational Aspects
                            Clinical Pharmacology and Translational Research
     171   Accepted                               Transporter Proteins II : How to Scale In Vitro Data on and Transpo
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism Human Trans
     182   Accepted         Regulatory Sciences Pharmaceutical Stability: Science and Regulation
     191   Accepted                               BCS and BDDCS Based Strategies for Oral Drug Development
                            Formulation Design & Development
     196   Accepted                               Molecular Imaging Technologies for ADME -Tox Studies
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
     206   Accepted                               Imaging Technology for Understanding Process in Pharmaceutical M
                            Physical Pharmacy & Biopharmaceutics
     209   Accepted                               Current Status Discovery
                            Medicinal Chemistry, Drug Design andof Oligonucleotide Chemistry and Application
     211   Accepted                               Nuclear Receptors -Important New Players in Pharmacology
                            Pharmacology and Biochemistry
     213   Accepted                               New Molecular Discovery
                            Medicinal Chemistry, Drug Design and Targets-Based Anti-Cancer Drugs: from Small Molec
     234   Accepted                               Development of
                            Physical Pharmacy & BiopharmaceuticsEffective Fixed Dose Combination Therapies for Glo
     239   Accepted         Regulatory Sciences ―Non-clinical Dose Formulation: Time for Regulatory Guidance?
     278   Accepted         Biotechnology         Developments in Technologies for Process Related Impurities Detec
292   Accepted                                    Nature's Chemical Diversity: Science and Practice
                            Medicinal Chemistry, Drug Design and Discovery
295   Accepted                                    Nanoparticulate Drug Delivery Systems: Fundamentals
                            Formulation Design & Development
298   Accepted                                     & Engineering
                            Manufacturing Science Intelligent Pharmaceutical Product Design and Processing Using Da
299   Accepted                                    Pediatric Drug Development: a Learning Curve for Grown-Up Scien
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
300   Accepted                                    Improved Pulmonary Delivery of Drugs and Biologics
                            Formulation Design & Development
302   Accepted                                     & Engineering
                            Manufacturing Science Nanocrystals: Production, Stability, and Applications
313   Accepted              Biotechnology         Immune Response to Biotechnology Products
323   Accepted              Regulatory Sciences Technology Transfer and Process Validation in the Context of QbD
327   Accepted                                    Preservatives
                            Formulation Design & Development in Parenteral Products
336   Accepted                                    Is the Cocktail Approach Useful in the Assessment of Drug-drug Inte
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
338   Accepted              Biotechnology         Excipients for Protein Drugs Revisited
344   Accepted              Regulatory Sciences Solid State Forms of Drugs and Intellectual Property
346   Accepted                                    Single Cell and Discovery
                            Medicinal Chemistry, Drug Design Analyses for Accelerating Drug Discovery and Diagnosis
353   Accepted                                    Standards for
                            Analysis and Pharmaceutical Quality Essential Drugs
357   Accepted                                    Pharmacogenetics -Educating the Doctor, Metabolism and Transpo
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug the Pharmacist and the P
363   Accepted                                    Nose to Brain
                            Formulation Design & Development Delivery – Reality or Just Blowing Smoke?
367   Accepted                                    Drug-drug Interactions: are They Predictable?
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
371   Accepted                                    Transport Proteins I: Regulatory Mechanisms that Modulate Drug Di
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
373   Accepted                                    Penetrating the Pharmacogenomics, Drug Metabolism and Transpo
                            Pharmacokinetics, Pharmacodynamics Brain
392   Accepted                                    Transporter Proteins Iii: Clinical Relevance and Applications
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
403   Accepted                                    Progress In Modeling Disease Progression
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
408   Accepted                                    Enzyme Directed Prodrug
                            Medicinal Chemistry, Drug Design and Discovery Activation
413   Accepted                                    The Art and Science of Model Evaluation
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
425   Accepted              Biotechnology         New Frontiers in Biologics Development: Understanding and Mitigati
428   Accepted                                    Genotoxic and
                            Analysis and Pharmaceutical Quality Carcinogenic Impurities: Control and Regulation
431   Accepted                                    How Predictive are Animal
                            Clinical Pharmacology and Translational ResearchModels of Clinical Efficacy?
432   Accepted              Biotechnology         Antibody Interference in Bioanalytical Methods
441   Accepted                                    siRNA Delivery: Challenges
                            Medicinal Chemistry, Drug Design and Discovery and Opportunities
446   Accepted                                    Rational Drug Design and
                            Medicinal Chemistry, Drug Design and Discovery Discovery via Computational Modeling
453   Accepted                                    Reactive Impurities in Excipients -Characterization and Stabilization
                            Formulation Design & Development
462   Accepted                                    The Science of Freezing: Control, Excipients, Storage and Freeze-d
                            Physical Pharmacy & Biopharmaceutics
472   Accepted                                    Treating Blindness In the Developing World
                            Formulation Design & Development
478   Accepted                                    Prediction of Human Oral Pharmacokinetic Profiles from Preclinical a
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
479   Accepted                                    Improving Oral Absorption of Compounds Using High Energy Forms
                            Physical Pharmacy & Biopharmaceutics
480   Accepted                                    Integrating Dissolution Testing with Permeability to Predict Product P
                            Physical Pharmacy & Biopharmaceutics
519   Accepted                                    Fractal Pharmacokinetics and Non-Linear Metabolism
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, DrugDynamics and Transpo
532   Accepted                                    Nanotechnology from a -Z -Achievement In Drug Delivery and Tiss
                            Formulation Design & Development
533   Accepted                                    Inflammation and Stress Signaling
                            Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
534   Accepted                                    Personalized Medicine -Integrated Technologies
                            Clinical Pharmacology and Translational Research
535   Accepted                                    Pharmaceutical Challenges
                            Medicinal Chemistry, Drug Design and Discovery to Alzheimer's Disease
536   Accepted                                    New Synthetic Discovery
                            Medicinal Chemistry, Drug Design andTechnology In Drug Development
537   Accepted              Safety Sciences       Similarities and Differences In Global Safety Regulation
538   Accepted              Other                 Development and Evaluation of Academic Curriculum and Clinical C
539   Accepted              Other                 Pharmaceuticals Without Borders I: Developing and Delivering Med
540   Accepted                                    Translation of Pharmaceutical
                            Clinical Pharmacology and Translational Research Science to Practice
541   Accepted              Other                 Pharmaceuticals Without Borders Ii: the Regulatory and Supply Cha
542   Accepted              Other                 Pharmaceuticals Without Borders Iii: Ensuring the Integrity and Qua
548   Accepted                                    Ocular Drug Delivery
                            Physical Pharmacy & Biopharmaceutics
549   Accepted                                    Cutting
                            Please choose an option belowEdge in Vaccine Delivery
550   Accepted              Biotechnology         Biosimilars and Follow-on Biologics: a Global Perspective
580   Accepted              Regulatory Sciences Evaluating Medicines In the European Union
305                         Analysis              Bridging the Gap Between Traditional Medicine and the Western App
      Accepted-Pending Complete Data and Pharmaceutical Quality
320                                               Ascpt/aaps Joint Research
                            Clinical Pharmacology and Translational Symposium: Phase 0 Pharmacodynamics Trials in
      Accepted-Pending Complete Data
356                         Safety Sciences
      Accepted-Pending Complete Data              Pharmaceutical Waste and Environmental Pollution
385                         Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
      Accepted-Pending Complete Data              Metabolomics in Pharmaceutical Development
501                         Clinical Pharmacology and Translational Research
      Accepted-Pending Complete Data              What Do Industry and Regulators Need from Imaging?
552                         Physical              The BCS, BDDCS
      Accepted-Pending Complete Data Pharmacy & Biopharmaceutics and Regulatory Guidances
555                         Manufacturing Science Particles in Biopharmaceutical Parenteral Products
      Accepted-Pending Complete Data               & Engineering
557                         Formulation Design & Development Strategies for Poorly Soluble Drugs: Including Selected
      Accepted-Pending Complete Data              Formulation
559                         Regulatory
      Accepted-Pending Complete Data Sciences Enhancing the Development Pipeline: Strategies for Repurposing, Fi
564                         Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
      Accepted-Pending Complete Data              Ethnic Sensitivity in Pk/pd: Leveraging Clinical Development in Emer
565                         Clinical Pharmacology and Translational Research of Mechanistic/systems Biology Models I
      Accepted-Pending Complete Data              Open Source Development
566                         Analysis              Global Harmonization of Modern Bioanalytical Regulatory Practices
      Accepted-Pending Complete Data and Pharmaceutical Quality
570                         Regulatory
      Accepted-Pending Complete Data Sciences Establishing Clinically Relevant Dissolution Specifications In the Qua
 92   Combined by Admin     Biotechnology         Successful Vaccine Delivery: Needles or Needless?
152   Combined by Admin     Biotechnology         Quality, Safety and Efficacy of Biosimilar / Follow-on Biologics
183   Combined by Admin     Regulatory Sciences Biosimilars and Follow on Protein Products – a Global Perspective
222   Combined by Admin     Biotechnology         Ocular Drug Delivery: Recent Advances
227   Combined by Admin                           Ocular Drug Delivery
                            Physical Pharmacy & Biopharmaceutics
289   Combined by Admin     Biotechnology         Customizing Vaccines for the Future: Particulate Systems for the Ra
  3   Rejected                                    Microdialysis: a Pharmacogenomics, Drug Metabolism and Transpo
                            Pharmacokinetics, Pharmacodynamics Tool to Streamline Drug Development from the Benc
  5   Rejected                                    ‗structure‘ in Disordered Pharmaceutical Solids: Analytical Technique
                            Physical Pharmacy & Biopharmaceutics
  7   Rejected                                     & Engineering
                            Manufacturing Science Drug Sparing Scaleable Strategies in Solid Formulation Developmen
  8   Rejected                                     & Engineering
                            Manufacturing Science The Basics and Recent Advances in Softgel Technology
  9   Rejected                                     & Engineering
                            Manufacturing Science Roller Compaction -Scale Up Challenges and the Role of PAT
 11   Rejected                                    Impurity Specifications in the New Paradigm: Analytical and Regulat
                            Analysis and Pharmaceutical Quality
 14   Rejected                                    Challenges in
                            Analysis and Pharmaceutical Quality Analytical Method Transfer Across Labs, Countries an
 16   Rejected                                    How to Use Biomarkers to
                            Clinical Pharmacology and Translational ResearchPredict Clinical Outcome
 17   Rejected                                    Nmr-2057: a
                            Formulation Design & Development Novel Lyophilized Paclitaxel Formulation with Improved
 19   Rejected                                    Alternate Approaches to the Quality Control of the Aerosol Particle S
                            Analysis and Pharmaceutical Quality
 20   Rejected              Other                 Research in Neglected Global Diseases
 21   Rejected              Biotechnology         Defining and Qualifying Critical Reagents for Ligand Binding Assays
 22   Rejected              Manufacturing Science Terahertz Spectroscopy and Imaging – an Emerging Tool in Pharma
                                                   & Engineering
 23   Rejected                                     & Engineering
                            Manufacturing Science Blend Uniformity in the Manufacture of Solid Dosage Forms: Recen
 24   Rejected                                    Parenteral Science and Engineering Invited Poster-Podium Session
                            Formulation Design & Development
 25   Rejected              Biotechnology         Cutting-Edge Technologies in Peptide and Protein Drug Delivery
 27   Rejected                                    siRNA Delivery: Path Towards Innovation
                            Formulation Design & Development
 30   Rejected                                    Drug Quality
                            Analysis and PharmaceuticalTruths-Dispelling the Myths About Pharmaceutical R&D
 32   Rejected              Regulatory Sciences Global CMC Submissions for Small & Large Molecules: Scientific Ap
 33   Rejected                                    Thorough Qtc Studies in Oncology: Challenges and Limitations
                            Clinical Pharmacology and Translational Research
 34   Rejected                                     & Engineering
                            Manufacturing Science Paediatric Medicines -Formulation, Manufacturing and Compliance
 36   Rejected                                    Bioanalytical
                            Analysis and Pharmaceutical QualityGlobal Outsourcing of Chromatographic and Ligand Bin
 37   Rejected                                    Solubilzation Mechanism of Poorly Water-soluble Drugs for Dosage
                            Physical Pharmacy & Biopharmaceutics
 38   Rejected                                    Improving Lab
                            Analysis and Pharmaceutical Quality Efficiency: Role of Training Program in Pharmaceutic
 39   Rejected                                    Challenges in
                            Analysis and Pharmaceutical Quality Assessing Impurities for Over-the-Counter Drug Produ
 40   Rejected                                    Automation Advances in the Bioanalytical and Pharmaceutical Labor
                            Analysis and Pharmaceutical Quality
 41   Rejected                                    Understanding Physical Stability of Amorphous Pharmaceutical Solid
                            Physical Pharmacy & Biopharmaceutics
 42   Rejected                                    ―go Translational Research
                            Clinical Pharmacology and Placidly Amidst the Noise and Haste‖: the Problem of Unpredicta
 43   Rejected              Biotechnology         Preclincial Evaluation and Translation of siRNA Delivery to Humans
 44   Rejected                                    Accelerating Drug Development: Use of Imaging Biomarkers to Tran
                            Clinical Pharmacology and Translational Research
 45   Rejected              Regulatory Sciences Towards Global Harmonization of Regulations on Bioequivalence: a
 46   Rejected                                    Alternatives
                            Formulation Design & Developmentto Animal Testing for Dermatological/cosmetic Products
 47   Rejected                                     & Engineering
                            Manufacturing Science Global Perspective on Technology Transfer: Manufacturing and Ana
 48   Rejected              Regulatory Sciences The Regulatory Path Forward for Repurposing and Repositioning Old
 49   Rejected                                    Transdermal
                            Formulation Design & Development Drug Delivery, 35 Years of Progress? Current and Futu
 50   Rejected              Regulatory Sciences Therapeutic Protein Drugs: Regulatory Pathway for Nda/bla Submiss
 51   Rejected                                    Sex-Based Biology: what
                            Medicinal Chemistry, Drug Design and Discoveryis It? Why Does it Matter?
 53   Rejected                                    Anomalous Results in Regulated Bioanalysis: Global Industry Standa
                            Analysis and Pharmaceutical Quality
 55   Rejected                                    Implementation of
                            Physical Pharmacy & Biopharmaceutics QbD for Functionally Coated Products
 57   Rejected                                    Role Quality
                            Analysis and Pharmaceuticalof Automation of Analytical Methdos in a Fast Paced Drug Deve
 58   Rejected                          & Engineering
                 Manufacturing Science Solubility Enhancement by Hot Melt Extrusion
 59   Rejected                         Pressure Sensitive Adhesives for Transdermal Drug Delivery
                 Formulation Design & Development
 60   Rejected                         Ion Suppression and Matrix Effect in Lc-MS/MS Methods: Do They S
                 Analysis and Pharmaceutical Quality
 61   Rejected                         Effect of Phospholipids on the Efficiency, Reproducibility, Accuracy a
                 Analysis and Pharmaceutical Quality
 63   Rejected                         Sig Natural Products
                 Medicinal Chemistry, Drug Design and Discovery
 64   Rejected                         Sig Natural Products
                 Medicinal Chemistry, Drug Design and Discovery
 65   Rejected                         Sig Natural Products
                 Medicinal Chemistry, Drug Design and Discovery
 67   Rejected   Other                 Sig Natural Products
 68   Rejected   Other                 Sig Natural Products
 69   Rejected   Other                 Sig Natural Products
 70   Rejected                          & Engineering
                 Manufacturing Science Geriatric Medicines: Managing Instead of Treating
 71   Rejected                         Alternate Approaches to the Quality Control of the Aerosol Particle S
                 Formulation Design & Development
 72   Rejected   Regulatory Sciences Pediatric Development Programs and Regulations
 73   Rejected   Regulatory Sciences Pediatrics in the Eu
 74   Rejected                         Manufacture
                 Formulation Design & Development and Characterization of Particulates for Pulmonary Dru
 75   Rejected                         Setting Acceptance Criteria for Non-clinical Formulation Analysis Usi
                 Analysis and Pharmaceutical Quality
 76   Rejected                         Bioavailability and Efficacy of Bioflavonoids: Drug Delivery Strategies
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
 77   Rejected                         Advances in Science and Technology for Oral Drug Delivery
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
 78   Rejected                         Physiological and Pharmacological Roles of the ABC Efflux
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
 79   Rejected                         Does Intranasal Administration Enhance Brain Distribution; Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and and what
 80   Rejected                         Human Csf Concentrations;
                 Clinical Pharmacology and Translational Research How Predictive Can We Get?
 83   Rejected                         Strategies for
                 Analysis and Pharmaceutical Quality Developing Rugged and Reliable Quantitative Bioanaly
 84   Rejected                         Inhalation Therapy as the Cornerstone of Asthma and Copd Disease
                 Formulation Design & Development
 86   Rejected                         Drug-Disease Interaction, a
                 Clinical Pharmacology and Translational Research Source of Therapeutic Failure and Inter-
 87   Rejected                         Bbb Transporter and Cns Drug Penetration
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
 89   Rejected   Other                 Pharmaceutical Sciences: Past, Present and Future: Part 1: Impact o
 90   Rejected   Other                 Pharmaceutical Sciences: Past, Present and Future: Part Ii: Pharma
 91   Rejected   Regulatory Sciences Challenges of the Pharmaceutical Globalization: Regulation, Drug Pr
100   Rejected                         Managing Excipient Functionality: Considerations and Case Studies
                 Formulation Design & Development
101   Rejected                         Formulation
                 Formulation Design & Development Considerations and Excipients Selection for Fixed-Dose
102   Rejected   Regulatory Sciences Risk Management Plans and Risk Minimization
103   Rejected   Regulatory Sciences QT Prolongation Regulations and Current Expectations
104   Rejected                         Capsules -Materials Requirements, Manufacturing Process, Applica
                 Formulation Design & Development
105   Rejected   Regulatory Sciences Global Clinical Trials
106   Rejected                         Impact of Starting Materials on Granulation Processes
                 Formulation Design & Development
107   Rejected                         Chronopharmaceutics: Optimizing Drug Therapy and Efficacy
                 Clinical Pharmacology and Translational Research
109   Rejected                         Aids: an Update Research
                 Clinical Pharmacology and Translationalon Successes and Challenges in the Treatment of t
110   Rejected                         Tools to Accurately Define
                 Clinical Pharmacology and Translational ResearchPK-PD Relationships for Cns Drugs Durin
111   Rejected                         Investigating
                 Analysis and Pharmaceutical QualityOos Spec and Aberrant Analytical Results
112   Rejected                         Developing and
                 Analysis and Pharmaceutical Quality Validating Stability Indicating Methods Based on Cur
113   Rejected                         Conducting Forced Degradationj Studies : Conceptual Framework an
                 Analysis and Pharmaceutical Quality
114   Rejected   Biotechnology         Recent Advances in Gene and Stem Cell Therapies for the Treatme
116   Rejected                         The Clinical and Preclinical
                 Medicinal Chemistry, Drug Design and Discovery Marine Pharmacology Pipeline
118   Rejected                         Analytical Methods Transfer of Pharmaceutical Products
                 Analysis and Pharmaceutical Quality
119   Rejected                         Essentials of
                 Analysis and Pharmaceutical Quality Computer-Assisted Drug Design
121   Rejected                          & Engineering
                 Manufacturing Science Role of Advanced Process Control (Apc) in Pharmaceutical Manufac
122   Rejected                         Controlled Colonic Drug Delivery of Mesalamine: Formulation and O
                 Formulation Design & Development
124   Rejected                         Excipient Composition
                 Formulation Design & Development
125   Rejected                         Formulation
                 Formulation Design & Development of Pediatric Medicines
127   Rejected   Other                 Future of Combination Drug Therapy
129   Rejected                         Drug-excipient
                 Formulation Design & Development Interactions in Small and Large Molecule Drug Develo
130   Rejected                         Cocrystals as
                 Formulation Design & Development a Formulation Strategy
131   Rejected                         Enhanced Nutraceutical and Food Additive Delivery Using Lipid-base
                 Formulation Design & Development
132   Rejected                         Global Perspective on Lipid-based Drug Delivery : Accomplishments
                 Formulation Design & Development
133   Rejected                         Drug Delivery Nanoparticles : Global Strategies to Bridge the Gap Be
                 Physical Pharmacy & Biopharmaceutics
135   Rejected                         Novel Targets for Drug Discovery that Industry is Reluctant to Discus
                 Medicinal Chemistry, Drug Design and Discovery
136   Rejected                         Molecular Imaging
                 Physical Pharmacy & Biopharmaceutics and Drug Discovery/development
138   Rejected   Medicinal Chemistry, Drug Design and Discovery
139   Rejected                         In Vitro – In Vivo
                 Physical Pharmacy & Biopharmaceutics Correlation (IVIVC) of Immediate Release and Mod
142   Rejected   Safety Sciences       Safety Aspects of Biotechnology Derived Proteins
145   Rejected                         Nanotechnologies
                 Physical Pharmacy & Biopharmaceutics and Skin: Safety and Benefits
146   Rejected                         Nanotechnology Based Dermatopharmaceuticals
                 Formulation Design & Development
147   Rejected                         Advanced Encapsulation Applications; Going Beyond the Basics
                 Formulation Design & Development
148   Rejected                         Disposition of Nanoparticulate Drug-Carriers
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
150   Rejected   Biotechnology         Novel Technology and Reagents to Advance Bioanalytical Methods f
151   Rejected                         Invitro-Invivo Correlation for Predicting Human PK
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
153   Rejected                         Use of the Disintegration Versus Dissolution as the Regulatory Test
                 Analysis and Pharmaceutical Quality
154   Rejected                         Global Approaches to Performance Qualification of Apparatus 1 and
                 Analysis and Pharmaceutical Quality
156   Rejected                         Practical Solutions for Global Conterfeit and Substandard Drugs
                 Analysis and Pharmaceutical Quality
157   Rejected                         Unlocking the Potential of Cardiovascular Pharmacogenomics
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
158   Rejected   Regulatory Sciences Active Ingrediants in Cosmetic Formulations
159   Rejected   Safety Sciences       Chemical Agents and the Skin
160   Rejected                         Development of Generic Transdermal Delivery Systems
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
161   Rejected                         Individualized Cancer Therapy. from the Margins to the Mainstream
                 Clinical Pharmacology and Translational Research
162   Rejected                         Effect of Ketoconazole and Ashwagandha Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drugon Intestinal Transport of
163   Rejected                         In Vitro Approaches for the Evaluation of Multiple Organ Metabolism
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
164   Rejected                         In Silico Model-Aided Drug
                 Medicinal Chemistry, Drug Design and Discovery Design: Hype or Hope?
165   Rejected                         Bioanalysis of
                 Analysis and Pharmaceutical Quality Small Molecules in Tissue Samples by Lc-MS/MS Sup
166   Rejected   Regulatory Sciences Demonstration of Bioequivalence for Locally Active and Non-System
167   Rejected   Regulatory Sciences Outsourcing Bioavailability and Bioequivalence Studies to Contract R
168   Rejected   Regulatory Sciences Bioequivalence of Dermatological Products – In Vitro Approaches
169   Rejected   Regulatory Sciences Bioequivalence of Dermatological Products – In Vivo Approaches
172   Rejected   Biotechnology         A Forensic Approach to ‗particulates‘ in Pharmaceutical and Biotech
173   Rejected                         Forensic Approaches to Pharmaceutical Issues: Techniques; Regula
                 Formulation Design & Development
174   Rejected                          & Engineering
                 Manufacturing Science Quality by Design (Qbd) and Relevant Process Analytical Technolog
175   Rejected                         D3I Sunrise Section: Managing the Discovery-Development Interface
                 Medicinal Chemistry, Drug Design and Discovery
176   Rejected                         Four Decades Discovery
                 Medicinal Chemistry, Drug Design andof Cancer Crusade: Metastasis = Death Sentence and
177   Rejected                         Novel Technologies for ADME Studies
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
178   Rejected                         Target-Specific Drug Delivery Systems – Out of the Laboratory and I
                 Physical Pharmacy & Biopharmaceutics
179   Rejected                         Novel Approaches
                 Physical Pharmacy & Biopharmaceutics to Improve Oral Absorption of Peptide and Protein
180   Rejected   Regulatory Sciences Regulatory Basics of Drug Master Files (Dmf)
181   Rejected   Regulatory Sciences FDA Globalization Act of 2009 and Regulatory Impact on Pharmacet
184   Rejected   Safety Sciences       Bioterrorism and Counterproliferation – what it Means for the Private
185   Rejected   Regulatory Sciences Ask the Regulators – CMC Issues
186   Rejected   Regulatory Sciences Early Phase Quality – Regulatory Perspectives
187   Rejected                         Challenge to Utilize Transporters for Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics,Advanced Cancer Chemotherap
188   Rejected                         Future Application of Peptide Transporter Pepts for Advanced Thera
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
189   Rejected                         Advances in
                 Formulation Design & Development Science and Technology for Oral Drug Delivery
190   Rejected                         Harmonization
                 Formulation Design & Development of Ba/be Standard for Oral Drug Products
192   Rejected                         Highly Variable
                 Formulation Design & Development Drugs & Drug Products in Oral Absorption: Scientific
193   Rejected                         Transporter-Targeted Oral Drug Delivery
                 Formulation Design & Development
194   Rejected                         Impact of Intestinal Metabolism on Bioavailability of Oral Medicines
                 Formulation Design & Development
195   Rejected                         Drug-drug Interactions in Oral Drug Absorption: Scientific Understan
                 Formulation Design & Development
197   Rejected                         Novel Approaches to Improve Oral Absorption of Macromolecular Dr
                 Formulation Design & Development
198   Rejected                         Challenges in
                 Formulation Design & Development Drug Delivery Across Membrane Barriers
199   Rejected                         Oral Controlled
                 Formulation Design & Development Release Technologies
200   Rejected                         Formulation
                 Formulation Design & Development Strategies for Poorly Soluble Drugs with the Aim of Enha
201   Rejected                         Polymer-Utilized Technologies that Control the Dynamics of Therape
                 Formulation Design & Development
202   Rejected                         Recent Progress in Pulmonary Drug Delivery
                 Formulation Design & Development
203   Rejected                         Recent Advances in Transdermal Delivery
                 Formulation Design & Development
204   Rejected                         Proteomics Absolute Quantifications of P450 and Transporters: the G
                 Clinical Pharmacology and Translational Research
205   Rejected                         Progressive Technologies for Crystal Engineering Applied to the Pha
                 Physical Pharmacy & Biopharmaceutics
207   Rejected   Biotechnology         Targeted Sequence Conversion: Toward Correction of Disease-Resp
208   Rejected   Biotechnology         Mitochondrial Drug Delivery Systems and their Therapeutic Applicati
210   Rejected                         New Horizon of Peptide Drugs
                 Medicinal Chemistry, Drug Design and Discovery
212   Rejected                         Transport
                 Pharmacology and Biochemistry Proteins -from Physiology to Drug Action
214   Rejected   Biotechnology         Recent Advances in Non-Viral Gene Delivery
215   Rejected   Biotechnology         Rnai-Based Therapies: Development of Novel siRNA Delivery Syste
216   Rejected   Biotechnology         Novel Approaches for Macromolecular Drug Delivery
217   Rejected                         Mathematical
                 Formulation Design & Development Modeling of Controlled Drug Delivery: from Takeru Hig
218   Rejected   Biotechnology         Development of Drug Delivery Systems Based on Nanotechnology
219   Rejected   Biotechnology         Recent Progress in Cell-Based Therapy
220   Rejected   Biotechnology         Drug Delivery Across Epithelial and Endothelial Barriers
221   Rejected   Biotechnology         Lipid Nanoparticulates for Optimized Drug Delivery
223   Rejected   Biotechnology         New Trends of Bioimaging
224   Rejected   Biotechnology         Development of Novel Polymeric Drug Delivery Systems
225   Rejected   Biotechnology         Development of Novel Biomaterials for Biomedical Applications
226   Rejected   Biotechnology         Recent Progress in Nanotechnology for Optimized Controlled Drug R
228   Rejected                         Transporter Qsars
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
229   Rejected                         Metabolomics
                 Analysis and Pharmaceutical Quality Analysis
230   Rejected                         Clinical Relevance of Drug Transporters to Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Pharmacokinetics, Effica
231   Rejected                         Nanotechnologies:
                 Physical Pharmacy & Biopharmaceutics Ultrasound Guided Drug Delivery
232   Rejected                         : New Issues in the
                 Physical Pharmacy & Biopharmaceutics Oral Administration of Poorly Available Drugs
233   Rejected                         How Effective Have Biomarkers Been When Integrated Into Clinical
                 Clinical Pharmacology and Translational Research
235   Rejected   Regulatory Sciences Co-Processed Excipients -Functionality Benefits and Regulatory Gu
236   Rejected   Regulatory Sciences Extension of Biowaivers: Emerging Tools and Methodology
237   Rejected                         Molecular Imaging: a Key Enabler to Pharmaceutical Drug Developm
                 Physical Pharmacy & Biopharmaceutics
238   Rejected                         Nanoparticle
                 Formulation Design & Development Dissolution and Absorption: Biopharmaceutics, Physica
240   Rejected                         Improving the Efficiency in
                 Clinical Pharmacology and Translational ResearchNew Drug Development Using Adaptive S
241   Rejected                         Optimal Sampling Using Winpopt
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
242   Rejected                         Cns Drug Delivery – Principles, Methods and New Findings
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
243   Rejected                         Csf as a Marker for Brain Drug Exposure Metabolism and
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug-Good or Bad? Transpo
244   Rejected                         PK-PD Modeling in Anti-Viral Drug Discovery and Development: from
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
245   Rejected                         Modeling and Simulation to Overcome Antibiotic Resistance
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
246   Rejected                         Biotechnology
                 Formulation Design & Development Product Development in Pre-Filled Syringes and Auto
247   Rejected                         Species Differences in Drug Transporter Expression and Function
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
248   Rejected                         Pharmacometric Research
                 Clinical Pharmacology and Translational Applications in Benefit-Risk Evaluation and Compa
249   Rejected                         "Proof of Concept"or "Hope
                 Clinical Pharmacology and Translational Research of Concept‖: How Can Phase II Be Impr
250   Rejected                         Introduction
                 Formulation Design & Developmentof Disposables in Manufacturing Facility: Challenges and
251   Rejected   Regulatory Sciences Scientific Advice: Eu Vs Usa
252   Rejected                         Model-based Development
                 Clinical Pharmacology and Translational Research of Japanese Bridging and Non-Bridging D
253   Rejected                         Translational Modeling and Simulation in Oncology Drug Developme
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
254   Rejected                         Bioequivalence Pharmacogenomics, Drug Metabolism and
                 Pharmacokinetics, Pharmacodynamics of Topical Dermatological Drug Products Transpo
255   Rejected   Regulatory Sciences Strategies for Minimizing Importation Delays During Global Developm
256   Rejected                         Generic Antiepileptic Drugs: Pharmacokinetic, Therapeutic Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism andEquivalen
257   Rejected   Regulatory Sciences Are There Potential Problems with Generic Antiepileptic Drugs?
258   Rejected                         Clinical Problems with Generic Antiepileptic Drugs: Myth or Reality?
                 Clinical Pharmacology and Translational Research
259   Rejected                         Why Generic
                 Formulation Design & Development Antiepileptic Drugs Not Acceptable?
260   Rejected   Regulatory Sciences The Expectations and Challenges of Implementing ICH Q10 Quality
261   Rejected   Regulatory Sciences Postapproval Management Plan –applying Science and Risk Based
262   Rejected   Safety Sciences       How Safe are Generic Drugs for Epilepsy
263   Rejected   Biotechnology         Micrornas are Strikingly Novel Tools for Biotech Drug Discovery
264   Rejected                         Microrna-Based Research
                 Clinical Pharmacology and TranslationalNovel Biomarkers
265   Rejected                         Micro-Rnas
                 Pharmacology and Biochemistry
266   Rejected                         Women's Health Research
                 Clinical Pharmacology and Translational Issues in Translational Research
267   Rejected                         The Metabolic Syndrome: Challenges in Understanding the Emergin
                 Clinical Pharmacology and Translational Research
268   Rejected                          & Pharmacovigilance
                 Pharmacoepidemology Pharmaceutical Challenges of Metabolic Syndrome
269   Rejected                         Neurosteroid-Based Drug
                 Medicinal Chemistry, Drug Design and Discovery Discovery and Development
270   Rejected   Biotechnology         Post Translational Modifications and their Impact on Aggregation, PK
271   Rejected                         Impact of Electrostatics on Manufacturing and Performance of Inhale
                 Formulation Design & Development
272   Rejected   Biotechnology         Comparability Exercises During Drug Development. Case Studies R
273   Rejected   Biotechnology         Reversible Self Association of Therapeutic Proteins, Mechanism, Me
274   Rejected   Biotechnology         Rational Development of Freeze-dried Protein Formulations for Biolo
275   Rejected   Biotechnology         Advances in Lyophilization Formulation and Process Development fo
276   Rejected                         Inhalation Therapy as the Cornerstone of Asthma and Copd Disease
                 Formulation Design & Development
277   Rejected   Biotechnology         Novel Technologies in Process Control and Product Quality Assessm
279   Rejected   Biotechnology         Visible Particles in Biologics: How Clear it is
280   Rejected                         Drug Studies
                 Formulation Design & Development Conducted in Environmental Exposure Chambers: a S
281   Rejected                         Translational Approaches in
                 Clinical Pharmacology and Translational Research Alzheimer‘s Disease
282   Rejected   Regulatory Sciences Stability Challenges for Novel Biologic Products
283   Rejected   Regulatory Sciences A Comparability Protocol to Cover all Changes
284   Rejected                         Nanomedicine
                 Formulation Design & Development -Potential and Challenges in Advanced Drug Delivery
285   Rejected                         Translational
                 Formulation Design & Development Pharmaceutics: Addressing the Increasing Challenge o
286   Rejected                         Innovation in Phase 1: the Impact of Ich3, Advent of Ecta and How T
                 Clinical Pharmacology and Translational Research
287   Rejected                         Advances in Stimuli-Responsive Polymers for Enhanced Drug Relea
                 Physical Pharmacy & Biopharmaceutics
288   Rejected   Regulatory Sciences Pharmaceutical Development for Abbreviated NDA
290   Rejected                         Protein Binding and Antimicrobials -an Ongoing Challange
                 Clinical Pharmacology and Translational Research
291   Rejected                         Protein Binding and Antimicrobials -an Ongoing Challange
                 Clinical Pharmacology and Translational Research
293   Rejected                         ―what is Your Trial Worth?‖
                 Clinical Pharmacology and Translational Research
294   Rejected                         Minimal Anticipated Biological Effects Level (Mabel) and FIH Dosing
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
296   Rejected                         Addressing Unmet Global Needs in Drug Development and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism for Pediatrics
297   Rejected                         Drug with Uncommon Metabolism Pathways: Challenges in Drug De
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
301   Rejected                           Ultrasound Assisted Processing of Pharmaceuticals
                 Manufacturing Science :& Engineering
303   Rejected   Regulatory Sciences Herbal Supplements – Myth or Reality?
304   Rejected                         Predicting and Optimizing Pre-Clinical/clinical Pharmacokinetics Usin
                 Physical Pharmacy & Biopharmaceutics
306   Rejected   Other                 Bioanalytical Techniques in Support of Oligonucleotides Therapeutic
307   Rejected                         Oligonucleotide-Base Therapeutics
                 Pharmacology and Biochemistry
308   Rejected   Biotechnology         Interference in Pharmacokinetic and Anti-Therapeutic Antibody Assa
309   Rejected   Biotechnology         ―the 21st Century Lba Lab: Where are We Now?‖
310   Rejected                          & Engineering
                 Manufacturing Science Advanced Pediatric Formulation: Can We Match Pediatric Needs an
311   Rejected                          & Engineering
                 Manufacturing Science Quality by Design (Qbd) Based on Biopharmaceutics: How Can We
312   Rejected   Other                 Innovations of Learning and Education in Pharmaceutical University
314   Rejected                         The Science and Art of Designing a Successful Clinical Study for Nu
                 Medicinal Chemistry, Drug Design and Discovery
315   Rejected                         Clinical Application of Genomic Biomarkers -How and When?
                 Clinical Pharmacology and Translational Research
316   Rejected                         Personalized Pharmacotherapy -Integrating Trials Into Clinical Appli
                 Clinical Pharmacology and Translational Research
317   Rejected                         Intranasal Product Development: Issues and Applications
                 Formulation Design & Development
318   Rejected                         Personalized Pharmacotherapy Based on Pharmacokinetics -Towar
                 Clinical Pharmacology and Translational Research
319   Rejected   Regulatory Sciences Cta Requirements for China Registration or Global Registration
321   Rejected   Regulatory Sciences Drug Substances Starting Materials – Regulatory Perspectives, Chal
322   Rejected   Regulatory Sciences Orphan Drug Development – Opportunities, Challenges, and Curren
324   Rejected   Regulatory Sciences Development and Regulatory Challenges for Drug-device Combinati
325   Rejected   Regulatory Sciences Immunogenicity of Biotherapeutics -Regulatory Challenges and Cur
326   Rejected                         Target Validation Techniques for Drug Discovery
                 Medicinal Chemistry, Drug Design and Discovery
328   Rejected   Regulatory Sciences Bioequivalence of Dermatological Products; In Vitro Approaches
329   Rejected   Regulatory Sciences Bioequivalence of Dermatological Products; In Vivo Approaches
330   Rejected                         Siliconization
                 Formulation Design & Development for Parenteral Products
331   Rejected   Biotechnology         Preservatives in Parenteral Products
332   Rejected   Regulatory Sciences Preservatives in Parenteral Products
333   Rejected                          & Engineering
                 Manufacturing Science Siliconization for Parenteral Products
334   Rejected   Biotechnology         Siliconization for Parenteral Products
335   Rejected   Regulatory Sciences Siliconization for Parenteral Products
337   Rejected                         Iviv Relationships
                 Physical Pharmacy & Biopharmaceutics for Poorly Soluble Compounds: Overcoming Chall
339   Rejected                         Interindividual Variation of the
                 Clinical Pharmacology and Translational Research Susceptibility to the Drug-Induced Tox
340   Rejected   Biotechnology         Analytical Characteriztion of Antibody-Drug Conjugates: the Challeng
341   Rejected   Regulatory Sciences Intellectual Property – Patent Law 101 for Pharmacists
342   Rejected   Regulatory Sciences Intellectual Property -Recent Updates from a Regulatory Perspective
343   Rejected   Regulatory Sciences Intellectual Property – Follow-on Biologics (Biosimilairs)
345   Rejected                         Applications of
                 Analysis and Pharmaceutical Quality Imaging Technology in Dosage Form Development
347   Rejected                         Intracellular Trafficking of Transporters: their Implications in Drug Dis
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
348   Rejected                         Transporters in Pharmacogenomics,
                 Pharmacokinetics, Pharmacodynamics Drug Adverse Effect Drug Metabolism and Transpo
349   Rejected                         Measurement
                 Analysis and Pharmaceutical Quality Science and Compendial Standards: is "Ultimate"harm
350   Rejected   Regulatory Sciences Establishing Efficient Regulatory and Science-Based Strategies for S
351   Rejected   Regulatory Sciences A Regulatory and Risk-based Evaluation Strategy for Defining Multi-S
352   Rejected   Regulatory Sciences Evolving Regulatory Landscape: Implications for Harmonizing Globa
354   Rejected   Regulatory Sciences The New World Health Organization Stability Guidelines
355   Rejected   Regulatory Sciences Emerging Markets: Regulatory Challenges and Considerations
358   Rejected   Biotechnology         Drug Efficacy and Clinical Utility of Pharmacogenetics and Pharmaco
359   Rejected                         Polymorphism in Drug Transporters and Drug Discovery
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
360   Rejected                         Shape Matters! Engineering Particle Shape to Enhance Targeted D
                 Formulation Design & Development
362   Rejected                         New Frontiers
                 Formulation Design & Development in Addressing Oral Bioavailability Challenges
364   Rejected                         Unwanted Immunogenicity of Biologics
                 Physical Pharmacy & Biopharmaceutics
365   Rejected                         Pharmacogenetics/pharmacogenomics of Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, DrugXenobiotic Transporters
366   Rejected                         Translation of Pharmacogenetics and Pharmacogenomics
                 Clinical Pharmacology and Translational Research
368   Rejected                         The Importance of PK/PD Modeling and Simulation to Facilitate the D
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
369   Rejected                         Impact of In Silico Prediction of ADME Properties of Drugs Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism andon the Dr
370   Rejected                         Role of Active Transport in the Intestinal Absorption of and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug MetabolismDrugs
372   Rejected                         Regulation of Expression of Drug Metabolizing Enzymes and Transp
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
374   Rejected                         Recent Progress in Transporters Responsible for Drug and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism Disposition a
375   Rejected                         Paradigm Shift Pharmacogenomics, Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamicsof Medical Treatment by Pharmacogenomics and its
376   Rejected                         Clinical Impact of Latest Molecular Diagnosis
                 Clinical Pharmacology and Translational Research
377   Rejected   Biotechnology         The Bag Story -Practice of Disposable Systems in Modern Biotech M
378   Rejected                         Individualized Medicine in Post-Genome Era
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
379   Rejected   Biotechnology         High Concentration Liquid Products of Monoclonal Antibodies and Th
380   Rejected                         Oral Delivery
                 Formulation Design & Development Systems for Potent Drugs
381   Rejected                          & Engineering
                 Manufacturing Science Oral Delivery Systems for Potent Drugs
382   Rejected                         Phase Separation in Amorphous Pharmaceuticals – Case Studies of
                 Formulation Design & Development
383   Rejected                         Molecular Imaging to Investigate the Pharmacokinetics and Drug Re
                 Clinical Pharmacology and Translational Research
384   Rejected                          & Engineering
                 Manufacturing Science Modelling Roller Compaction Using Mechanistic and Simulation Meth
386   Rejected   Biotechnology         Double Chamber Cartridges for Therapeutic Proteins – Double the T
387   Rejected                         Aspects to Consider in Designing Ester-Based Prodrugs
                 Physical Pharmacy & Biopharmaceutics
388   Rejected   Biotechnology         Subvisible Particulate Matter in Proteinaceous Products – an Update
389   Rejected                          & Pharmacovigilance
                 Pharmacoepidemology Bridging the Access Gap with Telepharmacy
390   Rejected                          & Engineering
                 Manufacturing Science Considerations for Designing and Manufacturing Liposomal Dosage
393   Rejected                         Inhaled Antibiotics and Antivirals – Topical Delivery of Potent Agents
                 Formulation Design & Development
394   Rejected                         Symposium Title:
                 Physical Pharmacy & Biopharmaceutics Physical State of Drug in Drug Products: its Import
395   Rejected                         Have the Strategies for Early Preformulation and Formulation Develo
                 Physical Pharmacy & Biopharmaceutics
396   Rejected                         Clinical Pharmacology of Drug Transporters in Toxicity and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Disease
397   Rejected                         Natural Products from Synthetic Biology
                 Medicinal Chemistry, Drug Design and Discovery
398   Rejected                         A Strategy for
                 Analysis and Pharmaceutical Quality Rapid Method Development for Content Uniformity an
399   Rejected   Regulatory Sciences Regulatory CMC and Supply Chain Challenges for Clinical Trials
400   Rejected                         Natural Plant Products for
                 Medicinal Chemistry, Drug Design and Discovery Cancer Targeted Drug Delivery
401   Rejected   Other                 The Value of Project Management from a CMC Development Perspe
402   Rejected                         siRNA: Challenges and Opportunities
                 Clinical Pharmacology and Translational Research
404   Rejected                         Label Free Methods for Biomarker and Biotherapeutics Quantificatio
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
405   Rejected                         Implementation Pharmacogenomics, Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics of Quantitative Model-based Drug Development in D
406   Rejected                         PK-PD Modeling Research
                 Clinical Pharmacology and Translational in Anti-Viral Drug Discovery and Development: from
407   Rejected   Biotechnology         State of the Art Approaches for Detection and Data Analysis of Immu
409   Rejected                         Parallelism in Ligand Binding Assay Validations for Use in Biomarker
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
410   Rejected                         Bayesian Modeling in Meta-Analysis: Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Getting the Variability Right
411   Rejected   Regulatory Sciences Current Development and Regulatory Considerations for Equivalenc
412   Rejected                         Clinical Relevance of Ethnic Difference in Genetic Polymorphism of
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and TranspoM
414   Rejected                         Regional Drug
                 Formulation Design & Development Absorption Studies -Indispensable Technique for Mo
415   Rejected                         Challenges of Biomarker Measurement in Clinical Samples
                 Clinical Pharmacology and Translational Research
416   Rejected                         Long Term Implant Drug Release: Effects of Formulations Excipient
                 Formulation Design & Development
417   Rejected                         Preservation
                 Formulation Design & Development of API -Battle of Drying Technologies
418   Rejected   Regulatory Sciences Challenges in Submitting Failed Be Studies
419   Rejected                         Mathematical
                 Formulation Design & Development Tools for QbD of Modified Release Products
420   Rejected   Regulatory Sciences Using In Vivo Drug Delivery Profiles for Assessment of Bioequivalen
421   Rejected                         Use of Ko Models to Explore Mechanisms Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drugof Drug Transporter Intera
422   Rejected                         Biosimilars: Practical Challenges to Establish Comparability
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
423   Rejected                         Quality by Design as Applied to the Development and Manufacturing
                 Formulation Design & Development
424   Rejected                          & Engineering
                 Manufacturing Science Preservatives in Parenteral Products
426   Rejected                         Successful Strategies for Formulation-Dependent PK/PD of BCS II –
                 Physical Pharmacy & Biopharmaceutics
427   Rejected                         QbD and Biopharmaceutics: Implementation Within a Risk Assessm
                 Physical Pharmacy & Biopharmaceutics
429   Rejected                          & Engineering
                 Manufacturing Science Continuous Processing in API Manufacturing
430   Rejected                          & Engineering
                 Manufacturing Science Particle Engineering in API Manufacturing
433   Rejected                         Clinical Applications of Pharmacogenetics
                 Clinical Pharmacology and Translational Research
434   Rejected                         Clinical Interactions Between Drugs and Herbal/traditional Medicines
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
435   Rejected                          & Engineering
                 Manufacturing Science Cgmp: a Quality Systems Approach for Apis
436   Rejected                         Pursuing the
                 Formulation Design & Development Ideal Tablet Dosage Form: Advances in Taste-Masking
437   Rejected                          & Engineering
                 Manufacturing Science Pursuing the Ideal Tablet Dosage Form: Advances in Taste-Masking
438   Rejected                         Phytochemical
                 Formulation Design & Development Analysis and Formulation Challenges of Ethnobotanic
439   Rejected                         The – Omics in Drug Development
                 Medicinal Chemistry, Drug Design and Discovery
440   Rejected                         Natural Plant Prodrugs for
                 Medicinal Chemistry, Drug Design and Discovery Organ Targeted Drug Delivery
442   Rejected                         Now I am Pregnant, How Much Medicine Should I Take?
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
443   Rejected                         Biomarker Program in Translatioanl and Drug Development
                 Clinical Pharmacology and Translational Research
444   Rejected                         Re-Energizing
                 Formulation Design & Development the API-Formulation Interface
445   Rejected                         Structure-and-Mechanism-based Computational Drug Design and D
                 Medicinal Chemistry, Drug Design and Discovery
447   Rejected                         Generics -what Do They Mean to me
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
448   Rejected                         Selecting the Right
                 Physical Pharmacy & Biopharmaceutics Biorelevant Dissolution Medium
449   Rejected                         Bioanalytical
                 Analysis and Pharmaceutical QualityMethod Development Uplc or Lc-Ms/ms???
450   Rejected                         Application of Bayesian Approaches in Drug Development and Healt
                 Clinical Pharmacology and Translational Research
451   Rejected                         Developing Compendial HPLC Practices
                 Analysis and Pharmaceutical Quality
452   Rejected                         Challenges in Site-Specific and Intracellular Drug Delivery
                 Physical Pharmacy & Biopharmaceutics
454   Rejected                         Pharmacogenomics -Illustration of Case Studies
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
455   Rejected                         Selection of
                 Formulation Design & DevelopmentSolubilized Drug Formulations for Enhanced Oral Absor
456   Rejected                         Practical Lc-MS/MS Method Development
                 Analysis and Pharmaceutical Quality
457   Rejected                         Computer Based Simulation of Oral Drug Absorption
                 Formulation Design & Development
458   Rejected   Regulatory Sciences Role of Quality-by-Design in Streamlining API and Drug Product Dev
459   Rejected   Regulatory Sciences Global CMC Submissions: Challenges and Opportunities with Small
460   Rejected   Regulatory Sciences Strategic Management of CMC Dossiers in Ectd Format II
461   Rejected                         Pediatric Formulation Development
                 Formulation Design & Development
463   Rejected                         Dissolution Testing, BCS, and Optimized Clinical Outcome: Building
                 Physical Pharmacy & Biopharmaceutics
464   Rejected   Regulatory Sciences 505(B)(2) Applications: Challenges, Opportunities, and Case Studies
465   Rejected                         Formulation
                 Formulation Design & Development Development for Preclinical Studies
466   Rejected   Regulatory Sciences Global CMC Regulatory Submissions: Understanding of a Changing
467   Rejected                         Ocular Therapeutics -Focusing Beyond Pharmacological Approache
                 Formulation Design & Development
468   Rejected                         Microdosing: a Novel Translational Research Tool for Mechanistic S
                 Clinical Pharmacology and Translational Research
469   Rejected                         Optimizing Biopharmaceutic Properties Through Modified Release (M
                 Physical Pharmacy & Biopharmaceutics
470   Rejected   Regulatory Sciences Generics: are They the Future of Pharma Industry?
471   Rejected                         Dissolution, Absorption and Bioavailabiltiy: Mechanistic Modeling and
                 Analysis and Pharmaceutical Quality
473   Rejected                         Complex Drug Interactions: Significance and Evaluation
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
474   Rejected                         Effect of Ketoconazole and Ashwagandha Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drugon Intestinal Transport of
475   Rejected                          & Engineering
                 Manufacturing Science Emerging Analytical Methods in Biologics Process Development
476   Rejected                         Clinical Laboratory Diagnostics for Pharmacists
                 Clinical Pharmacology and Translational Research
477   Rejected                         Drug Dosing in Patients with
                 Clinical Pharmacology and Translational Research Chronic Renal Disease
481   Rejected   Regulatory Sciences QbD Approaches to Managing Extractables and Leachables for Biop
482   Rejected                         Role of Transporters in Drug Safety
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
483   Rejected   Regulatory Sciences Unique Regulatory Challenges in Drug Development and Registratio
484   Rejected                         Accelerating Drug Discovery with Integrated PK/PD Approaches
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
485   Rejected                         How Reliable are Virtual Screening and De Novo Design for Drug Di
                 Medicinal Chemistry, Drug Design and Discovery
486   Rejected   Regulatory Sciences Boot Camp for Global Cmc/gmp Initiatives for Biotech and Specialty
487   Rejected                         Monoclonal
                 Formulation Design & DevelopmentAntibodies and Rational Design of Targeted Drug Delive
488   Rejected                         Adaptive Designs and Model-based Dose Selection
                 Clinical Pharmacology and Translational Research
489   Rejected   Regulatory Sciences Bootcamp for Cmc/gmp Initiatives for Biotech and Speciality Pharma
490   Rejected                         Progress and Challenges
                 Medicinal Chemistry, Drug Design and Discovery in Vaccine Design and Development
491   Rejected                         Computational Discovery
                 Medicinal Chemistry, Drug Design andApproaches to Protein Drug Discovery and Developm
492   Rejected                         How Can In Vitro Activity
                 Medicinal Chemistry, Drug Design and DiscoveryData Be Used to Predict the Corresponding
493   Rejected   Biotechnology         Immunogenicity Testing for Biotech Products
494   Rejected   Regulatory Sciences How Could We Achive a Single Harmonized Regulatory Guidance fo
495   Rejected                         In Vitro In Vivo Extrapolation of Drug-drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drugand Drug Transporter Inte
496   Rejected   Regulatory Sciences QbD 101: Systematic Drug Development Using Quality by Design Ap
497   Rejected                          & Pharmacovigilance
                 Pharmacoepidemology Writing Inspiring Publications
498   Rejected                         Stability of Therapeutic Proteins: Problems and Solutions
                 Formulation Design & Development
499   Rejected   Regulatory Sciences Internet Supported Self Regulation of Local Medicine Distributors in L
500   Rejected                         Regulation of Drug Transporter Expressions via Non-Nuclear Recep
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
502   Rejected                         Use of Imaging Surrogate Markers in Monitoring Therapy
                 Clinical Pharmacology and Translational Research
503   Rejected                         Hot Melt Extrusion
                 Formulation Design & Development
504   Rejected                         Personalized Imaging -Making Probes for Specific Genomic and Pro
                 Clinical Pharmacology and Translational Research
505   Rejected                         Recist to Percist -the Ct Measure of Tumors Versus Functional Res
                 Clinical Pharmacology and Translational Research
506   Rejected                         Neurologic Biomarkers -New
                 Clinical Pharmacology and Translational Research Imaging Agents for Detection of Neuro
507   Rejected                         The Explosion of Research
                 Clinical Pharmacology and Translational Imaging Probes and Platforms in Drug Developme
508   Rejected                         Non-Invasive Assessment of
                 Clinical Pharmacology and Translational Research Radiation Injury -Applications in Determ
509   Rejected                         Dual Modality Imaging Probes and Applications in Biologic Research
                 Clinical Pharmacology and Translational Research
510   Rejected                         Use of Amyloid Imaging Agents in the Monitoring of Alzheimer‘s The
                 Clinical Pharmacology and Translational Research
511   Rejected                         What Industry and the FDA
                 Clinical Pharmacology and Translational Research Need from Imaging and from the Imagin
512   Rejected                         Use of Pet in Monitoring of
                 Clinical Pharmacology and Translational ResearchCancer Therapy
513   Rejected                         Oral Drug Product Dosage Forms from High-Energy Drug Product In
                 Formulation Design & Development
514   Rejected                         PK/PD Modeling Research
                 Clinical Pharmacology and Translational Using Imaging Approaches
515   Rejected                         Drug-drug Interaction Between Small Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Molecule and Macromolecules
516   Rejected                         Qbd: Do you Really Know what it Is? an Industry, FDA, and Academ
                 Physical Pharmacy & Biopharmaceutics
517   Rejected                         Early Risk Assessment as a Tool for Drug Metabolism and Transpo
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics,Increased Success in Drug Dis
518   Rejected                         Stability Across Scale: Making Sure that Formulation Stability Remai
                 Formulation Design & Development
520   Rejected   Regulatory Sciences Bioequivalence in the Xxi Century
521   Rejected                         Effect of Digestion
                 Physical Pharmacy & Biopharmaceutics on the Performance of Oily and Surfactive Lipid F
522   Rejected                         Organic and Medicinal Chemistry Technologies for Drug Design -Im
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
523   Rejected                         Modeling and Simulations Where to Start and How to Build System
                 Clinical Pharmacology and Translational Research
524   Rejected                         Imaging Agents Pharmacogenomics,
                 Pharmacokinetics, Pharmacodynamics as Biomarker Tools Drug Metabolism and Transpo
525   Rejected   Biotechnology         Clinical Development of Plasmid DNA-Based Gene Therapies
526   Rejected                         Personalized Healthcare in a Global Setting – Opportunities for Impr
                 Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
527   Rejected                         Quantitation of Pharmacogenomics, Drug Metabolism and Transpo
                 Pharmacokinetics, PharmacodynamicsOligonucleotides: Contrasting Sample Extraction Diffe
528   Rejected   Regulatory Sciences Process Validation – Impact of the Revised Guidance on Current Ind
529   Rejected                         Developing Predictive In Vitro Dissolution/release Test Methods for D
                 Physical Pharmacy & Biopharmaceutics
531   Rejected   Other                 Inflammation and Stress Signaling
553   Rejected                         Therapeutic Equivalence of Modified Release Drug Products – Emer
                 Physical Pharmacy & Biopharmaceutics
554   Rejected                                     Soybean: Inducer or Inhibitor of Cytochrome P-450 with Commonly U
                              Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism and Transpo
556   Rejected                Other                Effect of Space Shuttle and International Space Station Environment
558   Rejected                Regulatory Sciences QbD and Clinically Relevant Dissolution Specifications -How Do We
560   Rejected                Regulatory Sciences Real Time Release Testing: is it the Real Deal?
561   Rejected                Regulatory Sciences Regulatory Challenges and Implications for Forecasting In Vivo Perfo
562   Rejected                Regulatory Sciences Navigating New Rules Regarding Patent Law in the us, Eu and Asia
563   Rejected                Regulatory Sciences Influence of QbD on Analytical Methods and Control Strategy Develo
543                           Clinical             Nanotechnology: Clinical Aspects
      Submitter/Organizer Approved Pharmacology and Translational Research
551                                                Marketing
      Successfully Submitted Pharmacology and Biochemistry Coordinator
567   Successfully Submitted Biotechnology         Translational Considerations for Development of Ultra-Potent Antibo
568                                                Gastric Retentive Dosage Forms: Reality or Dream?
      Successfully Submitted Formulation Design & Development
569                                                Dynamic Dissolution Testing
      Successfully Submitted Physical Pharmacy & Biopharmaceutics
571                                                Mechanistic Understanding of Phase Transition and Stability of Phar
      Successfully Submitted Physical Pharmacy & Biopharmaceutics
572                                                Comparability and Immunogenicity: Challenges Faced and Follow-o
      Successfully Submitted Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug Metabolism with Transpo
573                                                Oral Bioperformance and 21st Century Dissolution
      Successfully Submitted Physical Pharmacy & Biopharmaceutics
574                                                Fractional Calculus and Kinetics En Route Metabolism and Transpo
      Successfully Submitted Pharmacokinetics, Pharmacodynamics Pharmacogenomics, Drug to Biopharmaceutics and
575                                                Milk as a Novel Oral Drug Carrier
      Successfully Submitted Formulation Design & Development
576                                                Mitigating Risks
      Successfully Submitted Analysis and Pharmaceutical Quality In Global Drug Supply Chain: Opportunities for Mod
577                                                Globalization of Pharmaceutical Regulations In us, Eu and China
      Successfully Submitted Physical Pharmacy & Biopharmaceutics
578   Successfully Submitted Regulatory Sciences Technology Showcase-Ectd Submissions
579   Successfully Submitted Other                 Impact of the Pharmaceutical Sciences
581                                                Soft Gelatin
      Successfully Submitted Formulation Design & DevelopmentCapsules for Oral Drug Delivery
582                                                 & Engineering
      Successfully Submitted Manufacturing Science Real-Time Release: are We There Yet?
583   Successfully Submitted Biotechnology         Immunogenicity of Biologics: Current Practice and Future Outlook
584   Successfully Submitted Regulatory Sciences Regulatory Pathway for the Registration of Biosimilar Products In the
585                                                Commercialization Potential of Novel Drug Delivery Systems: a Battl
      Successfully Submitted Formulation Design & Development
586   Successfully Submitted Regulatory Sciences Do Current Bioequivalence Criteria Ensure the Therapeutic Equivale
587                                                Development
      Successfully Submitted Analysis and Pharmaceutical Quality and Regulatory Considerations for Preparing New Form
588   Successfully Submitted Regulatory Sciences Bioequivalence of Critical Dose Drugs
589   Successfully Submitted Manufacturing Science Building a Design Space for a Solid Oral Dosage Form Across Scale
                                                    & Engineering
590                                                Translational
      Successfully Submitted Formulation Design & Development Biopharmaceutics: Facilitating Drug Development from
591   Successfully Submitted Regulatory Sciences Product Value Estensions: what is In Store for the Future of the Phar
592   Successfully Submitted Regulatory Sciences Biosimilars: Where are We Heading In the New Healthcare Reform?
593   Successfully Submitted Regulatory Sciences FDA-NIH Partnership: to Boost Regulatory Science and Decision Ma
144   Withdrawn                                    Nanotechnologies
                              Physical Pharmacy & Biopharmaceutics to Combat Resistance
391   Withdrawn               Biotechnology        Pre-Existing Human Antibodies: Bioanalytical Challenges and Safet
544   Withdrawn                                    Ocular Drug Delivery
                              Physical Pharmacy & Biopharmaceutics
545   Withdrawn               Biotechnology        Cutting Edge in Vaccine Delivery
546   Withdrawn               Biotechnology        Biosimilars and Follow-on Biologics: A Global Perspective
547   Withdrawn                                    Lisa Combine Test
                              Physical Pharmacy & Biopharmaceutics
                                 Session                                                                   Organizer 1
  Session Description             Type                 Proposed Speakers                  Organizer 1       Affiliation
                             Short Course Dr. Catherine Tuleu (Deputy Director of Centre
Increased interest in the development of pediatric medicines is inspired by regulatory Lumfor Paediatric Pharmacy Research Sc
                                                                                                          Patheon Inc.
                                                                                     Susan incentives but formulating drug products fo
                             Mini-symposiumChemical Entities in pharmaceutical development
Recent estimates are that 40-50% of NewColin Poutin or Chris Porter (Australia) OR Downey pipelines have poor water solubility
                                                                                                           or Ping Pharmaceuticals Inc
                                                                                     Dawn David HaussPatheon Gao (US), Formulatio
                             Roundtable        Dissolution testing and it's relevanceHorst-Dieter FriedelBayer Schering Pharma calib
                                                                                       to product release:- Moheb Formulators rely
Dissolution of a solid dosage form constitutes one of the primary tests with a significant clinical relevance. Nasr ( FDA)USP on t
                             Short Course An integrated perspective on ICH Q8, Q9, guideline (Q9) were
                                                                                     Charanjeet and Q11:- Moheb NasrImplementing I
The Pharmaceutical Development guideline (Q8) and the Quality Risk Management Q10, Jassal Wyeth issued in 2005 for publ
                                                                                                          3 decades, from the
Although clinical drug development has evolved along with pharmaceutical sciences over the last Dalhousie University applicatio
                                                                                     Pollen Yeung
                             Symposium Christine Garnett, USA "Bone mineral density and fractures in post-menopausal wome
                             Sunrise provide Qingcheng Mao, PhD; USA; drug/xenobiotic dispositionplacental handling of drugs/
                                               1                                     of P-gp and BCRP in mediated by transporters a
This Sunrise School is designed to Session.a comprehensive overview of Role Takuya Fujita                 Ritsumeikan University, Facul
                             Symposium Dr. Validation Guidance by the US FDA inArnold numerous conferences Symposium
                                                                                     Mark 2001,           Bristol-Myers Squibb, Inc.
Since the release of the Bioanalytical MethodMark Arnold, US, Symposium chair, Introduction;Dr. Brian Booth, US, across the gl
                                                the Davies, Ph.D., USA, Unique Issues for Inhalation products;Diane Burgess, USA,
This symposium is submitted on behalf ofNealFIP Special Interest Group Dissolution/Drug Release. Dissolution testing is a very
                             Symposium                                               Horst-Dieter FriedelBayer Schering Pharma
                             medicines in a Industry Speaker; USA; a number ofStephen and Techniques to Detect Counterfietrevi
Developing and delivering Mini-symposium                                              significant challenges. This Symposium with Me
                                               global environment has Analytical Strategies Colgan Pfizer Global Research & Dev
                             Symposium Dr. drugs from commonly StatesRegulations, safety and pharmacovigilance;Dr. Silvia
                                                                                     Carmen Tamayo Foresight Links grow worldwid
An increased interest in developing botanical Carmen TamayoUnitedused traditional herbal remedies continues to Corporation
                             Symposium Dr. Ikhlas Khan, dietary supplements on of ChamblissDietary Supplements through Im
                                                                                     Walter Botanical University of are designed
The FDA established final regulations requiring cGMPs forUSA, "Managing Quality August 24, 2007. The rules Mississippi to e
                             Symposium Irving Wainer, USA, Immobilized receptor- and transporter-based liquid chromatograp
                                                                                     Jun Haginaka          pharmacological and biochem
This symposium is focusing on development and application of affinity-based media for analytical,Mukogawa Women's Universi
                             Roundtable        Daan Crommelin, Ph.D., Utrecht University, Li
                                                                                     the necessary mix of education and experience fo
                                                                                                          Evonik Degussa Corporation
Pharmaceutical industry experiences great difficulty in finding candidates with Jian-XinNetherlands, EU Perspective-Protein expe
                                               User input and the process in implementing USP general demonstrate and document
Analytical instruments are essential tools for the pharmaceutical industry and should be qualified to chapter <1058>Horacio Pap
                             Roundtable                                              Paul Smith           Perkin-Elmer
                    
In      Sunrise Session PEAKERS & TOPICS1.History andFabio phase (RP) chromatography has Inc.
                                                                                                          Algorithme Pharma shown to
INTRODUCTION
 the past few years, the use of high pH mobile phase in reverse Garofolo of the Use of High pH Mobile Pha
                                               S                                       Fundamentals
Traditional Medicines                          A                                     Zuguang Ye           Chinese Academy of Prof. Dr.
                             Sunrise Session sia: Dr. Michiho Ito, Graduate School of Pharm. Sci., Kyoto University USA: Medical
                             Symposium 1. of new chemical entities aspects of supersaturation and its application in drug disc
                                                                                      from either
Increasing complexity in molecular structure Overview of fundamental resultingPing Gao identification of complex molecular ta
                                                                                                          abbott
                             Symposium KEYNOTE SPEAKERS & TOPICS the pharmaceutical industryBioServices Inc Bioana
                                                                                     Stephen Lowes        Advion has Regulated
INTRODUCTIONThe implementation of Dried Blood Spot (DBS) Sampling in 1. Fit for Purpose Approaches to been receiving co
                             Mini-symposium Domitri tools that USA, applied Jean Surian in DrugAstraZeneca Pharmaceuticals
                                               Dr.                                   at different          Development-Past, With the
The goal of the session is to discuss various in silico Agrafiotis,can beComputational toolsstages of drug development.Present a
                                                 important BY of pharmaceutical (Univ Geneva) AND when the peptide groups were
1.Synthetic peptides and proteins were anPROPSEDpart TUDOR ARVINTE industry until 1990esSUBMITTED BY GT TUCKER

                             Symposium                                               Tudor Arvinte        University of Geneva
                             Short Course PROPSED BY incorporation of concepts fromDanhof Leiden ANDpharmacokinetics
                                                                                     Meindert physiologically-based GT
PKPD models become increasingly mechanistic with the JOHAN GABRIELSSON (AZ, Molndal, Sweden)UniversityTUCKER 1.S
Currently there are two, largely distinct, approaches to understanding variability in pharmacokinetic behaviour. Population PK att
                             Roundtable                                              Zealand)2.Amin Rostami-Hodjegan (Univ Sheffiel
                                               1.Nick Holford (Univ Auckland, New Geoff Tucker            Academic Unit of Clinical Phar
                             Symposium PROPOSED BY ANKE-HILSE MAITLAND VAN Maitland-van der of Utrecht, Netherlan
                                                                                     Anke-Hilse DER ZEE - Univ Zee
                                                                                                          areas. University
The aim of the session is to show state-of-the art pharmacogenetics in several important disease UtrechtFurthermore it will be s
                             Roundtable        PROPOSED BY ENRICO MASTROBATTISTA (Univ The Devish University GT TU
                                                                                     Camilla on peptides, proteins and DNA are Phar
Vaccine development is challenged by the fact that many new subunit vaccines based Foged Utrecht) SUBMITTED BYofpoorly
                             Mini-symposium    EMEA Speaker - Stella Blackburn (UK) and risk management and minimization plans
                                                                                     Carlos Langezaal TOPRA
This session will review recent legislative changes concerning pharmacovigilanceor alternatively UK MHRA speaker; FDA speak
                              used to enable the development of some novel drug delivery systems. This session Squibb Compan
New excipients have been Symposium Wendy Dulin; Chris Moreton; Umang Shah; Joe Reo Bristol-Myers seeks to discuss
                                                                                     Otilia Koo
                             Mini-symposium    FDA speaker - Justina Molzon or Michelle Limoli (US)EMEA or national sharing inform
                                                                                     Carlos Langezaal TOPRA
In this session, the US FDA, EU EMEA/national Health Authorities, and Japanese Health Authority procedures forHealth Authori
                             Symposium Professor Martin J Lohse, University and physiological processes. Biological Sciences,
                                                                                       of Würzburg,
Signal transduction pathways are central to the control of normal homeostasisGavin Brooks Würzburg, Germany (e-mail: lohse@
                                                                                                          School of Aberrations in these
                             Short Course Kim Huynh-Ba, United States                Manuel Zahn          3R Pharma play a pivotal role
This is a 1 day course provided by U.S. Pharmacopeia and the American Chemical Society. Stability programsConsulting GmbH
                             Symposium Bernhardt costs and improve Novartis-MIT manufacturing and quality of drug produc
                                                                                     Sharmista Chatterjee FDA
Pharmaceutical industrial has great needs to reduceL. Trout, Director at efficiencies of Center for Continuous Manufacturing USA
                                               PROPOSED BY WIM JISKOOT (Univ Utrecht) and In the latter,University
                                                                                                          Leiden these particles can be
Subvisible particles are critical quality attributes in parenterals, including protein therapeutics. HANNS-CHRISTIAN MAHLER (R
                             Roundtable                                              Wim Jiskoot
                             Symposium GEORGE R. GUNN, be classified by their effect on drug potencyResearch & Develop
                                                                                     George Gunn          Centocor as neutralizing or no
Anti-drug antibody (ADA) responses to protein therapeutics canIII, Centocor R&D, U.S.A.; DEBORAH FINCO, Pfizer, U.S.A.; ER
                             Symposium R. Scott Obach, first-pass metabolism. Although the small intestine CT). Considerati
                                                                                     Manthena Varma Pfizer Inc
Oral bioavailability is a function of intestinal absorption andPh D. & Manthena Varma, Ph D. (Pfizer Inc., Grotonis regarded as an
                             Roundtable        Moderator: Duxin SunSpeakers:Andrew C.Sun Eschenbach, MDFDA are generated
                                                                                     Duxin Won            University of Michigan
The emergence of nanotechnology have greatly impact the management of cancer. Various nanoparticles, which Nanotechnolog
                                               state of art information and Other Biomarkers in Oncology Drugin the Pharma and d
                                                                                                          Daiichi Discovery and Deve
                              scientists with ―Overview of Genomicsand perspective on the use of genomicsSankyodiscoveryDevel
To provide pharmaceuticalMini-symposium                                              Daniel Salazar
                                               PROPOSED towards individualised Christian an opposite situation of Vienna
                                                                                      therapy, Noe        University may G observed fo
While genotyping of the patient has opened up the wayBY CHRISTIAN NOE (Univ Vienna) AND SUBMITTED BYbe TUCKERPr
                             Mini-symposium
                             Symposium PROPOSED BY OLE BJERRUM (Univ Copenhagen) SUBMITTED BY LACDR
                                                                                      responsible for     top 3 of drug / G TUCKER1.
ADRs related to hepatotoxicity, blood dyscrasias and drug hypersensitivity are Nico Vermeulenthe VU Universitywithdrawals dueR
                             Mini-symposium    PROPOSED BY OLE the United States, an integrative and translational TUCKERTh
                                                                                     Ole Bjerrum          University of Copenhagen
In current drug safety education and training both in Europe andBJERRUM (Univ Copenhagen) SUBMITTED BY Gapproach is l
                             Sunrise Sessionenny Wang, USA: Development and validation of an immunoassay for and thereby
                                               J                                     Murli Krishna        Bristol-Myers Squibb
Pegylation of biological therapeutics has emerged as an effective tool to enhance their pharmakokinetic propertiesa pegylated a
                             Roundtable        David A. markers to predict treatment outcome. Within the Medicine, USA, Clinically
                                                                                     Lawrence FleckensteinUniversity of Iowa College Of P
Pharmacogenomics aims to use molecular geneticFlockhart. M.D., Ph.D., Indiana University School of past decade there has be
                             Symposium PROPOSED BY INGOLD and limitations of of Kiel) SUBMITTED BYBasel   University of GT TUCKER
•
The aim of the session is to outline the chances but also complexity CASCORBI (Univ application of personalized medicine in 

                                                                                     Urs Meyer                                        


                                                                                                                                      cli
An increasing number of drugs have beenPROPOSED BY SIBYLLE NEUHOFF (Simcyp Ltd, UK) Simcyp
                             Symposium                                                cell uptake and     AND SUBMITTED BY GT TUC
                                                 shown to undergo significant activeSibylle Neuhoff efflux in humans, prompting the im
                             Sunrise Session of its critical quality attributes and any deviation from the defined limits might affect t
                                               D                                     Prabu
Stability of a pharmaceutical product is one r. Prabu NambiarVertex Pharmaceuticals Nambiar               Vertex, Inc
                              how to use the   Leslie Z. of BCS and BDDCS and BCS.Shinji Yamashita; Japan; Risk factors
                                                                                     Leslie Benet         University of drug products. p
APSTJ proposed:ConsiderMini-symposiumconcept Benet; USA; BDDCS for the successful development of oral Californiain oralIn
                             Symposium Shinji to utilize the molecular imaging technologies (such as Positron Emission Tomo
                                                                                     Shinji Yamashita Setsunan University
APSTJ proposed:Discuss about the advantagesYamashita; Japan; Visualization of drug absorption processes by PET.Oliver Lan
                             Symposium EtsuogYonemochi; Japan; Application of IR forms is the imaging for granulation proces
                                                                     h               Etsuo and Raman Toho University
APSTJ proposed:The fundamental aspect of a •design space• for solid oral dosage Yonemochi understanding of performance
                             Mini-symposium    have been tested for clinical Southern Denmark, Denmark;Yoshikazu Nakamura, The
                                                                                     Shigeki Sasaki        will focus on current
Oligonucleotides of relatively short length Jesper Wengel, University ofuse. This mini-symposium Kyushu University status of
                             Mini-symposium    PROPOSED BY HEYO to function (Univ Giefswald), SUBMITTED Arndt TUCKERR
                                                                                     Heyo Kroemer         Ernst gene expression. In ad
Nuclear receptors (NR) are intracellular located receptors, known KROEMERas important modulators ofMoritzBY GTUniversity
                             Symposium Minoru Yoshida, of which seem to be Inhibitors as anti Japanese Foundation for Can
                                                                                     Takao Yamori         new anti cancer drugs. This T
Cell biology has revealed a number of mechansims, some Riken, Japan, HDAC suitable target forcancer drugs;Stephen Taylor, s
                                               ―Saving lifes with combined healthcare therapies address unmet needs in theregimen
                                                                                                           via optimizing dosing safe an
Significant challenges continue to face the global pharmaceutical and antimalarialindustry to (CAT)Novartis Pharmaceuticals Cor
                             Roundtable                                              Handan He
                                               Rupesh procedures Rodrigo developed Bryan product testing but there USA 

Regulatory guidance for the validation of analyticalAmin, Ph.D., has beenLaureano, Celgene Corporation, Summit, NJ, is no guida
                             Roundtable                                              Peter for drug       Celgene Corporation        ―Wh
                                                                                                                                     

                             Short Course is a critical component in the development of a biologic CONFARMA France SARL
                                                                                     Ralf Holzinger        detection and characterizatio
Assessment of process-related impurities 4. Ned Mozier, Pfizer (process-related) Host Cell Proteinproduct. Many specialized tec
                                           attendees on Maureen A. and methods for United States, Chair/Organizer; topics Bell, include na
                                                                                                Maureen McKenzieDenali BioTechnologies, Unit
            This session would updateSymposium new sources McKenzie, Ph.D.,drug discovery from nature. The RobertwouldPh.D.,Inc.
                                          Sunrise Session) Dr. Daan Cromelin, products the challenges Bhattacharjee
                                                         1                                      Himanshu of delivering these specialized agents
                                                                                                                     University of Tennessee
            With the advent of novel pharmaceutical and biopharmaceutical Top Institute Pharma, Netherlands2) Dr. Alex Biris, Chief scientih
                                          Symposium PROPOSED BY PETER efficiently. Peter mining is a key component TUCKER
a)Inn
                                                                                                Data York            Institute of Pharmacetuical S
            Industry is seeking strategies to develop new dosages forms more YORK (Univ Bradford); SUBMITTED BY GTin the pharmaceu              

                                                                                                                                                


                                                         ―Optimizing PK/PD and dosing in as well using combined therapies in to treatment o
            Pediatric drug development presents many unique challenges both globally,children as in the United States. Due thelimited PK/P
                                          Sunrise Session                                       Tycho Heimbach Novartis Pharmaceuticals Cor
                                          Symposium PROPOSED BY DR AMIT MISRA delivery is Okamoto Central Drug Res the Luckno
            A key requirement in the design of efficacious medicines for respiratory drug(Pharmaceutics Div, and particle size ofInst, drug pa
                                                                                                Hirokazu the form Meijo University
                                          Symposium PROPOSED BY PROF J ANWAR drug Bradford UK); SUBMITTED BY GT TUCKER

            The desire to optimize drug-receptor interactions is increasingly yielding new(Univ candidates thatUniversity of Bradford assoc
                                                                                                Jamshed Anwar         have poor solubility and
                                          Symposium Tatsuhiro Ishida; Japan; Immunological responses to PEGylated cationic liposome
                                                                                                Eva Moller           foods - is of important scientif
            Immunogenicity of biotechnology products - such as biopharmaceuticals and genetically modified University an Copenhagen enc
                                                         Moderator Dr. Based Approach initiative has encouraged pharmaceutical companies
            The Pharmaceutical cGMP‘s for the 21st century – A-RiskT.G. VenkateshwaranFDA Perspectives:Vertex, Inc
                                          Roundtable                                            Prabu Nambiar          Mr. Nick Buhay, Director, FDA
                                          Symposium Committed topics and speakers:Overview of roles in product quality in parenteral dru
                                                                                                Qiang Ye             Otonomy, Inc.
            Antimicrobial preservatives are widely used in parenteral drug products and play criticalcurrent preservative useand safety. While
                                                         Lei a screening (USA)-Things to potential in ―cocktail‖ approaches;
                                          been proposed asZhang, Ph.D.tool to assess the considerZhangvivo drug-drug FDA Hong-Hui Zhou, P
            The cocktail approach has Roundtable                                                Lillian of in        CDER, interaction. Due to its
                                          Mini-symposium in protein formulations is for excipients – FDA person?
 Buffers for Roche Ltd.
                                                         •
                                                             
•

            The number of excipients that can be used Regulatory considerationssomewhat limited. Technical F.Hoffmann-Laprotein formula
                                                                                                                     but
                                                                                                Hanns-Christian Mahleralso regulatory and toxicol
                                                         Eyal Barash, Esq., Aptuit, US;

            In pharmaceutical chemistry, the solid state form of a drug can make or 

                                          Roundtable                                                                  a Esq., candidate. What for
                                                                                          Jeffrey A. Lindeman, as McNeil Consumer HealthcareL
                                                                                         break Abbie Gentry Ph.D.,clinicalO‘Brien Jones, US;

                                                                                                 its development                                   

                                          Symposium       and Single-cell Dovichi (USA) Department a Chemistry highly accelerated
                                                                                                Tsutomu Masujima of University of Washington
            New technologies of Chemical Cytometry 1)Prof. Norman Mass Spectrometry will open of new age Hiroshima University analyses
                                          Symposium        assure the Raimar Loebenberg, U. Anthony Canada;1)Jennifer Dressman, Frankfurt,
                                                                                                Alberta, DeStefanoUS Pharmacopeia
            Private and public standards are critical toModerator - availability of pharmaceutically equivalent and bioequivalent interchangeab
                                                          pharmacogenomics will have a up for prime time Speaker: Grace Kuo, Skaggs Schoo
            The knowledge of pharmacogenetics and 1. Pharmacogenomics: Gearing significant impact on the practice of medicine and hea
                                          Mini-symposium                                        Okezie Aruoma        Touro College of Pharmacy
                                          Sunrise Session r. Lisbeth Illum, Consultant, United Lisbeth Illum Per Djupesland, delivery and knowl
                                                         D                                       Kingdom;Dr.         Critical Pharmaceuticals Limite
            Delivery of drugs to the central nervous system (CNS) remains a challenge, despite recent advances in drugOptinose, Norway;D
                                           be clinically Yuichi Sugiyama; in deleterious Japan;for patients. Our knowledge prediction of tran
                                                                                                R. Theoretical       Pfizer
            Drug-drug interactions canSymposium important and result Univ. of Tokyo,effectsScott Obach approach for theof drug metaboliz
                                                         Potential Speakers
determinants of the absorption, disposition, efficacy and toxicity o
                                                                               

1.
            Membrane transporters with multi-substrate specificity are key
 Herman Koepsell, Institute of Anatomy and Cell Biology, Julius
                                          Mini-symposium                                        Guofeng You          Rutgers-The State University o
                                          Symposium brain capillary endothelial cells, expresses variety of drug transporters and enzymes.
                                                                                                Jean-Michel Scherrmann
                                                                                                                     University Paris Descartes
            The blood-brain barrier (BBB), formed by Jean-Michel Scherrmann (INSERMS), France, Drug transporter and metabolic enzym
                                          Symposium 1. Dr. Richard Kim, School of Medicine, University are well controlled by membrane tra
            Now, it has been widely recognized that membrane permeability of many therapeutic agents of Western Ontario, "Clinical Pharm
                                                                                                Ikumi Tamai          Kanazawa University
                                          Symposium Diane R. Mould, USA, "Evaluation ofNick Holfordeffect on models to describe of status over time
                                                                                                                     University the effect of
            Disease progression analysis focuses on characterizing the influence of a drug structural the change in diseaseAuckland placeb
                                          the concepts of developing P450 genetic variations in prodrugwith enzymes suchof Speaker: Majid P
                                                         1                                      Lawrence design (35  University as P450 and ester
            This session will introduce Sunrise Session.The role of produrgs that require bioactivationFleckensteinminutes) Iowa College OfM
                                          in model development and interpretation. Beginner Saeho Chong often Seoul National Sweeden,
                                                                                                 modelers are         puzzled with various quantitat
            Model evaluation is critical Sunrise Session eter Bonate, USA "The art and science in model evaluation";Karlsson,University "Mo
                                                         P
                                          Symposium Topics/Possible Speakers: therapeutic drugs. With more than Identifying Degradation
                                                                                       


                                                                                        

            Biotechnology derived drugs have become a significant proportion of 
(1) Computational Approaches in 300 therapeutic agents
                                                                                                Pankaj Paranjpe Bristol-Myers Squibb Compan
                                          Mini-symposium being carcinogenic to humans because of Senior Research Fellow, Analytical Scie
                                                         for                                    Arya Jayatilaka      Pfizer, Inc.
            Genotoxic compounds have the potential Suggested Speakers:Bernard A. Olsen, Ph.D.their ability to induce genetic mutations a
                                                         for attrition of drug candidates (US) OverviewIn most Pfizerstudy designs and illustra
                                                                                                 industry. of non-clinical
            Lack of clinical efficacy is a major reason 1) Arnab Mukherjee or Jing Liuin theArnab Mukherjee cases these drug candidates we
                                          Roundtable
                                          Roundtable     Philip Oldfield, CRL, Canada, Risk-based evaluation a immunogenicity on therapeutic
                                                                                                Joleen White         Bristol-Myers Squibb
            Accurate concentration measurement of biologic therapeutics in complex biological matrices isof critical and highly regulated as
                                          Symposium 1.Tumor-targeted delivery of siRNA by non-viral tool and as and effective cancer thera
                                                                                                Majid Moridani       Texas Tech University Health
            small interfering RNA (siRNA) is gaining increasing popularity both as a molecular biology vector: safe a potential therapeutic age
                                          Symposium Dr. William L. Jorgensen (Professor,Chang-Guo Zhan ―Virtual screening modeling/sim
                                                                                                  Yale University), University of Kentucky
            The talks in this symposium give a brief overview of rational drug discovery through state-of-the-art computational and de novo d
                                          Roundtable     Acidic pharmaceutical excipients may lead to significant instability, Ph.D.Bristol-Myer
                                                                                                Ajit Narang          Bristol-Myers Squibb
            Drug interactions with the impurities in polymericcomponents of PVA-based coating dispersionsJohn Castoro,especially for low d
                                          Symposium Moderator:Dirk Teagarden, Pfizer, St.life of Das
                                                                                                   LouisSpeaker 1: ProcessSt. Louis
                                                                                                                       Drug of Freezing and Thawi
            Frozen storage is a popular and effective method to significantly improve shelfTapan bulk API andPfizer,Substance that are othe
                                          developing     Abi Smith, UK, Vision 2020 – The Right to Sight Global Initiative; Dexiang Chen, USA,
                                                                                                Adrian Raiche        SurModics Pharmaceuticals
            Prevalence of blindness in Symposium countries is three to ten times higher than in developed countries. Based on a WHO stud
                                          Symposium Christopher Gibson, Merck, U.S.A.Prediction of task in drug discovery that is Dept of to
                                                                                                Zheng Yang           Bristol-Myers Squibb critical M
            Predicting the human pharmacokinetic properties of new chemical entities is an important human pharmacokinetics using recom
                                          Sunrise Session wayne Class II) make up nearly one-third of Solid Dispersion Physical Inc.
                                                                                                                     pharmaceutical Stability;Geor
            Low-solubility, high-permeability compounds (BSC Friesen USA Amorphous Spray-Dried all active Bend Research,ingredients (A
                                                         D                                      David Vodak
                                          Roundtable     Simulating Dissolution and Absorption During factors that can GI TractAnette Müllertz
                                                                                                Lillian Zhang        CDER, FDA
            Solubility, dissolution and permeation of the gastrointestinal membrane are the notable Absorption in theinfluence oral drug abso
                                          Sunrise must as undisclosed, assumption Fractal kinetics and Nonlinear Dynamics in Pharmaceutic
                                                         1
            Perhaps the most fundamental, as Sessiona) Applications of Fractals,upon which pharmacokinetics, clinical hospital boston and p
                                                                                                Luis Pereira         childrens pharmacology / har
                                          Short Course TBD                                      Hideyoshi Harashima  Hokkaido University
            The session is covering very widely the main achievements obtained with nanotechnology for the targeted delivery of anticancer
            TBD                                          T
                                          Sunrise Session BD                                    Hiroyuki Arai        University of Tokyo
            TBD                                          T
                                          Sunrise Session BD                                    Wolfgang Sadee Ohio State University
            TBD                           Mini-symposium TBD                                    Takeshi Iwatsubo University of Tokyo
            TBD                           Mini-symposium TBD                                    Kiyoshi Tomioka Kyoto University
                                                                                                Prabu the safety Vertex, Inc
            New drug development is a complex process with the ultimate goal of demonstratingNambiar and efficacy of the drug in the in
                                          Mini-symposium TBD
                                          Roundtable     TBD                                    Tetsumi Irie         Kumamoto University
            The curriculum for the preparation of pharmacists is a dynamic means by which pharmacists are educated for various employm
            TBD                           Symposium TBD                                         Lawrence FleckensteinUniversity of Iowa College Of P
                                          Symposium TBD                                         Toshiyuki Sakaede Kyoto University
            This program will explore the interrelationship between basic research and clinical practice by examining two therapeutic areas,
                                          Symposium TBD                                         John reasonable Univ of Colorado
            Delivering Pharmaceuticals to emerging markets and underserved populations at a Carpenter cost is a goal of the Pharmaceut
                                          Symposium TBD                                         Cynthia Brown        Eli Lilly & Co.
            Several events over the past few years have highlighted the devastating impact on public health when sub-standard or adulterat
                                          Mini-symposium zz                                     Hideyoshi Harashima  Hokkaido University
            Although the ocular diseases are usually medicated by local drug administration, there are tissue barriers that preventing easy a
ccine Delivery                            Mini-symposium                                                             O
                                                                                                Shinsaku Nakagawa saka University
            The US Congress introduced several initiatives to secure legislation for a US biosimilar approval pathway. Biosimilars (BS) and
                                          Symposium TBD                                         Robert Bell          Drug & Biotechnology Develop
                                          Mini-symposium Hilde Boone, EMEA                      Carlos Langezaal TOPRA
            This session will provide you with the opportunity to gain insight into the intricate nature of the European regulatory system from
                                           history behind it, there Haddad, Ph.D., University of Montreal, Canada. "A Community-Based Collab
            With thousands of years ofSymposium Pierre S.is worldwide acknowledgement of the role of the traditional health practitioner
                                                                                                Mary Murray          Nutrilite Health Institute
            Drug development is a long, complex and1.

                                          Symposium                                              Cancer Institute     trials Phase 0 clinical have on
                                                             Patricia process. Novel compounds entering clinical Mitchell Pharmaceutical Cons
                                                          expensiveLaRusso, MD, Karmanos David Mitchell (USA) – are estimated to trials: An
                                          Mini-symposium Tetsuji Nishimura,Japan,PharmaceuticalNishimuraJapanProf. institute of health scie
                                                         Dr.                                    Tetsuji waste in National Bent Halling-Sorense
            In 1990s, several studies have reported the occurrence of pharmaceuticals and personal care products (PPCPs), as new enviro
                                          Mini-symposium PROPOSED metabolomics in the pharmaceutical industry and the potential TUCKER
                                                                                                Rima Kaddurah        SUBMITTED BY
            Goals and Objectives: 1. To understand the potential ofBY TOMAS HANKEMEIER (Uinv Leiden), Duke University GT for diagn
                               Roundtable       increase in exploratory technologies Narayan Cheruvuto Covidien Ltd
                                                                                       over the past 20 30 years. From drug discovery
Medical imaging has experienced a huge 1. Laura L. Boles Ponto, Ph.D.Associate ProfessorPET Imaging CenterUniversity of Io
                               Open Forum 1. BCS: Concepts and Application, Gordon intestinal permeability, BDDCS: widely us
The Biopharmaceutics Classification System (BCS), based on aqueous solubility andAmidon, Ph.D., USA; 2.has been Concepts
                               Open Forum 1. Proposal to Revise USP General Chapter Injections by Desmond G. Hunt, USP

Organized by:Vinay Radhakrishnan - PfizerBrian Rhodes - GSK_________________The quantification and characterization 
 s                2.A
                                                                                                                                       of
                               Open Forum being used in several different ways to excipients – FDA efforts and      
Criticality from an in
Excipient criticality is a new phrase that is Regulatory expectations with respect as we try to prioritizespeaker
 resources under
                                are availing Topic 1: 505-b-2 Regulatory Pathway approval of new products, particularly combinat
More and more companiesOpen Forum the filing category 505 (b) (2) for getting and strategies. Ruth E. Stevens, PhD, MBA, Ch
Ten years into the new millennium, the pharmaceutical industry, following the worldwide trend to leverage the advantages of dev
                               Open Forum TBD
Opening Remarks:
      
Start with a definitions.
 Open Source Model Development
 Mechanistic Systems Biology Models

                               Open Forum TBD       

                                                    •                                   
•                                         Existing
                                                                                                                                   

                                science has •
     Introduction, advancements. Ph.D., Roche
 A has been seen in multiple areas of
                                                                                                 

                                                                                                 •

Bioanalytics, like any otherOpen Forum seen its share ofSurendra Bansal, Excellent progresshistorical assessment of the develo
                               Open Forum Paul in vivo performance is an important it Can Help to Set Clinically Meaningful Spec
                                                                                      How Tammara         Merck
Correlating in vitro dissolution specifications to Dickinson, AstraZeneca, QbD: Vijay step towards achieving biowaivers and hence
                                                strategy to fight WIM JISKOOT (Leiden there SUBMITTED BY GT TUCKER
1.

1.Vaccination has been a very successful PROPOSED BYinfectious diseases. Still,Univ); is an increasing number of infectious d
                               Symposium                                                                                            

                                                                                                                                    

                                                                                                                                   
 Op
                               biotechnology Dr. Peter Richardson (EMEA / and supplied as new therapeutics for difficult-to-treat d
Past three decades, many Symposium products have been developedEU) perter.richardson@emea.europa.eu; Dr. Emily Sha
                               Symposium The European legislation - Huub biosimilar approval pathway. University; (BS) and
The US Congress introduced several initiatives to securePerspectivefor a USSchelekins, MD, PhD, Utrecht Biosimilars The US P
                               Symposium Hitoshi Sasaki; Japan; Ocular pharmacokinetic/pharmacodynamic posterior part ofthe
APSTJ proposed:Drug delivery to the retina and vitreous remains a challenge in ophthalmology because the modeling.Sarah F. H
                               Symposium PROPOSED BY ARTO administration); delivery systems (topical, local injection, impla
Ocular PK (barriers, compartments, models, transporters, sites ofURTTI (Univ Helsinki), SUBMITTED BY GT TUCKERSteve Ke
                               Symposium PROPOSED BY CAMILLA FIGED (Univ Copenhagen); SUBMITTED BY GT TUCKER
Vaccine development is challenged by the fact that many new subunit vaccines based on peptides, proteins and DNA are poorly
                               Mini-symposium   Elizabeth de Lange, The NetherlandsorMargareta Hammarlund-Udenaes, Sweden,Th
Background: The transition from the bench top to the bed site is often limited by the lack of robustness in predicting safety and e
                               traditionally Introduction: Chandan due to and Chitra Telang
1. large molecules coming out of co
                                                                                                   



Pharmaceutical APIs have Symposium been crystalline. HoweverBhugra the nature of insoluble Prof Marc Descamps: Driven Ma
                               to minimize Prof. K. Hapgood substance in early formulation development. While much informati
There is a continuing driveSymposium consumption of drug(Monash University), Australia, Scaleable strategies to reduce API u
                               Sunrise Session ickey of softgel technology and some Solutions, Conventional Softgel Technology: F
                                                R
This sunrise sesion will provide a basic overview Shelley, USA - Catalent Pharma of the technology's recent advances. As an ov
                               optimization Dr. Raafat Fahmy, USA - at full scale, the Formulation Factors pre-determined. It is
Many times when process Symposium studies are to be performedFDA, Influence offormulation has been and Process Paramet
                               Symposium Setting specification for genotoxic impurities:- A EMEA‘s guidances on genotoxic impu
A broad range of regulatory issues ranging from the FDA critical path initiative , FDA‘s andFDA perspectiveQualification of genot
                                                An Overview of Analytical Method Transfer
 K.Thomas, M.Sc.

                                                                                              

                                                                                              Saji                   Par
Transfer of analytical methods from R&D to QC/and testing facility is a major activity that takes place before 
 Pharmaceutica
                               Roundtable                                                                           commercialization o
                               Short Course Nick Holford, drug concentration, blood pressure) in Action pharmacology studies int
The translation from measurements of biomarkers (e.g.New Zealand, "Disease Progress, Drug clinical and Clinical Outcome"Yan
                               Poster/Podium Kaliappanadar formulation USA;NMR-2057: A Novel Lyophilized Paclitaxel Formulati
Abstract :Given the limitations of the current commercialNellaiappan;for paclitaxel (cremophor-ethanol formulation, Taxol®), we
                               Mini-symposium Jolyon Mitchel (Canada) Abbreviated Impactor Measurements –AIM; 

The Cascade Impactor Working Group of a)
International Pharmaceutical Aerosol Consortium on Regulation and
 Terrence T
                                                 the                                                                        b)

                                                                                                                            Science (IPA
                               Symposium Why are we primarily poor countries and one of the principal reasons is the lack of eff
Every day 35,000 people die from diseases that affect here today?Kishor Wasan, Faculty of Pharmaceutical Sciences, Universit
                               Roundtable       Bonnie a paper titled: Critical Ligand Binding Reagent Preparation/Selection: When S
In 2007 Bonnie Rup and Denise O'Hara co-wrote Rup, USA, TBD;Binodh DeSilva, USA, TBD
                               Symposium Dr Axel Zeitler (University of Cambridge, (a frequency of 1 THz equals a wavelength o
Over the last five years pharmaceutical research activities using terahertz radiationUK), Introduction to terahertz technology in p
                                of the challenging and controversial parameters in the production Covidien, USA, Title: Achieving ble
Blend uniformity is still oneSymposium Proposed Speakers: Narayan Kanikkannan, Ph.D., of solid dosage products. The hom
                                approximately eight chosen from will be selected from 2010 contributed abstracts in the topic/subto
This session will consist ofPoster/Podium To beposters which2010 submissions
                               Mini-symposium B. role in ensuring that Nordisk, Denmark, target site with high the delivery of pep
                                                L.
The method of drug delivery plays an importantKnudsen, PhD, Novo the drug reaches itsLipid modification forenough and sustai
                               Symposium         field for developing novel medicines. Introduction, challenges, with these novel comp
siRNA Therapeutics is a rapidly emerging 1. Prof. Saghir Akhtar; Kuwait; siRNA:There are huge prospects and general delivery la
Proposed Speech
     
         Symposium John L. Mattina, PH.D.Dr. John L. LaMattina ―It‘s easy to hate Big Pharma. After Pf
                                                                                              

                       ―Drug Truths – Dispelling the Myths About Pharmaceutical R&D‖
 was the former Senior Vice President,all,
                               Symposium Dr. Stuart L. Cantor, USA, CMC Submissions: Scientific and Common Sense Approac
The drug development process involves the generation of a great deal of technical and scientific information on both the drug su
                               Symposium Proposed Topics & limitations and opportunities studies in oncology: Do we need the
                                                                                 
a)
Goals and Objectives: To discuss and debate the challenges,Speakers: 
 Dedicated QTcin conducting thorough QTc studies o
                               Symposium N/A
Cancel this submission. Combined with FDD for short course.
                               Symposium 1 – ―Introduction to Bioanalytical Global Outsourcing: What Drives the Decision to Ou
INTRODUCTIONPharmaceutical and biotechnology companies continue facing unique challenges due to increased R&D costs,
                               Symposium Karsten Maeder (Germany)Gordon Amidon (MI, USA)Abu TM Serajuddin (NJ, USA)St
In this symposium, pharmaceutical principles and techniques to explain solubilization mechanism and phenomena of various po
                               Roundtable       1. Training requirement in a GMP environment - FDA speaker2. Key factors of trainin
Training program is mandatory in pharmaceutical analysis. Companies spend millions dollars annually to train their personnel o
                               Roundtable       Regulatory requirements for monitoring impurities in drug products existed for OTC dr
ICH has issued Q3 for assessing impurities for pharmaceutical drug products; however, there is no guideline - FDA speakersImp
                               Quality-by-Design concept, more samples for be required Metabolism Studies-Joe Short, Wyeth2.
To accommodate the new Symposium 1. Flexible automation toolsmayIn Vitro Drugto be analyzed in the Bioanalytical and ph
                               Symposium high energy solid materials for product. solid dispersions Dr. Lynne Taylor (Purdue Uni
Numerous challenges exist in developing 1. Crystallization of amorphous drug in A fundamental understanding of the physical s
                                                  PD modeling that constrain the ability of these models to predict have queried Richar
                                                                                              

                                                                                              


There are serious challenges in predictiveExperimental design for complex systems:
to be announced butbeyond the experime
                               Symposium
                               Sunrise Sessionennifer A. Doudna, which can regulate gene transcription and protein translation. The
                                                J
siRNAs and miRNAs are endogenous short segments of RNA UC Berkley, The basic science of siRNA and miRNA;Tamara Mink
                               Symposium Mats Bergstrom, USA, Presentation title: PET biomarkers to accelerate drug develop
It takes more than 12 years and costs more than 80 millions dollars to successfully develop a drug. To facilitate development of
                               Roundtable       Dr. Dirk Barends (The Netherlands) Overview of Bioequivalence regulations in the "Big
Currently the regulations concerning bioequivalence vary with the jurisdiction. This applies to the requirements for studies in hum
                               Mini-symposium   Michniak-Kohn, B. (US) A novel skin equivalent model for permeability testing; person
This session will discuss the alternatives to testing of topical and transdermal pharmaceuticals as well as cosmetics and Batheja
                               pharmaceuticals to under-served populations Testing, Regulatory Acceptance, understandings of the
Developing and delivering Symposium Comparison of Manufacturing, and countries requires significant and Supplies to Under
                               Symposium Dr. Robert Temple return of investment stays low, a new trend is repurposing the clin
As the attrition rate in pharmaceutical R&D remains high and from FDA, USA and his title: Regulatory requirements fromand rep
                               Short Course Organizers, Steven was approved by the FDA in 1979. The intervening 31 years year
The first specifically designed transdermal drug delivery patchA Giannos and Kenneth A Walters;Kenneth A Walters, UK, 35 have
                               Sunrise Session r. Hae of diseases provides opportunities for the development of novel therapeutic p
                                                D
The emerging understanding on the genetic basis Young Ahn, FDA, USA, presentation title: Regulatory pathway fordrugs to treat
                               Symposium 1.
         ―gender-based biology,‖ which was later modified to ―sex-based biology,‖ to refer to
In 1995, Florence Haseltine coined the term Wolfgang Sadée, Chair, Dept of Pharmacology, Director, Program in Pharmacogeno
                               Symposium KEYNOTE focus of worldwide regulatory agencies from the European Pharmaceutica
INTRODUCTIONThere has been a recent increased SPEAKERS & TOPICS1. Case Studies such as US FDA, Health Canada, E
                               Symposium Lawrence Yu, Ph.D., Food extended-release (ER) drug products, where the rate is str
Polymeric coating is often used to modulate the drug release rate forand Drug Administration, US,Understanding the impact of c
                               Symposium Dr Saranjit singhNIPR, IndiaKevin BynumBI, USA
To lower rising healthcare costs pharamaceutical industry is doing everything it can to control the cost of good. One major aspec
                             Symposium Costas Gogos, Ph.D.,New plastics industry Technology, US, HME as a Mature Manu
Hot-melt extrusion (HME) has been a widely applied technique in theJersey Institute ofand has matured to be a viable method to
                              most critical quality attribute speakers are: drug delivery system that assures desired drug delivery b
                                              The
Skin adhesion is by far theMini-symposium proposedof transdermal 1) Mr. Tim MitchellDow Corning CorporationEmail: timoth
INTRODUCTION
       The                       SPEAKERS/PANELISTS FDA Guidance suppression and matrix Validation make refe
                   
 2007 Crystal City white paper, as well as the& TOPICS1.Ion on Bioanalytical Method effect: Do we need f
                             Roundtable
                             Symposium SPEAKERS & TOPICS1.Efficiency, Reproducibility, Accuracy and acid, connected via
INTRODUCTIONPhospholipids are a class of lipids, which compose of a polar group and a pair of non-fatty Linearity Evaluation
                             Symposium Asia: Prof. Dr. Satoshi Omura, Kitasato University / Prof. Jinwoong Kim, Korea USA: P
Natural Products-based Medicines
                              as Drug Candidates
Bioactive Natural ProductsSymposium Asia: Prof. Dr. Motomasa Kobayashi, Graduate School of Pharm. Sci., Osaka Univers
                             Symposium Asia: Prof. Dr. Kozo
Synthesis of Natural Products and Their Related Compounds Shishido, Graduate School of Pharm. Sci., Tokushima University
                             Symposium          (CAM) & Dr. Haruki Yamada, Kitasato Institute for Life Sciences
Complimentary and Alternative MedicinesAsia: Prof.Self Medication
                             Symposium Kailash C. Upadhyaya, India / Prof. Michiho Ito, Kyoto University, Japan USA: Prof. Dr
Plant & Microbial Biotechnology
                             Symposium Asia: Prof. Dr. Yutaka Ebizuka, The University of Tokyo USA: Dr. Sheo B. Singh, Stev
Biosynthesis of Natural Products
                             Symposium Challenges with elderly are facing and medication management and the from ¡°ear
Goals and Objectives: 1.Provide the insight into the issuesmedicinal productswith managing their medicationof elderlyresulting no
                             Symposium          Group has been Canada, several aspects of cascade impactor (AIM);Terrence P. To
The IPAC-RS Cascade Impactor WorkingJolyon P. Mitchell,exploring Abbreviated Impactor Measurements measurements of the
                             brief update/overview on the regulations concerning pediatric Nathalie in the European Union (EU)
This session will provide a Symposium EMEA speaker either Agnes Saint Raymond orprogramsSeigneuret (UK);FDA speakea
                             Sunrise Session   Pediatric development programs and regulations - This Seigneuret (UK)
Session linked with proposed symposium EMEA Speaker either Agnes Saint Raymond or Nathaliesession will provide an update
                             Mini-symposium lives of millions of States, Novel Particulates for Advanced Pulmonary Inhalation A
                                               the
Pulmonary drug delivery has been saving Heidi Mansour, United asthmatics every day. From its early inception of inhaled powde
In support of non-clinical development (NCD) studies (non-GLP and GLP), the concentration, stability and homogeneity of the te
                             Symposium Proposed Speaker: Monica Whitmire, MPI Research.Setting analytical method develo
                              of Flavonoids: Drug Delivery StrategiesOrganizer: Marilyn Morris. Moderators: Marilyn Morris, Tony
Bioavailability and EfficacySymposium 1)Methylation and other chemical modifications to increase bioavailability and efficacy
                             Symposium Peter limit oral absorption, Current understanding of the intestinal absorption barrier.J
APSTJ proposed:There are various factors that Langguth;;Germany; including stability, solubility and permeability. However, we
                             Symposium        of the ABC Efflux Transporter ABCG2Organizer: Marilyn ABCG2. This talk will provide
Physiological and Pharmacological Roles Proposed topics and speakers1.Physiological function of Morris, University at BuffaloB
               

               In                             •
  interest on the use of the intranasal route of increased rapidly. The intranasal route
Background:
 the last couple of years thePhysiological and pharmacological aspectshasnasal administration of opioids. Ola Da
                             Roundtable
                                              •
 Physiologically-based PK model on prediction of extracellular fluid (brain ECF), often
Background:In the clinical setting, the possibility of direct measurement of free drug in brain brain ECF and CSF relationships fo
                             Roundtable
                             Short Course SPEAKERS & TOPICS
 Understanding support of Bioavailability, Bioequivalence, P
                                                                         
1.

INTRODUCTIONThe ability to develop a rugged and reliable bioanalytical method inthe Limitations and the Parameters that Effe
                             Mini-symposium   Speaker: (COPD) are Ph.D., University of Arizona;Country of Origin: USA;Topic # 1: R
Asthma and chronic obstructive pulmonary disease Paul Myrdal, obstructive lung diseases with significant implications for public
                             Symposium Fakhreddin more than one of Pharmacy example, rheumatoid arthritis University of A
Background & Rational. Patients are often treated for Jamali: Faculty condition. Forand Pharmaceutical Sciences. (RA) is often a
                             Mini-symposium Yuichi Sugiyama, Ph.D., barrier has been very important in drug discovery and de
                                              Dr.
Overcoming the challenges of delivery of drugs across the blood-brainDrug concentration in the cerebrospinal fluid and the unbo
                             Roundtable         Science has impacted various aspects of drug discovery, development and delivery th
Over last quarter century, PharmaceuticalSession Chair: Mario Rocci or Vinod P. ShahSpeakers: Leung Fong or Les BenetGeof
                                              Session Chair: Daan Crommelin
       

                                                                                   Speakers: in 2020‘. ThisMalcolm participants
                                                                                                          

FIP/BPS had launched a process to develop a view on ‗The Pharmaceutical Sciences Victoria Hale
includedRowland
 from
                             Roundtable                                                                                       
Speaker
                             Symposium Pharmaceutical globalization and related challenges: lead it, follow hearings held and
Pharmaceutical and biotech industries are experiencing challenges from globalization. Recent congressional it or oppose it, on M
                              of risks assessments and quality by design, there is anon Correlation Between Excipient Material Pro
In the current environment Roundtable         Larry Block, Introduction: Case Studies increasing need to conduct functionality chara
                             Symposium Otilia enhance understanding into the selection and formulation requirements, produ
The objective of this proposed symposium is to Koo, Formulation and excipients regulatoryfor fixed-dose combination drugas we
                             Short Course EMEA Speaker Stella Blackburn risk or alternatively UK and risk minimization, but w
This short course (4 hours) is associated with a proposed -mini symposia on (UK)management plans MHRA speaker; FDA speak
                              some non-antiarrhythmic drugs is their ability to TBD
                                              F
An undesirable property of Sunrise Session DA speaker from IRT team (US)delay cardiac repolarization. This session will briefly
                             Mini-symposium   L'Hote-Gaston, Jennifer, New materials and Processes for capsules. Capsules; Denn
This mini-symposium is focused on the materials and new developments in manufacturing hard shellHard Shell Besides oral del
                             Mini-symposium   Industry speaker in Regulatory and Asia to conduct clinical trials. Trials (TBD); a poin
This session will briefly present the current regulations in the US, EuropeAffairs involved with Global Clinical Subsequently Indus
                             compaction remain the most popular processes characterize starting materialsfor tableting. In this min
Wet granulation and roller Mini-symposium     Jerry Heng, New technologies to to improve powder properties for granulation; Otilia K
                             Mini-symposium   Franz combining the Time, Diagnostics and Therapeutics; recent C. Youan, USA, Ov
Chronopharmaceutics is an emerging discipline Halberg, USA, traditional goal of pharmaceutics withBi-Botti advances time bas
                             Symposium Proposed Chairs - Reina Bendayan and Jash Unadkat;Proposed Speaker 1King Holm
HIV infection and AIDS remain a global challenge. With almost 40 Million people infected with HIV, it is one of the most devasta
                             Roundtable       Ross Bullock, Virginia Commonwealth are needed in drug development to aid in ident
Background:Accurate pharmacokinetic-pharmacodynamic (PK-PD) relationshipsUniversity,USA. Microdialysis as a tool to incre
                             Sunrise Inc decision, OOS has PharmaceuticalFrank cGMP compliance. When stability testing reve
After the FDA vs Barr laboratories, Session aji ThomasPar been a cornerstone of Diana End
                                              S
                             Sunrise Session haranjeet JassalWyeth pharamaceuticalSaji ThomasPar Pharmaceutical
                                              C
Validation of analytcial methods have eveolved over time with the guidance issued by ICHand FDA. The approach to validation h
                             Short Course Dr. Tarik Veysoglu, PresidentAntioch Analytical the regulatory requirements

                                                 

                                                 

Content of the Forced Degradation course
The topics will include:

 The evolution of IncorporatedPharmaceutical 
 The ev
                                                  
                          

                                                                            
1.                                               2.
                                                                                                                              Consulting
                             Symposium Professor Robert A Brodsky, successful of Hematology, Johns number of prominen
Both gene and stem cell therapies represent significant promise for theMD. Divisiontreatment and cure of aHopkins Hospital, Ma
                             Symposium Proposed SpeakersChair (same as speaker # 4)Alejandro M.S. was approved in late
There are currently two FDA-approved marine-derived pharmaceutical agents: Ziconotide (Prialt®) which Mayer, Ph.D., Departm
                             is provided by Kim Huynh-Ba, United States
This one day short course Short Course U.S. Pharmacopeia and the American Chemical Society.Analytical methods are a majo
                             Short Course J. Phillip Chemical Society.This course will be especially valuable to both industrial an
This is a two day course provided by the American Bowen, United States; Alexander Tropsha, United States; Osman Güner, Un
                             Mini-symposium   which involves taking TBD; Dora the data generated Title TBD; Steve control and o
The next stage of PAT is process control, David Lovett, UK, Titleadvantage ofKourti, GSK in USA, from PAT tools, to Hammond, P
                             Poster/Podium Dr. and optimize a controlled release colon targeted drug delivery system for Mesalam
The purpose of this research was to develop Jayvadan PatelProfessor of Pharmaceutics and Principal, Nootan Pharmacy Colle
                             Sunrise Session hris Moreton; USA; Excipient composition
                                              C
Excipients are a key part of most drug delivery systems (formulations). They are a key component of any Design Space. Variabi
                             Roundtable       Chris Moreton; USA; Introduction recent years with the introduction of UK; Differences
The formulation of pediatric medicines has assumed greater significance in and ModeratorA Rostami-Hodjegan; regulatory incen
                             Symposium Dr. in the Sayeed, Director of Chemistry II, Office of Generic molecule from the drug
Currently, the majority of medicines available Vilayatmarket contain a single drug entity. Every new drugDrug, FDA, USA, ―Disco
                             Symposium         studies and method development in the area of drug-excipient interactions. This is an
This symposium will highlight recent case Lynne Taylor,US, Drug-excipient interactions involving small molecules; David Volkin, U
                                              1. 
 Topic Cocrystals- structure and differentiation from eutectic mixtures times. Micr
The number of poorly water-soluble candidates in pharmaceutical drug discovery has been on the rise in the recentand complex
                             Roundtable
                             attracted much interest in recent years Delivery Platforms pharmaceutical and food industries Casali
Lipid-based systems have Symposium 1.Nano-architextures as across the biotech, for Nutraceuticals, Dr. Nissim Garti, along
                             Roundtable       1.Oral lipid-based have been marketed over soluble small molecules: How we Mark
Delivery-enhanced drug products using lipid-based systems delivery systems for poorlythe course of the last two decades.can in
                             Roundtable       1.Cyclodextrin-Based Polymeric of nanoparticle Dr. Mark E. Davis, Division of Chemis
There have been significant advances in the development and application Nanoparticles, technologies for drug formulation and
                             Sunrise Session oderatorDuxin Sun, PhD;Speakers:Mark O¡¯Donnell, MDHarvard Cancer Center at
                                              M
Many novel targets that are extensively studied for new drug discovery. Many pharmaceutical companies have spent tremendou
                             Mini-symposium   Jean Luc Vanderheyden; U.K.; Development of new molecular markers and sophistica
Molecular imaging is an emerging technology that utilizes corresponding imaging agents (molecular probes) to visualize specific
              
We            Poster/Podium Clarina 1-methyl-3-phenylpyrrole analogues and Evaluation of N-methyl-2-phenylmal
Introduction
 have recently demonstrated that Manley-King; Sierra Leone;Synthesisare moderately potent competitive inhibito
In Vitro – In Vivo Correlation (IVIVC) requires an understanding of the formulation, critical manufacturing parameters, dissolution
                             Symposium James Polli, USA, IVIVC for Immediate Release Products (University of Maryland); Sr
                             Symposium PROPOSED BY OLE BJERRUM (Univ Copenhagen) new biologic BY G TUCKER1.S
The share of biologics among new registered drugs is steadily increasing. The safety aspects ofSUBMITTED entities (NBE‘s) du
                             Symposium PROPOSED titanium and zinc oxides used as UV filter and (Univ Paris) SUBMITTED
1.Recently, the safety of mineral nanoparticles such as BY ELIAS FATTAL AND PATRICK COUVREURother nanotechnologies w
                             Symposium Moderator/Organizer
 S.N.Murthy, USA
Speakers
 Bo number USA; anotechn
                                                                   
1.

BackgroundFocus on nanotechnology based dermatological products has increased
 recent years. AMichniak;of therapeutic an
                                                                                       


                                                                                        in           
1.

Summary
     The             this ―short course‖ Lightfoot, USA, Novel Approaches in Dosage recent trends related to encapsulat
            
 purpose of Short Course Donis to bring formulators up-to-date with the mostForm Design;Dennis Murachanian,
                             Symposium ―Particulate Drug-Carriers: Then known about the factors that Director, Division Head
Nanoparticulate drug-carriers have great clinical potential, however, little isand Now‖ Marcel Bally, Ph.D.,mediate their dispositio
New technology
    The       Sunrise Session urli Krishna, USA: Comparative of a family data to quantify an adnectin using prob
                  
 atomic force microscope or AFM is a versatile memberbioanalyticalof microscopes known as scanning antib
                                              M
                             Short Course Parnali Chatterjee;USA;InVitro-Invivo Correlation for Predicting Human cover areas in
This short course will highlight current methodology available in the industry to predict human PK. The course willPK
                             Symposium An Disintegration as a test stage explaining how importance until the BCS be justifie
This symposium will first present an overviewFDA Speaker will set thethat was diminished in a disintegration test could class 1 IC
                             Roundtable       An FDA use of mechanical the ASTM of dissolution apparatus 1 Procedure guidance
In October 2007 FDA issued draft guidance on theand/or an author of calibration document on the Standardand 2. The for Quali
                             Symposium 1.) Aline Franco, Interpol, France - an threat to global Impact of counterfeiting a the g
Counterfeiting and substandard drug products in global commerce representScope, Extent, and public health. There are in num
                              pharmacogenomicsR. Shuldiner, M.D. University of Maryland, USA, Pharmacogenomicsoptimize the
The goal of cardiovascularRoundtable          Alan is to guide cardiovascular drug development and selection so as to of Anti-plate
                             Mini-symposium   Karen Burke:USA:Antioxidants and nutrients in skin moisturizers -- do they be of majo
Regulatoiry issues surrounding "cosmeceuticals" would be a major topic for presentation and discussion. This would work?Bo M
                             Mini-symposium   Robert greatest exposure is the overview of is a need for a viable and standardized m
In a chemical attack the organ likely to suffer the Chilcott:UK:An historical skin. There chemical warfare agents and the skin.Boz
                             systems were Gary Cleary, USA, marketed commercially in the early 1980s. Since Handy, USA, Rol
Transdermal drug delivery Symposium developed and first Formulation and Manufacturing Challenges;Chris then, a number o
                             Symposium Scott A. Waldman, terms of Thomas Jefferson University, USA, Therapeutic burden
Individuals respond differently to anticancer therapies, both inMD, PhD,benefits and adverse effects. Important factors that contr
                             Poster/Podium Speaker's Name: Sharvan Kumar YamsaniCountry: IndiaTitle: Effect of ketoconazole
Purpose: To investigate the effect of P-glycoprotein (P-gp), an efflux transporter and CYP3A4 on transport of buspirone, a Pgpaa
                             Short Course Fred Guengerich: Nonhepatic drug metabolizing enzymesG. M. M. drug metabolism,
Drug metabolism in vivo are known to involve both the liver and nonhepatic organs. However, most studies inGroothuis: Drug m
                             Mini-symposium   Stefanus J Steyn (USA): Integration of context in silico was chosen as designation da
Computer-aided methods has become the key component of drug design. In thisphysicochemical, in silico, in vitro and in vivoto
                             Roundtable       Robert Betham, USA, "Approaches bioanalytical procedures bioanalytical challenges
Tissue as a matrix can pose a challenge in the development and validation of to overcoming the uniquefor pharmaceutical drug
                             drug products 1) Barbara Davit, Ph.D., J.D., activity are "Regulatory Perspective"; 2) Marc Lefebvre,
Bioequivalence studies for Symposium that are intended for systemic FDA, USA, generally determined by the measurement o
                                              1) Patrick Noonan, Ph.D., PK Noonan & Associates, USA, "Finding and communicatio
An effective Contract Research Organization (CRO)/Client relationship requires close collaboration and seamless identifying a q
                             Roundtable
                             Roundtable       Thomas Franz, M.D., Cetero, USA, ―Advances in in vitro methods‖; Vinod Shah, FIP, U
FDA Critical Path Initiatives suggest development of new approaches for assessment of bioequivalence of topical dermatologica
                                              Avi Yacobi, Ph.D., Taro, USA, assessment of bioequivalence of Benfeldt, U of Cope
FDA Critical Path Initiatives suggest development of new approaches for―Clinical endpoint studies‖; Dr. Evatopical dermatologica
                             Roundtable
                             Sunrise Session cott Aldrich; USA; UltraMikron; from the observation of haze in a formulation to a pos
                                              S
Many issues can arise during the development of a pharmaceutical agent, A Forensic Approach to ‗particulates‘ in Pharmaceutic
                             Symposium Gretchen pharmaceutical agent, from the observation of particulates/haze instrument
Many issues can arise during the development of a Shearer (McCrone Assoc.); USA; State of the Art techniques andin a formula
                             Symposium 1. New Concepts in Stabilization: The Complex Role of the general concept of system
The phrases ―Quality by Design‖ and ―Process Analytical Technology‖ are recent innovations, but Glass Dynamics; Marc Ciceron
                             Sunrise Session peaker to develop and launch a new drug has increased significantly, with a longer c
                                              S
It is well known that the overall investment needed examples: Annette Bak, Merck & Co, USA; John Higgins, Merck & Co, USA;
                             Symposium WHY WE‘RE LOSING THE WAR ON CANCER AND HOW TO signed the                       
Clifton Leaf, F
The year 2011 will symbolize the 40th anniversary of American War on Cancer since the President Nixon WIN IT
 Cancer Act
                             Mini-symposium   Speakers well as academia to and Academia located in the study
The symposium will bring speakers from industry asfrom Industry, CROs,discuss novel technologies to USA ADME properties o
                                              Giovanni has eliminated numerous drug candidates from Biopharmaceutics & program
                             pharmacological agents M. Pauletti, Ph.D., USA (Associate Professor of clinical development Pharma
Systemic toxicity of potent Roundtable
                             Mini-symposium Morishita, developing peptide and protein drugs as well as macromolecular drug de
                                              M.
During the last decade, the pharmaceutical progress in JAPAN, Use of cell-penetrating peptides in enhancing oral bioavailability
                             a regulatory submission that contains detailed Chemistry, Manufacturing and Controls (CMC) informa
                                              D
Drug Master File (DMF) is Sunrise Session r. Satyam UpadrashtaForest Labs
                             of 2009 is intended to enhance FDAMr. Scott Bornstein, of the FDA to prevent/minimize the entry of
The FDA Globalization Act Symposium Dr. Moheb Nasr, the funding and authorityAttorney/Partner, Greenberg-TraurugDr. Pra
                             Roundtable       Lawrence Kerr, Ph.D. The National Counterproliferation Center; Other FBI / threat req
The threat of bioterrorism presents significant challenges to America's public health system and preparedness for this CIA speak
                                              Keith biotechnology derived product encounter regulatory / MHW speaker.
The scientists involved in the development of a Webber, Ph.D., CBER, FDA; EMEA speaker; SFDA issues on daily basis. Some
                             Roundtable
Developing meaningful CMC specifications for early phase development of therapeutic products can be difficult task. Many time
                             Symposium Mohab Nasr, FDA; Carlos R. Langezaal, Ph.D., Sanofi-Aventis US LLC; Prabu Namb
                             Symposium Takeo proteins play an important role in taking up nutrients            cancer cells.Douglas
APSTJ proposed:Plasma membrane transporterNakanishi; Japan; Transporter-targeted drug delivery into and effluxing xenobio
                             Symposium Takuya advance in understanding utilize PEPTs for drug such as PEPT1 and PET2,
APSTJ proposed:Last decade, we had significant Fujita; Japan; Challenge to of peptide transporters delivery.Vadivel Ganapathy;
                             Symposium on evolving science and technology in Biopharmaceutics especially in oral drug abso
APSTJ proposed:Provide the information Peter Langguth; Germany; New technologies in drug formulation to improve oralabsorp
                             Symposium Chikako the regulatory standard of Regulatory concept for BA/BE.Lawrence rationale
APSTJ proposed:Discuss about the differences in Yomota; Japan; Japanese;BA/BE in USA, EU and JAPAN to find the Yu; USA
                             Symposium Sam the reason of high variability in oral Drugs :FDA Perspective.Shinji Yamashita; Ja
APSTJ proposed:Deepen the understanding ofHaidar; USA; BE for Highly Variable drug absorption and to review the method to
                             Symposium Ikumi Tamai; the role of transporters in tract : absorptive and exsorptive.Joseph W to
APSTJ proposed:Provide the up to date information on Japan; Transporters in GI oral drug absorption and delivery. PossibilityPo
                             Symposium Motohiro Kato; Japan; PK analysis on intestinal first pass metabolism.Peter Langguth;
APSTJ proposed:Provide the up to date information on the molecular aspects and the role of drug metabolizing enzymes in the
                             Symposium Shiew-Mei DDI studies of new drug candidates : FDA Perspectives.Toshihisa Ishikaw
APSTJ proposed:Provide the regulatory standard for Huang; USA; Projecting DDI Studies including both enzymes and transporte
                             Symposium M. the selections of Use of cell-penetrating peptides in enhancing During the last dec
APSTJ proposed:Macromolecular drugs limitMorishita; Japan; administration routes and formulation designs.oral bioavailabilityo
                             Symposium M. Morishita; Japan; Use of cell-penetrating peptides developed methodology that ha
APSTJ proposed:Intracellular delivery using cell penetrating peptide (CPP) vectors is a recentlyin enhancing oral bioavailabilityo
                             Symposium A. Rubinstein; Israel; are rapidly gaining importance in the Peppas; USA; industry. Th
APSTJ proposed:Oral controlled release drug delivery systems Colon-targeted delivery systems.N.A. pharmaceuticalLectin funct
                             Symposium         discovery created many Oral absorption enhancement water solubility as drug candid
APSTJ proposed:Recent advance in drugKunikazu Moribe; Japan; chemical substances with poorof poorly soluble drugs by usin
                             Symposium Shinji Sakuma; Japan; Manipulation of intestinal influx transporters which are respons
APSTJ proposed:The efficacy of therapeutic agents is often diminished by various factors such as low specificity against targets
                              is an attractive organ to Germany; not only small polymeric but also proteins and peptides, delivery
APSTJ proposed:The lungSymposium T. Kissel; administer Biodegradable molecules,nanocarriers for pulmonary drug because
                             Symposium K. Takayama; Japan; Effects of ethanol and L-menthol on the stratum corneum investi
APSTJ proposed:Transdermal delivery offers an attractive option for the delivery of drugs as it avoids first-pass degradation in th
                              Symposium 1. The factors do help compare ADME/Tox properties across species. The predictive
Preclinical pharmacokinetic and in vitro studies characterize andin improving the prediction of human clearance from animal dat
                              Symposium Kunikazu Moribe; Japan; Nano-sized crystal: in recent decades, especially in the pha
APSTJ proposed:Interest in the solid-state properties of drugs has grown tremendouslyRequirements for pharmaceutical dosage
                              Symposium Giuseppe Novelli; sequence conversion USAHiroyuki Kamiya; Japan
FIP SIG (Pharmaceutical Biotechnology) proposed:TargetedItalyDieter C. Gruenert;would be an attractive gene therapy approac
                              Symposium Michael P. Murphy; UK; Mitochondrial and molecular biology has provided useful Yum
FIP SIG (Pharmaceutical Biotechnology) proposed:Recent progress in genetics delivery.Volkmar Weissig; USA; DQAsome.inform
                              Symposium Hidetoshi Mukai, Kyoto Pharmaceutical University, so on. Recently, new mechanism
Peptides have been good candidates for drug developments, validation tools, discovery, and Japan, New Signaling Mechanism
                              Symposium PROPOSED BY HEYO KROEMER (Univ Griefswald), SUBMITTED BY GT TUCKER

Transport proteins are increasingly recognized as key players in drug disposition. The symposium covers a wide range of transp
                              Symposium Yoshinobu Takakura; Japan; Interferon gene therapy for cancer as well as design of pl
APSTJ proposed:Successful in vivo nonviral gene therapy requires optimization of gene delivery systems and allergic diseases.
                              Symposium Hideyoshi Harashima; Japan; Novel siRNA Delivery System: Multifunctional Envelope-
APSTJ proposed:RNA interference (RNAi) is a potent and specific post-transcriptional gene silencing event in which double-stra
                              Symposium Youngro Byun; South Korea; Development of drug conjugated heparin derivatives for
APSTJ proposed:Macromolecules with diverse physicochemical and biological properties have been used for drug delivery andi
                              Symposium Prof. Samir Mitragotri, overview on the current state of the art of mathematical model
Goals and Objectives:1. To give the audience an understandableUSA, Quantitative description of intracellular mass transport; Pr
                              Symposium        systems have Japan; Development of nanoparticle-containing and gene delivery. In
APSTJ proposed:Nano-particulate carrier Hiroaki Okada;been one of the most useful technologies in drugmicrospheres for drug
                              Symposium Shinsaku cell-based Japan; Both stem cells and immunogenic long-lived DC vaccin
APSTJ proposed:A great attention has been paid to Nakagawa; therapy.Engineering of highlysomatic cells could be a platform fo
                                and endothelial cells function as Japan; Transdermal for delivery of various drugs. In this symposium
APSTJ proposed:EpithelialSymposium Yukihiko Aramaki; the essential barriersdelivery of CpG-oligodeoxynucleotides for the t
                              Symposium Kazuo Maruyama; Japan; Novel nucleic acid drug delivery method various types of sm
APSTJ proposed:Liposomes are classical, but useful and powerful, lipid-based carrier for targeted delivery ofby liposomal bubble
                              Symposium Hideo Saji; Japan; have significant impact on drug delivery research. This symposium
APSTJ proposed:Recent advances in bioimaging techniquesDevelopment of Novel radiolabeled probes for SPECT imaging.Jan
                              Symposium Kazunori Kataoka; Japan; Intelligent polymeric micelles for drug release and targeted
APSTJ proposed:Novel types of polymeric drug delivery systems have been developed for controlled controlled drug release and
                              Symposium Teruo Okano; Japan; Novel technology pace sheet engineering for tissue repair.Anton
APSTJ proposed:New generations of biomaterials are being developed at a rapidof cell both for therapeutic applications and bas
                              Symposium Yasuhiko Tabata; drug release systems have been developed for drug based on dru
APSTJ proposed:Various types of polymer-based controlledJapan; Current status of regenerative medical therapyand gene thera
                              Symposium PROPOSED BY ARTO URTTI (Univ Helsinki), SUBMITTED BY GT TUCKER
Organ                  



ABC efflux and OATP; transporter-transporter and transporter-enzyme interplay; modelling; clinical significance; crystal structure
                               metabolic networks; analytical developments; phase 1 and 2 SUBMITTED BY GT TUCKER
Organ
Towards understanding of Symposium PROPOSED BY ARTO URTTI (Univ Helsinki),metabolism; bioinformatics data
                     


                                                                                                                               analysi
                              Mini-symposium K (Japan)Department of Pharmacy, Kyoto University Hospital, Faculty of Medicine
                                              Inui
Inter-individual variability of efficacy and toxicity is serious and troublesome problem in pharmacotherapy. In many cases, such i
                              Symposium PROPOSED BY ELIAS FATTAL (Univ of ultrasound contrast agents and drugs at
To discuss new developments in the design of nanotechnologies for the delivery Paris); SUBMITTED BY GT TUCKER
•
 the         


                                                                                                                             
 Nicola
                              Symposium PROPOSED BY JUAN IRACHE drugs
 SUBMITTED BY GT TUCKER
 of different
                                                                                      
-                                

                                                                                                                        


- To show different strategies intended to improve the oral bioavailability of (Spain); To discuss the benefits and limitsProf. Oya Al
                              Symposium Co-Chairs: Pollen K.F. Yeung, Ph.D., Professor the last 3 decades, from Pharmacokin
Although clinical drug development has evolved along with pharmaceutical sciences over of Pharmacy & Medicine,the applicatio
                              Symposium Chris Moreton, US;Brian Carlin, US;Alen Guy, US;David Schoneker, USFDA Speaker
Co-processed excipients are going to be very important to solve many of the excipient variability and functionality problems that
                              Symposium Bertil Abrahamsson, Ph.D., USA, "Current approaches in forecasting BA/BE during dr
In vivo bioavailability (BA) or bioequivalence (BE) studies are generally required for regulatory approval of drug products althoug
                              Symposium Speaker 1: Dr. Thomas today than ever before. Imaging Global Imaging Group Nova
The drug discovery and development process is more challengingKrucker, Head MolecularOnly a small fraction of drugs pass su
                              Roundtable      1. Lennart Lindfors (Sweden): how drug nanoparticles (< 100 nm) behave differently t
Goals and Objectives: 1) To discuss the theory and present examples ofTheory and physics of nanoparticle formulations of poor
                              Symposium        resulted Offen (US) Adaptive Designs as shorter, more innovative, intelligent Dykstr
Rising late stage clinical trial failures have1) Walter in several companiesconsideringTransformational Change? ;2) Kevinclinical
                              Short Course pharmacology (New Zealand) mainstream drug Using Winpopt
With the integration of quantitative clinicalStephen Duffullapproachesinto Optimal Samplingdevelopment comes the increased d
                              Symposium Margareta to the presence of the blood-brain barrier (BBB) and active efflux transport
CNS drug delivery can be difficult to accomplish due Hammarlund-Udenaes, Uppsala, Sweden: Methods for studying CNS drug
                              Roundtable      Yuichi Sugiyama, Tokyo University, Tokyo, Japan: Drug transporters at questioned in la
CSF as a short-cut for measurements of brain unbound, pharmacologically active drug concentrations has been the BBB and BC
                              Symposium        discuss application of Equivalent Constant Concentration quotient HIV/HCV PK/PD
Goals and Objectives: 1. This session will1. William Poland (US)PK-PDmodels from simple inhibitoryas a Key (IQ) methods to c
                              Symposium 1) George Drusano of thebiggest threats to society today. There are already reports of
Resistance Development against our antibiotic arsenal is one (US) An overview of modeling of Resistance;2) Alan Forrest (US) P
                              Sunrise Session for biotechnology products represents an exciting, growing paradigm in biotech indus
                                              C
Use of pre-filled syringes and autoinjectors onsiderations for prefilled syringes shipping and scale down model for evaluation of i
                                              Tetsuya transporters. There is an increasing Japan: of information on similarities and
Rodents are often used asRoundtablehuman drug Terasaki, Tohoku University, Sendai, amount Pharmacoproteomic strategies to
                               models of
The objectives are to recognize excellent abstracts submitted to AAPS in the area of emerging M&S techniques and clinical imp
                              Poster/Podium Speakers: 4 talks from submitted abstracts plus 2 talks from the votingprocess that wi
                                              1) Kevin Dykstra (US) where the first significant exposure to John Wagner in patients
                                                                                                         
2)
Phase II is typically the stage of a clinical development program – ―An Instructive (to me) Example‖;
 an NCE occurs(US) ―An In
                              Roundtable
                              Symposium Designing used with the use of disposable system: Challenges and the apparent adv
Disposable (single-use) systems have been recentlyfacilityin pharmaceutical and biotech manufacturing due to Considerations: M
                              Mini-symposium  FDA speaker: US Colangelo;EMEA or former EU Health Authority speaker: be simul
European and US scientific advice - Seeking EU only or Kim only; When should you consult both EU and US and can itTBD;Indu
                              Symposium 1) Yusuke Tanigawara a clinical phase III program to on Japanese population require
It is common knowledge that extrapolation of "foreign data" from (Japan) Japanese Experience the Bridging Studies through PMD
                              Symposium 1) Laurent Salphati (US) Translational PK/PD Modeling of Tumor Growth Inhibition: Pr
Although there are examples ofsuccessful integration of PK/PD modeling and simulation in oncologydrug development, the upta
                              Symposium 1) E. Benfeldt (Denmark) or approaches for the assessment of bioequivalence
As part of the "Critical Path" Initiative the FDA promote the use of new Vinod Shah (USA)Microdialysis in the assessment of derm
                              Sunrise Session important to move materials, clinical Documentation for Importing Drug Products in
                                               is
In a world of multinational development, itAnne Marie OConnell, US, "Regulatory supplies, and finished dosages forms acrossin
                              Symposium Generic AED Formulations: Scientific and Regulatory Issues Mansoor Khan, Ph.D., R.
Generic Antiepileptic Drugs: Pharmacokinetic, Therapeutic Equivalency and Regulatory Challenges ModeratorsD. Samba Redd
                              Symposium Generic AED Drugs?ModeratorsD. Samba Reddy, Ph.D., R.Ph.Texas A&M Ph.D., R.
Are There Potential Problems with Generic AntiepilepticFormulations: Scientific and Regulatory Issues Mansoor Khan,Health Sc
                              Roundtable      Generic AED Formulations: Scientific and Regulatory Issues Mansoor Khan, Ph.D., R.
Clinical Problems with Generic Antiepileptic Drugs: Myth or Reality?ModeratorsD. Samba Reddy, Ph.D., R.Ph.Texas A&M Health
                              Sunrise Session controversy of whether generic antiepileptic drugs (AEDs) Mansoor Khan, Ph.D., R.
                                              G
This Sunrise sesion will discuss the current eneric AED Formulations: Scientific and Regulatory Issues are interchangeable with
                              Symposium Potential Speakers-Gerald Migliaccio, Global provide a model for pharmaceutical qua
ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q10 Quality and Environmental Health and S
                              Symposium TBD
The concept of QbD presents opportunities and challenges to the pharmaceutical industry and regulatory bodies. Both bodies ag
                              Sunrise Session eneric AED Formulations: Scientific and Regulatory Issues are interchangeable with
                                              G
This sunrise session will discuss the current controversy of whether generic antiepileptic drugs (AEDs) Mansoor Khan, Ph.D., R.
                              Symposium MicroRNA symposium will feature presentations Reddy, Ph.D., R.Ph.

                                                                        


                                                                         

MicroRNAs Are Strikingly Novel Tools for Biotech Drug Discovery
Moderators
 Samba by:
 Eric N. Olson, Ph.D., University
                                                                                    
D.            
•
               
Texas A&M Hea
                              Roundtable
 •
 N. Olson, Ph.D., University of TexasTexas A&M Health Science Center, College
                                          

 Eric
MicroRNA-Based Novel Biomarkers 
Moderators
 Samba Reddy, Ph.D., R.Ph.

                                                          

                                                          D.                             
                              
•

                                                                                          Southwestern Medical Center
 Rajesh Mira
The main objective of this roundtable is to•

                              Roundtable                                                                    
•

                                                Rajesh Miranda, Ph.D., Texas A&M Health Science Center
 named ―Micro-RNAs‖ (
                                               provide key insights on most recently discovered biotech toolsRaghu Vemuganti, Ph.D
                                              Women‘s health roundtable will feature presentations and
 
 

                                                                                                          Women‘s Health Initiative:
This roundtable meeting will discuss women‘s health issues and provide an update on research by:
education in the neuroscien
                              Roundtable
This symposium will discuss the current status and future directions in the management of the metabolic syndrome (MS), with s
                               Symposium Metabolic syndrome symposium will feature presentations by:The Metabolic Syndrome
                                               Physiologic and Metabolic Abnormalities of Central metabolic syndrome (MS), with sp
This roundtable will discuss the current status and future directions in the management of theObesityRamachandran Vasan, M.D
                               Roundtable
                               Roundtable      Neurosteroid critical future directions for developing effective neurosteroid-based strat
This roundtable meeting will provide current status and roundtable will feature presentations by:Neurosteroid replacement therap
                               Symposium        part of the production process whether a part of the production or created post purifi
Post translational modifications whether aPost translational modifications (glycosylation, cysteinylation etc.)process (glycosylation
                               Mini-symposium  Prof Balachandran, Brunel pharmaceutical industry. Especially Instrumentation and
Electrostatics is an often neglected but important phenomenon in theUniversity UK - Overview of Availablethe triboelectrification
                               Symposium Case studies Xolair, Humira, Herceptin, progresses
Comparability exercises are a norm during biologics development as the program Myozyme through various stages of process
                                in proteins    Speakers: Sathish opalescence and incipient phase separation, yet is not readily mea
Reversible self associationSymposium that leads to apparent Hasige: Tentative title: Mechanism of Reversible Self-Association o
                                on teh market are lyophiles. Furthemrore, it is often a prodcut format that is used for clinical trials to
Almost half of the biologicsShort Course Carpenter, Pikal, Nail
                               Symposium Carpenter, Pikal, Cicerone, DePablo
Lyohilization is a critical technology that enable sthe development of products that would otherwise not be able to make it to the
                               Mini-symposium Paul Myrdal, University of Arizona, diseases with significant implications for public
                                               Dr.
Asthma and chronic obstructive pulmonary disease (COPD) are obstructive lungUnited States, Recent Advances and Challenge
                               Symposium potential will bring two critical analytical effort together, providing a analysis: 1. Thoma
The product-related and process-related impuritiesspeakers for product-related and process-related impurity platform to discuss
                               Symposium Suggested is the analysis of
        •

                                                                              visible particles. Indeed, lots according to the UPS metho
One of the routine lot release assays for therapeuticstopics/speakers:
 Visible particle assessment can be released or withheld
                               Symposium James Fish MD, Genentech, United States, Persistent, Perennial Allergy of patients w
Environmental Exposure Chambers (EEC) are ideal clinical settings to study anti-rhinitic nasal sprays for treatment to Cat Allerge
                               Symposium 1) Pascal Chanu (US) characterised by in modeling         
cognitive and functional in Alzheimer
Alzheimer‘s Disease (AD) is a devastating degenerative diseaseUse of ADNI data loss of 
 disease progressionability. The bi
                               Symposium Emily Schacter, USA FDA, Regulatory updates and Common Shortcomings present S
Over the past few years, Pharma companies have been placing an increased emphasis on Biologics. These productsin recent n
                                                a challenge because products and process can Study Protocol; ways. The number
Comparability studies continue to present Steve Martin, USA, Pfizer's Model Comparabilitychange in a lot ofSpeaker from Genzy
                               Symposium
                               Symposium Professor Yuhong progressed to the point a market launch although there are consid
The application of nanotechnologies to medical products hasXu, PR China, Design of of Peptide-Directed Drug Delivery System
                               Symposium Mark McAllister, UK Selection of succesful that warrants full Commercial Developme
The goal of the Early Development project team is to deliver a -drug product candidate formulations for First-in-Human (FIH) stud
                               developing      Jim Mcleod, becoming increasingly popular. Insight into human physiology and pharm
Exploratory approaches to Symposium therapeutics areUSA - Synthesis of the M3 guideline and its impact on exploratory clinical
                               Symposium Potential Speakers:1. Self-Assembly of Block external Copolymers Mediated by Coile
The rapidly developing field of ―Smart‖ polymeric materials, which respond to internal or and Graftstimuli, has been revolutionizin
                               Symposium 1. Proposed Speaker: Robert Products (ANDA) is submitted in the Module Intra and I
Currently Pharmaceutical Development (PD) for Abbreviated New Drug Iser, Counrty of Origin: USA. Proposed Title: 3.2 (section
                               Mini-symposium  Methods for determination of protein bindingPossible speakers:Hartmund well docum
Protein Binding and Antimicrobial activity.The importance of protein binding on the pharmacokinetics of antibiotics is Derendorf, G
                               Mini-symposium  Methods for determination of protein bindingPossible speakers:Hartmund well docum
Protein Binding and Antimicrobial activity.The importance of protein binding on the pharmacokinetics of antibiotics is Derendorf, G
                               Sunrise Session must be (USA) Measuring the development a clinical trial to the to pursue licensur
Information, in the form of clinical trial data,ill Poland ―purchased‖ by a drugcontribution oforganization in orderoverall developme
                                               B
                               Mini-symposium Honghui in biologic product Concepts and Algorithms; 2) Balaji Agoram (UK)
The objective is to understand the concept of MABELZhou (US) MABEL:development with case studies. Rationale: 
 A cas
                                               1)                                                                                Biologic
                                                                                                                                 

                                               ―Optimizing PK/PD and dosing in as well using combined therapies in to treatment o
Pediatric drug development presents many unique challenges both globally,children as in the United States. Due thelimited PK/P
                               Roundtable
                               important role in speakers for this session need to be determined after approval of session.
                                               The
Drug metabolism plays an Mini-symposium drug discovery for selection of candidate for development. During the development s
                               Symposium PROPOSED BY new processing techniques for altering the physico-chemical BY GT
The pharmaceutical industry has shown growing interest inPROF ANANT PARADKAR (Univ Bradford UK); SUBMITTED propert
                               Symposium Loren Israelsen, JD, Executive Director of the United Natural nutritional supplements.
More than 100 million Americans take vitamins or dietary supplements daily, including dozens of herbal Products Alliance, U.S.A
                                supplies of IVIVC and Modeling Strategies for Decision Making in Drug Development using deve
Lack of data and adequateRoundtable drug substance are major impediments to making clear decisions during early drugRelev
                               Symposium Sandra Carrieo; Canada; Hybridization Methods for agents. Depending on their mole
Oligonucleotides (ONs) have been studied extensively in recent years as potential therapeuticthe Quantitation of Various Classe
                               Symposium Richard great USA; Antisense therapeutic agents for medical applications. Therape
Oligonucleotide-base compounds continue to holdGeary;promise as novelTherapeutics.Page Bouchard; USA; Aptamer The des
                               Symposium        biopharmaceutics has been beset with non-specificity issues arising from various end
Advancement in bioanalytical sciences forSally Fisher, USA -Interference observed in PK and ATA assays and various strategies
                               Symposium Denise O‘Hara, USA, Reagent commitment to Standards; 
                  

                                                                                                                 Kerry Oliver, USA, Expa
The AAPS 21st Century LBA workshop has just completed. As part of ourCharacterizationmaking the concepts a reality, we are
                                pediatric formulation development has now undoubtedly become important in the world, there are so
APSTJ proposed:AlthoughSymposium Tetsumi Irie, Noriyuki Nameki; Japan; Pediatric needs from Japanese clinical practices
                               Symposium        •Quality by Design(QbD)•
                                                g                          Yomoda; Japan; Role of quality including for pharmaceutica
APSTJ proposed:The general concept forHaruhiro Okuda, Chicako h and applied biopharmaceutics by design IVIVC (In Vitro-In V
                               Symposium Mikio Nishida; JapanTetsumi Irie; for changes in Watanabe; JapanJ. Bootman; USAJ
APSTJ proposed:The purpose of these presentations is to discuss the needJapanYoshiteru pharmaceutical education in the univ
                               Short Course Yumei Lin,Ph.D., Senior Clinical Scientist, Nutrilite Health Institute, CA, treat 
preven
There is a worldwide interest in and use of foods, dietary supplements, natural products, and traditional herbs to USA.or―Thinkin

                               Symposium        of genomic biomarker is a key use of genomic biomarkers in research of molecular-t
APSTJ proposed:Nowadays, efficient useKazuto Nishio; Japan; Strategicto success of development of molecular-targeted drugs
                               Symposium Amin Rostami-Hodjegan; UK;Prediction overcome in the current pharmacotherapy. In
APSTJ proposed:Significant inter-individual variability is one of major issues to be of in vivo pharmacokinetics from in vitro data
                               Symposium 1.Current approaches to improve nasal deliveryMaureen DonovanProfessor,University
Intranasal route of drug administration is an attractive route because of highly permeable nasal mucosa resulting rapid absorptio
                               Symposium Jean-S&#233;bastien Hulot; by activities of metabolizing enzymes and in antiplatelet
APSTJ proposed:In many cases, the clearance of drugs is determined France; Potential of personalized medicinemembrane tran
                               Mini-symposium sFDA/CDE staff to present an overview of the regulatory requirements2) expert from
                                               1)
overview of REG CMC requirements for CTA submission in China for the purposes of 1) registration in China and 2) global regis
                                               Moderator - spots with respect to PfizerSpeakers.Regulatory guidnce Dr. Prabu Fro
Drug substance starting materials take many strategicArya Jayatilaka, Ph.D.regulatory aspects of drug substance- synthesis. Nam
                               Roundtable
Orphan drugs are indicated for the treatment of rare diseases which are defined as disorders or conditions affecting fewer than
                               Symposium Moderator - Dr. Prabu Nambiar, Vertex PharmaceuticalsRegulator's Perspectives - FD
                               Symposium Potential Speakers:Mark D. Kramer, Director Office of Combination the device and dr
Due to the advancement of medical and pharmaceutical science / technology, modern devices are combining Products Donna B
                               Symposium Moderator - Dr. Deepa Deshpande, Universal Regulatory Affairs IncFDA the structure
Immunogenicity is one of the key safety considerations for biologic/protein therapeutic products. Minor changes toSpeaker - Dr.
                               Symposium Wiederschain D, Novartis Recently, biological as well as chemical techniques have at
The target validation is a significant process for drug development. Institutes for BioMedical Research, Cambridge, Massachus
 The                                           situations where current approaches for the determination of equivalence are dated, a

 industry is increasingly experiencing Thomas Franz, M.D., Cetero, USA, ―Advances in in vitro methods‖; 

                               Roundtable                                                                               Vinod Shah, Ph.D
                                                                                                                        

 The                                           situations where current approaches for the determination
 Benfeldt, M.D., Ph.D., U
                                                                                                              Eva
                                                                                                              of

 industry is increasingly experiencing Avi Yacobi, Ph.D., Taro, USA, ―Clinical endpoint studies‖; 
 equivalence are dated, a
                               Roundtable
                               Symposium Committed topics and speakers:Introduction: importance, technology review, and curr
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopment-FG, Biotec
                               Symposium Committed topics and speakers:Overview of current preservative use in parenteral dru
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Excipients-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopm
                               Symposium Committed topics and speakers:Overview of current preservative use in parenteral dru
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Excipients-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopm
                               Symposium Committed topics and speakers:Introduction: importance, technology review, and curr
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopment-FG, Biote
                               Symposium Committed topics and speakers:Introduction: importance, technology review, and curr
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopment-FG, Biote
                              Symposium Committed topics and speakers:Introduction: importance, technology review, and curr
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopment-FG, Biote
                              Roundtable      IVIVR for poorly to guide a decade of experienceTycho and then to facilitate waiver o
Understanding of the IVIVR for poorly solubles is essentialsolubles: their formulation development Heimbach, Ph.D., USA;To ach
                               adverse reaction of drugs, and (Clinical Pharmacology Service, Liver Unit University Hospital Schoo
Idiosyncratic toxicity is rareSymposium M. Isabel Lucenamany researchers have challenged to predict the toxicity by accumula
                              Symposium Speaker in the development of name to be determined; (ADCs) for the selective deli
The past few years have seen significant progress from Seattle Genetics,antibody-drug conjugatesspeaker from ImmunoGen, n
                              Sunrise Sessioneffrey A. Lindeman, for that reason for Jones PLLC, US;

                                              J                                                            
Mark J. Buonauito, Esq., T
Patents are one of those ―facts of life‖ for pharmaceuticals and Ph.d., Esq, O‘Brienpharmacists. Patents can caver a pharmaceu
                               undergo significant changes with more on the horizon. Recent court Court Decisionsaddressed wha
US patent law continues toRoundtable          Michael Dzwonczyk, Esq., Sughrue Mion, US "Recent decisions have and Patent Ref
                              Symposium Mercedes Meyer, Esq., Drinker follow-on biologics. The intellectual property interests
Congress continues to trace out the contours for a regulatory scheme for Biddle, US; James Kelly, Esq. Eli Lilly, US;Other speak
                              Symposium Speaker 1: Professor Sergei of the physical and chemical composition - individual un
With the increased use of imaging technology, a greater understandingG Kazarian (NIR Imaging)Imperial College ofLondonDepa
                              Symposium Jashvand D. toxicity depends on not only those USA; Identification of the mitochondr
The contribution of transporters to drug disposition andUnadkat; University of Washington,substrate specificities but also the exp
                              Symposium Alfred H. Schinkel; The Netherlands Cancer Institute, by genetic factor or coadministe
Transporter regulates the tissue distribution of drugs. Therefore, the dysfunction of transportersthe Netherlands; ABC mulitdrug
                                              drug substance possible? Can the assiduous application of modern spectroscopic and
Is positive and absolute identification of a Bill Koch, Chief Metrology Officer, USP, USA, Moderator and Introduction, Drug Substa
                              Roundtable
                              Symposium Moheb Nasr FDA, ONDQAOpportunities of and barriers against a QbD laboratories o
Technology transfer is viewed as a process of conveying expertise originating in the drug or product developmentapproach to Te
                              Symposium Presenters1. Tom OliverFDA, ONDQAA Regulatory and concerning active pharmace
This AAPS symposium provides a risk-based perspective and recommendations for several topicsRisk-based evaluation strateg
                              Symposium Moheb NasrFDA, ONDQAEvolving Regulatory Landscape: An FDA PerspectiveNirdos
Drug and device manufacturers are grappling with intense levels of scrutiny from FDA, payors, consumers and the press, all of w
                              Mini-symposium  Sabine Kopp, WHO, Switzerland "Overview of new Zone IVa and IVb have been finali
The WHO Stability Guidance Document has been published, and requirements for stability at2009 WHO Stability Guidance"Tom
                              Sunrise West,G   more companies are looking PresidentSanofi AventisCMC Considerations for Produ
With the slow moving market in theSession opi VudathalaAssociate Viceto emerging markets to expand sales. Regulations in em
                              Symposium       one of the first clinical applications Speaker: Henk-Jan Guchelaar, Leiden University M
Pharmacogenomics is being regarded as 1. Translating Pharmacogenomics. of the postgenomic era. The genetic factors that ca
                              Symposium 1. Membrane drug absorption, disposition, targeting, and in clinical drug response, all
Genetic variants in membrane transporters may impact transporters and genetic variantsSpeaker: Kathleen M Giacomini, Unive
                               will present    overview of strategies for the synthesis and fabrication of States;Dr. William R. Kena
This roundtable discussionRoundtable anDr. Joseph DeSimone, University of North Carolina, Unitedorganic nanomaterials, spe
                              Symposium Professor Colin POUTON; UK, Drug Discovery New Trends and Technologies for poor
The purpose of this symposium is to increase awareness of new strategies and tools for addressing oral bioavailability. An additi
.                             Roundtable      PROPOSED of EVA HORN MOLLER (Univ a consensus in the area has not yet been
       The importance and relevance of immunogenicityBY biologics is stilldebated, and Copenhagen); SUBMITTED BY GT TUC
                               drug transporters in Giacomini; UCSF, USA; The pharmacogenomic approaches for clarifying the cli
Recently the importance ofSymposium Kathy the pharmacokinetics and subsequent pharmacological/toxicological effects of d
                              Sunrise Session Dennis J O‘Kane, Department of Laboratory Medicine and pathology, Nucleotide Po
                                              [1]
Pharmacogenetics and Pharmacogenomic (PGx) relies on the genetic makeup of an individual which impacts on how drug proc
                              Symposium        FDA, PK/PD modeling and simulation approach prediction of real-time whole-body ph
As mentioned in a critical path initiative byYuichi Sugiyama; The Univ. of Tokyo, Japan; The is a powerful tool to facilitate the drug
                              Symposium Fumiyoshi Yamashita; Kyoto Univ., Japan; Current Status are commercially available,
Because of the rapid increase in the calculation power of computers and several software packagesand Perspectives of In Silico
                              Symposium Ikumi Tamai; Kanazawa Univ., Japan; The role of OATPs in the intestinal absorption o
In the small intestine, some efflux transporters like P-gp, MRP2 and BCRP restrict the intestinal absorption of drugs, which lead
                              Symposium Ichiro Ieiri (Graduate are determined by epigenetic regulation as University), Japan, E
The expression of drug metabolizing enzymes and transportersSchool of Pharmaceutical Sciences, Kyushu well as genetic regul
                              Symposium Alfred H. Schinkel (The Netherlands drug transporters are deeply involved in the dispo
Animal studies including genetically modified ones have provide evidence that Cancer Institute), Netherlands, Genetically modifi
                              Short Course Majid Moridani (Texas Tech University for paersonalized medicine. Discuss about the
Goal and Objective: Provide the current conception and cutting-edge technologyHSC, USA)Current technology and platforms us
                              Roundtable      Anke-Hilse Maitland-van der Zee (Utrecht University, The Netherlands)Pharmacogene
Goal and Objective: Provide the current information for individualized medicine using the latest technology in various diseases.
                              Symposium Jan all involved disciplines, fermentation, to controlled freeze/thaw and transport disp
In particular in the biotechnology in practically Feuser, Germany, Smart approaches purification and final product productionof fro
                              Symposium Yusuke and information for individualized medicine in post-genome era. Discuss abou
Goal and Objective: Provide the latest technology Tanigawara (Keio University, Japan)Proteomics and metabolomics for clinical
                              Symposium Nick Warne, USA, Opalescence – an inherent property? How to set the specification;

For the application as subcutaneous or intramuscular injection often significant protein concentrations are necessary, in order to    

Summary
    This                              Professor Fernando Muzzio, Dept Chemical & of potent API‘s and stimulate discussion
            
 session will highlight the most significant challenges facing development Biochemical Engineering, Rutgers Univ
                              Roundtable
Summary
    This
            
 session will highlight the most significant challenges

                              Roundtable      PROGRAM OVERVIEW
facing development of potent API‘s and stimulate discussion
                                                                          

                        Moderator: Keith Hutchison, Vice
                                                                                                    

                                                                            Overall timing – 2 hours

                              Symposium Proposed Speakers1. Wim Jiskoot, Leiden University, The Netherlands;2. storage of a
Phase separation, an undesirable phenomenon from a product quality perspective, occurs during processing and/or Ann Newma
                              Symposium Yuichi in human (The and thereby, the receptor occupancy. PET has been used as i
PET enables measurement of the concentration Sugiyama body, University of Tokyo), Japan, Imaging for pharmacokinetic analys
                              been made       1. A Modified Mechanistic Model process and its predictability on scale-up using the r
Significant advances have Symposium in uderstanding the rollercompactionfor the Roller Compaction Process usingthe Rolling T
                                               toward more user-friendly application forms, monitoring toward prefilled syringes, pa
In the last years a clear trend is registeredMarkus Hemminger, Germany, Control, in-linein particular and characterization of doub
                              Symposium
                              Sunrise Session ric Williams, USA, Aspects to Consider in Designing Ester-Based Prodrugs
                                              E
This program is intended to provide a summary of the latest information regarding esterase cleavage of prodrugs with the goal o
                                               rather often also attributed to aggregates and protein particles, as large form of aggre
The immunogenicity of protein products isMary Crowell, USA, Advancements in analytical methods for subvisible particles;

                              Symposium                                                                                           
N.N.
                               environment call
                                              Kevin McDonald, Kevin McDonald, B.Sc.PHMThe NorthWest Company Ontario, Cana
Changes in the healthcare Mini-symposium for health care organizations to constantly evaluate new practice models designed t
                              Symposium 1.Prof. for delivering a variety or Prof. Gert entities. Several marketed liposomal pro
Liposomal dosage forms provide a great platformVladimir Torchilin (USA)of therapeuticStorm (Netherlands); "Overview of liposo
                              Mini-symposium Michael Newhouse, Mcmaster for molecules which are difficult to formulate for the
                                              Dr.
The lungs are getting more and more attention as possible absorption organUniversity, Canada, Inhaled Antibiotics: Why TOBI a
                              Symposium 1. Klaus Chair, CreightonUniversity and Raj Suryanarayanan (Sury), Ph.D., Professor,
Organizers: Alekha K. Dash, Ph.D., Professor and Wormuth, Ph.D., Surmodics;2. Greg Haughstad, Ph.D., Characterization Fac
                              Roundtable      Mehran Yazdanian, USAJane Hastedet, USA
Advances in high-throughput screening for drug leads in the pharmaceutical industry continue to identify compounds with high a
                              Symposium 1. Hitoshi Endou, PhD, Kyorin University School essential nutrients while limiting or pr
A crucial role of barrier epithelia is the protection of specialized compartments, by passing of Medicine, Japan, ―Consequences o

 The                          synthetic biology provides a powerful new of Chemical Engineering processes of biological systems
 
 recent emergence ofSymposium Jay D. KeaslingDepartment means for harnessing the and BioengineeringUniversity of
                              in today's Pharmaceutical Laboratory is the development of sample preparation methods for Content
One of the key challenges Poster/Podium Robert Houser;USA;A Strategy for Rapid Method Development for Content Uniformity
                               and Control Podium Presentations: significant each. (I have not identified specific speakers basis
Chemistry, Manufacturing, Symposium (CMC) challenges can be 30 minuteswhen Clinical Trials are conducted on a global at thi
                              Sunrise Session products polyphonols Flavonoid based prodrugs as selective anti-melanoma agents
                                              P                     


                                                                     
1.

                                                                     

In this sunrise, we will discuss natural plant otential speakers

 and their use, metabolism, toxicity and safety to selectively tar
                              Mini-symposiumpharmaceutical companies manage across research functions (Tox/ADME, Clinical, R
Project management components in mostMark Kryah, USA - Value of CMC Project Management During Late Phase Developme
                              Sunrise Session. Co-delivery of siRNA and a molecular biology tool and as potential therapeutic can
                                              1
small interfering RNA (siRNA) is gaining increasing popularity both as an anticancer drug for treatmentaof multidrug-resistant age
                              Mini-symposium  Y.Lin/J.F. Houle, USA/Canada, Quantification of pM levels of biomarker the gold stand
Label Free technologies are becoming a key element in LBA bioanalytical reagent development. Biacore (SPR) isby Diffractive O
                              Roundtable      QMBDD challenges in implementation of Quantitative Model-Based Drug Developmen
Goals and Objectives: To discuss the success and conceptual framework as it pertains to drug discovery and translational resea
                             Roundtable       discuss application Concentration as a Key HIV/HCV PK/PD Modeling Tool (Bill Polan
Goals and Objectives: 1. This session willEquivalent Constantof PK-PD models from simple inhibitory quotient (IQ) methods to c
                                             1. Shalini Gupta, PhD, Amgen, USA, "Latest improvements in However, the methodo
Immunogenicity testing for Symposium a regulatory requirement and implications on safety and labeling. traditional immunogenic
                             biologics is
                             Mini-symposium  Speaker 1: J. Lee, USA Similarity in for biomarker assays and can be one of the most
Parallelism has long been recognized as a key analytical validation parameter Biomarker Assay Validation; Speaker 2: J. Dunn, U
                             Mini-symposium   drug development efficiency, meta-analysis in meta-analysis: Vitamin tool in gaining
With the increasing pressure of improvingDon Berry, USA, "Bayesian model averaging has become an important E supplementak
                             Symposium Barbara Van Zweiten-Boot, Medicines Evaluation Board, Netherlands, soon. Howeve
Many orally inhaled drug products such as dry powder inhalers and metered dose inhalers are coming off patent "Regulatory app
                             Symposium Proposed Speaker1. Ethnicity influences on activity important demographic variable co
The metabolic enzymes and drug transporters play central roles in ADME/Tox. Ethnicity is an of drug metabolizing enzymes and
                             Roundtable      William a modified-release formulation, studiesClive Wilson; U.K.; Radio-Frequency
In the quest for finding a path forward for enablingBarr; USA; Intubation absorption several techniques are utilized e.g. in vitro dis
                             biomarkers is an1.Yan Zhang, of the pharmaceutical drug development process. The on clinical biom
Accurate measurement of Mini-symposium integral partBristol-Myers Squibb, USA,Influence of biological factorsmeasurement o
                             Mini-symposium  Clive Wilson; UK; Local vs. Systemic Drug Delivery - What molecular pathways are us
Non- oral routes of delivery have and continue to be important strategies for compounds that are not stable in the gastrointestina
                             Symposium 
      Speaker affiliation: Bulk/Tray Freeze Drying Technologies – Prof Mike Pikal, Uconn,
                                              

The superior stability associated with the dry solids compared to liquids coupled with the convenience/flexiblity in storage, opera
                                             Barbara for industry or Dale Connor, Pharm.D. FDA, Bioequivalence Data for ANDA
Recently, the U.S. FDA published a new guidance Davit, Ph.D. entitled ―Submission of SummaryUSA, "FDA experiences with im
                             Roundtable
                             Symposium Mansoor Khan; USA; Overview only thorough understanding release products andpo
Implementation of FDA's initiative of Quality by Design (QbD) requires notof 5 steps of QbD for modifiedof science and engineer
                             Roundtable      Mei-Ling Chen, Ph.D., FDA, USA, "The new pharmacokinetic and potential drug con
Assessment of bioequivalence (BE) is generally performed by conducting comparativeapproach: Theorystudies where use for bi
                             Symposium Qingcheng Mao, University of Washington, USA, Assessing the understanding of the
The use of knockout, mutant, and genetically-modified animals is proving useful for providing mechanistic role of BCRP/ABCG2
                             Roundtable      Vinod Shah biopharmaceuticals became the center of lively debates. US regulatory p
In recent years, the introduction of generic versions of (USA): Regulatory pathways to biosimilar approval on the The and Canada
                                             Speaker affiliation: Impact of molecule attributes regulatory guidance documents of Pr
FDA started to advocate the Quality-by-Design (QbD) concept few years ago based on the on pharmacokinetics, potency and sa
                             Roundtable
                             Symposium Committed topics and speakers:Overview of current preservative use in parenteral dru
This symposium proposal is Co-Sponsored by: SterileProducts-FG, Excipients-FG, Ophthalmic-FG, CMC-FG, ProcessDevelopm
                                             ―Successful strategies for Formulation-dependent critical in early drug compounds‖. a
Accurate predictions of human pharmacokinetic and pharmacodynamic (PK/PD) profiles arePK/PD of BCS II –IV development, 

                             Sunrise Session
                             Symposium Possible, proposed approaches and considerations Background/intro: Anette Muelle
Implementation of Quality by Design (QbD) is ushering in newspeakers with proposed titles:Forincluding further exploration and
                             Symposium Suggested Speakers:1. Dr. Mayur Lodaya2. Klavs Jensen, Ph.D., such as chemical,
Continuous processing has long been applied successfully in all the chemical/material processing industries Department of Chep
                             Symposium Suggested Speakers:1. Bing-Shiou size distribution and morphology. Ingelheim Phar
Physical properties of pharmaceutical particles are greatly affected by particleYangPrincipal ScientistBoehringer In many occasio
                             the concepts and practical aspects Pharmacogenetics in Clinical Medicine and Drug Discovery (35 m
                                             1
This session will introduce Sunrise Session) The Application ofof developing personalized treatment using pharmacogenomics (
                             Sunrise Session oderator: Phillip M. surrounding interactions amongst pharmaceuticals and currently
                                             M
In this session, participants will learn about some of the issues Gerk, PharmD, PhD;Candy Tsouronis, Pharm.D. Clinical Issues w
                             Short Course Keith E. Conerly, MBA, CQA, CQMDirector, and USP expertise, resulting in Pharmaco
This course builds upon GMP practices by incorporating a Quality Systems Approach Quality AssuranceUnited Statestime and m
                             Roundtable      1) Name: Gopi and the elderly, Position: Director, New Technology, EurandCountry: n
Approximately half of the population, in particular childrenVenkatesh, PhD have difficulty in swallowing tablets and capsules. A U
                             Roundtable      1) Name: Gopi and the elderly, Position: Director, New Technology, EurandCountry: n
Approximately half of the population, in particular childrenVenkatesh, PhD have difficulty in swallowing tablets and capsules. A U
                             Symposium 1.A.C. ADEBAJO Ph.D., NigeriaPhytochemical Analysis and Formulation of Nigerian a
Prohibitive high cost of orthodox drugs, cultural acceptability, less side effects, etc. have continued to make herbal drugs to be A
                                             Speaker tools and techniques in drug developmentSpeaker: Majid MoridaniTexas de
Genomics, proteomics and metabonomics are new1. Pharmacogenomicsthat are increasingly used in the optimization of drug Te
                             Roundtable
                                             1.
Phlorizin for targeting SGLT1 in ischemic stroke – target melanoma, ischemia strok
In this roundtable we will discuss natural plant products polyphonols as prodrugs to selectively Thomas Abbruscato, Associate P
                             Roundtable
                             Symposium 1. Steve changes. These physiological changes are expected to lead to alterations in
Pregnancy is associated with several physiologicalCaritis / Gary Hankins, USA, Physiological changes during pregnancy;2. Mary
                             Short Course 1. of disease progression and therapeutic Ph.D., St. Personalized medicine and teher
Biomarkers play an integral role in the study Introduction of objectives: Prasad Tata, response. Louis, MO.2. Drug development
                             Roundtable      Nara Variankaval, Merck & CO, USA; Aaron Cote, drug development process. Allerg
Currently, API and formulation development occupy two distinct spheres of activity within the Merck & Co, USA; Anu Gore,API is
                                             D
                             Sunrise Session r. William L. Jorgensen (Professor, Yale University), ―Efficient Drug Lead Optimizatio
Rational drug design based on protein structure and mechanism has recently resulted in impressive outcomes in drug discovery
                             Roundtable      1. C.T. Vishwanathan, FDA, a current market from of $100 Generics lose their pate
It has been projected that between 2005-2010, brand name drugs withUSA, or some oneshare EUrope,million will are acceptable
                             Symposium Clive Wilson, UK, Physiologocal challenges in condition is the subject of an increasing
The physiology of the gastro-intestinal tract in relation to drug dissolution and absorption the GI tractWerner Weitschies, German
                             Short Course Course Coordinator (s): Prasad Tata, St. Louis, UPLC offers certain advantages over
In this program we will draw a road map for bioanalytical campaign in drug development. MO, and Mario Rocci, NYIntroduction:
                             Symposium Amin Rostami-Hodjegan, UK, Incorporation of physiological – namely, knowledge in
Modelling and simulation of the processes that define the plasma concentration-time course of a drug and in vitroabsorption, dist
                             Short Course definitions of mechanisms, discussion of the relationship of polarity and separation m
Content, originating from USP-NF, coversHoracio N. Pappa, Ph.D.Senior Scientist, General Chapters GroupUSPSuggested Title
                             Symposium Overview of Site-specific Drug intracellular target-specific drug and gene delivery face
Drug targeting strategies that involve site specific prodrug activation and Activation StrategiesTycho Heimbach, Ph.D.Novartis P
                             Mini-symposium  Modeartor: Prasda Tata, this symposium we propose TBD Kathy Guicomini, UCSFSp
Pharmacogenomics an area is eciting and requiring lot of clarity, inSt. Louis, MOSpeaker 1: Titleto give an insight of pahrmacog
                             Symposium Ping Gao, USA, non-conventional active forms and formulations are required to achie
A large fraction of NCEs have sufficiently low solubility that"In Vitro Tests for Selection of Preferred Lipid-Based Formulations";R
                              to go over the essential aspects of LC-MS/MS method development with exaamples, difficulties Wye
In this short course we likeShort Course Moderator: Prasad Tata, Ph.D.Spekaer 1: Sample Prep and Robotics - Allenna Ji, and
                             Symposium Peter Swaan; simulation Langguth;Germany.FumiyoshiYamashita;Japan.
APSTJ proposed:Discuss focusing on 'Computer basedUSA. Peter of oral drug absorption'.
                             Short be primarily established Sanjay Sehgal; Chuck Hoiberg; Robert Bell; David Mitchell; (NDA) re
The drug product quality used to Course Vijay Tammara;and confirmed by end product testing. New Drug ApplicationJeff Blum
                             Symposium All are US based great deal of technical and scientific information on both the drug su
The drug development process involves the generation of aspeakers: Robert Bell; Ron Tatchek; Mohan Ganpathy; Sanjay Sehg
                             Short Course We will have Industry, Health Authority and eCTD expert Dossiers to cover the Forma
After a very successful AAPS-sponsored first meeting devoted to ¡§Strategic Management of CMC speakers in the eCTD above
                             Symposium Speaker 1: significant impact on development of new chemical entities (NCE). In mos
New pediatric regulations in Europe and the US have John N. Van den AnkerUniversity Medical Center, Utrecht, The Netherland
                             Symposium 1. Johan Gabrielsson, AstraZeneca, Sweden, Linking Formulation Principles to Pharm
Significant progress has been made to link in vitro dissolution profiles of all BCS class drugs directly to pharmacokinetic exposu
                             Symposium All US NDAs that can be submitted to the FDA. Upadrashhta; Henrietta Ukwu
The 505(b)(2) application is one of three types ofbased speakers:Avinash Nangia; Satyam A full NDA is "an application that cont
                             Sunrise Session alvinder VigBristol-Myers very challenging
                                             B
Preclinical formulation development for new Chemical entities can beSquibb Company due to limited API availabilty, limited prefo
                             Roundtable      1.Moheb due FDA, US,General Considerations for Submitting and improved 2.To-b
Driven by soaring worldwide demand for medicinesNasr,to increase of aging population, chronic diseases,Global NDAs; health
                             Roundtable      Michael Macular Degeneration degenerated retinal damage due to disease started u
Treatment of ocular disease such as Age-Related Young, USA,"Repair of (ARMD) and Diabetic Macular Edema (DME)or injury w
                             Symposium ModeratorPankaj B. Desai, the Critical Path to New Medical Products‖ identified the ne
In 2004, FDA in its white paper titled ―Challenges and Opportunity on Ph.D.Professor of Pharmacokinetics and Biopharmaceutic
                             Sunrise regulatory and expensive process of development of for Developing Modified-Release stee
                                             1
Today, with high quality standard ofSession. Avinash Thombre, Pfizer, US, The Roadmapa NCE, pharmaceutical industries Dosa
                             Symposium Salah Ahmed with generic drugs. (India) drugs are copies of brand-name drugs that
Almost half of all prescriptions today in the US are filled (US); Prakash ModyGenericand another invited speaker.
                              limited resources, and the Brasseur, in in vivo clinical studies due to ethical concerns, accurate and
With competitive timelines,Symposium 1. James G.restrictions Pennsylvania State University, US, Newest Simulation Models
                                             Speaker #1:Leslie Benet, Ph.D. gender, race, organ between Metabolizing Enzymes,
An individual‘s drug exposure can be altered by intrinsic factors (e.g., age,UCSF, USAInterplay dysfunction, genetic polymorphis
                             Mini-symposium
                             Poster/Podium Y. Shravan Kumar, efflux transporter Gannu, R. Shiva Kumar, of buspirone, a P-gp
Purpose: To investigate the effect of P-glycoprotein (P-gp), anD. Adukondalu, R. and CYP3A4 on transportY. Vamshi Vishnu, P.C
                             Sunrise Session oderator: Tapan Das (Pfizer, St. Louis) and TBDDirect measurement of form develop
                                             M
This session highlights recent advances and application of emerging technologies in parenteral (injectable) dosage surface adso
                              FIP pharmacists and Moridani, PharmD, PhD, Texas Tech HSC, USA2.John Porter, MD, underlying
The course is designed forShort Course 1.Majidclinical scientists interested in understanding clinical diagnostics andUCL, UK3.
Accurate assessment of kidney function is critical in the clinical setting to identify early chronic kidney disease (CKD), monitor ki
                             Symposium Speaker 1:Nancy Xu, M.DMedical Officer, Div. of Cardiovascular and Renal Drug Prod
                             Roundtable      OrganizerPrabu Nambiar, Vertex PharmaceuticalsIndustry perspective Pat Noland, l
The container-closure system is an integral part of pharmaceutical products and it is expected to protect the drug- product fromA
                                              metabolite‘s absorption, distribution, metabolism and elimination. They play a of Tran
Transporters can affect a drug‘s or a drugSpeaker #1:Kathy Giacomini, Ph.D.University of California, San FranciscoRole critical
                             Symposium
                              market continue growthOrazem, USA, Pharmaceutical markets nowresults of strong sales Hequn Yin
The global pharmaceuticalRoundtable          Dr. John during the last couple of years, largely as a and in the future; Dr. for new in
                             Symposium Tristan Maurer of Pfizer, U.S.A."Application key to success for many drug discovery pr
Understanding the drug target and compound characteristics that drive efficacy is the of PK/PD in Drug Discovery: Pfizer Experie
The talks in this roundtable session give aDr. William L. Jorgensen (Professor, Yale University), ―Virtual screening and de novo d
                             Roundtable       brief overview of computational drug design and discovery through state-of-the-art co
                             Short Course Edward Narke, USAHedley Rees, UKDaniel Torok modernize global regulation of the
ICH has introduced pharmaceutical manufacturing and product quality initiatives designed to Ph.D., USAStephan Krause Ph.D, U
                             Symposium Dr. Bin Liu (Associate thermostable monoclonal antibodies, University of California-S
The talks in this symposium will be focused on rational design ofProfessor, Department of Anesthesia, protein-protein interaction
                             Mini-symposium  Jose Pinheiro [USA], Adaptive Designs for Phase 3 Dose 3 attrition due to of the PhR
Poor dose selection has been identified one of the primary factors underlying the high rate of PhaseSelection: Report insufficient
                             Short Course Edward Narke, USAHedley Rees, UKDaniel Torok modernize global regulation of the
ICH has introduced pharmaceutical manufacturing and product quality initiatives designed to Ph.D., USAStephan Krause Ph.D, U
                             Symposium Dr. Christopher progress (Director, Center for Vaccines and Immunity, Nationwide C
The talks in this symposium will be focused on the currentM. Walkerand general challenges in design and development of variou
                                             D
                             Sunrise Session r. David Baker (Professor, University of Washington), ―State-of-the-art computationa
The lectures in this Sunrise session will demonstrate how state-of-the-art computational approaches can help to discover and de
                                             Dr. Donald Landry (Professor and Chair in vitro and Columbia University), ―Factors a
The talks in this roundtable session will be focused on the correlation between the of Medicine,in vivo activities of protein drugsa
                             Roundtable
                             Roundtable      Moderator: Prasad Tata, St. efficacy of biotech products immunogenicity St. LouisSpe
In addition to the pharmacodynamic measures to establish therapeuticLouisSpeaker 1: Title TBD, Andy Vicks,Ph.D. is an additio
                             Roundtable      Moderator - established between the regulatory agencies Dr. Moheb NasrEMEA Japa
Internacional Conference on Harmonization (ICH) wasGopi Vudathala, Sanofi AventisFDA Speaker - of the US, Europe and Spe
                             Roundtable      carefully extrapolate drug-drug, drug-food interactions and transporter interacions for
In this round table we will discuss how to Moderator - Prasad Tata, St. Louis, MOSpeaker 1. Drug-drug and drug-food or drug-hc
                             Sunrise Session oderator/Presentor: Dr. Nagesh Bandi
                                             M
Under the cGMP initiative for 21st Century the FDA has been encouraging pharmaceutical companies to invoke modern techno
                             Sunrise Session speakers art. We must
                                             3
Writing research paper or a scientific proposals is anto be decided.be able to introduce creativity into these writings rather than
                                             Dr. David Baker Rational approaches of Washington), protein drugs are becoming t
A common problem for therapeutic proteins is the stability.(Professor, University to stabilization of―Stabilization of protein drugsm
                             Roundtable
                             Roundtable      Peter via small medicine shops that often Feasibility of a Safe Pill Net; with other con
Most of the worlds population access medicinesPennefather, Canada, Technological distribute medicines together James Orbins
                             Sunrise Session liver expression of USA, Post transcript therefore of drug transporter expressions,
                                             J
Inflammation is known to link to changes inashvant D Unadkat,drug transporters andregulation markedly impair hepatic detoxific
                             Symposium Laura therapy
Use of imaging surrogate markers in monitoring L. Boles Ponto, Ph.D.PET Imaging CenterIowa City, Iowa 52242Brian R. MoyerC
                             Symposium Feng for pharmaceutical applications is growing rapidly. Bioavailability EnhancementS
Interest in hot melt extrusion (HME) techniques Zhang, Ph.D. - Application of Hot-Melt Extrusion in HME offers several advantag
                             Roundtable       specific genomic and proteomic City, Iowa 52242Brian R. MoyerContractor/ Subject M
Personalized imaging - making probes forLaura L. Boles Ponto, Ph.D.Iowa target
                             Roundtable      Laura L. Boles Ponto, Ph.D.Iowa City, Iowa
Recist to Persist - the CT measure of tumors versus functional residence and kinetics52242Brian R. MoyerContractor/ Subject M
                             Symposium Laura L. Boles Ponto, Ph.D.Iowa City, Iowa 52242Brian R. MoyerContractor/ Subject
Neurologic biomarkers - New imaging agents for detection of neuropathology and their use in measuring therapeutic efficacy M
                             Roundtable      Laura L. Boles Ponto, Ph.D.Iowa City, Iowa 52242Brian R. MoyerContractor/ therapy
The explosion of imaging probes and platforms in drug development and their integration assessing tumor response toSubject M
                             Roundtable      Laura L. Boles Ponto, Ph.D.Iowa City, Iowa 52242Brian boundaries
Non-invasive assessment of radiation injury - applications in determining appropriate radiotherapyR. MoyerContractor/ Subject M
                             Roundtable      Laura L. Boles Ponto, Ph.D.Iowa City, Iowa 52242Brian R. MoyerContractor/ Subject M
Dual modality imaging probes and applications in biologic research
                                             Laura of Alzheimer‘s Ph.D.Iowa
Use of amyloid imaging agents in the monitoringL. Boles Ponto, therapies City, Iowa 52242Brian R. MoyerContractor/ Subject M
                             Roundtable
                             Symposium Laura L. Boles the imaging sector, what imaging can realistically provide !!!
What industry and the FDA need from imaging and from Ponto, Ph.D.Iowa City, Iowa 52242Brian R. MoyerContractor/ Subject M
                             Sunrise therapy L
Use of PET in monitoring of cancerSessionaura L. Boles Ponto, Ph.D.Iowa City, Iowa 52242Brian R. MoyerContractor/ Subject M
                             Sunrise Session eert Verreck, Belgium, ―Solid Dosage Forms from Hot-Melt Extrusion (HME) therape
                                             G
Poorly water soluble drug substances with suboptimal oral absorption are prevalent in significant proportions within mostExtruda
                             Sunrise Session D
PK/PD modeling using imaging approachesr Meindert Danhof Leiden University
                             Roundtable      Proposed development of new biotherapeutics, studies of Tocilizumab with cytochrom
In recent years, there is a tremendous growth in the Speakers: 1.Disease-Drug interaction including proteins, monoclonal antibod
                             Roundtable      incorporated throughout of pharmaceutical industry. under QbD. Paul Dickinson, A
Quality by Design (QbD) has been rapidly1. Industrial experiencesthedrug product developmentThe role of industry, academia,
                             Roundtable      David Evans, of drug patents over Raritan, NJ;Dave Smith, same Sandwich, UK;Dav
The Pharmaceutical Industry faces the large-scale loss Johnson & Johnson, the next 3-4 years. At the Pfizer, time drug approvals
                             Symposium Raj Suryanarayanan, University of Minnesota, bench scale Physical and during the m
One of the tenets of Quality by Design (QbD) is that the drug formulation prepared at theTalk entitled: remains intactChemical St
                             Symposium 1a) Where are In 2012 the generic drug go?, Andre Jackson be worth 178 billion US$
The current market share of generic drugs is about 75%. we-Where do we need to market is forecast to PhD, CDER, OCP, FDA
                             Symposium 1.An overview of key to publications in by which lipid formulations can improve oral dr
Modern interest in lipid based formulations may be traced back in-vivo processes 1980‘s which tended to focus on the in-vitro dru
                             Symposium Tom A. Baillie, Univ. Washington, Seattle;Han experienced the arrival and use Perpig
The search for novel, not yet discovered chemical entities, which are druggable we havevan de Waterbeemd, Consultant, of seve
                             Sunrise Session oderator: Prasad Tata, Ph.D.Spekaer 1: Peter Bonate, GSKSpeaker 2: Ted Grecella
                                             M
Translational scientists and developmental pharmacokineticisits use Modeling and Simulation tools extensively. In this sunrise s
                             play the role harmless Prasad TataTwo light or fluorescence or
Pharmaco imaging agents Roundtable ofModerator agents that emitsspeakers: to be decided light up a tissue. These agents of
                             Symposium 1. Clinical Development of Hepatocyte Growth Factor Gene gene therapy Treatment
Plasmid-based gene delivery has had several successes in the past few years. Unlike the viral basedExrpession foronly positive
                             Symposium Urs one of the main focus areas to improve drug therapy regarding efficacy, also addr
Personalized healthcare has recently becomeA. Meyer, Biocenter Univ.Basel & Swiss Systems Biology Institute, Switzerland; Co
                              oligonucleotides poses numerous challenges, sometimes varying based upon the class of the oligo.
Quantitation of therapeuticRoundtable        J. Shawn Roach - USA; Mark Hail - USA; Marc Lemaitre - USA; Pam Pavco - USA; Re
                             (CFR parts      Moderators:
Steve Simmons. Ph.D., 

                                                          


Current cGMP regulations Roundtable 210 and 211) indicate the requirement of process validation New Product Quality Operatio
                                                            
                          Vice             
in
                                                                                      
 President, 
 both general as well as spe
                             Symposium oral dosage 
         
Gregory E. Amidon which are solubility 
 Shi, Ph.D. rate limited Ga
                                                                                                        Yi
Numerous challenges exist in developing Moderators: forms, especially those (Univ. of Michigan)
 dissolution (Abbott)
 (eg:
                                                                                                        or                    Ping
                                                                                                                              

                             Sunrise Session idenori infection, but excessive or Masayuki Miura - University of Tokyo; to a range
                                             H
Inflammation is a defensive response to injury and Ichijo - University of Tokyo;inappropriate inflammation contributes Makoto Ari
                             Open Forum 1. Potential Issues of Therapeutic Inequivalence for controlled manner to achieve des
Modified release (MR) drug products are complex dosage forms designed to release drug in aModified Release Products, Sune
                                        Open effect administration of soybean seeds (chronic & acute) on the bioavailability of drugs Saud
            The study was done to study the Forumof Dharmender Singh, Pharmaceutical Services, Al Hammadi Hospital Co., Riyadh,meta
                                        Open Forum space are essential to Pharmaceutical Dosage Form Payload Aboard Space Mission
            Efficacious medicines to treat illnesses in Lakshmi Putcha; USA; avoid untoward consequences of astronaut health. In this study
                                         to set dissolution specifications, no uniform and structured Biorelavent Dissolution Tests tests and s
            As per the current processOpen Forum Jennifer Dressman, Germany"Application of process for developing in vitrofor Predictio
                                        Open Forum Organized by:Nagesh Bandi, PhDPrabu pharmaceutical manufacturers to reduce prod
            The implementation of real-time release testing (RTRT) provides opportunities for Nambiar, PhDProposed Speakers1.Roger No
                                                            QbD: How it can help and industry are focusing specifications - Industry perspectiv
            To bring QbD principles to Open Forum 1.
 regulatory agencies to set clinically meaningfulon the development of biorelevant s
                                        dissolution testing,
                                        a successful Remi Yucel, US Patent OfficeScott Bornstein, from the US Patent Office as well as Eu
            This open forum builds on Open Forum 2009 Round Table, and would include speakers USAJeffrey A. Lindeman, Ph.D.O'BRIEN
                                        Open Forum Stephen T.Colgan (Pfizer), The Application concept of Quality by Design to the Quan
            The pharmaceutical industry during the past several years has started to embrace theof QbD for Analytical Methods to improve p
            TBD                         Mini-symposium   TBD                                                       N
                                                                                              Yasuhiro Matsumura ational Cancer Center Hospi
            First visit the web         Symposium I have no idea about this but we want to attend trade show.
                                        Hot Topic        3) Dr. M. Tabrizi, USATranslational Considerations, an overview therapeutics (ABTs)
            With the advancement in technologies employed for generation of antibodies, more potent antibody-based2) Dr. Gadi BornStein
                                        Hot (including Ken Waterman, USA: Gastric retentive dosage forms provide nowidely studied with m
            Gastric retentive dosage formsTopic          floating, expanding and adhering) for oral controlled release are benefit over conventi
                                        Hot Topic        David Sperry, Shobha very useful tools for understanding the in - Artificial Stomach an
            Dynamic multi-compartment dissolution testing technologies areBhattachar and Michael Hawley, US, Title vivo dissolution/precip
                                        Hot formulation enjoys Zografi (U. of Wisconsin at and development, likely due to the fact Madison) G
            It appears that solid dispersionTopic        George a renaissance in research Madison) Yu Lian (U. of Wisconsin at that more p
                                        Hot Topic        Joseph Bower, USA, Covance, Comparability regulatory challenge. This discussion w
            The emergence of follow-on biologics in recent years represents a unique scientific andand Immunogenicity: Challenges Faced
                                                          control tool since 1970 when USP in the development of solubilized formulations; M
            Dissolution testing has served as a qualityPing Gao –US – Dissolution studiesMethod 1 first appeared in USP XVIII. Since then,
                                        Hot Topic
                                                         Richard Magin; used in biophysical modelling. This applies to classical Fick‘s laws and
            Since the time of Newton integer order calculus has been USA; Fractional calculus: Introduction and applications to biomedical a
                                        Hot Topic
                                        G. Topic         Prof. Panos Macheras, University the use of milk as a solubilizing/dispersing agent fo
            Recent work (Charkoftaki, Hotet al: Int. J. Pharm. 2010, in press) focused onof Athens, School of Pharmacy, Athens, Greece, "M
                                        Hot Topic        Moderator: Moheb on an increasingly Presentations:1. Updating regulatory becomes
            Abstract: As pharmaceutical companies are beginning to relyNasr, FDATentativecomplex global network of suppliers, itand publi
                                        Hot Topic        Moderator: Lawrence X. Yu, Ph.D., Food and Drug AdministrationSpeakers:Globalizat
            Drugs have long been among the most rigidly regulated of all consumer products. All governments closely oversee the developm
                                                         Antoinette Azevedo, Founder e-SubmissionsSolutions.com; regulatory submissions.
            Electronic common technical document (eCTD) is gaining traction as the required format for electronic Reuben Jenkins, Omnicia
                                        Hot Topic
                                        Hot Topic        Speakers TBD                         Vinod Shah           TBD
            As a leader in the pharmaceutical sciences, the Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Fe
                                        Hot Topic        Dr. Emad Hassan; USA; The A to Z of Soft Gelatin Capsules Formulation and Manufac
            This session will discuss formulation design, process development, manufacturing scaleup as well as evaluation and stability tes
                                        Hot Topic        Moderators:Ajit S. Narang, Ph.D.Bristol-Myers Squibb (QbD) philosophy, process anal
            As the pharmaceutical manufacturing moves away from quality-by-testing to a quality-by-design Company andSherif I. Badawy,
                                        Hot Topic         affect Quamby, Genentech, USA Current industry practice: analytical strategies an
            Immune response to a biotherapeutic canValeriethe drug safety and efficacy-in patients. Assessment and characterization ofand
                                        Hot Topic        Keith Webber, the US, provides for United States, pathway for biosimilar and intercha
            The Health Care Reform Bill (HCRB), recently passed in Ph.D. (Invited), FDA,an abbreviated Regulatory Pathway for Biosimilar
                                        Hot is to        Dr. Abu Serajuddin,USA, solid dispersion; Dr. Ping Gao, USA, SEDDS; Dr. solely scien
            The purpose of this discussion Topicview the novel drug delivery development process as a business process than a Der-Yang L
                                                         Therapeutic Equivalence approving a new generic drug product Ph.D., JD. DBEII/OG
            Are there situations where Hot Topicfs current regulatory criteria for of Multiphasic Products: Barbara Davit,are inadequate to ens
                                        US-FDA

                                                         David Jacobson-Kram, Ph.DOffice of New Drugs, CDER,U.S. Food and Drug (previou
            In an effort to meet the medical needs of the developing world and to help in the search for new treatments, establishedAdminis
                                        Hot Topic
                                         narrow therapeutic range Representative; TPD Representative; FDA Representative
            Critical dose drugs includeHot Topic         EMEA/FIP (NTR) /index (NTI) drugs and are defined as those drugs where small diffe
                                        Hot Topic        Mansoor Khan, US FDA CDER (USA) "INTRODUCTION"; James Drennan, Dusques
            The US Food and Drug Administration (US FDA) has been working with the National Institute for Pharmaceutical Technology an
            Translational biopharmaceutics is emerging from integration of biopharmaceutics and QbD. It aims to deliver drug products with
                                        Hot Topic        Speaker 1: Maria Teresa Cruanes, USA, Quality Target Product Profile-drive specificat
                                        Hot lifecycle has become increasingly important in the Lesko, FDA
            Extending the product‘s patent Topic         Greg Szpunar, Merck & Co., Inc.; Larry pharmaceutical industry. High R&D costs, the
                                        Hot Topic        Vijay Tammara, markets is placing drug Midthun, agencies under pressure to realig
            The impending arrival en masse of biosimilars on WesternMerck & Co., Inc.; Karen regulatoryFDA
                                        Hot Topic        Robert Temple, FDA; Health announced
            The Food and Drug Administration and the National Institutes ofNIH Speaker TBD a plan to help the FDA make swifter decision
                                        Symposium PROPOSED BY ELIAS FATTAL (Univ Paris) SUBMITTED BY G TUCKER1.Russell J.
                                                                                              Elias Fattal         University of Paris Sud 11
            1.The development of drugs with high selectivity on a molecular target allows the design of efficient medicines with less toxicity.
            

                                           Beloo Mirakhur, occurring antibodies specific for Fab and Considerations: IgE Antib
              Many studies have documented the presence of naturallyBristol Myers Squib, USA "HypersensitivityFc (rheumatoid factor) frag
                                        Mini-symposium
                                        Mini-symposium                                        Hideyoshi Harashima  Hokkaido University
ccine Delivery                          Mini-symposium                                                             O
                                                                                              Shinsaku Nakagawa saka University
low-on Biologics: A Global PerspectiveSymposium                                               Robert Bell          Drug & Biotechnology Develop
            This is a test submission Personal Development
 Organizer 1                     Organizer 2 Organizer 2                      Organizer 3       Organizer 3
     Email        Organizer 2     Affiliation       Email      Organizer 3     Affiliation          Email
susan.lum@utoronto.ca
                Yunxia (Vivian) AstraZeneca vivian.bi@astrazeneca.com
dawn.downey@hotmail.com Bi
                Vivian Gray     V. A. Gray     vagray@rcn.com
horst-dieter.friedel@bayerhealthcare.com Consulting, Inc. Saji Thomas Par Pharmaceutical       sajithomas@msn.com
                Tom Sam
JASSALC@wyeth.com                              tom.sam@spcorp.com
                                Schering Plough Corporation
                Larry Lesko
pollen.yeung@dal.ca             FDA                           Bruno                            bruno.flamion@fundp.ac.be
                                               leskol@cder.fda.gov Flamion EMEA/CHMP Scientific Advice Working Party
                Qingcheng                      qmao@u.washington.edu
fujita-t@ph.ritsumei.ac.jp Mao University of Washington
                Brian Booth
mark.arnold@bms.com             FDA                           Howard Hill
                                               brian.booth@fda.hhs.gov                         hillh@ukorg.huntingdon.com
                                                                            Huntingdon Life Sciences
                Todd Cecil      U.S. Pharmacopeia
horst-dieter.friedel@bayerhealthcare.com       tlc@usp.org Chikako Yomota                      yomota@nihs.go.jp
                                                                            National Institute of Health Sciences
Stephen.T.Colgan@pfizer.com
                Michiho Ito
ctamayo2@comcast.net                           michihoi@pharm.kyoto-u.ac.jp
                                Kyoto University
wchambli@olemiss.edu
                Irving Wainer                  wainerir@grc.nia.nih.gov
haginaka@mukogawa-u.ac.jp National Institutes of Health
                Daan
jian.li@evonik.com Crommelin                   daan.crommelin@tipharma.com
                                Top Institute Pharma
                Frank Gargiulo MannKind Corporation
terasolutions@yahoo.co.uk                                     Somak Das
                                               FGargiulo@MannKindcorp.com                      somak.das@bms.com
                                                                            Bristol-Myers Squibb
fgarofolo@algopharm.com
                Tsutomu Hatano
yezuguang@vip.sina.com                         hatano@pharm.okayama-u.ac.jp
                                Okayama University
                Juan Irache
ping.gao@abbott.com                            jmirache@unav.es
                                University of Navarra
                Fabio                          fgarofolo@algopharm.com
lowess@advion.comGarofolo Algorithme Pharma Inc.
                Fumiyoshi Yamashita
jean.surian@astrazeneca.com Kyoto University   yama@pharm.kyoto-u.ac.jp
tudor.arvinte@unibas.ch
                Johan Gabrielsson
m.danhof@lacdr.leidenuniv.nl AstraZeneca Johan.Gabrielsson@AstraZeneca.com
                Yuichi SugiyamaThe University sugiyama@mol.f.u-tokyo.ac.jp
g.t.tucker@sheffield.ac.uk                     of Tokyo
                Donna
a.h.maitland@uu.nl Arnett UAB                                 Stephen Kimmel
                                               Arnett@ms.soph.uab.edu                          stevek@mail.med.upenn.edu
                                                                            University of Pennsylvania
cfo@farma.ku.dk                 American Association of Pharmaceutical Scientists
                Enrico Mastrobattista          e.mastrobattista@uu.nl
                Yusuke Tanigawara University, School of Medicine
                                Keio
carlos.langezaal@sanofi-aventis.com            tanigawa@sc.itc.keio.ac.jp
                Paul Wan Sia Heng
otilia.koo@bms.com                             phapaulh@nus.edu.sg
                                National University of Singapore
carlos.langezaal@sanofi-aventis.com
                James Bradner Dana-Farber Cancer Institute/Harvard Medical School
g.brooks@reading.ac.uk                         james_bradner@dfci.harvard.edu
                Bryan Tweedy ACS
manuel.zahn@3rpc.com                           b_tweedy@acs.org
                Jiahui Hu
sharmista.chatterjee@fda.hhs.gov               jiahui.hu@novartis.com
                                Novartis Pharmaceuticals Corporation
                John Carpenter
w.jiskoot@lacdr.leidenuniv.nl Univ of Colorado john.carpenter@ucdenver.edu
                Deborah Finco Pfizer
ggunn@its.jnj.com                              deborah.finco@pfizer.com
                J. Brian HoustonThe University brian.houston@manchester.ac.uk
manthena.v.varma@pfizer.com                    of Manchester
                Gert
duxins@umich.edu Storm                         g.storm@pharm.uu.nl
                                Utrecht University
                Hyo                            hkuh@catholic.ac.kr
dsalazar@dsi.com Jeong Kuh The Catholic University of Korea
christian.noe@univie.ac.at
npe.vermeulen@few.vu.nl
                A,
obj@farma.ku.dkHayes                           awallacehayes@comcast.net
                                Harvard University
                Yoshinobu       Kyoto
murli.krishna@bms.com Takakura University      takakura@pharm.kyoto-u.ac.jp
                David Flockhart Indiana University
l-fleckenstein@uiowa.edu                       dflockha@iupui.edu
                Mary Relling
urs-a.meyer@unibas.ch                          mary.relling@stjude.org
                                St. Jude Children's Research Hospital
                Hiroyuki Kusuhara
s.neuhoff@simcyp.com                           kusuhara@mol.f.u-tokyo.ac.jp
                                University of Tokyo
                Latiff Hussain FDA
prabu_nambiar@vrtx.com                         latiff.hussain@fda.hhs.gov
                Hiroaki                        yuasa@phar.nagoya-cu.ac.jp
benet@itsa.ucsf.edu Yuasa Nagoya City University
shinji@pharm.setsunan.ac.jp
yone@phar.toho-u.ac.jp
                Christian Hoe
sasaki@phar.kyushu-u.ac.jp University of Sydneyshoe7855@usyd.edu.au
                Erin Schuetz                   erin.schuetz@stjude.org
Kroemer@uni-greifswald.de St. Jude Children's Research Hospital
                Robert Shoemaker
yamori@jfcr.or.jp               DPT            shoemakr@mail.nih.gov
                Tycho Heimbach
handan.he@novartis.com                         Tycho.Heimbach@novartis.com
                                Novartis Pharmaceuticals Corporation
pbryan@celgene.com
rho@confarma.fr Satish Singh    Pfizer, Inc.   satish.singh@pfizer.com
               De-an Guo                       gda5958@163.com
maureen@denalibiotech.com Shanghai Institute of Materia Medica,CAS
               Rogerio                         rgaspar@ff.ul.pt
hbhattac@uthsc.edu Gaspar University of Lisboa (Portugal)                                       bjl@kangwon.ac.kr
                                                               Beom-Jin Lee Kangwon National University
               Elizabeth
p.york@bradford.ac.uk Colbourn                 c
                               Intelligensys Ltdolbourn@intelligensys.co.uk
               Jeffrey Barrett Children's Hospital of Philadelphia - University of Pennsylvania
Tycho.Heimbach@novartis.com                    barrettj@email.chop.edu
               Peter York
okamotoh@ccmfs.meijo-u.ac.jp                   p.york@bradford.ac.uk
                               Institute of Pharmacetuical Innovation, Bradford University, UK
               Rainer Muller Free Universitympharma@zedat.fu-berlin.de
j.anwar@bradford.ac.uk                           Berlin
ehm@farma.ku.dk                                of Tokyo
               Tatsuro Irimura The University irimura@mol.f.u-tokyo.ac.jp
               Thirunellai Venkateshwaran venkattg@wyeth.com
prabu_nambiar@vrtx.com         Wyeth Research
qiang.ye@hotmail.com
               Hiroyuki Kusuhara
hua.zhang@fda.hhs.gov                          kusuhara@mol.f.u-tokyo.ac.jp
                               University of Tokyo
               Mary Cromwell Genentech, Inc.
hanns-christian.mahler@roche.com               cromwell.mary@gene.com
               Keiji Yamamoto Chiba University
agentry@its.jnj.com                            yamamotk@p.chiba-u.ac.jp
tsutomu@hiroshima-u.ac.jp
ajd@usp.org Raimar Loebenberg                  raimar@ualberta.ca
                               University of Alberta
               Ross McKinnon University of South Australia Hiroshi Suzuki University of Tokyo
okezie.aruoma@touro.edu                        ross.mckinnon@unisa.edu.au                       suzukihi-tky@umin.ac.jp
               Dennis O'Connor                 dennis.oconnor@boehringer-ingelheim.com
lisbeth.illum@illumdavis.com Boehringer-Ingelheim
               Akihiro Hisaka University of Tokyo
r.scott.obach@pfizer.com                       hisaka-thy@umin.ac.jp
               Kathleen
gyou@rci.rutgers.edu Giacomini                 kathy.giacomini@ucsf.edu
                               Schools of Pharmacy and Medicine, University of California San Francisco
               Margareta Hammarlund-Udenaes
                               University of Uppsala
jean-michel.scherrmann@inserm.fr               mhu@farmbio.uu.se
               Bruno Stieger
tamai@p.kanazawa-u.ac.jp University of Zurich  bstieger@kpt.unizh.ch
               Peter Milligan Pfizer
n.holford@auckland.ac.nz                                       Liping Zhang                     liping.zhang3@bms.com
                                               peter.a.milligan@pfizer.com Bristol- Mayers Squibb
               Majid Moridani Texas Tech University Health Sciences Center
l-fleckenstein@uiowa.edu                       moridani@yahoo.com
               Liping Zhang Bristol- Mayersliping.zhang3@bms.com
saehochong@snu.ac.kr                             Squibb
               Zhi-Nan Chen                    znchen@fmmu.edu.cn
pankaj.paranjpe@bms.com Chinese Academy of Engineering         Vikram Sadineni                  vikram.sadineni@bms.com
                                                                              Bristol-Myers Squibb Company
               Jan Zorgdrager                  jan.zorgdrager@solvay.com
Arya.Jayatilaka@pfizer.com Solvay Pharmaceuticals B.V.
               Jing Liu
Arnab.Mukherjee@pfizer.com Pfizer              jing.liu@pfizer.com
               Michaela
joleen.white@bms.com Golob MerckSerono Michaela.Golob@merck.de
               Hiroaki                         okada@ps.toyaku.ac.jp
moridani@yahoo.comOkada Tokyo University of Pharmacy and Life Sciences
zhan@uky.edu   Akiko Itai                      itai@immd.co.jp
                               Institute of Medicinal Molecular Design
               Sherif Badawy Bristol-Myers Squibb Company
ajit.narang@bms.com                            sherif.badawy@bms.com
               Hirofumi Takeuchi
tapan.k.das@pfizer.com                         takeuchi@gifu-pu.ac.jp WinterUniversity of Munich
                               GIFU Pharmaceutical University  Gerhard                          gerhard.winter@lrz.uni-muenchen
               Ruiwen Shi
araiche@surmodics.com          Allergan        Shi_Ruiwen@allergan.com
yangz@bms.com                                  jinding@mail.ncku.edu.tw
               Jin-Ding Huang National Cheng Kung University
               Katsuhide Terada
vodak@bendres.com              Toho University terada@phar.toho-u.ac.jp
               James Polli
hua.zhang@fda.hhs.gov                          jpolli@rx.umaryland.edu
                                                                of Artursson
                               University of Maryland SchoolPerPharmacy University of Uppsala   per.artursson@farmaci.uu.se
               Panos Macheras  University of Athens
luis.pereira@childrens.harvard.edu             macheras@pharm.uoa.gr
               Elias Fattal
Harasima@pharm.hokudai.ac.jp                   elias.fattal@u-psud.fr
                               Universite de Paris-Sud
               Makoto Arita
harai@mol.f.u-tokyo.ac.jp                      marita@mol.f.u-tokyo.ac.jp
                               University of Tokyo
               Hitoshi Sasaki
wolfgang.sadee@osumc.edu Nagasaki University   sasaki@nagasaki-u.ac.jp
iwatsubo@mol.f.u-tokyo.ac.jp
               Kai-Xian Chen                   kychu@mail.shcnc.ac.cn
tomioka@pharm.kyoto-u.ac.jp Chinese Academy of Science
               Eva-Maria Muchitsch Innovations GmbH
prabu_nambiar@vrtx.com         Baxter          eva_muchitsch@baxter.com
               Henri Manasse ASHP
tirie@gpo.kumamoto-u.ac.jp Jr.                 evp@ashp.org
               Bill Charman Monash University
l-fleckenstein@uiowa.edu                       bill.charman@vcp.monash.edu.au
               Cynthia Reilly ASHP
sakaedat@pharm.kyoto-u.ac.jp                   CReilly@ashp.org
               Kenneth Norris
john.carpenter@ucdenver.edu Pfizer             kenneth.j.norris@pfizer.com
               Sabine
brownck@lilly.com Kopp         WHO             kopps@who.int
               Arto Urtti
yakusetu@pharm.hokudai.ac.jp                   arto.urtti@helsinki.fi
                               University of Helsinki
               Kazuo Maruyama
nakagawa@phs.osaka-u.ac.jp Teikyo University   maruyama@pharm.teikyo-u.ac.jp
               Teruhide
rgb@drugbiodev.com Yamaguchi                   yamaguch@nihs.go.jp
                               National institute of health sciences
carlos.langezaal@sanofi-aventis.com
               Xiaoliang Wang                  wangxl@imm.ac.cn
marya.murray@nutrilite.com Institute of Materia Medica, CAMS
               Alex Sparreboom Jude
                               St.             alex.sparreboom@stjude.org
david.mitchell@mitchellpharma.com Children's Research Hospital
               Bent Halling-Sørensen
nishimur@nihs.go.jp                            bhs@pharma.ku.dk
                               University of Copenhagen
rima.kaddurahdaouk@duke.edu
                             Mary Spilker
             narayan.cheruvu@covidien.com                    Mary.Spilker@pfizer.com
                                              Pfizer Global Research & Development
, USA; 2. BDDCS: Concepts and Application, Leslie Benet, Ph.D., USA; 3. EU Perspectives, Professor Peter Langguth, Johannes Gutenberg
Desmond G. Hunt, USP
      2.Analytical techniques for measuring subvisible particles by Cristy Dougherty, GSK

                           
                                                                                     
3.Challenges in quantifying an
speaker

Criticality from an innovator‘s perspective – speaker from a PhRMA company
     
Criticality from a generic manufacturer‘s perspective
h E. Stevens, PhD, MBA, Chief Scientific Officer and Executive Vice President, Camargo Pharmaceutical ServicesTopic 2: 505-b-2 and Reg


                                                                                                                        

                                                                                                                        •

al assessment of the development of bioanalytical technologies in the regulated and unregulated environment, TBA 
 Thoughts on incorpora
                            Nagesh Bandi
              vijay_tammara@merck.com Wyeth                  bandin@wyeth.com
ED BY GT TUCKER
1.
    

                                                                                       

                                                                                                                2.

                       
 Opening lecture: Vaccine delivery from factory to lymphocyte. Martin Friede (WHO)
 Delivery of classical and new
ea.europa.eu; Dr. Emily Shacter (FDA / USA)Emily.shacter@fda.hhs.gov; Dr. Anthony Ridgway(Health Canada / Canada)Anthony_Ridgway@
Utrecht University; The US Perspective - Keith Webber, PH.D., FDA; The Australian Perspective - TGA Representative; The Asian Experien
dynamic modeling.Sarah F. Hamm-Alvarez; USA; Current understanding of expression of genes functioning in lipid homeostasis in the eye: i
ED BY GT TUCKERSteve Kern (USA)K. Tojo (Japan)A.Urtti (Finland)
UBMITTED BY GT TUCKERa) Introduction to vaccine delivery and particulate vaccine formulations, Asso. Prof. Camilla Foged, University of
 rlund-Udenaes, Sweden,The value of microdialysis in pre-clinical safety and efficacy studies;Hartmut Derendorf, United States orMeindert D
                                                                   

                                                                   2.
 Marc Descamps: Driven Materials: Amorphous Crystal Duality
 Dr. Simon Bates or Prof Rodolfo Pinal: Refined X Ray diffraction technique
 e strategies to reduce API utilization in high shear granulation; Dr. Feng Li (Merck & Co Inc), USA, Material sparing approaches to predict fe
 tional Softgel Technology: Formulation, Development, and Manufacturing; Norm Stroud, USA - Catalent Pharma Solutions, Vegicaps Soft T
actors and Process Parameters on Functional Attributes of Sustained-Release Theophalline Tablets Prepared by Roller Compaction; Dr. Abh
pectiveQualification of genotoxic impunities:- A safety perspectiveAnalytical challenges for PPM specification:- saji ThomasGenotoxic impurit
          

          Par
s, M.Sc.
 Pharmaceutical
      
Method Transfer Strategy and Case Studies – Across Lab, Continent and Countries
      Joerg Hermann, Ph.D.,

                                                                                                                      
                      
G
on and Clinical Outcome"Yaning Wang, USA, "Tumour Size and Survival in Cancer"Andy Hooker, Sweden, "Designing time to event trials"
 philized Paclitaxel Formulation with Improved Efficacy, Safety and Product Stability;
                 

                 b)

ements –AIM; 
 Terrence Tougas (USA) LPM/SPM Ratio and Impactor Sized Mass as Alternative QC Metrics to Grouped Stages;
 Dave        
c)

 ceutical Sciences, University of British ColumbiaThe Global Disease Burden and Medicine Needs of the Global Poor Michelle Childs, Directo

 to terahertz technology in pharmaceutical R&D and processing. Dr Zeitler is regarded as one of the world-leading experts in pharmaceutical
en, USA, Title: Achieving blend uniformity in the manufacture of solid dosage forms - Formulation and process considerations and applicatio

cation for the delivery of peptide therapeutics;W.-C. Shen, PhD, University of Southern California, USA, Receptor-mediated endocytosis as a
nges, and general delivery landscape 2. Prof. Vladimir Torchilin (USA) or Prof. Gert Storm (Netherland); Liposomal delivery of siRNA 3. Prof.
er Senior Vice President, Pfizer Inc and President, Pfizer Global Research and Development. In this role, Dr. LaMattina oversaw the drug di
nd Common Sense Approaches for Success; Dr. Kadriye Ciftci, USA, Regulation of Biologics and Biosimilars;European speaker, Europe, TB
                                   

                                   
Dr.                                       
b)
n oncology: Do we need them? 
 Nenad Sarapa, Johnson and Johnson. 
 Thorough QTc studies in oncology – regulatory perspective.

at Drives the Decision to Outsource and What are the Benefits and Challenges‖ (Dr. Fabio Garofolo, Algorithme Pharma, CANADA).
 – ―Wh  2
                                                                                                                                       

 TM Serajuddin (NJ, USA)Stefanie Siepe (Switzerland)Beom-Jin Lee (Korea)
aker2. Key factors of training program - A compliance or audit officer
products - FDA speakersImpurity guidelines for OTC Products - Industry speakersIs there different requirement of assessing impurities betw
Studies-Joe Short, Wyeth2. Flexible automation tools for In Vivo Drug Metabolism Studies-Tom Lloyd, Wyeth3. New automation advances i
Dr. Lynne Taylor (Purdue University)2. Fundamental understanding of moisture adsorption, mobility and crystallization of amorphous solidsD
 ced but have queried Richard Bergman (USC) and have two alternates in mind if necessary including Sorell Schwartz from Georgetown Univ
NA and miRNA;Tamara Minko, Rutgers, The pharmaceutical delivery and translational research of siRNA and miRNA to humans.
  to facilitate development of anticancer drugs.Yuichi Sugiyama, Japan, Presentation title: PET biomarkers to assess targeted delivery of drug
alence regulations in the "Big 3";Prof. Dr. Kam Midha (Canada) What can be done to harmonize in vivo bioequivalence studies?;Dr. Chikako
 permeability testing; Batheja, P. (US) Development and validation for a phototoxicity assay for topical products; Dayan, N. (US) Implication o
ance, and Supplies to Under-Served Countries.1. Mukund Yelvigi, Wyeth Pharm.2. Jason Kamm, Tunnell Consulting, Inc.
 y requirements from the clinical perspective; Dr. Lawrence Lesko from FDA, USA and his presentation title: Regulatory requiremnets from cl
nneth A Walters, UK, 35 years of progress in TDD?;Kenneth Miller, USA, Modern development challenges in TDD;Gary Cleary, USA, Clinical
ory pathway for therapeutic proteins.DR. JOSEPH P. BALTHASAR, USA, presentation title: Pharmacokinetic and pharmacodynamic modelin
                                                          
2.

r, Program in Pharmacogenomics, Ohio State University
 Ameeta Parekh, Ph.D., Director, R&D Programs, Office of Women's Health, US
he European Pharmaceutical Companies (Philip Timmerman, Johnson & Johnson on behalf of EBF, BELGIUM);2. Case Studies from Global
nderstanding the impact of coating uniformity on quality of extended-release drug products;Carl R. Wassgren, Ph.D. Purdue University, US, D
US, HME as a Mature Manufacturing Technology;Lian Yu, Ph.D., University of Wisconsin¨CMadison, US, Compound Suitability and Formula
 ing CorporationEmail: timothy.p.mitchell@dowcorning.comPhone: 989-496-8652Fax: 989-496-5710Mr. Michell's background includes 15 yea
d matrix effect: Do we need full or partial validation for the same compound in different species? (Dr. Eric J. Woolf, Merck Research Laborato
acy and Linearity Evaluation of Different Analytical Techniques to Remove Phospholipids in Bioanalysis by LC-MS/MS (Dr. Eric J. Woolf, Mer
 inwoong Kim, Korea USA: Prof. Dr. Kuo-Hsiung Lee, School of Pharmacy, University of North Carolina/ or Prof. Dr. Yoshito Kishi, Harvard U
Pharm. Sci., Osaka University USA: Prof. Dr. A. Douglas Kinghorn, College of Pharmacy, Ohio State University Eur.: Prof. Dr. M. A. Lacaille
 Sci., Tokushima University USA: Prof. Dr. J. Du Bois, Stanford University / or Jeffrey Aube, University of Kansas Eur.: Prof. Dr. Akois Fuers

versity, Japan USA: Prof. Dr. Toni M Kutchan, Donald Danforth Plant Science Center, Missouri / Prof. David E. Cane, Brown University, USA
SA: Dr. Sheo B. Singh, Stevens Institute of Technology, New Jersey (Biosynthesis of Platensimycin) / Prof. Rodney Croteau, Washington Un
 gement of elderly from ¡°early old¡± to ¡°late old¡±. Dr. Judith Beizer (Hopkins University NY). Alternate speaker: Prof. Brad Williams (Univers
ements (AIM);Terrence P. Tougas, United States, Large Particle Mass (LPM) / Small Particle Mass (SPM) Ratio and Impactor Sized Mass (IS
 eigneuret (UK);FDA speaker Diane Murphy (US);Industry Speaker Samuel D Maldonado (US); Industry Speaker with formulation experience
Seigneuret (UK)
nced Pulmonary Inhalation Aerosols;Kim Chan, Australia, Characterization of Powders in Manufacturing;Timothy Wiedmann, United States, R
 ng analytical method development and validation, and sample analysis acceptance criteria from a CRO and Sponsor relationship perspective
e bioavailability and efficacy of flavonoids. Thomas Walle, Medical University of South Carolina, 2)Nanoparticles as a drug delivery strategy t
ntestinal absorption barrier.James Polli; USA; Formulation approach for the advanced drug delivery.Shinji Yamashita; Japan; Extrapolation of
ABCG2. This talk will provide information on stem cell expression and function of ABCG2, as well the role of ABCG2 in the transport of endo
 inistration of opioids. Ola Dale Professor, M.D., PhD, Department of Circulation and Medical Imaging, Norwegian University of Science and T
CF and CSF relationships for drugs with different physicochemical properties De Lange EC, Leiden/Amsterdam Center for Drug Research/Ph
and the Parameters that Effect Sensitivity and Specificity during the Development of Chromatographic Assays (Dr. Mario L. Rocci, Jr, Preval
y of Origin: USA;Topic # 1: Recent Advances and Challenges in Treating Asthma and COPD via Inhalation;Speaker: Abhishek Gupta, Ph.D.,
 cal Sciences. University of Alberta, Edmonton, Alberta, Canada, Reduced drug potency despite increased plasma concentration; Luigi M Bi
ebrospinal fluid and the unbound concentration of CNS drugs in the brain; Dr. Haojing Rong, Ph. D., Predictability of preclinical in vitro and in
 ung Fong or Les BenetGeoff Tucker or D BreimerT Nagai



Malcolm Rowland
     
Speaker from India?
 
                                       

                                                                                    


                                             Scenario Analysis – Daan Crommelin
Alternate speakers: Lyle Bootman, Donald Light, Charles H
 it, follow it or oppose it, and how? Lee Jia, Ph.D. Project Manager, NCI/NIH, USA;The globalization of pharmaceutical regulationDavid Vogel
 ween Excipient Material Properties and their Functionality; Chris Moreton, Pharmacopeia and Academic Advancements in Excipient Functio
dose combination drug products; Admassu Abebe, New control systems that can improve scale-up and manufacturing success; Victor Wong
  MHRA speaker; FDA speaker - Gerald Dalpan (US); Industry speaker - Val Simmons, Eli Lilly (UK)

 r Hard Shell Capsules; Dennis O'Connor, Inhalation Capsule-Powder Delivery Requirements; Thombre, Avinash, Novel Controlled-release C
   Clinical Trials (TBD); Industry speaker in Clinical Affairs involved with Global Clinical Trials (TBD); Industry speaker in Pharmaceutical Affair
  erials for granulation; Otilia Koo, Case-studies: New wet granulation techniques and PAT methods to monitor the process; Dilbir Bindra, Roll
   Bi-Botti C. Youan, USA, Overview of ChronoPharmaceutics; Bernard Bruguerolle, France, Chronopharmacokinetics; Shigehiro Ohdo, Japa
 oposed Speaker 1King Holmes (University of Washington, USA)or Mark Wainberg (McGill University,Canada)- AIDS: A Global Challenge; Pr
  crodialysis as a tool to increase the probability of successful development of neuroprotective agents. Dean F. Wong, Johns Hopkins Univers

 Pharmaceutical
edPharmaceutical Consulting and TrainingU.S.A.A one-day short course titled:Conducting Forced Degradation Studies: Conceptual Framewo
                                                                      

                                                                      


Johns Hopkins Hospital, Maryland, USA. ―Stem cell therapy for cancer‖;
Professor Christine Mummery, PhD. Leids University Medical Cen
 M.S. Mayer, Ph.D., Department of Pharmacology, Midwestern University, Downers Grove, IL 60515; amayer@midwestern.edu; (630) 515-6

 d States; Osman Güner, United States
  le TBD; Steve Hammond, Pfizer in USA, Title TBD
 pal, Nootan Pharmacy College, Visnagar-384315. Gujarat, INDIA. (O) +91-2765-231800, (M) +91-9825565796

mi-Hodjegan; UK; Differences between children and adultsWHO speaker; CH; Factors to be considered when formulating pediatric medicines
 eric Drug, FDA, USA, ―Discovery of molecules with a possibility of usage in a combination drug therapy‖; Prof. Robert B. Raffa, Professor &
all molecules; David Volkin, US, Drug-excipient interactins involving large molecules;Jim McGinity, US, The impact of excipient choice on poly
 tectic mixtures and complexation
   
                                                
 
 Topic Ccocrystals with improved dissolution – a
                                      Speaker – Nair Rodriguex from Univ. of Michigan
 
 
 2.
cals, Dr. Nissim Garti, Casali Institute of Applied Chemistry, Chemistry Dept., The Hebrew University, Jerusalem, ISRAEL;2.Development of D
 l molecules: How we can increase the number of drug products on the market? Dr. William Charman, Monash University, Institute of Pharm
 E. Davis, Division of Chemistry and Chemical Engineering, California Institute of Technology, Pasadena, CA, USA;2.Lipid-Based Nanoparticu
 DHarvard Cancer Center at Dana Farber Cancer Institute, USAClinical trial updates for Hsp90 inhibitors in cancer therapy;Duxin Sun, PhDAs
cular markers and sophisticated molecular imaging equipments;Yuji Kuge; Japan; Designing the best treatment plan and monitoring system
 on of N-methyl-2-phenylmaleimide analogues as inhibitors of MAO-B
   (University of Maryland); Srini Tenjarla, USA, Example IVIVCs for MR Products;FDA presenter to be determined, USA, Pros and Cons: Tools
BMITTED BY G TUCKER1.Speakers can be found from the regulatory and industrial partners in the ICH, or from various industrial companie
 UR (Univ Paris) SUBMITTED BY G TUCKER
•
          


                                                   
 Richard Guy (University of Bath UK) In vitro fate and assessment of nanoparticles after skin
Bo

 Michniak; USA; anotechnology based Dermato-pharmaceuticals- An overview
             Rutger‘s University
2.

                                                                                       
                   

                                                                                                           

                                                                                                          
 Nava Dayan; USA; Nanotechnology
 esign;Dennis Murachanian, USA, Formulation Approaches for New Capsule Polymers;Keith Hutchison, UK, First-in-Human Formulation Tre
 h.D., Director, Division Head, BC Cancer Agency, and Professor-UBC, Canada,, mbally@bccr.ca, 604-675-8020

        :

                                                                                                                   
―Tumor Microenvironmen
 antify an adnectin using antibodies and aptamersLinda Obenauer-Kutner, USA: Atomic force Microscopy - a new tool to characterize protein
 cting Human PK
 egration test could be justified for use instead of a Dissolution Test;Johannes Kramer for PHAST in Germany will promote the statistical argu
  tandard Procedure for Qualification for Basket and Paddle Dissolution Apparatus will review the document and its implementation;Erika Stipp
pact of counterfeiting in the global environment2.) Roger Bates, American Enterprises Institution, USA - Developing country perspectives on a
 rmacogenomics of Anti-platelet Agents; Anke-Hilse Maitland-van der Zee PharmD, PhD, Utrecht University, Netherlands, Pharmacogenetics
 urizers -- do they work?Bo Michniak:USA:Retinoids in over-the-counter products -- safety issues?David DRAKE:USA:Essential oils -- flavorin
  are agents and the skin.Bozena Michniak:USA:An organotypic skin model for studies on VX analogues.Ken Walters:UK/USA:Design and ev
nges;Chris Handy, USA, Role of a CRO in Generic TD SystemsSharad Govil, USA, International Issues influencing Transdermal Developmen
 y, USA, Therapeutic burden in cancer revealed by molecular staging; Magnus Ingelman-Sundberg, Karolinska Institute, Sweden, Cytochrom
Title: Effect of ketoconazole and ashwagandha on intestinal transport of buspirone
sG. M. M. Groothuis: Drug metabolism by nonhepatic tissue slices.J. Brian Houston: Drug metabolism by pulmonary and intestinal microsom
n silico, in vitro and in vivo data to direct chemical series selection and optimization; Suobao Rong (USA): Homology-model based approach
 que bioanalytical challenges presented by tissue samples".Gary Schultz, USA, "Biomarker analyses in DNA tissue samples"Walter Korfmach
spective"; 2) Marc Lefebvre, Ph.D., Algorithme Pharma Inc., Canada, "Non-systemically absorbed oral drug products"; 3) Leon Shargel, Ph.D
    "Finding and identifying a quality CRO "; 2) XX, Reliance Clinical Research Services Pvt Ltd, India, "CRO perspective"; 3) CT Viswanathan,
methods‖; Vinod Shah, FIP, USA, ―Bioequivalence based on in vitro comparison‖; Invited, FDA, USA, ―Regulatory perspective‖.
 Dr. Eva Benfeldt, U of Copenhagen, Denmark, ―Microdialysis and DPK‖; Invited, FDA, USA, ―Regulatory perspective‖.
  articulates‘ in Pharmaceutical and Biotech Products
 
   OR

                                                          
 Maria Toler; USA; Pfizer Inc; A Forensic Approach to ‗particulates‘ in Pharmaceutic
  t techniques and instrumentation used in trace analysisScott Aldrich (Independent Consultant)from UltraMikron; USA; Regulatory implication
 ass Dynamics; Marc Cicerone-NIST2. Henning Gieseler, Univ. Erlangen; Germany; Process Analytical Technology: What adds value? 3. Rob
  Higgins, Merck & Co, USA; Ron Borchardt, University of Kansas, USA; Sesha Neervannan, Allergan, USA; Sanjeev Kumar, Merck & Co, U
W TO WIN IT
      Clifton Leaf, Fortune magazine, USA;
CURRENT VIEW ON CANCER METASTASES AND HOW TO INTERRUPT THE PRO
                  
                                       


                                                           


 Biopharmaceutics & Pharmacokinetics, University of Cincinnati) ―Molecular Epitopes for Tumor-selective Drug Delivery‖; Andrew Polson, Ph
 nhancing oral bioavailability of therapeutic peptides and proteins; Wei-Chiang Shen, USA, Modifying the physicochemical nature of macromo

 , Greenberg-TraurugDr. Prabu Nambiar, Vertex Pharmaceuticals
 enter; Other FBI / CIA speaker(s).
  / MHW speaker.
ventis US LLC; Prabu Nambiar, Ph.D., Vertex Pharmaceuticals; Asia Speaker.
 ry into cancer cells.Douglas D. Ross; USA; Impact of Modulating Expression of Breast Cancer Resistance Protein (BCRP/ABCG2) in Multidr
delivery.Vadivel Ganapathy; USA; Neurological impact of peptide transporters. H. Daniel; Germany; Nutritional impact of Peptide transporters
 ulation to improve oral absorption.James Polli; USA; IVIVC in oral drug absorption: Science to regulations.Shinji Yamashita; Japan; Innovativ
  r BA/BE.Lawrence Yu; USA; FDA Guideline for BA/BE including BCS standard.Tomas Salmonson; SE; EU; Guideline for BA/BE.
spective.Shinji Yamashita; Japan; Prediction of food effect on oral drug absorption.Jennifer B. Dressman; Germany; Solubility and dissolution
and exsorptive.Joseph W Polli; USA; Industrial perspective on drug targeting through transporters.Per Artursson; Sweden; Impact of intestina
metabolism.Peter Langguth; Germany; Formulation technology to avoid intestinal metabolism of drugs to improve oral BA.K.E. Thummel; US
  spectives.Toshihisa Ishikawa; Japan; Transporter mediated DDI in oral drug absorption.Hans Lenner&#228;s; Sweden; Human studies on D
nhancing oral bioavailabilityof therapeutic peptides and proteins.Wei-Chiang Shen; USA; Modifying the physicochemical nature of macromole
nhancing oral bioavailabilityof therapeutic peptides and proteins.S.F. Dowdy; USA; Tat mediated delivery of macromolecular siRNA therapeuti
 . Peppas; USA; Lectin functionalized complexation hydrogels for oral protein delivery.K. Sako; Japan; Controlled drug release from a salting-
   poorly soluble drugs by using colloidal nanoparticles composed of drug/polymer/surfactant ternary ground mixture.Hassan Benameur; UK; C
nsporters which are responsible for glucose absorption by polymer conjugates bearing glucose moieties.Claus-Michael Lehr; Germany; The p
s for pulmonary drug delivery.A. Yamamoto; Japan; Improvement of pulmonary absorption of insulin and other water-soluble compounds by p
  the stratum corneum investigated by synchrotron X-ray diffraction.G. Cleary; USA; Transdermal Controlled Release Systems.R.H. Guy; UK;
 n clearance from animal data. Iftekhar Mahmood, PhD, FDA2. Quantification of Human cytochrome P450 with Mass Spectrometry analysis.
  s for pharmaceutical dosage forms.Na&#237;r Rodr&#237;guez-Hornedo; USA; Cocrystals: Molecular Design of Pharmaceutical Materials.
  miya; Japan
eissig; USA; DQAsome. Yuma Yamada; Japan; MITO-Porter.
  New Signaling Mechanism of Fragmented Peptides (Cryptides);Anil Sehgal,UCSF, New Applications of Peptides in Discovery,Manufacturing
                              


                               

 BMITTED BY GT TUCKER
Drug transport as a prerequisite of drug action – state of the art
       
                                

                                                                                                                                 


                                                                                                 Richard B. Kim, London, Ontario
Drug resist
ancer and allergic diseases.Ernst Wagner; Germany; Extracellular targeting of synthetic therapeutic nucleic acid formulations.Kevin G. Rice;
 m: Multifunctional Envelope-Type Nano DeviceStefaan C. De Smedt; Belgium; Optimization of polyplex- and lipoplex-based siRNA delivery.D
ated heparin derivatives for inhibition of angiogenesis and cancer cell growth.Wei-Chiang Shen; USA; Protein drug delivery by conjugation wi
racellular mass transport; Prof. Nicholas Peppas, USA, Modeling of drug release from swellable devices; Prof. Juergen Siepmann, France, D
  ining microspheres for drug and gene delivery.Teruna J. Siahaan; USA; Targeted and controlled release drug delivery system using nanopar
 ogenic long-lived DC vaccines.Ram I Mahato; USA; Gene expression and silencing for improved islet transplantation.Timothy Allsopp; UK; E
 godeoxynucleotides for the treatment of atopic dermatitis.Justin Hanes; USA; Mucus-penetrating nanoparticles for drug and gene delivery to
   method by liposomal bubbles and ultrasound.Vladimir P Torchilin; USA; Tumor-targeted nanomedicines: doxorubicin-loaded, long-circulatin
 bes for SPECT imaging.Janos Peti-Peterdi; USA; Recent advances in multiphoton imaging.Karsten Mader; Germany; Benchtop-NMR and M
 r controlled drug release and targeted delivery.Jindrich Kopecek; USA; Development of novel HPMA copolymer-bound constructs for drug ta
 eering for tissue repair.Antonios G Mikos; USA; Engineering complex tissues with novel biomaterials.Jeffrey A. Hubbell; Switzerland; Synthet
 edical therapy based on drug delivery technology.Hamidreza Ghandehari; USA; Development of novel polymer hydrogels for drug and gene
                       

                       


ED BY GT TUCKER
Organisers – Maeda (Tokyo), Per Artursson (Uppsala)
           

                                                                               Speakers:
 Sugiyama (Tokyo)

                                                                                          

                                                                                          Y.                    
J.Hochman (USA)
  
Someone
                       

                       


ED BY GT TUCKER
Organisers – Raimo Ketola (Helsinki) and Moshe Finel (Helsinki)
Hospital, Faculty of Medicine, Kyoto University, Kyoto, Japan.Significance of MDR1 (P-glycoprotein) in clinical pharmacotherapy;Giacomini KM
D BY GT TUCKER
•
     

                      

                     
 Nicolas Tsapis (University of Paris Sud, France) Particle engineering for the design of new ultrasound contrast agents

                 

                 


   GT TUCKER
Prof. Oya Alpar
     
University of London, UK

Recent advances in chitosan-based vectors as delivery systems for biotherapeuti
 cy & Medicine, Pharmacokinetics and Metabolism Laboratory, Dalhousie University, Halifax, NS, Canada B3H 3J5; Lawrence Lesko, Ph.D.,
 choneker, USFDA Speaker TBD, US
forecasting BA/BE during drug development"; Alfredo Garcia Arieta, Ph.D., Spain, "Application of BCS for biowaiver determination - an EMEA
 Global Imaging Group Novartis Institutes for BioMedical Research Inc. (NIBRI) 250 Massachusetts Avenue Cambridge, MA 02139, USA Sug
 particle formulations of poorly soluble drugs; 2. Xavier Pepin (US): Theory and measurement of changes in solubility due to nanosizing: Kelv
al Change? ;2) Kevin Dykstra (US) Concentration response or Dose/response for Adaptive Designs? ;3) Itay Perlstein (US) Flexible Study De

hods for studying CNS drug delivery in early discovery, ALT. Structure-Brain Exposure Relationships in Rat and Human of Unbound Drug Co
 nsporters at the BBB and BCSFB. CSF vs unbound blood concentrations and their relationship with active efflux.Elizabeth CM de Lange, Le
n as a Key HIV/HCV PK/PD Modeling Tool2. Alan Perelson (US) Modeling Hepatitis C Virus Kinetics: Effectiveness Models;3. Anjaneya Chim
stance;2) Alan Forrest (US) Patient Studies Modeling Surrogates and their Linkages: Mic, Clinical Scoring and PK/PD Indices of Effect;3) Ale
own model for evaluation of impact of shipping pressure changes; Advait Badkar, Pfizer Inc; General overview and current trends for use of p
macoproteomic strategies to map the human BBB transporters – expression and function in humans in comparison with other species.
Jas    

                                                                                                                                        


 m the votingprocess that will be conducted approximately 3 months prior to the annual meeting
 
2)                                                                     
3)

 John Wagner (US) ―An Industry Perspective on Lead Optimization?‖;
 Joga Gobburu or Yaning Wang (US) ―A Regulatory View of Phas
enges and Considerations: Mirium Monge, Stedim Biotech, France;Methods and implementation challenges for use of disposables in biotech
Authority speaker: TBD;Industry speaker: TBDPanel members: above speakers with additional heads of regulatory affairs.
 ridging Studies through PMDA's Reviews of NDAs;2) Susumu Nakade (Japan) Successes and Challenges in industrializing M&S based dev
 Tumor Growth Inhibition: PredictingActive Clinical Doses from Preclinical Studies in Xenograft Models;2) Jane Latz (US) Application of Popu
 is in the assessment of dermatological bioequivalence;2) A. Bunge (USA)Discussion of new approaches using stratum corneum tape strippi
  Importing Drug Products into the United States"Speaker TBD, US, "Documentation Requirements Required for International Transport"
 es Mansoor Khan, Ph.D., R.Ph.U.S. Food and Drug AdministrationGeneric AED Formulations: Pharmacokinetic and Biopharmaceutical Issu
 es Mansoor Khan, Ph.D., R.Ph.U.S. Food and Drug AdministrationGeneric AED Formulations: Pharmacokinetic and Biopharmaceutical Issu
 es Mansoor Khan, Ph.D., R.Ph.U.S. Food and Drug AdministrationGeneric AED Formulations: Pharmacokinetic and Biopharmaceutical Issu
 es Mansoor Khan, Ph.D., R.Ph.U.S. Food and Drug AdministrationGeneric AED Formulations: Pharmacokinetic and Biopharmaceutical Issu
Environmental Health and Safety Operations at PfizerKaren Ginsbury, PCI Pharmaceutical ConsultingZena Kaufman, Abbott Quality and Reg

es Mansoor Khan, Ph.D., R.Ph.U.S. Food and Drug AdministrationGeneric AED Formulations: Pharmacokinetic and Biopharmaceutical Issu
                                                                  

                                                                  •
                                                     
•

 N. Olson, Ph.D., University of Texas Southwestern Medical Center
 Rajesh Miranda, Ph.D., Texas A&M Health Science Center
 Raghu Ve
              
•
                                                        

                                                                         •

Medical Center
 Rajesh Miranda, Ph.D., Texas A&M Health Science Center
 Raghu Vemuganti, Ph.D., University of Wisconsin
 

   

   •
                                                
•

 er
 Raghu Vemuganti, Ph.D., University of Wisconsin
 Samba Reddy, PhD/RPh, Texas A&M Health Science Center
    




 


Women‘s Health Initiative: Current Controversies and Future Directions

                                                                       

                                                                       Farida Sohrabji, Ph.D.

                                                                                             

                                                                                             Texas A&M Health Science Center 
Mens
                                                                                                                             

                                                                                                                             


  by:The Metabolic Syndrome: Progress Towards one Definition for an Epidemic of our TimePaul Zimmet, M.D.International Diabetes Institute
 yRamachandran Vasan, M.D.Boston University Medical SchoolIntegrated Approach for Prevention and Treatment of the Metabolic Syndrome
 rosteroid replacement therapy for CNS disorders Michael A. Rogawski, M.D., Ph.D.University of California at DavisNeurosteroids: Structure-A
 uction process (glycosylation, cysteinylation etc.) or created post purification by design (e.g pegylation) can have significant impact on the bio
 ailable Instrumentation and Innovations;Dr Noakes, INEOS, UK - Relevance for Inhalation Product Manufacturing;Dr Frank Thielmann, Nova

 eversible Self-Association of a full length mAb Organizers/Moderators: Sathish and Satish


ent Advances and Challenges in Treating Asthma and COPD via Inhalation;Dr. Abhishek Gupta, Novartis, United States, Engineered Formula
   impurity analysis: 1. Thomas M. Dillon, Amgen. Tdillon@Amgen.com (product-related), disulfide bond characterization of IgG2. 2. Arthur J.
                                                         
•

  according to the UPS method--USP representative
 Visible inspection for particles according to the European pharmacopeia--EP represent
  rennial Allergy to Cat Allergen: An Improved Clinical Model for Study of Cat Allergic Patients in Aerosolized Environmental Exposure Chambe
                                            

                                            2)
ase progression in Alzheimer‘s Disease;
 Julie Stone (US) Cross-Species Scaling of A(beta) response to gamma-secretase inhibitor;
 Am       3)
                                                                                                                                            

mon Shortcomings in recent Stability packages in Novel Biologics Products;Nanda Subbarao, USA, Stability Package for Stem Cell and other
 otocol; Speaker from Genzyme, USA, 'What to do if the comparability study fails, a case study; Emily Schacter, US FDA, Shortfalls in recent
ected Drug Delivery System for Cancer Treatment; Dr. David Owen, Australia, Novel Dendrimers for Drug Delivery and Half Life Extension; P
  or First-in-Human (FIH) studies; Colin Rowlings, USA - Rapid formulation optimisation for Phase II and downstream commercial developme
mpact on exploratory clinical research; David Jones, UK; Kimberley Maynard, USA; Don Nichols, USA;
 opolymers Mediated by Coiled-Coil Domains (Jindrich Kopecek, University of Utah or TBD) 2. Stimuli-Responsive Micelles and Vesicles Bas
 . Proposed Title: Intra and Inter supplier variability in raw material and its impact on the product quality and the manufacturing process: Proc
akers:Hartmund Derendorf, Gainesville, Florida, USA ORCharlotte Kloft, Halle, GermanyIn-vitro models investigating impact of protein bindin
akers:Hartmund Derendorf, Gainesville, Florida, USA ORCharlotte Kloft, Halle, GermanyIn-vitro models investigating impact of protein bindin
 rial to the overall development program
  2) Balaji Agoram (UK) A case study on PK-PD modeling approach to determine MABEL of an agonist mAB;3) Frank Hoke (US) MABELs of c
                                                                         

                                                                         


   therapies in the treatment of malaria and other tropical diseases‖; 
Jan-Stefan VanderWalt, Division of Clinical Pharmacology Department
   approval of session.
 rd UK); SUBMITTED BY GT TUCKERa) Sonocrystallization and Melt sonocrystallization for pharmaceuticals: Anant Paradkar, Institute of Ph
 ural Products Alliance, U.S.A.
 
                                                                                      

                                                                                                                        


                                   ―Commercial and regulatory issues facing the global dietary supplements industry‖;
Arnold Vlietinck, Ph.D.,L
  g Development using Relevant Data: A Primer for all Formulation and DMPK Scientists; Dr. John Chung, SimulationsPlus; or Dr. Masoud Ja
 uantitation of Various Classes of Oligonucleotides in Biological Matrices, Advantages, Limitations and Challenges.To be determined; USA; An
  ard; USA; Aptamer Therapeutics.Akshay Vaishnaw; USA; siRNA Therapeutics.Arthur M Krieg; USA; Toll-Like Receptor Therapeutics.
 ssays and various strategies to reduce or overcome effect in assays; Mauricio Maia, USA- Impact of various interfering molecules on PK ass
     

  s; 
Kerry Oliver, USA, Expansion of Dynamic Range Using Bead Based Assays;
          Holger Pils, USA, Development of a Generic Ligand Bindin
                                                                                       

m Japanese clinical practices - Points for pharmaceutical development.Litsa Mathis; USA; FDA experience with pediatric drug development.D
 by design for pharmaceutical development.Arzu Selen; USA; FDA experience with pediatric drug development.Alan Royce; USA; Pharmaceu
 be; JapanJ. Bootman; USAJ. J. De Gier;The Netherlands
 Institute, CA, USA. 
 
―Thinking outside the box and changing the clinical research approach for nutriceuticals: a case study for a successful c
 rs in research of molecular-targeted drugs.Simon Mallal; Australia; Prevention of hypersensitivity to drugs - what we learned from abacavir.M
 cokinetics from in vitro data - population approach.Hiroshi Suzuki; Japan; Clinical pharmacology and personalized medicine in cancer therap
DonovanProfessor,University of IOWA, US.2.Nasal drug delivery compared to other transmucosal routes and consumer insights Rick S Chan
  zed medicine in antiplatelet therapy.Akihiro Hisaka;Japan; What we can prevent from genomic test of P450.Richard B. Kim;USA; Systematic
 y requirements2) expert from industry (such RDPAD or large pharm company) to discuss the practical experience on dossier prep and intera
  tory guidnce - Dr. Prabu Nambiar, Vertex PharmaceuticalsFDA Perspectives - Dr. Stephan Miller, FDAEMEA Perspectives - Speaker TBDCh
 egulator's Perspectives - FDA Speaker TBDRegulator's Perspectives - EMEA Speaker TBDIndustry Perspectives - Dr. Nick Mehta, Shire Hu
mbination Products Donna Bea-Tillman, PhDDirector, Office of Device Evaluation, CDRH Ramzi Dagher, MD Medical Team LeaderDivision o
Affairs IncFDA Speaker - Dr. Kathy Lee, FDAEMEA Speaker - Dr. G. Narayanan, MHRAIndustry Perspectives - Dr. Mary Cromwell, Genentec
  ch, Cambridge, Massachusett, RNAi system for oncology validation;Angus Bell1,Wroclaw University ofTechnology, Poland,Chemical Target
methods‖; 
   Vinod Shah, Ph.D., FIP, USA, ―Bioequivalence based on in vitro comparison‖; 
 Be Decided, FDA, USA, ―Regulatory perspectiv
              
                                                                                
To
 
Eva                                                                                    

                                                                                         To

 Benfeldt, M.D., Ph.D., U of Copenhagen, Denmark, ―Microdialysis and DPK‖; 
 Be Determined, FDA, USA, ―Regulatory perspective‖
   technology review, and current industry status - Mike Akers (Baxter)Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP -
ervative use in parenteral drug products: Sandeep Nema/Parag Kolhe (Pfizer)Mechanism and advantages/disadvantages of various common
ervative use in parenteral drug products: Sandeep Nema/Parag Kolhe (Pfizer)Mechanism and advantages/disadvantages of various common
   technology review, and current industry status - Mike Akers (Baxter)Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP -
   technology review, and current industry status - Mike Akers (Baxter)Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP -
    technology review, and current industry status - Mike Akers (Baxter)Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP -
 eimbach, Ph.D., USA;To achieve the desire outcome: In vitro dissolution consideration and designPaul Dickson, Ph.D., UK;How to use pharm
nit University Hospital School of Medicine), Spain, relationship between GST null mutation and drug-induced liver injury;Munir Pirmohamed (T
 peaker from ImmunoGen, name to be determined; speaker from Genentech, name to be determined; speaker from FDA, name to be determ
 ;
  Mark J. Buonauito, Esq., Takeda Pharmaceuticals, North America

     
                                                                    

urt Decisions and Patent Reform Efforts"William McGowan, J&J, US "Impact of Recent Court Decisions on Pharmaceutical Development Str
Esq. Eli Lilly, US;Other speakers TBD
 perial College - LondonDepartment of Chemcial EngineeringSpeaker 2. Sekulic, S. Sonja (Multivariate analysis in Imaging using spectroscop
   ntification of the mitochondrial targeting signal of the human equilibrative nucleoside transporter 1 (hENT1): implications for interspecies diff
Netherlands; ABC mulitdrug transporters: biological and pharmacological rolesKen-ichi Inui; Kyoto University, Japan; Cooperation of OCTs an
 nd Introduction, Drug Substance and Drug Product Identity - What's Good Enough;Moheb Nasr or John Kauffman, FDA, USA, FDA Anti-cou
 gainst a QbD approach to Technology TransferNirdosh JagotaVice President, CMC-RegulatoryWyeth ResearchTechnology Transfer in the n
  isk-based evaluation strategy for defining multi-sourced active pharmaceutical ingredient (API) starting materials.2. Mohan GanapathyExecu
  : An FDA PerspectiveNirdosh JagotaVice President, CMC-RegulatoryWyeth ResearchEvolving Regulatory Landscape: An Industry Perspect
WHO Stability Guidance"Tom Shultz, J&J, US "Considerations for Stability Studies Supporting Emerging Markets"Nanda Subbarro, US, "Stra
   C Considerations for Product Approval in Emerging markets: Prabu NambiarVice PresidentVertex Pharmaceuticals
uchelaar, Leiden University Medical Center, The NetherlandsE-mail: h.j.guchelaar@lumc.nl; 2. Pharmcogenetics of drug hypersensitivitySpea
  athleen M Giacomini, University of California, San Francisco, CAE-mail: kmg@itsa.ucsf.edu;2. Pharmacogenomics of membrane Transporte
d States;Dr. William R. Kenan, Jr., North Carolina State University, United States;Dr. Stephanie Gratton, University of North Carolina, United
ds and Technologies for poorly water soluble drugsDr Vincent JANNIN; France, Pharmaceutical Development NCE with new excipientsProfes
 ); SUBMITTED BY GT TUCKER1.                 Regulatory considerations, FDA (Amy Rosenberg, CBER, FDA) 2.               Regulatory considerations, EM
proaches for clarifying the clinical drug response and adverse effects;
    
Ichiro Ieiri; Kyusyu Univ., Japan; The impact of genetic polymosphisms
and pathology, Nucleotide Polymorphism Laboratory, Mayo Clinic, Rochester, Minnesota, USA
             
                                  
[2]
                                                                                                                                           

                                                                                                        E-mail: okane.dennis@mayo.edu;

 Willia
  n of real-time whole-body pharmacokinetics using the PBPK modeling integrated with in vitro kinetic information of multiple metabolic enzym
 and Perspectives of In Silico Pharmacokinetics;Sean Ekins; University of Medicine & Dentistry of New Jersey, USA; In silico pharmacologica
  n the intestinal absorption of drugs;Hans Lennernas; University of Uppsala, Sweden; Novel approaches to understand the importance of dru
  Kyushu University), Japan, Epigenetic regulation of genes encoding drug-metabolizing enzymes and transporters;Kenneth K. W. To (Nationa
  herlands, Genetically modified mouse to investigate the role of transporters in drug disposition and response;Douglas H. Sweet (Medical Un
   technology and platforms used in pharmmagogenetics testing; Dr. Urs A. Meyer (University of Basel, switzerland) Pharmacogenomics - Lost
 Netherlands)Pharmacogenetics and biomarkers of cardiovascular disease; Vicki L. Ellingrod (University of Michigan, USA)Pharmacogenetic
 eze/thaw and transport of frozen bulk;Karoline Bechtold-Peters, Germany, Waste not wash - disposable fill& finish systems;Ingrid Markowic,
nd metabolomics for clinical application; Daniel W. Nebert (University of Cincinnaty, USA) Innovative strategies for individualized medicine: C
How to set the specification;
 
N.N., Issues with processing high concentration liquid formulations;
     Michael Adler, Switzerland, Formulation too
                                                                                                          

                                                                                                                      



al Engineering, Rutgers University, NJ. "Micro-dosing Technologies for Manufacture of Clinical Trial Products";
Professor Martin Kuentz, Pro
                                                                                


                                                                                 

 rator: Keith Hutchison, Vice President R&D, Capsugel Division of Pfizer.
"Micro-dosing Technologies for Manufacture of Clinical Trial Produ
e Netherlands;2. Ann Newman, Seventh Street Development Group, U.S.A.;3. Michael Pikal, University of Connecticut, U.S.A.;4. Ted Randol
 g for pharmacokinetic analysis;Tetsuya Suhara (National Institute of Radiological Sciences), Japan, Determination of the appropriate therape
  n Process usingthe Rolling Theory of Granular Solids-- Rohit Ingale, Astra Zeneca, USA;2. Finite Element Analysis of the Roller Compaction
 and characterization of double-chamber cartridge siliconization;
    Christina Lichtblau, Germany, Comparison of two siliconization procedures i
                                                                      

er-Based Prodrugs
  or subvisible particles;
 N.N., Definition of an analytical standards for common use;

                            
                                                                Barbara Rellahan, USA, Orthogonal approach ? – curren
                                                                                             

  est Company Ontario, CanadaMichael Kimber, PhD, Healthstar, New Queensland, AU (pending) http://www.healthstar.qld.edu.au/hstn_staf
erlands); "Overview of liposomal dosage forms and future prospects"2. Dr. Mei-Ling Chen (USA/FDA) or alternate; "Excipient consideration fo
 aled Antibiotics: Why TOBI and Other Aminoglycosides Have Such Clinical Importance;Dr. Sally-Ann Cryan, Royal College of Surgeons, Irela
  Ph.D., Characterization Facility, University of Minnesota;3. Clive Roberts, Ph.D., Nottingham Nanotechnology and Nanoscience Centre, Univ

                                                                                                                                  


                                                                                                                                   

ne, Japan, ―Consequences of human URAT1 dysfunction: hypouricemia, gout, and exercise induced acute renal failure‖;
2. Bjoern Bauer, P
 BioengineeringUniversity of California, Berkeley 5885 Hollis St., MC 3224 Berkeley, CA 94720Email: keasling@berkeley.eduPhone: (510) 64
 ment for Content Uniformity and Assay Sample Preparation in The Pharmaceutical Laboratory
                                                                                                                                      
 Challenges
                                                                                                                                       

                                                                                                                                       

 ified specific speakers at this time, but it will be fairly straightforward to secure excellent speakers if this session is approved)
•

ective anti-melanoma agents – Majid Moridani - Assistant Professor, School of Pharmacy, & School of Medicine, Texas Tech University HSC,
uring Late Phase DevelopmentJohn Morris (tent), USA - Value of CMC Project Management During Early Phase DevelopmentTBD - Value of
ent of multidrug-resistant cancer. (35 min)Speaker: Tamara Minko, Professor & ChairErnest Mario School of Pharmacy at Rutgers, The State
 of biomarker by Diffractive Optics Technology;Speaker TBD,USA, Quantification of mAbs on Biacore; Current and Future utility; M. Dysinge
overy and translational research.Zheng Yang (Bristol-Myers Squibb Co., USA);Successes and Challenges in Application of QMBDD in drug d
 /PD Modeling Tool (Bill Poland, Pharsight Corp., USA)PK-PD Modeling for Prospective Prediction of Anti-Viral Efficacy Using Human PK and
 s in traditional immunogenicity detection methods"; 2. a speaker from non-ligand binding technology flat-form company (TBD), USA , "Novel
dation; Speaker 2: J. Dunn, USA, Statistical Methods for Analysis of Similarity: Speaker 3: L.King, USA, Similarity in Biotherapeutic assay De
 ysis: Vitamin E supplementation and mortality"; Bill Gillespie, USA, "Population Dose-Response Model for ADAS-cog Scores in Patients with
Netherlands, "Regulatory approaches- an EMEA perspective"; Jun Zhang, M.D.,MPH, Health Canada, "Regulatory approaches- a TPD persp
 g metabolizing enzymes and transporters: what do recent results from Global/Asian studies tell us. Andrew Williams PhD, Pfizer Oncology La
son; U.K.; Radio-Frequency controlled absorption studies
ogical factors on clinical biomarker measurement;2. Binodh DeSilva, Amgen, Inc., USA, Detection of total, free, and bound endogenous prot
 t molecular pathways are used and might have cross reactivity throughout the body 
   Adrian Raiche; USA; Endotoxin and residual solvent lev
                                                                                       

                                                  

                                                  


 s – Prof Mike Pikal, Uconn, Storrs, Connecticut
Speaker affiliation: Bio-Stabilization by foam drying: The advantages of not freezing. Victor
A, "FDA experiences with implementation of the new guidance and case studies - what information FDA can derive from them"; Yu Chung Ts
 ified release products andpotential roles of mathematical tools at each stepRonald Siegel; USA;Introduction to methods of mathematical mo
 eory and potential use for bioequivalence demonstration"; xx, USA, "Potential markers or biomarkers for in vivo drug delivery profiles"; Ian W
ng the role of BCRP/ABCG2 on the fetal distribution of drugs using ABCG2 KO mice; Ronald Oude Elferink, Netherlands Cancer Institute, Am
 roval on the US and Canada;EMEA regulator (UK): Experience with biosimilar approval in Europe;Sandoz representative (Switzerland): The
macokinetics, potency and safety, guidance to apply QbD principals to molecule selection and developmentSteve Swanson , Amgen Inc., Tho
ervative use in parenteral drug products: Sandeep Nema/Parag Kolhe (Pfizer)Mechanism and advantages/disadvantages of various common
                              


                               

 of BCS II –IV compounds‖. 
Shoufeng Li, PhD, Novartis Pharma, East Hanover, US, Global Technical R&D or Martin Mueller-Zsigmondy, N
 kground/intro: Anette Muellertz and I may tag team or one of us may present (Country of origin: Denmark or U.S.A);Predictive in vitro, and in
n, Ph.D., Department of Chemical Engineering, MIT3. Dr. Alexis Pellek4. Dr. Patricia Van Arnum
  tBoehringer Ingelheim Pharmaceuticals, Inc.900 Ridgebury Rd./P.O. Box 368Ridgefield, CT 06877-03682. Dr. Praveen K. SharmaResearch
ne and Drug Discovery (35 min)Majid Moridani, PharmD, PhD, DABCC, FACBSchool of Pharmacy & School of MedicineTexas Tech Universi
 s, Pharm.D. Clinical Issues with Herbal Products and Traditional Medicines;Phillip M. Gerk, Pharm.D., Ph.D. Mechanisms in Herb-Drug Inter
anceUnited States PharmacopeiaCountry of Origin: USAPresentation Title: cGMP: A Quality Systems Approach for APIs
  chnology, EurandCountry: USA Title: An ODT Is Not Enough: Innovating Through Taste-masking Technology2)Name: Jin-Wang Lai, PhDPos
  chnology, EurandCountry: USA Title: An ODT Is Not Enough: Innovating Through Taste-masking Technology2)Name: Jin-Wang Lai, PhDPos
nd Formulation of Nigerian Anti-diabetic, Anti-malarial and Dermatological Herbal Drugs.2.Molara Orafidiya, Ph.D, NigeriaSome Formulation
  ker: Majid MoridaniTexas Tech Univ HSC, Texas, USA Majid.moridani@ttuhsc.eduOr Felix Frueh from MedcoSpeaker 2. Proteomics in drug
mas Abbruscato, Associate Professor, School of Pharmacy, Texas Tech University HSC, Amarillo, Texas, 79106 Thomas.Abbruscato@ttuhsc.
 es during pregnancy;2. Mary Heibert, USA, Renal secretion pathways are altered in pregnancy;3. Knudson LE, Denmark, Placental Transpo
s, MO.2. Drug development role of Biomarkers - Larry Lesko, FDA.3. Biomarkers, Surrogate markers, disease markers. - Speaker TBD.4. Id
 & Co, USA; Anu Gore, Allergan, USA; Titles will support the abstract but has not been determined yet.
  cient Drug Lead Optimization Guided by Free-Energy Calculations‖; Dr. David Baker (Professor, University of Washington), ―De novo design
 pe, Generics are acceptable alternatives to brand name drugs;2. People's Pharmacy or Consumer Group advocate, What is the problem wit
 Werner Weitschies, Germany, Gut motility and dissolutionPatrick augustijns, Belgium, Human intestinal fluidsJennifer Dressman, Biorelevan
Mario Rocci, NYIntroduction: Need of an ideal bioanalytical method never ealytical ending excercise. - Prasad Tata, PH.D. St. Louis, MO.1: A
 al and in vitro knowledge in parameter estimation of PBPK models using Bayesian approach; Roger W. Jelliffe, USA, Individualised Drug Th
 rs GroupUSPSuggested Title: Developing Compendial HPLC Practices
 Heimbach, Ph.D.Novartis Pharmaceuticals Corporation, NJChallenges in Enzyme Activated Prodrug StrategiesJarkko Rautio, Ph.D.Universi
 D Kathy Guicomini, UCSFSpekaer 2: Metabomics - Peter Guingrich, Nashville, TN Speaker 3: Title TBD. Speaker TBD.
  ipid-Based Formulations";Roy Haskell, USA, "In Vitro Tests for Selection of Preferred Nanoparticle Formulations";David Vodak, USA, "In Vitr
nd Robotics - Allenna Ji, WyethSpeaker 2. Resolution and IS selection, preliminary method. Chinna Pammidi, Houston TXSpeaker 3: Title an
amashita;Japan.
ell; David Mitchell; Jeff Blumenstein; Prabu Nambiar; Deepa Deshpande;
 han Ganpathy; Sanjay Sehgal
  peakers to cover the above suggested topics. It will be another day to immerse ourselves in CMC aspects of the eCTD.
 ter, Utrecht, The NetherlandsTitle: Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considera
mulation Principles to Pharmacokinetics and Pharmacodynamics Applications in Drug Discovery and Development; 2.Raimar Loebenberg, U
hhta; Henrietta Ukwu

mitting Global NDAs; 2.To-be-determined. SFDA, China, Evolving Expectations of Sino FDA in CMC Submissions;3. Tobias Massa, BMS, U
 ge due to disease or injury using progenitor and stem cells", Michael Young, USA; Albert Maguire, USA,"Regaining vision in pediatric patient
  netics and BiopharmaceuticsDirector, Drug Development Graduate ProgramThe James L. Winkle College of PharmacyUniversity of Cincinn
 ping Modified-Release Dosage Forms; 2. Christos Reppas School of Pharmacy, University of Athens, Greece, Understanding of Colonic Abs
 ited speaker.
, Newest Simulation Models of Drug Dissolution in the Gastrointestinal Tract for Poorly Soluble Drugs and its Role in Drug Product Developm
 een Metabolizing Enzymes, Transporters and Disease States: Examples of Complex Drug Interactions;Speaker #2:Amin Rostami-Hodjegan
umar, Y. Vamshi Vishnu, P.Chinna Reddy, M.Sarangapani, Y. Madhusudan Rao
 easurement of surface adsorbed protein layer: Relevance to biologics formulation and process.Speaker 1: TBD (Pfizer formulation group or,
John Porter, MD, UCL, UK3.R Carmel, MD, NY, USA4.R Vieth, PhD, University of Toronto, Canada5.R Gupta, Monilek Hospital and Researc
  scular and Renal Drug Products, FDA/CDERRenal Function Estimation: Assays and Equations;Speaker 2:William J. Spruill, PharmD, FASH
  perspective - Pat Noland, ABC LabsIndustry Perspective II - Rex Roberts, West Pharmaceutical ServicesRegulatory perspective - FDA Spe
 , San FranciscoRole of Transporters in Drug Safety;Speaker #2: Yuichi Sugiyama, Ph.D. The University of TokyoJapanDrug-induced Toxicity
  in the future; Dr. Hequn Yin, USA, The unique regulatory requirements for registration of new medicine in India; Dr. Huifen Faye Wang, USA
rug Discovery: Pfizer Experience";Cliff Dilea of Novartis, U.S.A."PK-PD-Tumor Kinetic Modeling & Therapeutic Translation of Preclinical Test
tual screening and de novo design for drug lead generation and optimization‖; Dr. Donald Landry (Professor and Chair of Medicine, Columbia
USAStephan Krause Ph.D, USA
ia, University of California-San Francisco), ―Targeted drug delivery to mesothelioma cells using functionally selected internalizing human sing
Selection: Report of the PhRMA Dose-Ranging Studies Working GroupVladimir Draglin [USA], Evaluation of Novel Adaptive Designs for Dos
USAStephan Krause Ph.D, USA
and Immunity, Nationwide Children‘s Hospital), ―Challenges and opportunities for development of new generation of safe, protective vaccines
tate-of-the-art computational approaches for rational design and development of clinically useful proteins‖; Dr. Ken Houk (Professor, UCLA),
 mbia University), ―Factors affecting in vivo activities of protein drugs‖; Dr. James Woods (Professor, University of Michigan), ―Development o
ndy Vicks,Ph.D. St. LouisSpeaker 2: Title: TBD, Brian Booth FDA
  Dr. Moheb NasrEMEA Speaker - Dr. Martin TerbergerJapan / MHLW Speaker - TBDIndian Drug Directorate officer - TBDChinese SFDA par
 rug and drug-food or drug-herb ineractions - Adedayo Adedoyin, Novartis.Speaker 2: TBD Title: drug -drug interactions or drug - drug-pgp int


 tabilization of protein drugs through computational design‖; Dr. Roger Sunahara (Associate Professor, University of Michigan), ―Protein engin
  Safe Pill Net; James Orbinski, Canada, Sustainable Distribution of New Drugs for Neglected Diseases using Local Partners; Kishor Wassa
 ug transporter expressions, and their synergistic, counteractive interplay; Rena Bendayan, Canada, HIV-1 viral envelope glycoprotein gp120
   Iowa 52242Brian R. MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical Counterm
Bioavailability EnhancementSakae Obara - Polymer Selection and Considerations in Hot Melt Extrusion; Professor Costas Gogos - Polymer D
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
   MoyerContractor/ Subject Matter Expert (SME)Chemical, Biological, Radiologic and Nuclear (CBRN) Medical CountermeasuresDHHS/Biom
                                    


                                     
                                                                                      

                                                                                                                            


  elt Extrusion (HME) Extrudates‖;
Craig McKelvey, USA, ―Solid dosage forms from Hot-Melt Extrusion (HME) Extrudates‖;
Ping Gao, USA

  Tocilizumab with cytochrome P450 substrates in vitro and in vivo. Mark Marino or Xiaoping Zhang, Hoffmann-La Roche, NJ USA. 2.Pharma
 der QbD. Paul Dickinson, AstraZeneca LLP. &#13;&#10;2. Regulatory approval of QbD submissions: updated review. Moheb Nasr, FDA. &
h, Pfizer, Sandwich, UK;David Jacobsen Kram, FDA;Bruce Psaty, Institute of Medicine & Univ. Washington;Tatsuo Kurokawa, Ministry of Hea
d: Physical and Chemical Stability During the Manufacturing Process&#13;&#10;&#13;&#10;James Drennan, Duquesne University, Talk ent
                             
2b)                                                                 
3c)
son PhD, CDER, OCP, FDA 
 Biosimilarity in Biologics, Angela Min Ph.D, CDER, OCP, FDA
 IVIVR versus BE, James Polli PhD, Scho
 ulations can improve oral drug delivery. Chris. Porter, University of Monash, Australia.2.Digestibility of polyglycolyzed lipid excipients and the
 erbeemd, Consultant, Perpignan, France;Bernard Testa, Univ.Lausanne, Switzerland or equivalent;Gisbert Schneider, JWG Univ. Frankfurt, G
GSKSpeaker 2: Ted Grecella

 e Exrpession for Treatment of Chronic Limb Ischemia Professor Ryiuichi Morishita, MD Department of Clinical Gene Therapy Department of
ogy Institute, Switzerland; Collen Masimirembwa, African Institute of Biomedical Science and Technology, Harare,Zimbabwe & AstraZeneca,
 USA; Pam Pavco - USA; Renta Hutabarat - USA; Michael Beverly - USA; Mark Sanseverino - USA; Paul Winkler - USA;
 ew Product Quality Operations and Process Knowledge, 
    Global Quality and Compliance

                                                           
                               
Wyeth Pharmaceuticals
Joe Famularae

                                                                                                                    


                                                                                                                     
                 
Directo
 Shi, Ph.D. (Abbott)
 
Ping Gao, Ph.D. (Abbott) 
 

                                                  
                      
1.
                                                                         
 Overview of in vitro test methods and challenges in developing in
 versity of Tokyo; Makoto Arita - University of Tokyo; Gokhan Hotamisligil - Harvard School of Public Health; Joan Claria - University of Barce
 ed Release Products, Suneel Gupta, Ph.D., Impax Labs, USA;2. Regulatory Considerations for Establishing Bioequivalence of Modified Rele
di Hospital Co., Riyadh, Saudi Arabia
 load Aboard Space Mission FlightsMonica Chuong; USA; Effect of Space Shuttle and International Space Station Environment on Stability of
  issolution Tests for Prediction of In Vivo Performance"Vijay Tammara, Merck and CompanyIn Vitro In Vivo Correlations: Regulatory Opportu
  posed Speakers1.Roger Nosal, Executive Director-Pfizer, CMC2.Moheb Nasr, ONDQA, FDA3.Mohan Ganapathy, Executive Director-Merck
                                                                

                                                                2.

cations - Industry perspective: Paul Dickinson, Astra Zeneca
 Clinically meaningful specifications – FDA Perspectives: Dr. Patrick Marroum
 A. Lindeman, Ph.D.O'BRIEN JONES PLLC, USA
alytical Methods to the Quantification of a Trace-level Genotoxic Degradant; Ganapathy Mohan (Merck), The Application of QbD on the Cont
               yhmatsum@east.ncc.go.jp

erview 2) Dr. Gadi BornStein USATitle: Preclinical considerations for development of ultra-potent antibody-based therapeutics. 3) Dr. Diane S
 ide no benefit over conventional controlled release, non-disintegrating tablets;TBD
S, Title - Artificial Stomach and dissolution dissolution apparatus;M. Sugawara, Japan. Title - In vitro cell absorption model.
 of Wisconsin at Madison) Geoff Zhang (Abbott LaboratoriesLynn Taylor (Purdue University) Tonglei Li ( U. of Kentucky) Eric Munson ( U. of K
ogenicity: Challenges Faced with Follow-on Biologics Jaya Goyal, USA, Biogen Idec, Clinical Studies for a Comparability ProgramSusan Hur
  solubilized formulations; Michael Hawley – US- Modifying the dissolution diffusion layer of salts of poorly soluble basic drugs to improve dis
  applications to biomedical and biophysical phenomenaAris Dokoumetzidis; Greece; Applications of fractional kinetics to Biopharmaceutics a
 armacy, Athens, Greece, "Milk as a Solubilizing Agent for Lipophilic Drugs";Georgia Charkoftaki, University of Athens, School of Pharmacy, A
 pdating regulatory and public standards - Ali Al-Hakim, FDA2. Developing modern analytical methods to detect contaminants - Cindy Buhse,
 strationSpeakers:Globalization of Pharmaceutical Regulations: EU perspective, Suzette Kox, BelgiumGlobalization of Pharmaceutical Regul
m; Reuben Jenkins, Omnicia; Gensinger, Gary, MBA, Director, Regulatory Review Support Staff, Office of Business Process Support, CDER
                               Mitsuru HashidaKyoto University
                 Dr.vpshah@comcast.net                        hashidam@pharm.kyoto-u.ac.jp
 es Formulation and Manufacturing for Oral Drug Delivery.Dr. Anna Eidelman; USA; Analytical Method Development and Stability of Soft Gela
mpany andSherif I. Badawy, Ph.D.Bristol Myers Squibb CompanySpeakers:Topic: RTR in API Vs. Drug Product ManufacturingPerson:Ali Afna
 ce: analytical strategies and clinical impact assessment;Steve Swanson, Amgen, USA - Emerging technologies for immunogenicity assessm
atory Pathway for Biosimilar Products in the US: An Update on the Provisions and Current Guidances; Raja Velagapudi, PhD, Teva Pharma
 SA, SEDDS; Dr. Der-Yang Lee, USA, controlled release dosage forms; Dr. Indranil Nandi, USA, Generic business innivation
  Davit, Ph.D., JD. DBEII/OGD/OPS/CDER/FDA (15 min)The Role of Partial AUC Analysis in Bioequivalence Evaluation, Laszlo Endrenyi, Ph
U.S. Food and Drug Administration10903 New Hampshire AvenueSilver Springs, MD.David De Antonis, Ph.D.Senior DirectorAnalytical Resea

; James Drennan, Dusquesne University (USA) "PROCESS MODELING FOR DEVELOPMENT OF A DESIGN SPACE"; Lee Kirsch, Univers
oduct Profile-drive specification setting;Speaker 2: Anette Müllertz, Denmark, The Biopharmarceutics Risk Assessement Road Map;Moderat



            elias.fattal@u-psud.fr
y Considerations: IgE Antibodies to Cetuximab"; Deborah Finco-Kent, Pfizer, USA "Anti-galactose-alpha 1,3 galactose Antibodies and PK A
                           Arto Urtti
            yakusetu@pharm.hokudai.ac.jp                  arto.urtti@helsinki.fi
                                          University of Helsinki
            nakagawa@phs.osaka-u.ac.jp
                           Teruhide
            rgb@drugbiodev.com Yamaguchi                  yamaguch@nihs.go.jp
                                          National institute of health sciences
                  Moderator 1 Moderator 1                           Moderator 2 Moderator 2
  Moderator 1      Affiliation         Email        Moderator 2      Affiliation         Email     Moderator 3
Susan Lum        Patheon Inc. susan.lum@utoronto.ca
                                 dawn.downey@hotmail.com AstraZeneca
Dawn Downey Patheon Pharmaceuticals Inc Yunxia (Vivian) Bi                         vivian.bi@astrazeneca.com
                 Bayer Schering Pharma
Horst-Dieter Friedel                              Vivian Gray     V. A. Gray       vagray@rcn.com Thomas
                                 horst-dieter.friedel@bayerhealthcare.com Consulting, Inc.        Saji
Charanjeet JassalWyeth           JASSALC@wyeth.comTom Sam                           Corporation
                                                                  Schering Ploughtom.sam@spcorp.com
Pollen Yeung                     pollen.yeung@dal.ca Lesko
                 Dalhousie University             Larry           FDA                             Bruno
                                                                                   leskol@cder.fda.gov Flamion
Takuya Fujita                    fujita-t@ph.ritsumei.ac.jp MaoUniversity of Washington
                                                  Qingcheng
                 Ritsumeikan University, Faculty of Pharmaceutical Sciences qmao@u.washington.edu
Mark Arnold                      mark.arnold@bms.com
                 Bristol-Myers Squibb, Inc.       Brian Booth     FDA                             Howard Hill
                                                                                   brian.booth@fda.hhs.gov
                 Bayer Schering Pharma
Horst-Dieter Friedel                              Todd Cecil      U.S. Pharmacopeia
                                 horst-dieter.friedel@bayerhealthcare.com          tlc@usp.org Chikako Yomota
                                 Stephen.T.Colgan@pfizer.com
Stephen Colgan Pfizer Global Research & Development
                                 ctamayo2@comcast.net
Carmen TamayoForesight Links Corporation Michiho Ito              Kyoto University michihoi@pharm.kyoto-u.ac.jp
Walter Chambliss                 wchambli@olemiss.edu
                 University of Mississippi
                                 haginaka@mukogawa-u.ac.jp National Institutes of Health
Jun Haginaka Mukogawa Women's University          Irving Wainer                    wainerir@grc.nia.nih.gov
Jian-Xin Li                      jian.li@evonik.com               T
                 Evonik Degussa Corporation Daan Crommelin op Institute Pharma     daan.crommelin@tipharma.com
Paul Smith                                        Frank Gargiulo MannKind Corporation
                 Perkin-Elmer terasolutions@yahoo.co.uk                                           Somak Das
                                                                                   FGargiulo@MannKindcorp.com
                                 fgarofolo@algopharm.com
Fabio Garofolo Algorithme Pharma Inc.
Zuguang Ye                       yezuguang@vip.sina.com
                                                  Tsutomu
                 Chinese Academy of Medical Sciences Hatano                        hatano@pharm.okayama-u.ac.jp
                                                                  Okayama University
Ping Gao         abbott                           Juan Irache
                                 ping.gao@abbott.com                               jmirache@unav.es
                                                                  University of Navarra
                                 lowess@advion.com Garofolo Algorithme Pharma Inc.
Stephen Lowes Advion BioServices Inc              Fabio                            fgarofolo@algopharm.com
Jean Surian                      jean.surian@astrazeneca.com Kyoto
                                                   LP
                 AstraZeneca Pharmaceuticals Fumiyoshi Yamashita University yama@pharm.kyoto-u.ac.jp
Tudor Arvinte                    tudor.arvinte@unibas.ch
                 University of Geneva
Meindert Danhof Leiden University                 Johan Gabrielsson
                                 m.danhof@lacdr.leidenuniv.nl AstraZeneca          Johan.Gabrielsson@AstraZeneca.com
Geoff Tucker                      of Clinical Pharmacology
                                                  Yuichi Sugiyama
                 Academic Unit g.t.tucker@sheffield.ac.uk                            Tokyo
                                                                  The University ofsugiyama@mol.f.u-tokyo.ac.jp
                 Utrecht der Zee a.h.maitland@uu.nl Arnett UAB
Anke-Hilse Maitland-van University                Donna                                           Stephen Kimmel
                                                                                   Arnett@ms.soph.uab.edu
                                 cfo@farma.ku.dk  Enrico Mastrobattista
Camilla Foged The Devish University of Pharmaceutical Sciences                     e.mastrobattista@uu.nl
                                                                  American Association of Pharmaceutical Scientists
                 T
Carlos Langezaal OPRA                             Yusuke Tanigawara University, School of Medicine
                                                                  Keio
                                 carlos.langezaal@sanofi-aventis.com               tanigawa@sc.itc.keio.ac.jp
Otilia Koo                       otilia.koo@bms.com Wan Sia Heng
                 Bristol-Myers Squibb Company     Paul                             phapaulh@nus.edu.sg
                                                                  National University of Singapore
                 T
Carlos Langezaal OPRA            carlos.langezaal@sanofi-aventis.com
Gavin Brooks                     g.brooks@reading.ac.uk of Reading
                                                   University                      james_bradner@dfci.harvard.edu
                 School of Biological Sciences, James Bradner Dana-Farber Cancer Institute/Harvard Medical School
Manuel Zahn                      manuel.zahn@3rpc.com
                 3R Pharma Consulting GmbH Bryan Tweedy ACS                        b_tweedy@acs.org
                 FDA
Sharmista Chatterjee                              Jiahui Hu
                                 sharmista.chatterjee@fda.hhs.gov                  jiahui.hu@novartis.com
                                                                  Novartis Pharmaceuticals Corporation
Wim Jiskoot                      w.jiskoot@lacdr.leidenuniv.nl Univ of Coloradojohn.carpenter@ucdenver.edu
                 Leiden University                John Carpenter
                                 ggunn@its.jnj.comDeborah
George Gunn Centocor Research & Development, IncFinco Pfizer                       deborah.finco@pfizer.com
Manthena VarmaPfizer Inc                          J. Brian Houston                   Manchester
                                 manthena.v.varma@pfizer.comThe University ofbrian.houston@manchester.ac.uk
Duxin Sun                        duxins@umich.edu Storm
                 University of Michigan           Gert                             g
                                                                  Utrecht University.storm@pharm.uu.nl
                                  Pharma Development
                                                  Hyo                              hkuh@catholic.ac.kr
Daniel Salazar Daiichi Sankyodsalazar@dsi.com Jeong Kuh The Catholic University of Korea
                                 christian.noe@univie.ac.at
Christian Noe University of Vienna
                                  LACDR
Nico Vermeulen VU University /npe.vermeulen@few.vu.nl
Ole Bjerrum                      obj@farma.ku.dk Hayes
                 University of Copenhagen         A,                               awallacehayes@comcast.net
                                                                  Harvard University
Murli Krishna                    murli.krishna@bms.com Takakura University takakura@pharm.kyoto-u.ac.jp
                 Bristol-Myers Squibb             Yoshinobu       Kyoto
                 University of Iowa College Of Pharmacy
Lawrence Fleckenstein                             David Flockhart Indiana University
                                 l-fleckenstein@uiowa.edu                          dflockha@iupui.edu
Urs Meyer                        urs-a.meyer@unibas.ch
                 University of Basel              Mary Relling                     mary.relling@stjude.org
                                                                  St. Jude Children's Research Hospital
Sibylle Neuhoff Simcyp                            Hiroyuki
                                 s.neuhoff@simcyp.com Kusuhara                     kusuhara@mol.f.u-tokyo.ac.jp
                                                                  University of Tokyo
Prabu Nambiar Vertex, Inc                         Latiff Hussain FDA
                                 prabu_nambiar@vrtx.com                            latiff.hussain@fda.hhs.gov
Leslie Benet                     benet@itsa.ucsf.edu Yuasa Nagoya City University
                 University of California         Hiroaki                          yuasa@phar.nagoya-cu.ac.jp
                                 shinji@pharm.setsunan.ac.jp
Shinji YamashitaSetsunan University
                 T
Etsuo Yonemochi oho University   yone@phar.toho-u.ac.jp
Shigeki Sasaki Kyushu University                  Christian Hoe
                                 sasaki@phar.kyushu-u.ac.jp University of Sydney   shoe7855@usyd.edu.au
                                 Kroemer@uni-greifswald.de                         erin.schuetz@stjude.org
Heyo Kroemer Ernst Moritz Arndt University Erin Schuetz St. Jude Children's Research Hospital
                                 yamori@jfcr.or.jpRobert Shoemaker
Takao Yamori Japanese Foundation for Cancer Research DPT                           shoemakr@mail.nih.gov
Handan He                        handan.he@novartis.com
                                                  Tycho Heimbach
                 Novartis Pharmaceuticals Corporation                              Tycho.Heimbach@novartis.com
                                                                  Novartis Pharmaceuticals Corporation
Peter Bryan                      pbryan@celgene.com
                 Celgene Corporation
                                 rho@confarma.fr
Ralf Holzinger CONFARMA France SARL Satish Singh Pfizer, Inc.                      satish.singh@pfizer.com
Maureen McKenzie                  maureen@denalibiotech.com Shanghai Institute of Materia Medica,CAS
                 Denali BioTechnologies, Inc. De-an Guo                              gda5958@163.com
                 University       hbhattac@uthsc.edu GasparUniversity of Lisboa (Portugal) Beom-Jin Lee
Himanshu Bhattacharjee of Tennessee                Rogerio                           rgaspar@ff.ul.pt
Peter York                        p.york@bradford.ac.uk Colbourn
                                                   Elizabeth       Intelligensys UK
                 Institute of Pharmacetuical Innovation, Bradford University, Ltd colbourn@intelligensys.co.uk
                                  Tycho.Heimbach@novartis.com
                                                   Jeffrey                           barrettj@email.chop.edu
Tycho HeimbachNovartis Pharmaceuticals CorporationBarrett Children's Hospital of Philadelphia - University of Pennsylvania
Hirokazu Okamoto                  o                Peter York
                 Meijo University kamotoh@ccmfs.meijo-u.ac.jp                        p.york@bradford.ac.uk
                                                                   Institute of Pharmacetuical Innovation, Bradford University, UK
                                  j.anwar@bradford.ac.uk
Jamshed Anwar University of Bradford                                                 mpharma@zedat.fu-berlin.de
                                                   Rainer Muller Free University Berlin
Eva Moller                        ehm@farma.ku.dk
                 University of Copenhagen                                              Tokyo
                                                   Tatsuro Irimura The University ofirimura@mol.f.u-tokyo.ac.jp
Prabu Nambiar Vertex, Inc                          Thirunellai     Wyeth Researchvenkattg@wyeth.com
                                  prabu_nambiar@vrtx.com Venkateshwaran
Qiang Ye         Otonomy, Inc. qiang.ye@hotmail.com
Lillian Zhang                                      Hiroyuki
                 CDER, FDA hua.zhang@fda.hhs.govKusuhara                             kusuhara@mol.f.u-tokyo.ac.jp
                                                                   University of Tokyo
                 F.Hoffmann-Lahanns-christian.mahler@roche.com
Hanns-Christian Mahler              Roche Ltd.     Mary Cromwell Genentech, Inc. cromwell.mary@gene.com
Abbie Gentry                      agentry@its.jnj.com
                 McNeil Consumer Healthcare Keiji YamamotoChiba Universityyamamotk@p.chiba-u.ac.jp
Tsutomu Masujima                  tsutomu@hiroshima-u.ac.jp
                 Hiroshima University
                 US
Anthony DeStefano Pharmacopeia    ajd@usp.org Raimar Loebenberg                      raimar@ualberta.ca
                                                                   University of Alberta
                                  okezie.aruoma@touro.edu                            ross.mckinnon@unisa.edu.au
Okezie Aruoma Touro College of Pharmacy Ross McKinnonUniversity of South Australia Hiroshi Suzuki
Lisbeth Illum                     lisbeth.illum@illumdavis.com Boehringer-Ingelheim
                 Critical Pharmaceuticals Limited  Dennis O'Connor                   dennis.oconnor@boehringer-ingelheim.com
R. Scott Obach Pfizer                              Akihiro Hisaka University of Tokyo
                                  r.scott.obach@pfizer.com                           hisaka-thy@umin.ac.jp
Guofeng You                       gyou@rci.rutgers.edu Giacomini
                                                   Kathleen                          kathy.giacomini@ucsf.edu
                 Rutgers-The State University of New Jersey Schools of Pharmacy and Medicine, University of California San
                 University       jean-michel.scherrmann@inserm.fr
Jean-Michel Scherrmann Paris Descartes                             University of Uppsala
                                                   Margareta Hammarlund-Udenaes      mhu@farmbio.uu.se
Ikumi Tamai                       tamai@p.kanazawa-u.ac.jp
                 Kanazawa University               Bruno Stieger University of Zurichbstieger@kpt.unizh.ch
Nick Holford                      n.holford@auckland.ac.nz
                 University of Auckland            Peter Milligan Pfizer                             Liping Zhang
                                                                                     peter.a.milligan@pfizer.com
                                  moridani@yahoo.com
                                                   Lawrence Fleckenstein of Iowa College Of Pharmacy
Majid Moridani Texas Tech University Health Sciences Center        University        l-fleckenstein@uiowa.edu
                                   University
Saeho Chong Seoul National saehochong@snu.ac.kr                                      liping.zhang3@bms.com
                                                   Liping Zhang Bristol- Mayers Squibb
                                  pankaj.paranjpe@bms.com
Pankaj Paranjpe Bristol-Myers Squibb Company                                         znchen@fmmu.edu.cnSadineni
                                                   Zhi-Nan Chen Chinese Academy of Engineering       Vikram
Arya Jayatilaka Pfizer, Inc.                       Jan Zorgdrager Solvay Pharmaceuticals B.V.
                                  Arya.Jayatilaka@pfizer.com                         jan.zorgdrager@solvay.com
Arnab MukherjeePfizer                              Jing Liu
                                  Arnab.Mukherjee@pfizer.com Pfizer                  jing.liu@pfizer.com
Joleen White                      joleen.white@bms.com Golob MerckSerono Michaela.Golob@merck.de
                 Bristol-Myers Squibb              Michaela
                                  moridani@yahoo.com Okada Tokyo Universityokada@ps.toyaku.ac.jp
                                                   Hiroaki
Majid Moridani Texas Tech University Health Sciences Center                            of Pharmacy and Life Sciences
Chang-Guo Zhan                    zhan@uky.edu Akiko Itai
                 University of Kentucky                                              itai@immd.co.jp
                                                                   Institute of Medicinal Molecular Design
Ajit Narang                       ajit.narang@bms.comBadawy Bristol-Myers Squibb Company
                 Bristol-Myers Squibb              Sherif                            sherif.badawy@bms.com
Tapan Das                         t                Hirofumi
                 Pfizer, St. Louisapan.k.das@pfizer.com Takeuchi                     takeuchi@gifu-pu.ac.jp Winter
                                                                   GIFU Pharmaceutical University    Gerhard
                                  araiche@surmodics.com
Adrian Raiche SurModics Pharmaceuticals Ruiwen Shi                 Allergan          Shi_Ruiwen@allergan.com
Zheng Yang                        yangz@bms.com    Jin-Ding Huang National Cheng jinding@mail.ncku.edu.tw
                 Bristol-Myers Squibb Dept of Metabolism & Pharmacokinetics Kung University
David Vodak                       vodak@bendres.com
                 Bend Research, Inc.               Katsuhide TeradaToho University terada@phar.toho-u.ac.jp
Lillian Zhang    CDER, FDA hua.zhang@fda.hhs.gov   James Polli                       jpolli@rx.umaryland.edu
                                                                                                     Per Artursson
                                                                   University of Maryland School of Pharmacy
Luis Pereira                      luis.pereira@childrens.harvard.edu
                                                   Panos Macheras niversity of Athens
                 childrens hospital boston / harvard medical schoolU                 macheras@pharm.uoa.gr
                 Hokkaido University
Hideyoshi Harashima                                Elias Fattal
                                  harasima@pharm.hokudai.ac.jp                       elias.fattal@u-psud.fr
                                                                   Universite de Paris-Sud
Hiroyuki Arai                     harai@mol.f.u-tokyo.ac.jp
                 University of Tokyo               Makoto Arita University of Tokyo  marita@mol.f.u-tokyo.ac.jp
                                  wolfgang.sadee@osumc.edu Nagasaki University
Wolfgang SadeeOhio State University                Hitoshi Sasaki                    sasaki@nagasaki-u.ac.jp
Takeshi Iwatsubo                  iwatsubo@mol.f.u-tokyo.ac.jp
                 University of Tokyo
Kiyoshi Tomioka Kyoto University                   Kai-Xian Chen                     kychu@mail.shcnc.ac.cn
                                  tomioka@pharm.kyoto-u.ac.jp Chinese Academy of Science
Prabu Nambiar Vertex, Inc                          Eva-Maria       Baxter
                                  prabu_nambiar@vrtx.com Muchitsch Innovations GmbH  eva_muchitsch@baxter.com
Tetsumi Irie                      tirie@gpo.kumamoto-u.ac.jp Jr.
                 Kumamoto University               Henri Manasse ASHP                evp@ashp.org
                 University of Iowa College Of Pharmacy
Lawrence Fleckenstein                              Bill Charman Monash University
                                  l-fleckenstein@uiowa.edu                           bill.charman@vcp.monash.edu.au
Toshiyuki SakaedeKyoto University                  Cynthia Reilly
                                  sakaedat@pharm.kyoto-u.ac.jpASHP                   CReilly@ashp.org
John Carpenter Univ of Colorado                    Kenneth Norris
                                  john.carpenter@ucdenver.edu Pfizer                 kenneth.j.norris@pfizer.com
Cynthia Brown Eli Lilly & Co. brownck@lilly.com    Sabine Kopp WHO                   kopps@who.int
                 Hokkaido University
Hideyoshi Harashima                                Arto Urtti
                                  yakusetu@pharm.hokudai.ac.jpUniversity of Helsinki arto.urtti@helsinki.fi
Shinsaku NakagawaOsaka University                  Kazuo Maruyama
                                  nakagawa@phs.osaka-u.ac.jp Teikyo University       maruyama@pharm.teikyo-u.ac.jp
Robert Bell                       rgb@drugbiodev.com Yamaguchi
                                                   Teruhide
                 Drug & Biotechnology Development, LLC                                 of health sciences
                                                                   National instituteyamaguch@nihs.go.jp
                 T
Carlos Langezaal OPRA             carlos.langezaal@sanofi-aventis.com
Mary Murray                        Institute       Xiaoliang WangInstitute of Materia Medica, CAMS
                 Nutrilite Health marya.murray@nutrilite.com                         wangxl@imm.ac.cn
                                  david.mitchell@mitchellpharma.com
                                                   Alex            St.               alex.sparreboom@stjude.org
David Mitchell Mitchell Pharmaceutical Consulting Sparreboom Jude Children's Research Hospital
Tetsuji Nishimura                 nishimur@nihs.go.jp
                                                   Bent            University of Copenhagen
                 National institute of health sciences Halling-Sørensen              bhs@pharma.ku.dk
                                  r
Rima Kaddurah Duke Universityima.kaddurahdaouk@duke.edu
            Narayan Cheruvu                                   Mary Spilker
                              Covidien Ltd narayan.cheruvu@covidien.com                           Mary.Spilker@pfizer.com
                                                                                 Pfizer Global Research & Development
Langguth, Johannes Gutenberg University, Germany; 4. FDA Perspectives, Lawrence Yu, Ph.D., FDA, USA;5. Panel Discussion, Panelists: S



3.Challenges in quantifying and characterizing visible particles by Maria Toler, Pfizer
 
4.Particles in biopharmaceutical parenteral products -
ric manufacturer‘s perspective – speaker from a GPhA company
      
Criticality from an excipient manufacturer‘s perspective – speaker from an
vicesTopic 2: 505-b-2 and Regulatory experienceFDA Speaker - TBDTopic 3: 505-b-2 and Industry Experience Dr. Ganapathy Mohan, Me


         

         •
                                                                                                                 
•

 , TBA 
 Thoughts on incorporating modern bioanalytical developments with regulatory guidance, EMEA representative TBA
 Globalization
              Vijay Tammara Merck                             Nagesh Bandi
                                               vijay_tammara@merck.com Wyeth                     bandin@wyeth.com

2.
                                                                                         
3.


 Delivery of classical and new vaccines (via various routes). Dr. Gideon Kersten (NVI)
 The oral route. Dr. Ed Lavelle (Trinity College Dub
a / Canada)Anthony_Ridgway@hc-sc.gc.ca; Dr. Teruhide Yamaguchi (MHLW / Japan)yamaguch@nihs.go.jp; Dr. Martina Weise (BfArM / Ge
 esentative; The Asian Experience - SFDA / MHW Representative
n lipid homeostasis in the eye: implications for ocular drug delivery.Arto Urtti; Finland; Promise of ocular gene therapy.

of. Camilla Foged, University of Copenhagen, Denmarkb) Trends and technologies in vaccine formulation, Prof. Bruno Gander, ETH, Zurich,
 orf, United States orMeindert Danhof, The Netherlands,Filling in the gaps: free concentration-time courses at the site of drug action as predic
                                                                      

                                                                      3.                                           
4.
 ined X Ray diffraction techniques – Identifying disordered crystals
 Prof Calvin Sun: Material properties of API
 Prof Peter Wildfong: Cor
paring approaches to predict feasibility, to scale up and to build robustness of roller compaction products; Dr. Susan Lum (Patheon Inc), Can
arma Solutions, Vegicaps Soft Technology: An Alternative to Gelatin - Containing Softgels
  by Roller Compaction; Dr. Abhay Gupta, USA - FDA, Title TBD; Dr. Peter Kleinebudde, Germany, Title TBD; Dr. Daniel Brown, UK, AstraZ
  saji ThomasGenotoxic impurities :- A global perspective
tries
 Joerg Hermann, Ph.D.,

       
                        Genentech, Inc

                                
               
Challenges in Transferring non-chromatographic methods
    
Dana C. Vaughn
 
Procter & Gamble
 esigning time to event trials"

                       

                       c)
                                                                    
d)

 s to Grouped Stages;
 Dave Christopher (USA) Improved accuracy in MMAD Determinations; 
 Jorge Quiroz and Helen Strickland (USA
bal Poor Michelle Childs, Director of Policy and Advocacy, Access to Medicines Campaign, Médecins Sans Frontières.The Role of Universitie

ading experts in pharmaceutical terahertz technology. He has over five years of experience in the field and has pioneered a number of the co
s considerations and application of QbD tools;James Prescott, M.S, Jenike & Johanson, Inc. USA, Title: Has the draft guidance on Powder B

 ptor-mediated endocytosis as an efficient means for the oral delivery of protein drugs;F. M. Voronese, PhD, Padua University, Italy, PEGylatio
 omal delivery of siRNA 3. Prof. Achim Aigner (Germany) or Prof. Thomas Kissel (Germany) or Prof. Mark Davies (USA); Polymer based siRN
 LaMattina oversaw the drug discovery and development efforts of over 12,000 colleagues in the United States, Europe and Asia. He retired
 European speaker, Europe, TBD;
                                 


                                  Dr.                                                                 

                                                                                                      c)
 ology – regulatory perspective. 
 Norman Stockbridge, FDA or Some one from oncology division
 Exposure –QTc response modeling 


                   

                   2
me Pharma, CANADA).
 – ―What‘s Unique about Ligand Binding Assay Bioanalysis and What Have We Learned from Outsourcing?‖ (Dr. H


 nt of assessing impurities between OTC and Rx products?
 3. New automation advances in pharmaceutical analyses-Rick Lung, AstraZeneca4. Advances in Automating Sample Preparation - TBD5.
allization of amorphous solidsDr. Ravi Shanker (Pfizer) 3. Characterization of crystallization kinetics of amorphous drugs and related solid d
Schwartz from Georgetown University Medical Center. (haven‘t heard back from Dr. Bergman as of yet) - transient dynamics in disease mod
  miRNA to humans.
 assess targeted delivery of drug to the brainKim L. R. Brouwer, USA, Presentation title: gamma scintigraphic biomarkers to assess localized
 uivalence studies?;Dr. Chikako Yomoto (Japan) Use of biowaiver concepts in the regulation of Bioequivalence.
  s; Dayan, N. (US) Implication of new REACH guidelines; Panel Discussants are speakers and in addition: Wertz, P. (US) with expertize in bi
nsulting, Inc.
Regulatory requiremnets from clinical pharmacology perspective; Dr. Dr. David Jacobson-Kram from FDA, USA and his title: Regulatory requ
TDD;Gary Cleary, USA, Clinical challenges with novel TDD systems;Samir Mitragotri, USA, Physical skin permeation enhancement technolog
and pharmacodynamic modeling of therapeutic proteins
                                                                
3.

 Office of Women's Health, US Food and Drug Administration
 Vivian Pinn, MD, Associate Director for Women‘s Health, Director, Office of
M);2. Case Studies from Global Contract Research Organizations (CROs) (Dr. Stephen Lowes, Advion BioServices, USA and Dr. Fabio Garo
 , Ph.D. Purdue University, US, Digital genesis of coating uniformity;Prof. Sir Michael Pepper, Cavendish Laboratory, University of Cambridge
mpound Suitability and Formulation Stability of Amorphous Dosage Forms;Jian-Xin Li, Ph.D.,Evonik-Degussa Corporation and Dave Wallick,
ell's background includes 15 years at Dow Corning working in the silicone field. Prior to his current role the Healthcare group, he spent 7 ye
 oolf, Merck Research Laboratories, USA)2.Do we still need to evaluate ion suppression and matrix effect if we use a stable labeled internal
-MS/MS (Dr. Eric J. Woolf, Merck Research Laboratories, USA)2.Impact of Phospholipids in Regulated Bioanalysis: Case Studies (Dr. Mario
 of. Dr. Yoshito Kishi, Harvard University / or Prof. Dr. Paul A. Wender, Stanford University Eur.:?
ity Eur.: Prof. Dr. M. A. Lacaille-Dubios, Faculte de Pharmacie, Universite de Bourgogne, France / Prof. Ronald R Cutler, Faculty of Health B
nsas Eur.: Prof. Dr. Akois Fuerstner, Max-Planck-Institute, Germany

E. Cane, Brown University, USA Eur.: Prof. Dr. Rob Verpoorte, Leiden University, Netherland / Prof. Avrelija Cencic, Slovenia
odney Croteau, Washington University, USA Eur.: Prof. Dr. Joachim Stoeckigt, Institute for Pharmacy, Mainz University, Germany / Prof. Mich
er: Prof. Brad Williams (University of LA;)Risks associated with inappropriate medications, non adherence and adverse drug events in geriatr
 o and Impactor Sized Mass (ISM) as Alternative Quality Control Metrics to Grouped Stages;J. David Christopher, United States, Improved A
 ker with formulation experience (US)Panel members include above and Health Canada Representative (Canada)

 thy Wiedmann, United States, Relevant Particle Properties Models for Translational Studies of Pulmonary Drug Delivery
Sponsor relationship perspectiveProposed Speaker: Dr. Jianmei Kochling, Genzyme Corporation.Analytical methods and specifications for d
 es as a drug delivery strategy to increase bioavailability and efficacy of flavonoids. Chun-Ching Lin, Kaohsiung Medical University, Kaohsiung
mashita; Japan; Extrapolation of intestinal absorption from animals to man.
ABCG2 in the transport of endogenous substrates and protection against toxins. Alfred Schinkel, The Netherlands Cancer Institute, Amsterd
gian University of Science and Technology, Trondheim, Norway
•
     


                                                                    
 Preclinical PKPD Studies on Intranasal Administration of CNS Drugs using
 m Center for Drug Research/Pharmacology, leiden University, lange_l@lacdr.leidenuniv.nl
•
    

                                                                                               

                                                                                              
 Relationship between exposure and non-specif
                                                             
2.

   (Dr. Mario L. Rocci, Jr, Prevalere Life Sciences, USA)
 Impact of non rugged bioanalytical methods on reliability and quality of data produ
 eaker: Abhishek Gupta, Ph.D., Novartis Pharmaceuticals Corporation;Country of Origin: USA;Topic # 2: Engineered Formulations in Asthma
asma concentration; Luigi M Biasucci: Luigi M. Biasucci, Instituto Cardiologia, Universita, Catholic University of the Sacred Heart, Rome, Ital
 bility of preclinical in vitro and in vivo assays for human CNS penetration; Dr. Bo Feng, Ph. D., The in vivo role of BCRP and P-gp in drug CN

otman, Donald Light, Charles Hoban, Mike Powell, Jacqueline Hunter, Geoff Kipling (GSK)
      

                                                                                              


aceutical regulationDavid Vogel, PhD. Professor of Political Science. University of California, Berkeley, USA;Solving the global drug price cris
ancements in Excipient Functionality Tests; Umang Shah, Excipient Functionality Testing in a QbD World: Regulatory Perspectives
facturing success; Victor Wong, Technologies to monitor process and product quality, as well as to manage risks


ash, Novel Controlled-release Capsules
peaker in Pharmaceutical Affairs involved with Global Clinical Trials (TBD);Panelists: Above session speakers with representatives from othe
  the process; Dilbir Bindra, Roller compaction: Will formulation platforms accelerate or hinder development?
 kinetics; Shigehiro Ohdo, Japan, Changes in Toxicity and Effectiveness with Timing of Drug Administration: Implications for Drug Safety
 )- AIDS: A Global Challenge; Proposed Speaker 2Kim Adkision (GlaxoKlineSmith Inc., USA) - Challenges in Drug Development;Proposed Sp
 . Wong, Johns Hopkins University, USA. PET to determine neuroreceptor occupancy for dose optimization.


n Studies: Conceptual Framework and Laboratory Practice
D. Leids University Medical Center, Leiden, The Netherlands. (e-mail: c.l.mummery@lumc.nl)―Pluripotent stem cell-derived cardiomyocytes fo
 @midwestern.edu; (630) 515-6951Speaker # 1: David Burgoyne, Ph.D., British Columbia, CanadaSuggested presentation title: Marine Clin



 6

 formulating pediatric medicines for global use
 . Robert B. Raffa, Professor & Chair, Temple University, USA,―Pharmacological evaluation of combination of drug therapy‖; Dr. Pradeep Sat
 pact of excipient choice on polymorph stability; Peter Wilfdong, US, Recent advances in analytical characterization of drug-excipient interact
ls with improved dissolution – a formulation strategy?
 Speaker – Novartis
3. 

                                                        
                  


                                                                           
 Topic – Regulatory view on cocrystal containing products
     
Spe
m, ISRAEL;2.Development of Disease-Specific Vitamin E Based Nutraceuticals, Dr. Andreas Papas, President and CSO, YASOO Health, Jo
sh University, Institute of Pharmaceutical Sciences, Parkville, AUSTRALIA;2.Oral lipid-based delivery systems for macromolecules: After a ve
USA;2.Lipid-Based Nanoparticulates, Dr. Pieter Cullis, Founding Scientific Director, Centre for Drug Research and Development, University o
ncer therapy;Duxin Sun, PhDAssociate Professor of Pharmaceutical SciencesUniversity of Michigan, USANovel inhibitors to disrupt protein-p
nt plan and monitoring system of cancer and atherosclerosis using molecular imaging;Timothy J. MacCarthy; U.S.A.; Roles of molecular ima

ned, USA, Pros and Cons: Tools to Move Forward: A Regulatory Perspective; Presenter and title to be determined;
 om various industrial companies, some cancer institutes using toxicogenomic appoaches, and regulatory authorities (FDA or EMEA-related)
                                             
•

 ment of nanoparticles after skin application
 Silvia Gutteres (University of Rio Grande do Sul Brazil) Application of nanoparticles for skin del
                                                             
 
   3.

 a Dayan; USA; Nanotechnology based Cosmetic products 
 
 André E. Nel; USA; Safety and toxicity of nano drug delivery systems an
First-in-Human Formulation TrendsVaidyanathan Viswanath, Thailand, Capsule Filling Equipment Advances
020

 :

     
―Tumor Microenvironment-Mediated Drug Release: Chew on This‖ Robert D. Arnold, Ph.D., Assistant Professor, University of Georgia,
new tool to characterize protein therapeuticsStuart Lindsay, USA: Apatamer reagents: challenges and progress to date

 will promote the statistical arguments for Disintegration correlation to Dissolution;Monica Chung of Massachusetts College of Pharmacy and
 d its implementation;Erika Stippler for USP will discuss the limitations of the ASTM procedure and the USP tool kit that addresses Mechanic
 oping country perspectives on approaches to anti-counterfeiting3.) TBD, Chinese government -High and low tech solutions to anti-counterfei
Netherlands, Pharmacogenetics of Cardiovascular Risk Therapy; Issam Zineh, PharmD., US FDA, USA, Pharmacogenetics of Chronic Cardio
KE:USA:Essential oils -- flavoring or antimicrobials?Nava Dayan or Amit Mitra:USA:Regulatory aspects of the cosmetics industry.Three speak
Walters:UK/USA:Design and evaluation of skin permeation retarders.Ernest Braue:USA:Skin exposure reduction paste against chemical war
 ncing Transdermal DevelopmentMario Gonzalez, USA, PK and regulatory concerns related to Generic TD Systems
a Institute, Sweden, Cytochrome P450 pharmacogenetics and cancer, Mark J. Ratain, MD, University of Chicago, USA, Individualized antica

 monary and intestinal microsomes.J. Gandolphi: Tissue slice co-culture for the evaluation of drug toxicityAlbert P. Li: Integrated multiple org
mology-model based approach for optimizing drug design in neurological sciences; Martin Stahl (Switzerland): Integrating molecular design re
ssue samples"Walter Korfmacher, USA, "LC-MS imaging approaches for tissue samples"
roducts"; 3) Leon Shargel, Ph.D., Applied Biopharmaceutics, USA, "Application of systemic drug bioavailability and drug exposure to establis
rspective"; 3) CT Viswanathan, Ph.D., FDA, USA, "Compliance, FDA and sponsor audits".
 ory perspective‖.

o ‗particulates‘ in Pharmaceutical and Biotech Products
on; USA; Regulatory implications of particulate matter in dosage formsCase Study I (Parentrals/Biologics)Maria Toler - Pfizer, or a TBD speak
ology: What adds value? 3. Robin Bogner, UConn; USA; Adjusting for The Process for Impact of Natural Process Variation. 4. Nancy Harper,
Sanjeev Kumar, Merck & Co, USA; Presentation titles and content will support the topic but has not been determined yet.
 OW TO INTERRUPT THE PROCESSES
            
Robert Weinberg, A Professor of Biology at MIT, USA, who won the national Medal of Science for

g Delivery‖; Andrew Polson, Ph.D., USA (Scientist, Genentech, Inc.) ―Antibody-drug Conjugates in Oncology: Principles of Safety and Efficac
 icochemical nature of macromolecular drugs by reversible lipidization; A. Bernkop-Schnurch, Austria, Bioadhesive delivery systems for impro




 otein (BCRP/ABCG2) in Multidrug Resistance in Cancer Cells.Gergely Szakacs; Hungary; Differential expression drug transporters in Cance
  l impact of Peptide transporters.
  nji Yamashita; Japan; Innovative strategies for development of oral drug products: In silico to clinical.
Guideline for BA/BE.
  many; Solubility and dissolution : impact of absorption.
 on; Sweden; Impact of intestinal transporters on oral drug development.
 rove oral BA.K.E. Thummel; USA; Molecular aspects of intestinal metabolism.
  ; Sweden; Human studies on DDI in oral drug absorption: Enzymes or transportes?
ochemical nature of macromolecular drugs by reversible lipidization.A. Bernkop-Schnurch; Austria; Bioadhesive delivery systems for improvin
acromolecular siRNA therapeutics.U Langel; Sweden; Applications of cell-penetrating peptides in regulation of gene expression.
  led drug release from a salting-out taste-masking system.
  xture.Hassan Benameur; UK; Case studies on development of liquid-filled capsule formulations.Kinam Park; USA; Hydrotropic polymer mice
s-Michael Lehr; Germany; The potential of mucoadhesive polymers as pharmaceutical additives with absorption-enhancing functions.Jindrich
   water-soluble compounds by polyaminesT. Minko; USA; Intratracheal liposomal delivery of siRNA, antisense oligonucleotides and anticance
 elease Systems.R.H. Guy; UK; Drug delivery to the skin from sub-micron polymeric particle formulations.
h Mass Spectrometry analysis. Ai-Ming Yu, PhD, Department of Pharmaceutical Sciences, University at Buffalo. 3. Understanding Absolute s
gn of Pharmaceutical Materials.Noriyuki Takata; Japan; Cocrystal Screening of Pharmaceutical APIs Using Slurry Crystallization, and its appl


 des in Discovery,Manufacturing, and Therapeutics;Jan-Christoph Westermann,University of Queensland, Brisbane, Queensland, Australia, N
                    

                    


 , London, Ontario
Drug resistance in cancer – still a transport related issue?
 
                             

                                                                                                               


                                                                                  Alfred Schinkel, Amsterdam
Cardiovascular drug transport –
 cid formulations.Kevin G. Rice; USA; Engineered nanoscaled polyplex gene delivery systems
 ipoplex-based siRNA delivery.Dimitry Samarsky; USA; new strategy for oral delivery of siRNA based on particulate carrier systems.
  drug delivery by conjugation with cationic cell-penetrating peptide.Wim E. Hennink; the Netherlands; Simultaneous delivery of doxorubicin a
  . Juergen Siepmann, France, Diffusion controlled drug delivery systems; Prof. Peter York or Dr. Qun Shao, UK, Neural networks for drug rel
  delivery system using nanoparticles modified with cell adhesion molecules.Alexander T. Florence; UK; Pharmaceutical nanotechnology: Mor
 antation.Timothy Allsopp; UK; ES cell technology: an introduction to genetic manipulation, differentiation and therapeutic cloning.
es for drug and gene delivery to mucosal tissues.Mark Gumbleton; UK; Astrocytic modulation of system L transporters in brain microvasculatu
 orubicin-loaded, long-circulating liposomes modified with cancer-specific monoclonal antibody.Daan Crommelin; the Netherlands; Developm
Germany; Benchtop-NMR and MRI--a new analytical tool in drug delivery research.
 er-bound constructs for drug targeting.Leonard W. Seymour; UK; Toward more effective gene delivery: combination dual responsive polypep
A. Hubbell; Switzerland; Synthetic biomaterials as instructive extracellular microenvironments for morphogenesis in tissue engineering.
er hydrogels for drug and gene delivery.Claus-Michael Lehr; Germany; Advances in nanotechnology for overcoming biological barriers.
 

J.Hochman (USA)
   Someone from the group that reported the crystal structure of Pgp in Science. 

                      
                                                                                


 pharmacotherapy;Giacomini KM (USA)Division of Clinical Pharmacology and Experimental Therapeutics, Department of Biopharmaceutical
                                
•

 ew ultrasound contrast agents
 Gregory M. Lanza (Cardiovascular Division Washington Univ. School of Medicine, Saint Louis, USA) Molecu
                                   


                                   
Prof. Jean-Pierre Benoit 

 ivery systems for biotherapeutics


                          Université d‘Angers, FR

                                                               
                       The
                                                                                      
 lipid nanocapsules: a new delivery system for th
H 3J5; Lawrence Lesko, Ph.D., Director, Office of Clinical Pharmacology, Food and Drug Administration, Center for Drug Evaluation and Rese

waiver determination - an EMEA perspective"; Christos Reppas, Ph.D., Greece, "Predicting food effects based on in vitro dissolution coupled
 ambridge, MA 02139, USA Suggested presentation title: " Spelling Molecular Imaging for the New Grammar of Drug Discovery;Speaker 2:D
olubility due to nanosizing: Kelvin equation;3. Cory Berkland (US): Case studies on the use nanoparticle formulations;4. Michael B. Bolger (U
Perlstein (US) Flexible Study Designs in Phase I;4) Cyrus Mehta (US) Simulation Tools for Adaptive Designs;

                                                                                            


                                                                                             

 d Human of Unbound Drug Concentrations in the Brain Interstitial and Cerebrospinal Fluids
Tetsuya Terasaki, Sendai, Japan: Pharmacopr
 lux.Elizabeth CM de Lange, Leiden University, Leiden, the Netherlands: CSF vs brain target site concentrations.Xingrong Liu, Pfizer Global R
 ness Models;3. Anjaneya Chimalakonda (US) PK-PD Modeling for Prospective Prediction of Anti-Viral Efficacy Using Human PK and in-Vitro
d PK/PD Indices of Effect;3) Alexander Vincks (US) Resistance Modeling in a Clinical Setting;4) Vincent Tam (US) Kill Curve Modeling and R
  and current trends for use of prefilled syringes and autoinjectors; Thomas Schoenknecht, Amgen Inc;Case Study on development of autoinj
                           


                            

arison with other species.
Jash Unadkat, University of Washington, Seattle, USA: Species differences in P-glycoprotein Activity at the Blood

                                     
4)
US) ―A Regulatory View of Phase II‖;
 Jonathan French (US) ―An Adaptive Approach to Phase II‖


or use of disposables in biotech manufacturing: Adam Goldstein, Genentech
atory affairs.
  industrializing M&S based development in Japan;3) Sriram Krishnaswami (US) Modeling and Simulation to design a non-bridging dose resp
e Latz (US) Application of Population PK and PK/PD Modeling Approaches in the Development of Alimta;3) Jeffrey Barrett (US) Modeling and
g stratum corneum tape stripping;3) Guy, R (UK)Near Infrared Spectroscopy and new imaging techniques for skin;4) FDA representativeDisc
for International Transport"
 tic and Biopharmaceutical IssuesJames C. Cloyd, Pharm.DUniversity of Minnesota School of PharmacyGeneric AED Formulations: Clinical
 tic and Biopharmaceutical IssuesJames C. Cloyd, Pharm.DUniversity of Minnesota School of PharmacyGeneric AED Formulations: Clinical
 tic and Biopharmaceutical IssuesJames C. Cloyd, Pharm.DUniversity of Minnesota School of PharmacyGeneric AED Formulations: Clinical
 tic and Biopharmaceutical IssuesJames C. Cloyd, Pharm.DUniversity of Minnesota School of PharmacyGeneric AED Formulations: Current
aufman, Abbott Quality and RegulatoryNicholas Cappucino, Eagle Pharmaceuticals and member of ICH Quality Implementation Group

 tic and Biopharmaceutical IssuesJames C. Cloyd, Pharm.DUniversity of Minnesota School of PharmacyGeneric AED Formulations: Clinical
                   
•
                                               
•

alth Science Center
 Raghu Vemuganti, Ph.D., University of Wisconsin
 Samba Reddy, PhD/RPh, Texas A&M Health Science Center
   

                   

ersity of Wisconsin


                       

                       

                                                              

                                                                                       Catherine Woolley, Ph.D.

 Health Science Center 
Menstrual cycle-Related Neurological and Psychiatric Conditions
                       Northwestern Universi
                                                                                                               

 .International Diabetes Institute, AustraliaPhysiologic and Metabolic Abnormalities of Central ObesityRamachandran Vasan, M.D.Boston Uni
ment of the Metabolic Syndrome Christina Aquilante, Pharm.D.University of Colorado Denver School of Pharmacy Nonpharmacological Appr
DavisNeurosteroids: Structure-Activity RelationshipShridhar V. Andurkar, Ph.D.Midwestern UniversityNeurosteroids as Novel Antiepileptic Ag
ave significant impact on the biophysical characteristics and biological function of the molecule. This symposium will be aimed at elucidating
uring;Dr Frank Thielmann, Novartis - Device/ Formulation Interactions - How Important is Electrostatics




 ed States, Engineered Formulations in Asthma/COPD Disease Management: Aiming for the Holy Grail of Inhalation Therapy;Dr. Badrul Chow
cterization of IgG2. 2. Arthur J. Chirino, Xencor. art@xenor.com (product-related) product-related impurities in general. 3. Daotian Fu. Genzym
                                        
•
                                                                                           

                                                                                                                                      •

 n pharmacopeia--EP representative 
 Alternatives to manual inspection for visible particle assessment--Deborah Shnek (Amgen)
 Identific
nvironmental Exposure Chambers;Anthony Fisher, M.D., Ph.D., Archimedes, United Kingdom, Assessment of the Pharmacokinetics of Intran
                            

                            3)
 mma-secretase inhibitor;
 Amol Tendolkar or or Brian Corrigan (US) Modeling and simulation approaches in Alzheimer‘s Disease;
 Timo    
4)
ackage for Stem Cell and other cell Therapy Products; Marina Dobrovskaya, USA, NIH-NCI, Stability/Analytical Challenges for Nanoparticle
er, US FDA, Shortfalls in recent Comparability Study Protocols and reports.
ivery and Half Life Extension; Professor Vicki Colvin, USA, Cytotoxicity of Nanoparticles; Dr. Tugrul Kararli, USA, Predicting Nanoparticle Ab
stream commercial development; Peter Scholes, UK - Maximising formulation flexibility within clinical studies via a translational pharmaceut

 sive Micelles and Vesicles Based on Polypeptide Diblock Copolymers (Sebastien Lecommandoux, University of Bordeax, France) 3. Dual St
 e manufacturing process: Process variability to achieve product quality2. Proposed Speaker: Aloka Srinivasan, Country of Origin: India. Pre
 igating impact of protein binding on antimicrobial activity Possible speakers:Markus Zeitlinger, Vienna, AustriaClinical implications of protein
 igating impact of protein binding on antimicrobial activity Possible speakers:Markus Zeitlinger, Vienna, AustriaClinical implications of protein

  Frank Hoke (US) MABELs of current biologic targets: Review
                                                                                                                    

                                                                                                                    


 cal Pharmacology Department of Medicine Faculty of Health Sciences University of Cape Town; Cape Town South Africa;
―Proven Pediatric

 Anant Paradkar, Institute of Pharmaceutical Innovation, University of Bradford, UKb) SAXS technique for particle engineering: Professor Rob
       

       


 stry‖;
Arnold Vlietinck, Ph.D.,Laboratory of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical, Biomedical and Veterinary Scie
mulationsPlus; or Dr. Masoud Jamei from Simcyp, or Dr. Raimar Loebenberg, University of Alberta, Canada; Successful IVIVC and human ex
 ges.To be determined; USA; Analysis of a Biomarker and Immunogenicity.Renta Hutabarat; USA; Quantitation of Aptamers in Biological Mat
  Receptor Therapeutics.
 nterfering molecules on PK assays; Kate Peng, USA- Impact of various interfering molecules on ATA assays; Mark Ma, USA- Title TBD (acce
ment of a Generic Ligand Binding Liquid Handling Script;

Bluegrass Biggs, USA, Validation of Automated Ligand Binding Assay System.
   
Ran
 h pediatric drug development.David Elder; UK; Pharmaceutical development strategy for pediatric formulation.Henk van den Berg, UK; Phar
 t.Alan Royce; USA; Pharmaceutical development using quality by design.Paul Dickinson; UK; Clinical relevance of in vitro restings during Qu

                                               

                                               


 a case study for a successful clinical study‖;
Michael J. Balick, Ph.D., vice president and chair, Research and Training, Philecology Curator
hat we learned from abacavir.Michael Murphy; USA; Genomic biomarkers in standardized therapy - future prospects.
  ized medicine in cancer therapy.Wofgang Sad&#233;e; USA;Personalized therapy - translation from trials to clinical application.
 consumer insights Rick S Chan, PhD, MRPharmSDirector, Open Innovation, New Product Development, Venture Group,GlaxoSmithKline Co
Richard B. Kim;USA; Systematic approach for pharmacogenomics of metabolizing enzymes and transporters.
ence on dossier prep and interaction with SFDA3) expert to provide perspectives on FDA requirements vs SFDA requirements etc.
 Perspectives - Speaker TBDChallenges - Industry perspectives - Dr. Chris Senanayake, Boeringer Ingelheim
 ives - Dr. Nick Mehta, Shire Human Genetic Therapies
 Medical Team LeaderDivision of Oncology Drug Products, Office of New Drugs, CDERSteven Koepke, Ph.D.SRK Consulting LLCSemih Okt
   - Dr. Mary Cromwell, Genentech
 ology, Poland,Chemical Target Validation Studies;Martin Hintersteiner,Novartis Institutes for BioMedical Research, Innovative Screening Tech
 A, USA, ―Regulatory perspective‖.
 USA, ―Regulatory perspective‖
ners by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly)Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jos
 advantages of various commonly used preservatives: Brian Meyer (Merck)Screening methods and selection criteria for preservatives in pare
 advantages of various commonly used preservatives: Brian Meyer (Merck)Screening methods and selection criteria for preservatives in pare
ners by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly)Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jos
ners by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly)Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jos
ners by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly)Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jos
on, Ph.D., UK;How to use pharmacokinetic approach to help? James Li, Ph.D., USA
iver injury;Munir Pirmohamed (The University of Liverpool), UK, Pharmacogenomic analysis for the drug-induced toxicity;Urs A. Boelsterli (U
er from FDA, name to be determined

harmaceutical Development Strategy"

  is in Imaging using spectroscopy)Analytical Research and Development, Pfizer Global R&D, Groton, CT 06340, USASpeaker 3: William H.
 mplications for interspecies differences in mitochondrial toxicity of fialuridine.Yoshikatsu Kanai; Osaka University, Japan; Integrated physiolog
 Japan; Cooperation of OCTs and MATEs in drug dispositionBruno Stieger; University of Zürich, Switzerland; Inhibition of hepatobiliary transp
 fman, FDA, USA, FDA Anti-counterfeiting Initiatives;WHO IMPACT Initiative Speaker, Europe, The Use of Spectroscopy to Combat Distributi
 chTechnology Transfer in the new Paradigm: ICH Q10 (Quality Systems) to the RescueRoger NosalExecutive Director, CMC-RegulatoryPfize
  als.2. Mohan GanapathyExecutive Director, CMCMerck & COAPI Processing and strategy evaluation for small molecules 3. Duncan Low S
andscape: An Industry PerspectiveJeffrey J. Blumenstein, Ph.D. Vice President, Quality-RegulatoryJohnson and JohnsonUnraveling the Supp
  ets"Nanda Subbarro, US, "Strategies to meet WHO Stability Guidance for Vaccines"
 uticals
 ics of drug hypersensitivitySpeaker: Arlene R Hughes, GlaxoSmithKline, Research Triangle Park, North Carolina E-mail: Arlene.r.hughes@g
  omics of membrane TransportersSpeaker: Quing Yan, MedImmune Inc, Mountain View, CA. E-mail: yanq@medimmune.com;3. Endothelial
ersity of North Carolina, United States;
   NCE with new excipientsProfessor Christopher PORTER; Australia, Regulatory and Toxicology requirement for oral lipid drug delivery Dr. Ha
    Regulatory considerations, EMEA (Robin Thorpe, NIBSC, UK) 3.             Causality of structural changes in therapeutic proteins (WimJiskoot, L
mpact of genetic polymosphisms of drug transporters on the pharmacokinetics of drugs;
        
Kazuya Maeda; The Univ. of Tokyo, Japan; The pred
                        
[2]
                         

  dennis@mayo.edu;

 William Newman, Department of Medical genetics, Manchester Academic Health Sciences Center, St Mary‘s Hosp
  on of multiple metabolic enzymes and transporters;Geoff Tucker; University of Sheffield, UK; A Framework for Assessing Inter-individual Var
 , USA; In silico pharmacological approaches for drug discovery: virtual ligand screening and profiling;Philippe Manivet; Hôpital Lariboisière, F
 derstand the importance of drug transporters in the intestinal drug permeability directly in humans;Mariko Morishita; Hoshi Univ., Japan; The
  ters;Kenneth K. W. To (National Cancer Institute, National Institutes of Health), USA, miRNA regulating the expression of ABCG2 in resistan
  Douglas H. Sweet (Medical University of South Carolina), USA, Organic anion transporters in the kidney;Kathleen M. Giacomini (University o
 and) Pharmacogenomics - Lost in Translation; Ross Maccinone (University of South Australia, Australia) Pharmacogenetics 2020: Barriers a
  chigan, USA)Pharmacogenetics of adverse drug reactions in psychiatry; Toshiyuki Sakaeda (Kyoto University, Japan) Pharmacokinetics and
  nish systems;Ingrid Markowic, FDA/CDER, US, Particulate matter, leachables and integrity of bags - the safety aspect;Kirsten Lauber, Germ
 s for individualized medicine: Combining technology; Silvio Aime (University of Torino, Italy) Latest technology of Molecular imaging
  r, Switzerland, Formulation tool box for high concentration liquid formulations;
  
Karoline Bechtold-Peters, Germany, High concentration liquid
   

   


 
Professor Martin Kuentz, Professor of Pharma Technology, University of Applied Sciences Northwestern Switzerland, Muttenz, Switzerland
                                      



 nufacture of Clinical Trial Products"
Professor Fernando Muzzio, Dept Chemical & Biochemical Engineering, Rutgers University, NJ. 

        
―Q
                                                                                                                                              

                                                                                                                                             


nnecticut, U.S.A.;4. Ted Randolph, University of Colorado, U.S.A.;5. Evgenyi Shalaev, Pfizer, Inc. U.S.A;AAPS Member Sections benefitting f
 ation of the appropriate therapeutic dose based on the receptor occupancy;Margareta Hammarlund-Udenaes (Uppsala University), Sweden,
nalysis of the Roller Compaction Process-- AntonioZavaliangos, Drexel University, USA;3. Development of Instrumented Rolls for Modelling
 f two siliconization procedures including particulate matter characterization;
   Ingo
                                                                                  
 Presser, Germany, Novel holding system for lyophilization a

                                                                                                              

                                                                                                              Satish Singh or Linda Narhi or H
Orthogonal approach ? – current view of what is required for subvisible particle characterization and control;

 healthstar.qld.edu.au/hstn_staff.htmEmily Alexander, PharmD, BCPS, Envision Telepharmacy, Alpine, TX, US
nate; "Excipient consideration for designing liposomes" 3. Dr. Tom Redelmeir (Canada); "Liposome manufacturing process: Case study 1" 4.
Royal College of Surgeons, Ireland, Respiratory Antivirals - Drugs, Vaccines and Novel Therapies;Dr. David Edwards, Harvard University, Uni
 and Nanoscience Centre, University of Nottingham;4. Fred Vogt, Ph.D., GSK, USA;5. Thomas Rades, Ph.D., New Zealand.

              

              


 nal failure‖;
2. Bjoern Bauer, PhD, University of Minnesota, USA, ―Prevention of seizure induced up-regulation of P-glycoprotein by COX-2 i
 @berkeley.eduPhone: (510) 642-4862Sarah E. O'ConnorDepartment of ChemistryMassachusetts Institute of Technology77 Massachusetts A

 on is approved)
•
 

                    
                                                                                   
 Stability Challenges and Strategies
                   
 Challenges with Sourcing, Approving and Supplying Comparators for Clinical Trials
•


                                                                                                         

                                                                                        
2.

ne, Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@ttuhsc.edu 
 Dietary flavonoids for colorectal cancer - Gerd Bobe
 se DevelopmentTBD - Value of CMC Project Management in Alliances
Pharmacy at Rutgers, The State University of New Jersey, 160-Frelinghuysen Road, Piscataway, NJ 08854-8022, USA.Phone: (732) 445-383
 t and Future utility; M. Dysinger, USA, Quantification of Biotherapeutics with Octet and comparison to ELISA for IVT sample analysis;
Application of QMBDD in drug discovery and translational research. Tristan Maurer (Pfizer Inc, USA) or Mohammed Tabrizi (Anaptys Bio, USA
  Efficacy Using Human PK and in-Vitro Data (Chee Ng, Bristol-Myers Squibb Co., USA)Modeling Hepatitis C Virus Kinetics: PK/PD Versus T
  company (TBD), USA , "Novel technology flat-forms for immunogenicity testing under development"; 3. Gopi Shankar, PhD. MBA, Centocor,
arity in Biotherapeutic assay Development and Validation
AS-cog Scores in Patients with Alzheimers Disease byMeta-Analysis of a Mixture of Summary and Individual Data", Leon AAron, UK, "Analyt
atory approaches- a TPD perspective"; xx, Japan, "Regulatory approaches – an MHLW perspective"; Hartmut Derendorf, Ph.D., USA, "Prosp
 illiams PhD, Pfizer Oncology La Jolla, CA Alternative speaker: pharmacogenetics/genotype associations for major cytochrome P450 Enzym

 e, and bound endogenous protein in the presence of a neutralizing antibody3.Kerry Oliver, Radix Biosolutions, USA, Assay development of m
 dotoxin and residual solvent levels in ocular dosage forms – approaches to removal with application to other non-oral formulations 
  
Erem Bil
                                                                                         


                                                                                          

vantages of not freezing. Victor B, Universal Preservation Technologies, San Deigo
Speaker affiliation: Spray Drying: Applications to oral a
 erive from them"; Yu Chung Tsang, Apotex Inc., Canada, "Industry perspectives on the new requirements"; xx, speaker from EMEA, "An EM
 o methods of mathematical modeling and numericalsimulation for controlled drug release kinetics and formulations Carl Wassgren; USA; Dis
 vo drug delivery profiles"; Ian Wilding, Ph.D., USA, "Molecular imaging in assessing bioequivalence: Examples".
 etherlands Cancer Institute, Amsterdam, Utilityof KO mice to assess complex behavior of ezetimibe in vivo; Joseph Ware, Genentech, USA,
 resentative (Switzerland): The successful development of a human growth hormone biosimilar;Each speaker will be limited to a 10 min pres
eve Swanson , Amgen Inc., Thousand Oaks Speaker affiliation: Application of QbD concepts to Formulation design, Steve Shire Genentech
 advantages of various commonly used preservatives: Brian Meyer (Merck)Screening methods and selection criteria for preservatives in pare
                                                                                                         

                                                                                                         


or Martin Mueller-Zsigmondy, Novartis, TRD, Basel Switzerland; or Hequn Yin, Novartis Shanghai;
―Bioavailability, Absorption and Drug Effe
U.S.A);Predictive in vitro, and in silico methods: Jim Polli or Anette Muellertz (country of origin: U.S.A or Denmark); Early development, prepar

 r. Praveen K. SharmaResearch Investigator IIProcess Research & DevelopmentBristol-Myers Squibb Co.1 Squibb DriveNew Brunswick, NJ
of MedicineTexas Tech University HSC1406 S CoulterAmarillo, Texas, 79106majid.moridani@ttuhsc.edu2) A regulatory perspective on pharm
Mechanisms in Herb-Drug Interactions: Enzymes and Transporters;Bill Gurley, Ph.D. USA Herb-Drug Interactions: Clinical Effects;
ach for APIs
2)Name: Jin-Wang Lai, PhDPosition: Sr. Director, Formulations and Analytical Labs, EurandCountry: USATitle: Moderator3)Name: Jeff Worth
2)Name: Jin-Wang Lai, PhDPosition: Sr. Director, Formulations and Analytical Labs, EurandCountry: USATitle: Moderator3)Name: Jeff Worth
h.D, NigeriaSome Formulation Challenges of Natural Products3Mary Murray, Ph.D, USATitle: TBA4.Moji Adeyeye, Ph.D, USASolid State Ch
oSpeaker 2. Proteomics in drug development Robyn P. Araujo, PhDCenter for Applied Proteomics and Molecular Medicine, George Mason U
6 Thomas.Abbruscato@ttuhsc.edu 
2.
  

                                     

                                    
 Flavonoid based prodrugs targeting melanoma tyrosinase– Majid Moridani - Assistant Professor, Sc
E, Denmark, Placental Transport of drugs;4. Josh Unadkat, USA, or Nakano S, Japan, Regulation of Drug metabolism and transport in pregn
e markers. - Speaker TBD.4. Identification and validation of Biomrkers - Validation or Qualification? Jane Bai, FDA5. Biomarker based disea

 Washington), ―De novo design of novel protein drugs‖.
vocate, What is the problem with generics
Jennifer Dressman, Biorelevant dissolution mediaJames Polli, USA, Predictive dissolutionAnette Müllertz, simulating digestive processes in
 Tata, PH.D. St. Louis, MO.1: Advantages of UPLC or LC-MS/MS - Speaker TBD.2. What is the ideal an ideal analytical method for drug dev
e, USA, Individualised Drug Therapy Using Bayesian Methods

esJarkko Rautio, Ph.D.University of Kuopio, FinlandMolecular Basis of Strategies for Targeted Intracellular Drug and Gene DeliveryBrian Sto
 aker TBD.
ons";David Vodak, USA, "In Vitro Tests for Selection of Preferred Solid Amorphous Dispersion Formulations";Jennifer Dressman, Germany, "
 Houston TXSpeaker 3: Title and Speaker TBDSpeaker 4: Title and Speaker TBDSpeaker 5: Title and Speaker TBD




and pharmacokinetic considerations Speaker 2: Speaker from FDA/EMEATitle: Regulatory considerations in pediatric development Speake
ment; 2.Raimar Loebenberg, University of Alberta, Canada,Relevant Dissolution and Formulation testing and QbD to Predict PK/PD and Cl


sions;3. Tobias Massa, BMS, US, Strategy and Experience in Managing Global CMC Regulatory Submission: An Industrial Perspective;
aining vision in pediatric patients with adenovirus associated RPE65"; Normal Radke, USA, "Treatment of blindness by retinal transplant"
 PharmacyUniversity of Cincinnati3225 Eden AvenueCincinnati, OH 45267-0004Phone: (513) 558-3870Fax:            (513) 558-0978Email: pa
, Understanding of Colonic Absorption: Physiological aspects and consequences for biorelevant dissolution method development; 3. Christ
Role in Drug Product Development;2. Gordon Amidon, University of Michigan, US, Predictive Mechanistic Approaches for Drug Product Abso
ker #2:Amin Rostami-Hodjegan, PharmD., Ph.D. University of Sheffield, UK & Simcyp Ltd., UKModeling and Simulations to Predict Complex

BD (Pfizer formulation group or, Amgen)Silicone oil ID and silicone layer thickness in prefilled syringe by reflectometry and Raman fingerprint
 , Monilek Hospital and Research Centre, India6.Hitoshi Sasaki, PharmD, Nagasaki, Japan7.Brian Irons, PharmD, USA8.AJ O'Sullivan. MD, U
 illiam J. Spruill, PharmD, FASHP, FCCPUniversity of Georgia, USAComparison of eGFR with estimated creatinine clearance in the dosing o
 gulatory perspective - FDA Speaker - TBDToxicology perspectives - FDA Speaker - TBD
  kyoJapanDrug-induced Toxicity: Can We Predict It?;Speaker #3:Joe Polli, Ph.D.GSKHow to conduct transporter studies to mitigate safety-re
dia; Dr. Huifen Faye Wang, USA, Lessons learned from recent bioequivalence studies to support new drugs registration in China; Dr. Dalia W
c Translation of Preclinical Test Systems";Robert Carr of Abbott, U.S.A."PK/PD modeling in immunology drug discovery";Zheng Yang of Brist
  nd Chair of Medicine, Columbia University), ―Drug discovery through structure-and-mechanism-based computational design‖.

elected internalizing human single-chain antibodies‖; Dr. Duxin Sun (Associate Professor, University of Michigan), ―Targeted Drug Delivery in
Novel Adaptive Designs for Dose-Response CharacterizationChyi-Hung Hsu [USA], Value of Exposure-Response Analyses for Characterizat

tion of safe, protective vaccines against infection, cancer, and allergy‖; Dr. Wayne Koff, ―AIDS Vaccine Development: Challenges and Oppor
  Ken Houk (Professor, UCLA), ―De novo design of novel, thermostable proteins‖.
y of Michigan), ―Development of a promising long-lasting enzyme therapy: In vitro and in vivo studies‖; Dr. Michael Owens (Professor, Unive

officer - TBDChinese SFDA participant - TBDLatin America (Brazil/Argentina) Mexico Representative - TBD(International representatives as
eractions or drug - drug-pgp interactions.


sity of Michigan), ―Protein engineering for stabilization‖.
  Local Partners; Kishor Wassan, Canada, Formulating old drugs for neglected diseases in sustainable ways.
 al envelope glycoprotein gp120 triggers an inflammatory response and regulates the functional expression of P-gp; David Miller, USA, Altern
clear (CBRN) Medical CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201
ssor Costas Gogos - Polymer Dispersive and Distributive Mixing - Principles and Extrusion Practice; Professor James McGinity - Formulatio
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
 l CountermeasuresDHHS/Biomedical Advanced Research and Development Authority (BARDA)Washington, DC 20201Mary E. Spilker, PhD
               

               

                                                                           

                                                                                            


) Extrudates‖;
Ping Gao, USA, "Incorporating SEDDS into Hard- and Soft- shell Capsules";
Roger Gordon, USA, ―Development and Comm

n-La Roche, NJ USA. 2.Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies. Honghui Zhou, or Kathleen
ed review. Moheb Nasr, FDA. &#13;&#10;3. Academic understanding of QbD. Jim Drennan, Duquesne Univ. &#13;&#10;
 tsuo Kurokawa, Ministry of Health, Labour and Welfare, Japan or European (EMEA) equivalent;
  Duquesne University, Talk entitled: Risk Assessment and the Manufacturing Process&#13;&#10;&#13;&#10;Mansoor Khan, FDA, Talk ent
                                                                      

                                                                      4d)
 sus BE, James Polli PhD, School of Pharmacy, Univ. Maryland 
 Novel dosage forms / Aerosols BE, Bing Li, Ph.D. CDER, DBE, FDA
               
5e
ycolyzed lipid excipients and their effect on drug solubilisation in the GI Medium.Jean F. Cuiné, Novartis, USA3.Gastrointestinal lipolytic enzym
 hneider, JWG Univ. Frankfurt, Germany;Philip J. Hajduk, Abbott, Abbott Park;


al Gene Therapy Department of Medicine Osaka University (RM), Osaka Japan2. Clinical Devleopment of Fibroblast Growth Factor Express
are,Zimbabwe & AstraZeneca, Sweden;James McLeod, Schering-Plough, Kenilworth, NJ;Nick H.G. Holford, Department of Pharmacology a

      


       

ticals
Joe Famularae
   
Director, Office of Compliance, 

 

                                                           FDA
Presenters
Process Validation Guidance – Expectations for New and Legac
                                                                 

                                                                 
        


                                                                           

                                                                    

                                                                    Dr.                                   


                                                                                                           

and challenges in developing in vitro –in vivo relationship (IVIVR) 
 G.E. Amidon (University of Michigan)
2. Design of a biphasic dissol
oan Claria - University of Barcelona
Bioequivalence of Modified Release Products: FDA Perspectives, Barbara Davit, Ph.D., FDA, USA; 3. Approaches to Ensuring Therapeutic
 tion Environment on Stability of Topical Patch and Cream Formulations and Water Soluble Vitamins in Multivitamin Supplement
orrelations: Regulatory Opportunity and Strategy Arzu Selen, FDATitle: Challenges (Opportunities) in Setting Clinically Relevant Dissolution S
 athy, Executive Director-Merck, CMC4.Speaker from Novartis or GSK
                                                           

                                                           3.

rspectives: Dr. Patrick Marroum or Dr. Arzu Selen, ONDQA
 Application of Biorelavent Dissolution Tests for Prediction of In Vivo Performan

 Application of QbD on the Control Stratgy of a Drug Product; Moheb Nasr (FDA), Regulatory Perspectives from the US; EU Regulator (TBD)
                             National Cancer Center Hospital East
              Yasuhiro Matsumura              yhmatsum@east.ncc.go.jp

sed therapeutics. 3) Dr. Diane Seimetz, Germany or Dr. Scott Hamond USA, Case Study: catumaxomab or MT103

 ption model.
 Kentucky) Eric Munson ( U. of Kansas) Donghua Zhu (Abbott Laboratories)
omparability ProgramSusan Hurst, USA, Pfizer, Non-Clinical Components in a Comparability ProgramFDA/CDER, Invited, Expectations Rega
 uble basic drugs to improve dissolution performance; David Sperry - US – artificial stomach duodenum simulations for development; Greg A
  kinetics to Biopharmaceutics and Pharmacokinetics
 Athens, School of Pharmacy, Athens, Greece, "Development of Novel Milk-Based Oral Formulations:Case Studies"
ct contaminants - Cindy Buhse, FDA3. Role of Chemometrics in the modern analytical era- Bill Welsh, Univ of Missouri, St.Louis
zation of Pharmaceutical Regulations: China Perspective, Guowei Sun, ChinaGlobalization of Pharmaceutical Regulations: US perspective, J
 siness Process Support, CDER; TBD
               Vinod Shah     TBD                            Mitsuru HashidaKyoto University hashidam@pharm.kyoto-u.ac.jp
                                              Dr.vpshah@comcast.net
pment and Stability of Soft Gelatin Capsules.
 ct ManufacturingPerson:Ali Afnan, Ph.D.Organization: US FDATopic: Overview of NIR-based RTR in Pharmaceutical ManufacturingPerson:E
 es for immunogenicity assessment and future trend;Amy Rosenberg, FDA, USA - Regulatory perspectives on immunogenicity of biologics
Velagapudi, PhD, Teva Pharmaceuticals, USA, Biosimilar Product Development in the US from a Global Manufacturer's Perspective; Scott J.
 ness innivation
Evaluation, Laszlo Endrenyi, Ph.D., University of Toronto (15 min)Evaluation of Extraneous Factors on Drug Release from Multiphasic MR Pr
 Senior DirectorAnalytical Research and Development PfizerGroton, CTBernard A. Olsen, Ph.D.Senior Research FellowAnalytical Sciences R

GN SPACE"; Lee Kirsch, University of Iowa (USA); "STABILITY CONSIDERATIONS IN DEVELOPING A DESIGN SPACE"Other investigators
 sessement Road Map;Moderator 1: Arzu Selen, USA;Moderator 2: Timothy Schofield, USA.



             Elias Fattal                   elias.fattal@u-psud.fr
                             University of Paris Sud 11
 galactose Antibodies and PK Assay Development; HGS or Roche speaker TBD, USA "Anti-IFN Antibodies and Impact on Assay Developme
               Moderator 3      Moderator 3                     Speaker          Speaker                       Speaker
                Affiliation       Email           Speaker      Company Presentation Speaker Company
                                                                             Exploring a Risk Management Approach
                                                 Tom Sam Schering Plough Corporation Susan LumPatheon Inc. Towards Developing the Op
                                                             M               Formulation Development Using Lipid Excipients
                                                 Chris Porter onash University                 David FulperCatalent Pharma Solutions, Inc.
               Par Pharmaceutical                Gert Ragnarsson
                                 sajithomas@msn.com          MPA                               Patrick EMEA Perspective
                                                                             Dissolution and QbD anMarroum FDA
                                                             P               Applying the Principles QbDSchering Plough Corporation
                                                 Saji Thomas ar Pharmaceutical                 Tom Sam to Analytical Methods
                                 bruno.flamion@fundp.ac.bePfizer
                                                 Richard Lalonde
               EMEA/CHMP Scientific Advice Working Party                                       Jasper DingemansePharmaceuticals in Clinical Trial
                                                                                                           Actelion
                                                                             Modeling Clinical Outcome and Biomarker Response Ltd
                                                             Mao             Role of Placental P-Glycoprotein and BCRP in Fetal University
                                                 Qingcheng University of Washington            Phillip GerkVirginia Commonwealth Drug Exposure
                                 hillh@ukorg.huntingdon.com
               Huntingdon Life Sciences          Brian BoothFDA              Introduction      Howard HillHuntingdon Life Sciences
                                  of Health Sciences
                                                 Neal
               National Instituteyomota@nihs.go.jp Davies                    Unique Issues Diane Burgess      Products
                                                             Washington State University for InhalationUniversity of Connecticut
                                                             A               Counterfeiting PerspectivesInterpol Aei
                                                 Roger Bates merican Enterprises Institution   Aline Plancon from the
 .kyoto-u.ac.jp                                              Foresight Links Corporation and Botanical DrugUniversity
                                                 Carmen Tamayo               Health Claims Michiho Ito Kyoto Development: from Seed to Patien
                                                                             Managing          Loren Israelsen Natural Products Alliance
                                                                                                           United
                                                 Ikhan KhanUniversity of Mississippi Quality of Botanical Dietary Supplements Through Implem
                                                 Jun Haginaka                Monodispersed Molecularly University of Pavia for Pharamceutical a
                                                             Mukogawa Women's University                    Imprinted
                                                                                               Gabriella Massolini Polymers
@tipharma.com                                    Daan Crommelin                                 – Public Private
                                                                             E U PerspectiveLarry AugsburgerPartnerships and their Role in Educ
                                                             Top Institute Pharma                          University of Maryland
                                 somak.das@bms.com Pappa
               Bristol-Myers Squibb              Horacio     USP                               Nicholas FDA
                                                                             Aiq a USP Perspective Buhey
                                                             Algorithme Pharma Inc. of High Ph Mobile Phase in Lc-Esi(+)-Ms/ms Under Reve
                                                 Fabio Garofolo              Application       Ray Briggs Icon
  kayama-u.ac.jp                                 Zuguang Ye                  Standardized Evaluation Hatano
                                                                                               Tsutomu Okayama Safety and
                                                             Chinese Academy of Medical Sciences of Tcm Drug University its Safe Use In Chi
                                                 Ping Gao abbott                               Lawrence Yu FDA
                                                                             Overview of Fundamental Aspects of Supersaturation-Based Drug D
                                                             Algorithme Pharma Inc.
                                                 Fabio Garofolo                                Neil SpoonerGSK
                                                                             Introduction to Dbs Technique and Comparison Between Dbs and P
                                                             Kyoto University
                                                 Fumiyoshi Yamashita                            Visualization Techniques for ADME
                                                                                                           U
                                                                             Data Mining andTudor Oprea niversity of New Mexico Screening
                                                             University of Geneva Be Determined Loidl
                                                 Tudor Arvinte               Title to          Gunther Bachem AG
on@AstraZeneca.com                                           AstraZeneca Dynamical Systems Analysis In Mechanistic PKPD Modeling
                                                 Johan Gabrielsson                                         Leiden
                                                                                               Meindert Danhof University
  u-tokyo.ac.jp                                  Nick Holford                To Be Determined
                                                             University of Auckland                        The University
                                                                                               Amin Rostami-Hodjegan of Manchester
                                 stevek@mail.med.upenn.edu
               University of Pennsylvania                    Maitland-van derIntroduction In Pharmacogenetics
                                                 Anke-Hilse Utrecht UniversityZee              Ann Daly University Newcastle
                                                 Wim Jiskoot                 Customized Vaccines for the Future:Vaccines or Diagnostics
                                                             Leiden University                             Novartis Needles & Needleless?
                                                                                               Derek O'Hagan
                                                             Keio University, School of Medicine and Outcome of the ICH E2e Working Group
                                                 Yusuke Tanigawara                              Work
                                                                             Summary of the Gerald Dalpan  FDA
                                                                             Advances and Examples of Finnbrit Consulting
                                                                                                            New
                                                 Otilia Koo Bristol-Myers Squibb CompanyRichard Moreton Excipients in Novel Drug Delivery S
                                                             FDA
                                                 Janice Soreth                                 Toshiyoshi Tominaga
                                                                                                           PMDA
                                                                             Us FDA Mechanisms for Sharing Information Between Regulators
  dfci.harvard.edu                               Gavin Brooks                Targeting the Cell Cycle Machinery for the Treatment
                                                                                               Martin LohseUniversity
                                                             School of Biological Sciences, University of Reading of Wuerzburg of Cardiovascu
                                                             3R              The Impact of the New whoPfizer Global Research & Development
                                                                                                            Stability
                                                 Manuel Zahn Pharma Consulting GmbH Kenneth Waterman Guideline on Global Stability Te
                                                             University of Washington Micro Reactor Technology for Drug Substance Synthesis
                                                 Brian Marquardt             Continuous                    AstraZeneca
                                                                                               James Kraunsoe
ucdenver.edu                                     Wim Jiskoot                 Visualizing Subvisible Particles in an Academic Setting
                                                             Leiden University                             MedImmune
                                                                                               Mariana Dimitrova
                                                                             Case Studies: Comparative Analysis of Cell-Based and Competitive
                                                                                               Daniel Baltrukonis
                                                 Bonnie Wu Centocor Research & Development, Inc Pfizer
manchester.ac.uk                                             Pfizer
                                                 Manthena Varma Inc                             Physicochemical and Biochemical Aspects in Evalu
                                                                                                           The University
                                                                             Consideration toAmin Rostami-Hodjegan of Manchester
                                                                             Delivery of siRNA and Peptide for Cancer Therapy
                                                 Leaf HuangUniversity of North Carolina Silvio Aime Università degli Studi di Torino
                                                                             Overview of Genomics and Other Biomarkers In Oncology Drug
                                                                                               Axel
                                                 Gary KelloffNational Institute of Health SciencesUlrich Max Planck Institute for BiochemistryDisc
                                                 Klaus BøgesøLundbeck                          Patrick Zarrinkar
                                                                             Design of Multitarget Drugs Ambit Biosciences
                                                             VU University /Reactive Intermediates: theLeiden Universityfor Human Adrs
                                                 Nico Vermeulen               LACDR                         Molecular Basis
                                                                                               Bob van de Water
 comcast.net                                     Ole Bjerrum                 New Public        A, (Eu/efpia) Supported Pan European Modular Pro
                                                             University of Copenhagen PrivateHayes Harvard University
  .kyoto-u.ac.jp                                                                               Yasuo TsutsumiBioanalysis of
                                                                                                             the
                                                 Mark Rose Amgen, Inc Experimental Challenges InOsaka University PEGylated Peptides
                                                             Indiana University
                                                 David Flockhart                               Kathryn Phillips
                                                                                                           University of Tests
                                                                             1. Clinically Available PharmacogenomicCalifornia, San Franscisco
                                                                             The               Mary Relling Jude Children's Research Hospital
                                                                                                           St.
                                                 Urs Meyer University of Basel Contribution of Pharmacogenetics to Personalized Medicine
 u-tokyo.ac.jp                                               Simcyp
                                                 Sibylle Neuhoff                               Hiroyuki Kusuhara
                                                                                                            for Transporters to
                                                                             Scaling In Vitro Assay Data University of Tokyo Predict the In Vivo Ou
                                                             Vertex, Inc
                                                 Prabu Nambiar                                 Stability: Science and Regulation
                                                                             Pharmaceutical Latiff Hussain FDA
 oya-cu.ac.jp                                    Leslie Benet                Title to          Shinji
                                                             University of CaliforniaBe DeterminedSakuma   Setsunan University
                                                                             Pet and           Shinji Yamashita
                                                                                                           Setsunan ADME of
                                                 Duxin Sun University of Michigan Fluorescent Imaging to StudyUniversity Tumor Targeting An
                                                             National        Annular Bed Flow  Jukka Rantanen
                                                                                                           University of Copenhagen
                                                 Paul Wan Sia Heng University of Singapore Patterns In a Bottom Spray Coating Process and t
                                                             Kyushu University
                                                 Shigeki Sasaki                                David Corey niversity of of Rna
                                                                                                           U
                                                                             A New Tool for Site-Specific ModificationTexas
                                                             Ernst Moritz Arndt University David Moore aylor College from Physiology to Thera
                                                                                                           B
                                                 Henriette Schwabedissen Nuclear Receptors and Transport Proteins:of Medicine
                                                 Takao Yamori                Identification of a NovelShoemaker
                                                                                               Robert Pi3k DPT
                                                             Japanese Foundation for Cancer Research Inhibitor for Cancer Treatment
 @novartis.com                                               Van der Waqlt Saving Lifes        Unmesh DeodharAntimalarial Therapies
                                                 Jan-Stefan University of Cape Town with CombinedNovartis Pharma AG via Optimizing D
                                                                             Ncdfa             Rupesh Amin
                                                 Peter BryanCelgene Corporation -a Regulatory Prospective  Celgene
                                                             P
                                                 Satish Singh fizer, Inc.                      Xing Wang Pfizer
                                                                             Mechanisms of Protein Degradation
                                                                             Modern Research of Chinese Herbal of Michigan
                                                                                              Peter Kaufman
                                                De-an Guo Shanghai Institute of Materia Medica,CAS UniversityMedicines
                                 bjl@kangwon.ac.kr
                Kangwon National University     Beom-Jin Lee                 To University Deepak Thassu
                                                            Kangwon NationalBe Determined                   Pharmanova
 ensys.co.uk                                                Intelligensys Ltd eural and Evolutionary Computing in Pharmaceutical Formulation
                                                Elizabeth Colbourn           N                Murat TurkogluMarmara University
                                                            Children's Hospital of Philadelphia - University Challenges In Pediatric Dose Project
                                                Jeffrey Barrett              Children are Not Small Adults: of Pennsylvania
                                                            Meijo University orous Microparticles York Institute of Pharmacetuical Innovation, B
                                                Hirokazu Okamoto             P                Peter for Pulmonary Drug Delivery
  .fu-berlin.de                                             University of Bradford Stabilising Nanocrystals: Calculation of Surface & Interfacia
                                                Jamshed Anwar                Towards                        Free
                                                                                              Rainer Muller University Berlin
                                                Wim Jiskoot Leiden University                 Tatsuro Irimura University of Tokyo
                                                                                                            The
                                                                             Formulation-Related Causes of Immunogenicity
                                                Rick Friedman
                                                            FDA                               Evdokia Process Validation and Fda‘s Perspectives
                                                                             FDA's New Guidance on Korakianiti
                                                                                                            EMEA
                                                            Pfizer           Current Pharmaceutical
                                                                                              Tony Pidgeon
                                                Sandeep Nema Global Biologics Preservative Use inPatheon     Parenteral Drug Products
 u-tokyo.ac.jp                                  Honghui Zhou                 Application in Drug Development: an Industry Perspective
                                                            Johnson and Johnson               Uwe Fuhr University Hospital of Cologne
                                                            F.Hoffmann-La Roche Ltd.          Kishore RavuriF. Hoffmann-La
                                                Hanns-Christian Mahler Excipients for Protein Formulation Revisited Roche
                                                            Toho University rystal Design for the Optimal Performance of Solid Pharmaceutical
                                                Katsuhide Terada             C                              O'BRIEN JONES PLLC
                                                                                              Jeffrey Lindeman
                                                            Hiroshima
                                                Tsutomu Masujima University                   Mass Spectrometry for Drug Discovery and Diagnos
                                                                             Live Single-Cell Norman DovichiUniversity of Washington
                                                            University
                                                Raimar Loebenberg of Alberta                  Roger Williams States
                                                                                                            United
                                                                             The Value of In Vitro Dissolution Testing Pharmacopeia
                                 suzukihi-tky@umin.ac.jpAruoma College Drug Interactions, Pharmacogenetics and Pharmacogenomics: Teac
                University of Tokyo             Okezie      Touro            of Pharmacy Ross McKinnon      University of South Australia
@boehringer-ingelheim.com                                   Critical Pharmaceuticals Limited DeliveryNovartis Pharmaceuticals Corporation
                                                Lisbeth Illum                                 Shyeilla Dhuria
                                                                             Nose to Brain Drug
                                                            University of Tokyo to Be Determined Yeo Simcyp Limited
                                                Akihiro Hisaka               Title            Karen
                                                Guofeng You                  The Diversity in Kathleen Giacomini of Pharmacy and Medicine, Univ
                                                                                              Post-Translational Modification of Drug Transporters
                                                            Rutgers-The State University of New Jersey      Schools
                                                            University Paris Descartes        Margareta Hammarlund-Udenaes
                                                                                                             and Enzyme Activity
                                                Jean-Michel Scherrmann Balance Between TransportUniversity of Uppsala in the Blood-Brain B
                                                Ikumi Tamai                  Involvement and InteractionUniversity of ZurichIntestinal and Pulmon
                                                            Kanazawa University                              of
                                                                                              Bruno Stieger Transporters in
                                 liping.zhang3@bms.com University of Auckland Modifying Treatments. Design and Analysis for Demonstrati
                Bristol- Mayers Squibb          Nick Holford                 Disease                        Leiden
                                                                                              Meindert Danhof University
                                                            Texas Tech University Health Sciences Center
                                                Majid Moridani                                Teruko Imai umamoto Prodrug Design
                                                                                                            K
                                                                             The Role of P450 Genetic Variations in University
                                                Liping Zhang                                   for Population Pharmacometric Model Building and D
                                                            Bristol- MayersBasic Concepts Andrew Hooker
                                                                              Squibb                        Uppsala University
                                 vikram.sadineni@bms.com Department of Disulfides and their Stability University ofand Proteins
                Bristol-Myers Squibb Company Christian Schoneich              Pharmaceutical Chemistry, In Peptides Kansas, Lawrence, KS
                                                            Pfizer,
                                                Arya Jayatilaka Inc.                          Gopi of Genotoxic Impurities In API
                                                                             Advances In Analysis Vudathala Sanofi-Aventis
                                                            Leiden
                                                Meindert Danhof University                    Don Nichols   Pfizer Global
                                                                             Mechanism Based PK-PD for TranslationResearch & Development
                                                            Sailstad and Associates Inc. Have a Problem Here": How to Spot Interference from
                                                Jeffrey Sailstad             "Houston, We Michaela Golob    MerckSerono
                                                            Korea             of Science and TechnologyTokyo University of Pharmacy and Life S
                                                                                              Hiroaki Okada
                                                Ick Chan Kwon Institute Non-Viral and Disease-Specific Delivery Systems for siRNA Therapy
                                                             Zhan            Structure        Martin Hofmann-Apitius
                                                                                                            Fraunhofer Institute for Alhorithms
                                                Chang-GuoUniversity of Kentucky and Mechanism Based Drug Design and Discovery and S
                                                Shaukat AliBASF Corporation                   Thomas FarrellColorcon
                                                                             Controlling Reactive Components in Polymeric Pharmaceutical Excip
                                 gerhard.winter@lrz.uni-muenchen.de of Minnesota of Freezing and Thawing, and Impact of Slow/fast Freeze-T
                University of Munich                        University
                                                Raj Suryanarayanan           Process          W Hinrichs University of Groningen
                                                            Pfizer           Strategies Development Vision2020: The Right to
                                                                                              Peter Ackland
                                                Michelle Marra Global Research & for Ophthalmic Formulation Development Sight
                                                Zheng Yang                   Evaluation of Metabolism & Pharmacokinetics
                                                                                              Hannah Jones Global Research & Development
                                                                                                            Pfizer
                                                            Bristol-Myers Squibb Deptof Various Methodologies In Predicting Human Oral Phar
                                                            National         Physical Stability of Amorphous Research, Inc.
                                                                                              Dwayne Biomaterials Center
                                                                                                            Bend
                                                Kohsaku Kawakami Institute for Materials Science, FriesenFormulations: is it Predictable?
                                 per.artursson@farmaci.uu.se
                University of Uppsala                                        Dissolution Specifications: Consideration of Dissolution and Permea
                                                                                              Shinji Yamashita
                                                James PolliUniversity of Maryland School of Pharmacy        Setsunan University
                                                                             Nonlinear Biology and Bioinformatics, University
                                                                                              Michael Weiss Martin Luther
                                                Robert BiesCenter for ComputationalDynamics In PK/PD AnalysisIndiana University School of M
                                                            Hokkaido         NanotechnologyElias Fattal Universite de Paris-Sud and Application
                                                Hideyoshi Harashima University                  for In Vivo Gene Delivery: Concept
                                                            U                Title            Takahisa NakamuraSchool of Public Health
                                                Makoto Arita niversity of Tokyo to Be Determined            Harvard
                                                            Ohio             Large-Scale Genotyping and Full Sequencing in Personalized Medic
                                                Wolfgang SadeeState University                Hitoshi SasakiNagasaki University
                                                            University of Tokyo
                                                Taisuke Tomita                                Mechanisms
                                                                             Alzheimer Drug Peter Seubert   Elan
                                                            Kyoto
                                                Kiyoshi Tomioka University                    Paul ReiderPrinceton University
                                                                             Asymmetric Synthesis of Pharmaceuticals
                                                            Baxter Innovations GmbH and Jack Weet Vertex, Inc of Implementing a Global S
                                                Eva-Maria Muchitsch          Challenges        Practical Considerations
                                                Jerry Bauman                 Issues Chicago Steven Sheaffer University of Pharmacy Education In Pra
                                                            University of Illinois at and Challenges In Contemporary the Sciences in Philadelphia
 p.monash.edu.au                                            M                Public           Julie Jacobson Drug Discovery for Neglected
                                                                                                            and
                                                Bill Charman onash University Private Partnerships Bill and Melinda Gates Foundation Disea
                                                            University of Tokyo
                                                Hiroshi Suzuki                                Shiew-Mei Huang
                                                                                                            FDA
                                                                             Metabolic Analysis of Serum Specimens from Patients Suffering from
                                                Julie Dennis                 CPPs (Certificate of Pharmaceutical Products) and Associated Chall
                                                                                              Adran SabirDr.Reddy's Laboratories Ltd
                                                            Pfizer Global Research & Development
                                                            The              The               of DeliveringNational Medicines the Global of Pharm
                                                Andreas Seiter World Bank Challenges Shaohong JinQualityInstitute for to a Control Patient P
                                                            Nagasaki University Segment Drug Delivery Systems: Challenges and Solutions
                                                Hitoshi Sasaki               Anterior         Arto Urtti University of Helsinki
  m.teikyo-u.ac.jp                                          Osaka University TechnologyRyo Dc-Based Cancer Immunotherapy
                                                Shinsaku Nakagawa            Dds                for SuzukiTeikyo University
                                                Keith WebberFDA                               Marie-Christine Bielsky
                                                                             The U.S. FDA Perspective MHRA
                                                Hilde Boone EMEA             Evaluating Medicines In the European Union

 @stjude.org
  Panel Discussion, Panelists: Speakers, James Polli, Ph.D., and Chi-Yuan Wu, Ph.D.
                                                                               

                                                                               5.Particles in biopharmaceutical parenteral products - Regu
aceutical parenteral products - Impact of manufacturing by Nitin Rathore, Amgen

perspective – speaker from an excipient manufacturer
  

 ce Dr. Ganapathy Mohan, Merck and company


              
•
                                                       

                                                                        •

 sentative TBA
 Globalization of data submission, FDA representative TBA
 Current update on standardization of global bioanalytical practi

                                    
4.
                                                                                               

Ed Lavelle (Trinity College Dublin).
 The nasal route. Prof. Per Brandtzæg (…), Prof. Maria Jose Alonso (Univ. Santiago de Compostella)
5
Dr. Martina Weise (BfArM / Germary)m.weise@bfarm.de; Representatives from Industry (TBD)(IFPMA,PhRMA, EGA etc.);

 herapy.

f. Bruno Gander, ETH, Zurich, Switzerlandc) Vaccine Delivery. Needless, needles, or needleless? Prof. Wim Jiskoot, Division of Drug Deliver
the site of drug action as predictors for clinical safety and efficacy;Markus Mueller, Austria,How does free concentration at the site of action in
   
4.
PI
 Prof Peter Wildfong: Correlation of material properties from database with the API disordering potential
   

Susan Lum (Patheon Inc), Canada, Development case studies to predict tooling adhesion on compression and the challenges of scale up fro

  Dr. Daniel Brown, UK, AstraZeneca, Title TBD;One other speaker from industry, most likely USA, Vishal Gupta, Covidien, or Patheon, Nova

           

           Procter & Gamble Pharmaceuticals

a C. Vaughn
                               



iroz and Helen Strickland (USA) Characterization and Estimation of the Variabillity of Cascade Impactor Determinations including AIM. 


 ntières.The Role of Universities in Access and Innovation for Developing Countries Amy Kapcznski, Faculty of Law, University of California, B

 pioneered a number of the commercially used applications in the field;Dr Philip Taday (TeraView Ltd., UK), Latest developments in terahertz
he draft guidance on Powder Blends helped to solve and prevent blend and dosage uniformity problems?; Siva Vaithiyalingam, Ph.D., FDA,

adua University, Italy, PEGylation in protein drug delivery: the sucess and future challenges.
ies (USA); Polymer based siRNA delivery systems4. Prof. Diane Burgess or Prof. Sangeeta Bhatia (USA); Emerging siRNA delivery systems
s, Europe and Asia. He retired from this position in December, 2007. Dr. LaMattina was a 30 year veteran of Pfizer Inc having joined as a m

                           

                           
Dr.               

ure –QTc response modeling 
 Ene Ette, Anoixis


                                                           

                                                           3
ned from Outsourcing?‖ (Dr. Huifen Faye Wang, Pfizer, USA) 
 – ―Large Molecules Offshore Outsourcing - Sponsor Considerations: a Cas



g Sample Preparation - TBD5. Validation of Automated Methods - TBD
 hous drugs and related solid dispersions Dr. Alan Zhu (Abbott) 4. Predictive methodologies of a long-term physical stability of amorphous d
 sient dynamics in disease modeling for diabetes and the insights with respect to identifiability and population variability issues in these comp

biomarkers to assess localized drug drug interactions.FDA speaker (TBD), USA and presentation title: MRI biomarkers to assess disease act

 rtz, P. (US) with expertize in biochemistry of skin in novel skin models; Klausner, M. expert (commercial) on EpidermFT and other marketed

A and his title: Regulatory requirements from the preclinical perspective; and a 4th speaker from ONDQA (TBD), FDA, USA and his presenta
 eation enhancement technologies;Bozena Michniak-Kohn, USA, Chemical skin permeation enhancement technologies;Mark Prauznitz, USA

                                                      

                                                      4.

en‘s Health, Director, Office of Women‘s Health, NIH
 C. Noel Bairey Merz, MD, Professor of Medicine, Cedars-Sinai Heart Institute, LA, C
vices, USA and Dr. Fabio Garofolo, Algorithme Pharma, CANADA);3. Case Studies from the North American Pharmaceutical Companies (D
atory, University of Cambridge, UK, Applications of terahertz pulsed imaging to tablets with sustained release coating;Janie Dubois, Ph.D.,M
Corporation and Dave Wallick, Ph.D.Dow Chemical,USA, Pharmaceutical Excipients for Hot Melt Extrusion;Craig McKelvy, Ph.D., Merck & C
 ealthcare group, he spent 7 years developing silicone PSAs (including high performance dimethyl, solventless and screen-printable) and silic
e use a stable labeled internal standard? Case Studies (Dr. Patrick T. Vallano, Mylan Pharmaceuticals, USA)3.Impact of LC-MS/MS Ion supp
alysis: Case Studies (Dr. Mario L. Rocci, Jr, Prevalere Life Sciences, USA)3.Understanding the Retention Behavior of Phospholipids in Solid

 d R Cutler, Faculty of Health Bioscience, East London University


 ncic, Slovenia
University, Germany / Prof. Michel Rohmer, Strasbourg Univeristy, France
 adverse drug events in geriatric patients. Dr. Alex Fu (Cleveland Clinics OH) Alternate: Jerry Gurwitz Harward University MA);Design and de
her, United States, Improved Accuracy in Mass Median Aerodynamic Diameter (MMAD) Determinations; Helen Strickland, United States, Cha
ada)

 g Delivery
ethods and specifications for different dosage forms at different phasesProposed Speaker: Dr. Noel D. Premkumar, Analytical Bio-Chemistry
g Medical University, Kaohsiung, Taiwan or H. Mukhtar, University of Wisconsin or Nirmalendu Das Indian Institute of Chemical Biology, Kolk

 ands Cancer Institute, Amsterdam, The Netherlands.2.Role in drug disposition and multidrug resistance in cancer. Y. Sugiyama, University o
ministration of CNS Drugs using a New Minimal-Stress Freely-Moving Rat Model. Stevens J / de Lange EC. Division of Pharmacology, LACD
 ween exposure and non-specific binding for 33 CNS drugs in mice. Maurer TS, Department of PK, PD and Drug Metab., Pfizer Global Resea
                                                                                                                      

                                                                                                                      3.

ability and quality of data produced: Regulatory Concerns (Dr. Eric J. Woolf, Merck Research Laboratories, USA)
 Systematic approaches
 eered Formulations in Asthma/COPD Disease Management: Aiming for the Holy Grail of Inhalation Therapy;Speaker: Martyn Clarke, Ph.D.,
of the Sacred Heart, Rome, Italy. Predictions of mobility and mortality in port-myocardial infarction patients, Inflammation; Virginia D Schmith:
 of BCRP and P-gp in drug CNS penetration.


olving the global drug price crisis: establishing an independent, public, non-profit drug development corporation Stan Finkelstein, MD. Engine
gulatory Perspectives




 with representatives from other regions, e.g. Canada, Asia, Latin-America.

mplications for Drug Safety
 rug Development;Proposed Speaker 3A. Kashuba (University of North Carolina, USA) or Charles Flexner (John Hopkins University, USA) - C




                                                                              

                                                                              


 cell-derived cardiomyocytes for cardiac cell therapy and as disease models‖;
Professor Gavin Brooks, BPharm, PhD. University of Reading
d presentation title: Marine Clinical Pipeline: Development of Wound Healing and Anti-inflammatory Candidates based on the Class of Marine




drug therapy‖; Dr. Pradeep Sathe, FDA, USA, ―Pharmacokinetic profiling of multiple drug molecules in a combination drug therapy and regul
 ation of drug-excipient interactions.
crystal containing products
 
                       
 
  4.
                              Speaker – FDA, TBD
 
 Panel Discussion 
            

 t and CSO, YASOO Health, Johnson City, TN, USA; 3.Encapsulation of Flavors in Lipid-Based Systems, Dr. Robert Sobel, Director of Techn
 for macromolecules: After a very long ride, is it time for a reality check? Dr. Panayiotis P. Constantinides, Biopharmaceutical & Drug Delivery
 and Development, University of British Columbia, Vancouver, CANADA;3.Pharmaceutical Development Considerations with Nanomaterials a
el inhibitors to disrupt protein-protein interaction in molecular chaperone complex
U.S.A.; Roles of molecular imaging in drug development: from the viewpoint of pharmaceutical company;

ned;
 orities (FDA or EMEA-related).2.Safety testing of biosimilarsJan Willem van der Laan, National Institute for public Health and the Environme
                                     
•

on of nanoparticles for skin delivery
 Nancy Monteiro Riviere (University of North Carolina at Chapel Hill, USA) Toxicological aspects of skin
nano drug delivery systems and cosmetics
  
         
 
   4.

                                                    
 
 Robert L. Bronaugh; USA Regulatory perspective of Transdermal nanotechnolog

                                                                         
―Determining In Vivo Drug Release from Nanoparticulate Drug-
                                                                         :

ofessor, University of Georgia, U.S., rarnold@rx.uga.edu, (706) 542-6813.


ss to date

setts College of Pharmacy and Health Sciences will provide a case study;Raimar Loebenberg of Alberta University in Canada will discuss the
 ol kit that addresses Mechanical Calibration and Performance Verification testing;An International industry speaker will discuss the experienc
ech solutions to anti-counterfeiting 4.)Patrick Lukulay, USP, USA - Educating and Engaging Consumers (global outreach)Panel 5.)Discussion
macogenetics of Chronic Cardiovascular Drugs: Applications and Implications
cosmetics industry.Three speakers will be chosen
 on paste against chemical warfare agents (SERPACWA)J. Denis:USA:Skin decontamination against VX.Three speakers will be selected.
stems
 go, USA, Individualized anticancer therapies based upon genetic makeup; Ross McKinnon, Ph.D., University of South Australia, Australia, G

ert P. Li: Integrated multiple organ co-culture for the evaluation of multiple organ metabolism and toxicity.
 Integrating molecular design resources within modern drug discovery research.

 and drug exposure to establish bioequivalence for certain locally acting drug products"; 4) Chris Hendy, Ph.D., Novum, USA, "Application of




a Toler - Pfizer, or a TBD speaker from Bausch-Lomb or Amgen; USACase Study II (Solid Dosage Forms/Ophthalmics)Tomoyuki Yokobori, Q
ess Variation. 4. Nancy Harper, Pfizer, Groton; USAQbD for a Small Molecule Parenteral. I. Risk Assessment5. Steve Nail, Baxter, and Linas

                                                                                                                 

                                                                                                                 


 national Medal of Science for his discovery of both the first human oncogene and the first tumor-suppressor gene
CANCER DORMANCY,

Principles of Safety and Efficacy‖; Robert Justice, M.D., USA (Director, DDOP/CDER) ―Preclinical Testing of Antibody-Drug Conjugates‖; Law
 sive delivery systems for improving oral absorption of macromolecular drugs




ion drug transporters in Cancer Cells.




 e delivery systems for improving oral absorption of macromolecular drugs.
 gene expression.

USA; Hydrotropic polymer micelles containing acrylic acid moieties for oral delivery of poorly soluble drugs.
on-enhancing functions.Jindrich Kopecek; USA; Polymer-drug conjugates for colon-specific delivery of anticancer drugs.
 oligonucleotides and anticancer drug.
 o. 3. Understanding Absolute species Difference of Hepatobiliary Transporters for ADME-Tox species selection. Yurong Lai, PhD, Pfizer Inc
 rry Crystallization, and its application for solid dosage forms.Jouko Yliruusi; Finland; Effective modification of particle surface using ultrasonic


 bane, Queensland, Australia, NMR in Peptide Drug Development;N. Cioffi, University of Bari, Via Bari, Italy,chitosan nanoparticles for peptide



                                                     

 Cardiovascular drug transport – relevance for therapy
                           


                                                                                   

                                                       Heyo K. Kroemer, Greifswald
In silico approaches to predict the impact of drug trans

 ulate carrier systems.
  eous delivery of doxorubicin and gemcitabine to tumors in vivo using prototypic polymeric drug carriers.
 K, Neural networks for drug release modeling
  aceutical nanotechnology: More than size.
 herapeutic cloning.
 sporters in brain microvasculature endothelial cells.
  in; the Netherlands; Development of long-circulating liposomes with effective drug-targeting capacity.

 nation dual responsive polypeptide vectors.
 sis in tissue engineering.
  ming biological barriers.


 partment of Biopharmaceutical Sciences, University of California at San Francisco, San Francisco, CA 94158, USA.Significance of organic ca
                                                                                                      
•

  cine, Saint Louis, USA) Molecular imaging and drug delivery by nanosized ultrasound contrast agents 
 Don Martin (Seagull technology Aus
                                             


                                              

 s: a new delivery system for the oral route 
Prof. Simon Benita

                                  

                                                                  Hebrew University of Jerusalem, IL
New strategies in drug formulation to m
  r for Drug Evaluation and Research (CDER), White Oak Office Bldg 51, Rm 3178, 10903 New Hampshire Ave., Silver Spring, MD 20993, US

 d on in vitro dissolution coupled with physiologically-based PK modeling"; Leslie Benet, Ph.D., USA, "Drug metabolism and transporter effects
 of Drug Discovery;Speaker 2:Dr. Bohumil BednarSenior investigator Merck Research Laboratories Department of Imaging WP44C-2, 770 Su
 ulations;4. Michael B. Bolger (US): Gastrointestinal simulation of nanoparticle dissolution and absorption.


                                                                                           

                                                                                           

                                                                                           

 ki, Sendai, Japan: Pharmacoproteomic strategies to map the human BBB transporters.
Quentin Smith, Texas Tech University, Amarillo, Tex
 ns.Xingrong Liu, Pfizer Global Research and Development, Groton CT, USA: CSF and plasma free concentrations as surrogate measuremen
 y Using Human PK and in-Vitro Data;4. Bambang Adiwijaya (US) A Novel, Multi-Variant, Viral Dynamic Model of Genotype 1 Hcv to Assess th
 US) Kill Curve Modeling and Resistance;
  tudy on development of autoinjector; Tom Nicholai, Abbott;Silicone free lubrication system; Vinay Sakhrani, Triboglide;Regulatory considerati
                                                                      

                                                                      


  lycoprotein Activity at the Blood-brain and Blood-placental Barrier.
Margareta Hammarlund-Udenaes, Uppsala University, Uppsala, Sweden




 esign a non-bridging dose response study in Japanese RA patients;4) Shashank Rohatagi (India) Predictive Population Pharmacokinetic/Pha
 ffrey Barrett (US) Modeling and Simulation in Pediatric Oncology Drug Development;4) Rajnikanth Madabushi (US) Integration of Pharmaco
 skin;4) FDA representativeDiscussion of the various approaches from the regulatory view point;

 ric AED Formulations: Clinical Problems and ControversiesMichael D. Privitera, M.DUniversity of Cincinnati Medical Center Generic AED For
 ric AED Formulations: Clinical Problems and ControversiesMichael D. Privitera, M.DUniversity of Cincinnati Medical Center Generic AED For
 ric AED Formulations: Clinical Problems and ControversiesMichael D. Privitera, M.DUniversity of Cincinnati Medical Center
 ric AED Formulations: Current Standards and Future DirectionsYatindra Joshi, Ph.D.Teva Pharmaceuticals
 ty Implementation Group

 ric AED Formulations: Clinical Problems and ControversiesMichael D. Privitera, M.DUniversity of Cincinnati Medical Center
 M Health Science Center
 



        

        Northwestern University
Pathophysiology and Treatment of Perimenstrual Epilepsy in Women

 , Ph.D.
                      


                                
                                                               Samba Reddy, Ph.D., R.Ph.

                                                                                                
                        Texas
                                                                                                                         

andran Vasan, M.D.Boston University Medical SchoolIntegrated Approach for Prevention and Treatment of the Metabolic Syndrome Christina
 acy Nonpharmacological Approaches for Decreasing the Risk of Metabolic SyndromeRajesh Krishna, Ph.D.Merck Research Laboratories
 roids as Novel Antiepileptic AgentsSamba Reddy, Ph.D., R.Ph.Texas A&M Health Science Center
um will be aimed at elucidating the latest advances in our understanding of these changes. The focus will be on the impact of these modifica




alation Therapy;Dr. Badrul Chowdhury, United States FDA, A Clinical and Patient Perspective in Management of Asthma and COPD;
 general. 3. Daotian Fu. Genzyme. Daotian.Fu@genzyme.com (product-related) Protein glycosylation (potentially another person from Genzy
                      

                      •
                                                                    

                                                                                            •

orah Shnek (Amgen)
 Identification and characterization of visible particles in drug product
 Effect of visible particles on safety and efficacy
 the Pharmacokinetics of Intranasal Drugs in Patients with Nasal Congestion or After Nasal Congestion Relief with Nasal Spray Decongestan
                        
4)
n Alzheimer‘s Disease;
 Timothy Nicholas (US) A systems biology approach to identifying treatments for Alzheimer‘s Disease.
        

al Challenges for Nanoparticle Products; Speaker from Gene Therapy Company, USA, Stability Packages for DNA and RNA products

SA, Predicting Nanoparticle Absorption Differences Between Animals and Humans
via a translational pharmaceutics platform; Michael Kaufmann, USA - Formulation challenges faced for expediting oral development of onco

of Bordeax, France) 3. Dual Stimuli-Responsive Drug Delivery Systems (You-Han Bae, University of Utah OR TBD)4. Novel pH or Thermos
n, Country of Origin: India. Presentation Title: Impact of Material Attributes on ANDA product design and performance3. Proposed Speaker:
Clinical implications of protein binding: from daily routine to drug development of antimicrobialsPossible speakers:Otto Cars, Uppsala, Swede
Clinical implications of protein binding: from daily routine to drug development of antimicrobialsPossible speakers:Otto Cars, Uppsala, Swede


             

             

                                                                                 

                                                                                                


 outh Africa;
―Proven Pediatric Formulation Strategies Leading to Globally Marketed Products ‖; 
Despina Solomonidou, PhD, Novartis Ph

 cle engineering: Professor Robert Price, University of Bath, UKc) Commercialization of ultrasound assisted crystallization : Dr, Graham Ruec
Biomedical and Veterinary Sciences, University of Antwerp, Universiteitsplein 1, 2610 Antwerp, Belgium,
 "Developments in Regulatory Matte
                                                                                                         

uccessful IVIVC and human exposure predictions of BCS Class II-IV compounds;Dr. Sherry Ku, Wyeth, or Ganga Sunkara or Hequn Yin of N
n of Aptamers in Biological Matrices, HPLC to HLIHA.Hewei Li; USA; Quantitation of mRNA Biomarkers, siRNA Gene Knockdown and miRNA

Mark Ma, USA- Title TBD (accepted);Kay Stubenrauch, Germany (TBD)
nd Binding Assay System.
    
                                                                 

                              Randy Julian, USA, Data standardization for Ligand Binding Assays


                                                                                                

.Henk van den Berg, UK; Pharmaceutical development for pediatric use under European registration.
ce of in vitro restings during Quality by Design.Tahseen Miza;EU; The relationship between biopharmaceutics and Quality by Design.

d Training, Philecology Curator of Economic Botany, and director of the Institute of Economic Botany for the New York Botanical Garden. USA
spects.
 linical application.
 ure Group,GlaxoSmithKline Consumer Healthcare, US.3.Intranasal product development: Case StudyAnna Slater, PhDDirector, Intranasal P

DA requirements etc.


SRK Consulting LLCSemih Oktay, PhDVP of Regulatory Affairs and Engineering, Micromed Laboratories

arch, Innovative Screening Technologies, Vienna, Austria, Single-bead, Single-molecule, Single-cell Fluorescence;Owa Takashi,Eisai, Japan,


s (case study) - John Fan & Jose Casillas (Amylin Pharmaceuticals)Prefilled syringe Case Study - Thomas Nicholai (Abbott)Silicone-free lubr
 riteria for preservatives in parenteral drug products: Qiang Ye (Otonomy)Preservative-drug, preservative-excipient, and preservative-packag
 riteria for preservatives in parenteral drug products: Qiang Ye (Otonomy)Preservative-drug, preservative-excipient, and preservative-packag
s (case study) - John Fan & Jose Casillas (Amylin Pharmaceuticals)Prefilled syringe Case Study - Thomas Nicholai (Abbott)Silicone-free lubr
s (case study) - John Fan & Jose Casillas (Amylin Pharmaceuticals)Prefilled syringe Case Study - Thomas Nicholai (Abbott)Silicone-free lubr
 s (case study) - John Fan & Jose Casillas (Amylin Pharmaceuticals)Prefilled syringe Case Study - Thomas Nicholai (Abbott)Silicone-free lubr

ced toxicity;Urs A. Boelsterli (University of Connecticut School of Pharmacy), USA, drug-induced liver injury and mitochondria dysfunction;Da




  0, USASpeaker 3: William H. Doub (Regulatory aspect)Division of Pharmaceutical Analysis, Food and Drug Administration,1114 Market St.,
  ity, Japan; Integrated physiology of proximal tubular organic anion transport.Hisamitsu Hayashi; University of Tokyo, Japan; Impaired localiza
 nhibition of hepatobiliary transporters is a potintial mechanism of hepatotoxicityJashvand D. Unadkat; University of Washington, USA; Identifi
  ctroscopy to Combat Distribution of Counterfeit and Sub-standard Medicines
   Director, CMC-RegulatoryPfizerQuality Risk Management Principles: Bridging R&D and Commercial Operations
  ll molecules 3. Duncan Low Sr. Director, API processing Amgen API Processing and strategy evaluation for biotech-derived materials
  d JohnsonUnraveling the Supply Chain Complexity: A major issue that is very little understood


 na E-mail: Arlene.r.hughes@gsk.com3. Utilizing biomarkers in drug discovery strategies: The pharmacogenetics hypothesis.Speaker: David
 edimmune.com;3. Endothelial nitric oxide synthase polymorphism Speaker: Glen E Cooke, Ohio State University, Division of Cellular Medici

or oral lipid drug delivery Dr. Hassan BENAMEUR, Belgium, Lipid Drug Delivery tools to advance oral bioavailability
apeutic proteins (WimJiskoot, Leiden University) 4.       Immunogenicity assays (Anthony R. Mire-Sluis or Christopher Horvath,Amgen, USA;
Univ. of Tokyo, Japan; The prediction of the change in the pharmacokinetics of drugs by genetic polymorphisms from in vitro experiments;
       Al
                                                                                                                                                

ciences Center, St Mary‘s Hospital, University of Manchester UK. E-mail: William.newman@manchester.ac.uk
         

                                                                                                                  


r Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations;Meindert Danhof; Leiden University, The Nether
Manivet; Hôpital Lariboisière, France; Novel computational approaches for the modeling of membrane transporters;Matthias Reuss; Univers
 ishita; Hoshi Univ., Japan; The novel function of drug excipients as an active enhancer of intestinal absorption by the inhibition of of drug efflu
  pression of ABCG2 in resistant tumor cells;Magnus Ingelman-Sundberg (Karolinska Institute), Sweden, Pharmacoepigenetics of drug metab
 leen M. Giacomini (University of California, San Francisco), USA, Delivery of platinum drugs to the tumor cells;Ikumi Tamai (Kanazawa Unive
macogenetics 2020: Barriers and future aspects
                                                                             @
 , Japan) Pharmacokinetics and pharmacogenomics in esophageal cancer • chemoradiotherapy
  y aspect;Kirsten Lauber, Germany, Recent innovations in disposable fluid handling technologies
 of Molecular imaging
many, High concentration liquid SUSPENSIONS – an alternative approach?
        

  itzerland, Muttenz, Switzerland. ―QbD and Process Control for Low Dose Drugs‖ 
    

                            


                            
―QbD and Process Control for Low Dose Drugs‖
Professor Martin Kuentz, Professor of Pharma Technology, Un
   Rutgers University, NJ. 


                                                 



  Member Sections benefitting from the proposed session - APQ, BIOTEC, FDD, MSE, and PBB
 (Uppsala University), Sweden, Species difference in the transport activity at the blood-brain barrier;Owen N. Witte (University of California, L
 trumented Rolls for Modelling the RollerCompaction Process--Ron Miller, ex. BMS
  ding system for lyophilization and transport of double chamber cartridges;

N.N., Future directions and visions as regards appropriate deliver

Satish Singh or Linda Narhi or Hanns-Christian Mahler, The industries‘ view – the white paper


                                                                                            


 ring process: Case study 1" 4. Dr. Andreas Wagner (Austria); "Liposome manufacturing process using cross flow injection: Case study 2" 5.
 wards, Harvard University, United States, Inhaled Large Porous Particles of Capreomycin for Treatment of Tuberculosis;
 New Zealand.

                                          

                                          


 n of P-glycoprotein by COX-2 inhibition‖;
3. Kathy Giacomini, PhD, UCSF, USA –or- Ken-ichi Inui, PhD, Kyoto University Hospital, Japan, ―Im
 Technology77 Massachusetts Ave., 18-592Cambridge MA 02139Email: soc@mit.eduPhone: (617) 324-0180Sheo B. SinghMedicinal Chemis

                                                            
 Extemporaneous Preparation Strategies for Rapid Clinical Assessment of Experi
                                                             

                                                             

 bility Challenges and Strategies for Global Clinical Trials
•

  colorectal cancer - Gerd Bobe, National Cancer Institute—Frederick, 1050 Boyles Street, Building 576, Rm. 110, Frederick, MD 21702. E-m

 22, USA.Phone: (732) 445-3831 ext.214, Fax: (732) 445-3134, Email: minko@rci.rutgers.edu; 2. Potency of siRNA mediated knockdown in
 or IVT sample analysis;
mmed Tabrizi (Anaptys Bio, USA)
Virus Kinetics: PK/PD Versus Time-Varying Drug Effectiveness Models (Alan Perelson, Los Alamos National Lab., USA)
Shankar, PhD. MBA, Centocor, USA , "Data analysis techniques to assess immunogenicity"; 4. Jogarao Gobburu, PhD, FDA, USA, "Regulato

Data", Leon AAron, UK, "Analytical expressions for combining population pharmacokinetic parameters from different studies"
Derendorf, Ph.D., USA, "Prospects on the use of PK studies for demonstrating BE of orally inhaled products"; Wallace Adams, Ph.D., USA,
major cytochrome P450 Enzymes in native and first- and third-generation Japanese populations. Keith Wilner, PhD, Pfizer Oncology La Jolla

  USA, Assay development of multiplexed assays for clinical biomarkers4. John Allison, Veeda Clinical Research, USA, Design of fit-for-purp
 on-oral formulations 
  Erem Bilensoy; Turkey; Role of excipients in modified formulations for ocular and other non-oral routes of administratio
                         

                                                                                                                    


                                                                                                                     

ay Drying: Applications to oral and parenteral dosage forms- David Lechuga; Nektar Therapeutics, San Francisco
Speaker affiliation: Dry P
x, speaker from EMEA, "An EMEA perspective on submission of failed BE studies".
 tions Carl Wassgren; USA; Discrete element modeling of high shear wet granulation andtablet coating in relation to the quality of modified re
s".
oseph Ware, Genentech, USA, Oatp1b2 KO mouse as a system to study hepatic uptake; Maciej Zamek-Gliszczynski, Eli Lilly, USA, Applicati
 will be limited to a 10 min presentation, followed by a discussion on a set of questions prepared by the moderators and previously presented
 esign, Steve Shire Genentech, San FranciscoSpeaker affiliation: Application of QbD concepts to Lyophilization process design and commer
 riteria for preservatives in parenteral drug products: Qiang Ye (Otonomy)Preservative-drug, preservative-excipient, and preservative-packag
                                                                                                                                  



 bility, Absorption and Drug Effect Modeling to Drive Drug Discovery and Development – What has worked – what has failed?‖; 
Hyo-Kyung
ark); Early development, preparing for the future: Maria Cruanes (Country of origin: U.S.A); From Early development to scale-up and lifecycle

quibb DriveNew Brunswick, NJ 089033. Dr. Omar SalmanAPI Process TechnologyPfizer, Inc.Kalamazoo, MI 49009
  egulatory perspective on pharmacogenomics and the implication on drug development (35 min)Shshi Amur, PhDFDAShashi.Amur@fda.hhs
 ions: Clinical Effects;

 Moderator3)Name: Jeff WorthingtonPosition: President, SenopsysCountry: USA Title: Developing Palatable Pharmaceuticals: Optimizing Se
 Moderator3)Name: Jeff WorthingtonPosition: President, SenopsysCountry: USA Title: Developing Palatable Pharmaceuticals: Optimizing Se
yeye, Ph.D, USASolid State Characterization of Naturally Occurring Anti-Malarials5. TBA
lar Medicine, George Mason University, 10900 University Boulevard, MS4E3, Manassas, VA 20110, USA.Speaker 3. Metabonomics in drug d
ridani - Assistant Professor, School of Pharmacy, & School of Medicine, Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@
tabolism and transport in pregnancy;5. Shinya Ito, Canada, Drug Excretion in milk - mechanisms and implications;
 FDA5. Biomarker based disease progression modeling - Hartmut Derendorf, Univ. Florida.6. Biomarker program will it replace PK and send



 ulating digestive processes in the GI tract
 analytical method for drug development excercise. Tom Krnes, VCU.3. How to develop a UPLC or LC-MS/MS method - Mario Rocci4. LC-M


ug and Gene DeliveryBrian Storrie, Ph.D.University of Arkansas for Medical Sciences, Little Rock, ARQuantum dot-FRET technology for enh

 ennifer Dressman, Germany, "Application of Biorelavent Dissolution Tests for Prediction of In Vivo Performance";Anette Mullertz, Denmark, "
 r TBD




 pediatric development Speaker 3: Robert G. Strickley, Gilead Pharmaceuticals, USATitle: Formulation strategies for pediatrics Speaker 4. J
  QbD to Predict PK/PD and Clinical outcome. 3. Gordon Amidon, University of Michigan, USA, Worldwide Applications and Impacts of the B


 An Industrial Perspective;
 dness by retinal transplant"
     (513) 558-0978Email: pankaj.desai@uc.eduSpeaker 1: Stephen Dueker, Ph.D., Vitalea Science, IncTopic: AMS - A Verstatile Quantia
method development; 3. Christer Tannergren, AstraZeneca, Sweden, Understanding of Colonic Absorption: Usefulness of permeability and s
 roaches for Drug Product Absorption; 3. Mike Bolger, Simulation Plus, US,A Comparative Overview of Predictive Models Integrating Dissolo
 imulations to Predict Complex Drug Interactions;Speaker #3:Ping Zhao, Ph.D. Office of Clinical PharmacologyCDER, FDAPHONE: 301-796

tometry and Raman fingerprinting Speaker 2: Marcus Lankers
mD, USA8.AJ O'Sullivan. MD, University of New South Wales, Sydney, Australia
nine clearance in the dosing of drugs in elderly patients;Speaker 3:John Wagner, MD, Ph.D. Merck & Co., Inc.Which equation to use in rena

ter studies to mitigate safety-related issues in drug development;Speaker #4:Shiew-Mei Huang, Ph.D. (or Lei Zhang, Ph.D.)FDA Perspective
 gistration in China; Dr. Dalia Wajsbrot, USA, Meeting regulatory requirements for successful registration in Brazil.
discovery";Zheng Yang of Bristol-Myers Squibb, U.S.A."PK/PD modeling in discovery; case studies from the trench"
tational design‖.

an), ―Targeted Drug Delivery in Cancer Therapy‖; Dr. David Baker (Professor, University of Washington), ―Rational Design of novel protein-pr
nse Analyses for Characterization of Dose-Response

opment: Challenges and Opportunities‖; Dr. Allan Saul (Malaria Vaccine Development Unit, NIAID, National Institutes of Health), ―Progress a

 hael Owens (Professor, University of Arkansas Medical School), ―In vitro and in vivo studies on the functions and stability of monoclonal anti

 nternational representatives as much as possible)Middle East/Africa Representative - TBD




 P-gp; David Miller, USA, Alternative speaker: Seizure-induced uprequlaton of P-gp at the BBB via glutamate and COX2 signaling.
 ARDA)Washington, DC 202013. Mary E. Spilker, Pfizer Global Research and Development San Diego, CA 92121
 r James McGinity - Formulation and Process Development Considerations for Hot Melt Extrusion; Charlie Martin - Scale-up of the extrusion
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
 DC 20201Mary E. Spilker, PhD Biotherapeutics & Translational Research Department of Pharmacokinetics, Dynamics & Metabolism Pfizer G
                                                                                                               

                                                                                                               


 USA, ―Development and Commercialization Aspects of Incorporating Lipids and SEDDS Into Softgel Capsules‖;
Bruno Hancock, USA, ―Me

 s. Honghui Zhou, or Kathleen Seitz, PhD, Centocor Research & development, USA3.The scientific rationale for biotherapeutics and small d
  &#13;&#10;

 ;Mansoor Khan, FDA, Talk entitled: Quality by Design and Stability: an FDA Perspective&#13;&#10;&#13;&#10;Steve Byrn, Purdue Universi
                                
5e)
 Li, Ph.D. CDER, DBE, FDA
 Shape analysis versus point estimates comparisons, Luis Pereira PhD, Children‘s Hospital / Harvard Medica
  .Gastrointestinal lipolytic enzymes and their relevance to lipid based formulationsFrédéric Carrière, EIPL-CNRS, Marseille, France4.Experim



 oblast Growth Factor Expressin for Treatment of Critical Limb Ishemia Dr. Sigrid Nikol, MD Division of Cardiology Swiss Cardiovascular Cen
Department of Pharmacology and Clinical Pharmacology, University of Auckland School of Medicine, New Zealand;One speaker from FDA or

 xpectations for New and Legacy Products
  Vibhakhar Shah, Ph.D., 

                                           
                        
                            

                                                                                                 


                                                                     Office of Compliance, FDA
Role of QbD and six-sigma in re-defining p



 2.

 Design of a biphasic dissolution-partition method and its application to evaluation of BCS II drug products
 Yi Shi (Abbott)
3. Applica
                                                                                                             

                                                                                                             
Dr.             


                                                                                                                               


 aches to Ensuring Therapeutic Equivalence of Modified Release Products - Academic Perspectives, Kamal Midha, Ph.D., D.Sc., University o
 amin Supplement
Clinically Relevant Dissolution Specification from In Vivo and In Vitro CorrelationsPaul Dickinson, Astra ZenecaQbD: How it can help to set cli

                                                                                 

                                                                                 4.

Prediction of In Vivo Performance: Mohan Ganapathy, Executive Director-Merck, CMC
 Case Study from industry: Speaker from Novartis

m the US; EU Regulator (TBD), Regulatory Perspectives from the EU
                                                      National Cancer Center Hospital East Studies of Nk012, an Sn-38 Incorporating Mic
                                           Yasuhiro Matsumura      Preclinical and Clinical

T103



ER, Invited, Expectations Regarding Comparability in a Product Life Cycle
ations for development; Greg Amidon –US – BCS system and its applications to dissolution testing; Robert Havenaar – Netherlands – Predi

udies"
 Missouri, St.Louis
 Regulations: US perspective, Justina Molzon, US

m.kyoto-u.ac.jp

 eutical ManufacturingPerson:ETS Skibsted, Ph.D.Organization: Novo Nordisk A/S, DenmarkTopic: Prediction of Dissolution and Hardness o
immunogenicity of biologics
facturer's Perspective; Scott J. Bornstein, USA, A Mechanism to Challenge Patents: How It Works for the Biosimilar Products in the US?

elease from Multiphasic MR Products: A case study: Anitha Palamakula, Ph.D., R.Ph. DBEII/OGD/OPS/CDER/FDA (15 min)Multiphasic Prod
ch FellowAnalytical Sciences R&DEli Lilly Co.Indianapolis, INStephen Colgan, Ph.D.Associate Research FellowRegulatory CMC, PGRDPfiz

GN SPACE"Other investigators in the effort may also be called upon to provide short presentations. These include, Prinicipal Investigators, R




d Impact on Assay Development"; Industry speaker TBD, USA "RF Antibodies and Impact on Assay Development"; Alyssa Morimoto, Genen
    Speaker                       Speaker          Speaker                      Speaker         Speaker
 Presentation Speaker            Company        Presentation Speaker           Company Presentation Speaker
                 Prabu NambiarVertex, Inc      Global PediatricCatherine Considerations In Pediatric on the Scientific, / EMEA Gui
                                                                 Dosage Tuleu
                                                                            University of London
                                                                                            Perspectives Michael Repka
Case Studies on Pharmaceutical Development of CMC / Regulatory Forms for the Global MarketDevelopment (FdaTechnical, a
                 Duncan Craig University SoftPhysical Shell Liquid-Filled Capsules
                                                 and Hard
The Science and Art of Manufacturingof East AngliaCharacterization of Semi-Solid Lipidic Formulations
                  It's Relevance
                              Merck            Dissolution and QbD an Industry Perspective
Dissolution andAndreas Abend in Life Cycle of a Product an FDA Perspective
                 Gopi Vudathala
                              Sanofi-Aventis Q10 and Q11 Moheb Nasr and     F                               Betzy Fritschel
An Integrated Perspective on ICH Q8, Q9, How Do you Manage QualityDA Risk? ICH Guilines Q8,q9,q10 and Q11: How The
                 Kevin Krudys FDA              Role of Biomarker-Clinical Outcome Relationship in Clinical Drug Development: FDA
                                                                John Wagner Merck           Open of Action
Use of Biomarkers in the Early Clinical Development of a Hypnotic with a New Mechanism Source Biomarkers: Practice and Pit
Transport Activity and Impact of Human Placental Multidrug Resistance-Associated Proteins (Mrps)
                 Eric Woolf Merck
Title to Be Determined                                          Olivier In Support Health An Eu Registration Applications Bioanalyt
                                                                            French           Products Safety Agency
                                               Regulated Bioanalysis LeBlaye of Global DrugRegulatory Perspective on -an Indus
                 Kazuo Maruyama University
                              Teikyo           Targeted         J. Michael Irish Medicines Board of Fip Special Dosage Forms Guide
New Approaches for Complex Parenteral Products Intracellular DrugMorris                     Review
                                                                             Delivery with Liposomes
                 Patrick Lukulayfrom
Counterfeiting PerspectivesUSP Interpol Strengthening Developing Countries to Detect Counterfeit and Sub-Standard Medicin
                 on Herbal Medicines and Related Researchand SafetyBritish Columbia Institute of Technology Evidence Based
                              Bioxel
Field Research Silvia Etcheverry Laboratory                       Works Aiming at their Development and Use in Practice
                                                                                            Quality
                                               Quality, EfficacyPaula Brownof Herbal Medicines Control of Nps: an
                 Brad WilliamsQuality          Critical Quality De-An GuoChinese Supplements Learned U.S.
                                                                Supplemetn Manufacturing Operation in the
                                                                                            Lessons
Experiences Implementing FDA Systems in a BotanicalAttributes for Dietary Academy of Sciences from Implementing Qualit
                 Columns for  National Institutes and Membrane Chromatography: Working atSelective Enrichment of Phosphopep
                                               Cellular Reactions
Enzyme-Based Irving WainerChiral Separationof Health Yasushi Ishihama       Keio University Highly the Intersections of Pharmacology a
                   -IndustrialNational Education for the Future
                               Pharmacy        Asia Perspective
U S PerspectivePaul Wan Sia Heng University of Singapore -Education and Training Programmes
                 Robert       McDowall Consulting
Aiq in Qa/qc Oerations McDowall                A European Perspective on Aiq
History and Fundamentals of the Use of High Ph Mobile Phase in Bioanalysis: a Review of the Literature
                 Yoshiaki Amakura
                              Matsuyama University
                                               Characterization of Natural Ligands
Effects of Tannins and Related Polyphenols on Antibiotic-Resistant Bacteria for Aryl Hydrocarbon Receptor Using a Reporter
                 Jean PierreUniversity of Angers Nanocapsules: a ToolJ&J Improving Factors Contributing to the Development of
                               Benoit          Lipid            Markus Performance
Delivery of Poorly Soluble Drugs: Evaluation of In Vitro and In VivoBrewster for            Oral Drug Absorption?
                 Philip Future Directions in Advantages/disadvantages Sanofi-AventisClinicalSpot (Dbs) Samples in Regulated B
Recent Advances andTimmerman                    the Use of Dried Development, Beerse, Belgium Pharmacokinetic Aspects of Drugs
                                                                Gary EmmonsUsing Dried Blood
                                                                             of
                              J&J Pharmaceutical Research & Blood Spot (Dbs) Samples for the Quantitative Bioanalysisof Dbs: P
                 Lennart Lindfors
                              AstraZeneca Monte Carlo
Persuing the Drug-Likeness Concept In Drug DiscoverySimulations to Predict Drug Physical Properties In Aqueous Solutions
                 Gregoire Ferring              Title to Be Determined
Title to Be Determined Schwach Pharmaceuticals A/S Sachin Mittal                            Title to Be Determined
                                                                            Merck Research Laboratories
                 Joseph Balthasar
                              University at Buffalo, ModelingBart Ploeger Role of Target Mediated Drug Disposition
                                               PKPD
Receptor Theory In Mechanistic PKPD Modeling SUNY                           LAP&P Consultants BVSystems Analysis
                                                                 of Biologics:              Disease         Phil Lowe
To Be Determined
                 Julia Adverse Drug Reactions
Pharmacogenetics ofKirchheiner                                  Stephen Kimmel
                                                                            University      How Do We
                              Ulm University Pharmacogenetics of Antidepressantsof Pennsylvania Bring Pharmacogenetics Into P
                 Christian the Future Vaccines & Diagnostics21st Century
Customized Vaccines for Mandl Novartis         Vaccines for the
                 Nayan AcharyaIssued Industry Guidance Documentation on Risks Evaluation and Minimization Systems
                              Eli
FDA Experience with RecentlyLilly              Pharmacovigilance and Risk Management Planning with Principles and Practicalities
                 Wendy DulinEvaluation Procedure by Ipec Thorsten Schmeller Products ContainingRequirements of New Cas
Updates on New ExcipientsPfizer                                             BASF Corporation
                                               Regulatory Approval Process for Drug         Characterization New Excipients, with Exc
                 Hilde Boone  EMEA             Eu EMEA Mechanisms for Sharing Information Mechanisms for Sharing Information
Setting Up the Office of International Programs Within the Japanese Pmda and the Pmda Between Health Authorities
                 Alexander Levitzki
                              The Hebrew University KinasesJames Bradner
                                               Protein of Jerusalem
                                                                  of Human Dana-Farber Cancer Institute/Harvard Medical a Target
                                                                             Disease        The Notch
G-Protein Coupled Receptors as Targets for the Treatmentand Phosphatases as Drug Targets Signaling Pathway asSchool f
                 Steven Baertschi
                              Eli Lilly          (ASAP) to Predict the Shelf-Life
                                                                Degradation National Institute ofof Lc-Ms Tools Characterization of D
                                                                                            Use Pharmaceutical Hofer
                                                                                                            Jeffrey
Accelerated Stability Assessment ProgramPredicting Drug Saranjit Singh Based on Short-Term Data InEducation and Resea
                 Christine Moore
                              FDA
Continuous Manufacturing for Drug Products     Regulatory Perspective on Continuous Manufacturing
                 Jun Liu      Genentech, Inc. in the Development of Protein Therapeutics
Applications of Subvisible Particle AnalysisTowards Understanding of Subvisible Particles in Protein Therapeutic Products
                 Mauricio MaiaGenentech/Roche  Ligand Binding and Cell-Based Assay Formats for Assessing Neutralizing Antibodies
Nonclinical Case Study Using Competitive Anti-Ranibizumab Neutralizing Antibody Assays: a Ligand-Binding Immunoassay with
                 Aleksandra University of Manchester Affinity to Efflux Transporters North First-Pass
                                               In Vitro-In      Mary PaineUniversity of and Gut Wall Metabolism on Howon the are
                                                                                            Influence of Dietary Substances Good Ab
Interplay Between Dissolution, Passive Permeability, Vivo Extrapolation of High Intestinal Carolina Extraction –the FractionInte
                              Galetin
                  Imaging-Guided Sinai School the Role Design of Nature's Own Nanoparticles to Create Multifunctional Agents
                              Mount            Mimicking the of
Mri Detection ofWillem Mulder Drug Delivery:of Medicine Lipo-Cest Agents
                                               The Oncologists
                                Cancer Therapy Development 6th Vital Sign – a Context of Vulnerability
                 as Basis forHoff
Oncogenomics Daniel Von Translational Genomics Research Institute
                 Hans Westerhoff
                              University Manchester
                                               Differential Network-Based Strategies: Counting on Data
From Genome to Drugs: Assessing Kinase Inhibitor Selectivity and Implications for Drug Discovery
                 Magnus as a Predictive Tool
                              Karolinska Institute
                                               Pharmacogenomics Park The UniversitySystems Pharmacology Approaches to Stu
                                                                Kevin
Cellular ToxicogenomicsIngelman-Sundberg for Human Adrs and Human Adrs                       of Liverpool
                 Eva its Training Innovations GmbH
                              Baxter
Where is the U.S. in Muchitsch Program Industrial and Regulatory Needs for Drug Safety Education and Training in a Global P
                  Novel Strategies for of Padua,Current Status Pharmaceutical Sciences
                              University       The Proteins
Development ofFrancesco Veronese PEGylated Department ofand Challenges of PEGylated Proteins
                 Lawrence Lesko
                              FDA              Pharmacogenetic Testing
2. Challenges of the Clinical Application of 3. FDA Perspective on Pharmacogenetic Testing
                 Rachel Tyndale
                              University of Pharmacogenetic Variation The UniversityPharmacogenomics of Drug Hypersensitivit
Clinical Pharmacogenomics in Cancer Toronto                                  in Smoking and Treatment Response
                                                                Munir Pirmohamed             of Liverpool
                 Yurong Lai Pfizer, Inc.                        Agnes Poirier Hoffmann-La Roche
                                                                            F.              Mechanistic Modelling of Drug Transport Pr
IVIVE for Hepatic and Renal Transporters In Silico Liver: Application of Targeted Proteomics In ADME / Tox for IVIVE
Stability Requirements for Generic Drug Approvals
Risk Factors in Human Bioinequivalence of Oral Dosage
                 Yuichi SugiyamaAbsorptionNew Strategy ofBengt Langstrom with Molecular Imaging Studies with Pet
                              The                with Pet
Molecular Imaging of Oral Drug University of Tokyo                          Uppsala         Pharmacokinetic Technology
                                                                 Microdosing Study University
                 Andre Processes Using Real Time Uv Imaging Together with Solid Terahertz Imaging Raman Spectroscopy
                                                                J Axel Zeitler
                                                                             Analysis of Cambridge
                                                                                             State Analysis Tablets Using Laser Induce
Insight Into DissolutionBlainPharma Laser A Novel Rapid Quantitative University ofDrug Migration onwithof Film Coatings -from R
                  Expression with Small Rnas
Activating GeneJens Kurreck                    Oligonucleotide-Based Strategies to Inhibit the Heart-Pathogenic Coxsackievirus B3
                              Technical University Berlin
                 Frances Xenobiotic Metabolism, Diabetes and Fatty Liver Disease
Car at the Crossroads ofSladek                 Hnf4 -its Ligand
                              University of California, Riverside Drug Prospects
                 Ulrike of Alveolar              Sarcoma        Tong-Hsuan Chang Inc. Monoclonal Antibody Against
                                                                            GlycoNex
Therapeutic TargetingSteinMDC Soft PartA New Metastasis Associated Gene, Macc1, from Bench to Bedside Cell Membran
                 Munir HussainBristol-Myers Squibb Company
                                               Impacting Hiv Patients Combination of Globe: Successful Development Fixed Dose
Finally Beating Malaria: Successful Development of a Fixed DoseLives Around theArtemether and Lumefantrine
                 Rodrigo Laureano
                              Celgene
Ncdfa -a Toxicologist Prospective              Investigation of Out-of-Specification Results for Ncdfa
                 Thomas DillonBiologics Disulfide Structural Variants Characterization and Risk Assessment:Mass
                               in                               Kelly Toler of the Igg2 Glycosylation Analysis by Characterizatipo
Process-Related ImpuritiesAmgen, Inc (Hcp and Protein-A): Analysis,Genzyme Antibody SubtypeRalf Holzinger Spectrome
                             Hendrik Luesch
                                         University of Plants Drug Discovery: Novel
                                                         Marine          John Cashman Human BioMolecular Research InstituteModes of Action
                                                                                                     Cyanobacteria and their
                                                                                                                          Early-Phase Developm
            Targeted Phytochemicals from Selected Florida and their Biotechnology Leads fromDrug Discovery Veronika Butterweck
            Nanoparticles and Drug Delivery; Basics
                             Kozo Manufacturing of Solid Dosage Forms Approach Century
                                         Hoshi           A               Svetlana Ibric
                                                                                      Belgrade University
                                                                                                    Applications of Neural Network
            Intelligent Design andTakayama University Novel Statistical in the 21st in Pharmaceutical Formulation DevelopmentData Mining
 : Challenges In Pediatric Dose Projection, PK/PD and Clinical Trial Design
                             Henderik Frijlink
                                         University of Groningen Treatment of TB : Isn't the Dose Too Large for Us?
                                                         Pulmonary
            Particle Engineering for Respiratory Drug Delivery
                             Amanda Barnard Materials Science & Issues Rabinow
                                         CSIRO           Phase Stability of Inorganic Nanocrystals: Targetingfor Organic Nanocrystals
                                                                         Barrett                     Lessons Applications of Nanocrystals in D
            Nanocrystals -Properties, Production Methods, StabilityEngineering Baxter Healthcare Corporation
                             Erwin CellsNovozymes
                                           in             Response       Reiko Teshima Assessing theImmunogenicity Sciences, Japan
                                                                                                     Unwanted Response to Biomolecules.
            Introduction: DendriticRoggen the ImmunePredicting Immunogenicity: National Institute of Health and of Genetically Modified Foo
                             Gretchen QbD Paradigm: EMEA Perspective an Industry Perspective
                                         Pfizer
            Process Validation Under Allison             Process Validation:
                             David Baker LT Plug Delivery Inc
                                         Q                and Preservative-PackageFDA
                                                                         Elaine Morefield
                                                                                       Interactions Regulatory Landscape of Preservatives in P
            Preservative-Drug, Preservative-Excipient,Preservative-Free Sterile Products
                             TBD ―cocktail‖
            Things to Consider inTBD FDAApproaches Regulatory Perspective on Utilization of Cocktail Approach In Clinical Investigation
                                                         A
                             Tim Polysorbates in Proteinrystallisation of Excipients
            The Use and Fate ofKamerzell                 C
                                         Genentech, Inc. Formulations
                             Eyal Barash Aptuit Inc.     Patent Implications of Amorphorous States
            Strategies for Patenting Novel Crystalline Forms of Drug Products
                             Renato Zenobi Zurich
                                         ETH             Single Cell Cells
                                                                         Edward Yeung State University
                                                                                      Iowa          Introduction
            Chemical Cytometry--the Chemical Analysis of Single Analysis for High-Throughput Screening of Metal Nanoparticles and Me
                             USP Chacra  University of Sao Paulo
                                                         Comparison      Jennifer Dressman Quality of Goethe Based on the Biopharmaceutics
                                                                                      Johann        Biowaivers University
            The Role of the Nadiain Providing Needed Standards of the Pharmaceutical Wolfgang Essential Drugs on the South American
                             Hiroshi Suzuki
                                         Education to Accelerate the Uptake of Personalized Medicine
                                                         Role
            Reforming Pharmaceutical University of Tokyo of Pharmacist in Edication of Pharmacogenetics and Pharmacogenomics in Jap
                             Per Djupesland
                                         Optinose
            Intranasal Delivery of Drugs to the Brain Device Characteristics for Nose to Brain Drug Delivery
                             Kazuya
            Title to Be Determined Maeda                 Title           Ping Zhao FDA
                                         University of Tokyo to Be Determined                       Title to Be Determined
                             Ken-ichi Inui
                                         Kyoto University Hospital
                                                         Gene Regulation of In Transporter ExpressionZurichto Drug Disposition
                                                                         Gerd Kullak-Ublick Hospital and of Hepatic and
                                                                                      University    Regulation
            Snps In Noncoding Regions of Transporters: Role In VariationDrug Transporters: Implications Drug Response Intestinal Drug T
                             Aspects of Tohoku University
                                         Brain           Molecular Mechanisms of Drugs Tech University Health Sciences Center
                                                                         Quentin SmithTexas         Transporter Expression and Anticancer Dru
            Drug Discovery Sumio Ohtsuki Penetration -How to Optimize New Transport Systems at the Blood-Brain Barrier as a Pathway
                              Anion Transporters: Role Blood-Brain Barrier Pharmacoproteomics:The Acquired Liver Injury During Analysis f
                                         Tohoku          in              Shiew-Mei Huang
                                                                                      FDA             of Role of Transporters
            Hepatic OrganicTetsuya Terasaki UniversityDrug Disposition and PharmacogeneticsQuantitative Transporter Protein Drug Deve
                             Rene BrunoUtility of        Modeling of Resources
                                                                          Tumor Growth-Survival Link During Anti-Cancer Treatment
                                                                                      Los           Linking Short-Term
            Disease Systems Analysis: Certara Collaborative Datathe Alan Perelson Alamos National Laboratory Viral Kinetics to Long-T
            Carboxylesterases -Targets for Drug and Prodrug Efficacy and Pharmacokinetics
            ―methods and Techniques for Population Pharmacometric Model Building and Diagnostics‖
n Peptides and Proteins
                                                         Quality of and Medical Medicines – Genotoxic Impurities – Current Perspectives
            A Rationale for Determining, Testing, and ControllingManufactured Devices, Germany
                             Peter KasperFederal Institute for Drugs Specific Impurities in Pharmaceuticals that Possess Potential for Genotox
            How to Get it Right More Often – an Industry Perstive Biology Approaches for Target Selection
                                         B               Integrative
                             Debra Klatte oehringer-Ingelheim
            Introduction to Risk-based Approach to Evaluating Potential Interference
                             Rakesh SinghUniversity Atopic Dermatitis in Dexi by Nanogels for siRNA Delivery to Tumorfor Gene Drug Disco
                                                         Development of Targeted University of Pittsburgh Approaches Vasculature
                                                                          Center
            Transdermal Preparation for Treating of Nebraska MedicalMice LiusiRNA                   Non-Viral
                              Minin Lai Peking UniversitySystems Use of Information for Anti-inflammatory Treatment
            Combining TextLuhua and Virtual Screening: Direct Based Drug DesingExtracted from the Scientific Literature for In Silico Exper
                             Robert Reed of Reactive Components in Pva-Based Film Coatings
                                         C               Case
            Characterization and Control elsion Corporation Studies of Drug Product Instability Attributed to Reactive Components of Pharm
                             Sumie Yoshioka
                                         University of Connecticut Mobility of Kantor
                                                         Molecular       Angela       Pfizer
            Freeze Thaw and Freeze Drying of Nanoparticles and Vaccine Freeze-dried Formulation     Biologics Freezing, Cryoconcentration, and
                             Dexiang ChenPATH            Developing Global Health Vaccines: Progress, Challenges, and Opportunities
                                                                         Malik Kahook University of Case Study: Global Distribution of Avastin f
            Prevalence of Preventable and Treatable Blindness: a Thermostable Perspective Colorado Denver School of Medicine
                             Toshihiro Wajima & Co.Prediction of Human Pharmacokinetic Profiles Based
                                         Shionogi                        Sherry Ku Wyeth from Preclinical Data: In Silico Approaches and No
                                                                                                    Phrma Initiative In Human PK Prediction to
            Application of PBPK to the Prediction of Human Concentration-Time Profiles Pharmaceuticals on Pfizer Experience
                             Martyn Davies
                                         University of NottinghamFormulation
                                                         Reliable
            Experimental and Theoretical Methods for Analytical Techniquesof Kinetically Stable Solid Amorphous Dispersions
                             Bertil Abrahamsson
                                         of Dissolution Using Dissolution Oral Drug
            Simultaneous Assessment AstraZeneca and Permeation of and Permeability Modeling to Predict Formulation Performance
            Nonexponential Transit Time Distributions In Pharmacokinetic Systems
                             Leaf Nucleic Acids          The Challenge Jan Schnitzer
            Targeting Delivery ofHuangUniversity of North Carolina of siRNA Delivery                Targeting and Imaging Couvreur
                                                                                                                    Patrick on Caveolae Mediat
                                                                                      Proteogenomics Research Institute for Systems Medicine
            Presentation Title to Be Determined
            The Changing Nature of Biomarkers: How to Optimize an Individual's Drug Therapy
                             Douglas University of California, San Diego De Strooper
            Title to Be Determined Galasko                               Bart         Katholieke    Presentation Title to Be Determined
                                                         Presentation Title to Be Determined University Leuven
            Drug Discovery
            Drug Development and Evolution of Current Global Safety/pharmacovigilance Regulations
                             Koichiro Clinical
                                         Hiroshima University
            Experiential Education InOzawa Practice Curriculum Devleopment: Content and Politics
                             Andrin Oswald
                                         Novartis Vaccines & DiagnosticsGlobal Health: New
                                                         Vaccinology and Simon Croft ondon School of Hygiene and Tropical Medicine
                                                                                                    Contribution of Public[private Partnerships t
            The Bill & Melinda Gates Foundation's Strategy on Neglected TropicalLDiseasesTechnologies Create Global Opportunities
                             Tatsurou Himeji             Biological      Judith JacobiClarian Level Control
            Title to Be Determined Yagami Dokkyo University Effects of Blood GlucoseHealthBlockbuster Trials Evaluating Tight Glycem
                             Janeen Skutnik Global Emerging the Quality of Excipients
                                         Pfizer          Insuring MarketsTBA (Keynote presentation TBA
                                                                                                    Overcoming the Challenges of Regulatory F
            How Can QbD Submissions Be Used in Research & Development WHO During Manufacturing and Throughout the Supply C
                             Adriaan van Zyl Health Organization Resources" GIRP
                                         World           Ensuring the Martin Pharmaceutical Ingredients and Finished Products Full-line S
                                                                                                    The Impact of Diversion Within the Global
            A Case Study: "How to Address Drug Quality with Local Quality ofFitzgerald - European Association of Pharmaceutical -Scope, I
                              Posterior Neurotech        Encapsulated Cell Technology for
            Drug Delivery toWei Tao Segments: Barriers, Delivery Systems and Models the Retinal Drug Delivery
                             Joke Bouwstra
                                         Leiden University
                                                         Transcutaneous and Intradermal Vaccination
                                                                         Naoki (BubbleOsaka University
                                                                                                    Transcutaneous Vaccination System Using
            Cancer Immunotherapy Utilized Ultrasound Sensitive Liposomes Okada Liposomes) by Means of Microneedles and Nanopa
                             Teruyo
            The EMEA PerspectiveArato                     and Medical Devices Agency
                                                                         Junzhi Wang                The Asian Experience
                                         PharmaceuticalThe Japanese Perspective State Food and Drug Administration
 uropean Union
 rmaceutical parenteral products - Regulatory perspective TBD – EU speaker




                                                                                     

dardization of global bioanalytical practices, Steve Lowes, Ph.D., Advion BioServices


                                    
5.
                                                              

                                                                                                      6.

onso (Univ. Santiago de Compostella)
 The pulmonary route. Prof. Anthony Hickey (Univ. North Carolina)
 The dermal route. Dr. Joke Bo
 A,PhRMA, EGA etc.);



 f. Wim Jiskoot, Division of Drug Delivery TechnologyLeiden/Amsterdam Center for Drug Research (LACDR), The Netherlandsd) Novel-gene
 ree concentration at the site of action in healthy subjects relate to those in patients?;Hartmut Derendorf, United States and Larry Lesko, Unit

ssion and the challenges of scale up from data generated on miniaturized equipment

shal Gupta, Covidien, or Patheon, Novartis or Pfizer, Title TBD




 or Determinations including AIM. 
 

Faculty of Law, University of California, BerkeleyTools Development and Global Policy Peter Hotez, George Washington UniversityMaking the

, UK), Latest developments in terahertz spectroscopy and imaging technologies,Dr Taday has a very distinguished career in spectroscopy. B
ms?; Siva Vaithiyalingam, Ph.D., FDA, USA, Title: Current FDA perspective on blend uniformity testing in the manufacture of solid dosage pr


USA); Emerging siRNA delivery systems 5. Prof. Leaf Huang (USA); Tumor targeted delivery of siRNA 6. Prof. Rudy Juliano (USA); Endosom
eteran of Pfizer Inc having joined as a medicinal chemist in 1977. Over the years, he held positions of increasing responsibility for Pfizer Ce



                                                                          

                                                                          4
urcing - Sponsor Considerations: a Case Study‖ ((Dr. Han Gunn, Amgen, USA)
 – ―Small Molecules Offshore Outsourcing- Sponsor Consid




 -term physical stability of amorphous dispersions Dr. Marshall Crew (Agere)
                                                                 

                                                                 

                                                                 
                                           

                                                                                                             


pulation variability issues in these complex systems (both USA);
Modeling Heterogeneity in PK and PD systems:
Panos Macheras, (Unive

 MRI biomarkers to assess disease activity and to design enriched clinical trials

cial) on EpidermFT and other marketed skin alternatives.

QA (TBD), FDA, USA and his presentatoin title: Regulatory requirements from the CMC perspective.
ment technologies;Mark Prauznitz, USA, Microneedles;Adam Watkinson, AUS, The future of transdermal drug delivery

                                         
5.

ine, Cedars-Sinai Heart Institute, LA, CA
 Jill B. Becker, Professor of Psychology, Psychiatry Dept, University of Michigan, President of the
merican Pharmaceutical Companies (Dr. Douglas M. Fast, Pfizer, USA);4. Regulatory Agencies Perspective (Dr. Brian P. Booth, FDA, USA a
 release coating;Janie Dubois, Ph.D.,Malvern Instruments, Inc.,US, NIR imaging for assessment of coating thickness and coating uniformity
 usion;Craig McKelvy, Ph.D., Merck & Co., Inc., US, A Pharma Company Perspective of HME as a Means to Manufacture Drugs ¨C What Iss
lventless and screen-printable) and silicone release coatings (including fluorosilicone) for industrial and labeling applications. In the last 5 ye
 , USA)3.Impact of LC-MS/MS Ion suppression and Matrix Effect due to Phospholipids (Dr. Fabio Garofolo, Algorithme Pharma, CANADA)W
tion Behavior of Phospholipids in Solid Phase Extraction: Elimination of Matrix Effect in LC-MS/MS (Dr. Fabio Garofolo, Algorithme Pharma,




 Harward University MA);Design and development of appropriate and flexible oral dosage forms for elderly. Prof. Felix Ecker (Fulda Universit
ns; Helen Strickland, United States, Characterization and Estimation of the Variabillity in Cascade Impactor Determinations including AIM



D. Premkumar, Analytical Bio-Chemistry Laboratories, Inc. Radiolabeled (14C- and/or 3H) new molecular entities for preclinical and Phase 0
dian Institute of Chemical Biology, Kolkata, India.3)Liposomes as a drug delivery strategy to increase bioavailaibility and efficacy of flavonoid

 ce in cancer. Y. Sugiyama, University of Tokyo, or P.Borst, The Netherlands cancer Institute, or A. Sparreboom, Sidney Kimmel Comprehens
ge EC. Division of Pharmacology, LACDR Leiden University, Leiden, The Netherlands.
•
  


                                                                                      
 Drug delivery to the nasal cavity: in vitro and in vivo
D and Drug Metab., Pfizer Global Research & Development, Groton, USA.. 401 Eastern Point Rd, Groton, CT 6340. tristan_s_maurer@groto
             
3.

ories, USA)
 Systematic approaches to regulated bioanalytical method development – Considerations for a moving target (Dr. Stephen Low
 herapy;Speaker: Martyn Clarke, Ph.D., Glaxosmithkline;Country of Origin: USA;Topic # 3: A Clinical and Patient Perspective in Management
 ents, Inflammation; Virginia D Schmith: GlaxoSmithKline, Research Triangle Park, NC, US, Effects of inflammation on pharmacokinetics/ph



orporation Stan Finkelstein, MD. Engineering Systems Division, MIT, USAGlobal Pharmaceutical Outsourcing Trends and Assessing the Impa




xner (John Hopkins University, USA) - Current HAART Regimens and Drug Interactions;Proposed Speaker 4Ruth Tuomala (Harvard Univers




                                                                                                                                   


                                                                                                                                    

ks, BPharm, PhD. University of Reading, UK (e-mail: g.brooks@rdg.ac.uk). ―Gene therapy for the treatment of proliferative disease‖;
Profes
andidates based on the Class of Marine Natural Product known as the Pseudopterosins.Speaker #2: Dale E. Shuster, Ph.D., Director, Oncolo




n a combination drug therapy and regulatory aspects‖; Dr. Dilip Parikh, CEO, DPharma Group, Inc., Maryland, USA, ―Formulation and proces


ms, Dr. Robert Sobel, Director of Technology, FONA International, Geneva, IL, USA; 4.Nanotechnology Applications for the Food Sector and
des, Biopharmaceutical & Drug Delivery Consulting, LLC, Gurnee, IL, USA;3.Emerging parenteral lipid-based delivery systems for small mole
ent Considerations with Nanomaterials and Nanoparticles, Dr. Xing Jie Liang*, Laboratory of Nanobiomedicine and Nanosafety, National Cen
any;


ute for public Health and the Environment, Bilthoven, The Netherlands3. Clinical aspects of protein drug immunogenicityDr. Christian Ross P
                                                                      

 Hill, USA) Toxicological aspects of skin application of nanoparticles

 spective of Transdermal nanotechnologies. 
   


ug Release from Nanoparticulate Drug-Carriers‖ Brian S. Cummings, Assistant Professor, University of Georgia, U.S., bsc@rx.uga.edu, (706


 ta University in Canada will discuss the problems with the equipment specifications coming from harmonization
ustry speaker will discuss the experiences and interpretation of the path forward on Performance Qualification with case studies.
rs (global outreach)Panel 5.)Discussion with speakers, plus FDA or EMEA- "Is there a coordinated approach emerging for a solution?"


 VX.Three speakers will be selected.

niversity of South Australia, Australia, Genetic determinants of toxic risk assessment in cancer.

city.


dy, Ph.D., Novum, USA, "Application of clinical endpoint studies for the determination of bioequivalence".




rms/Ophthalmics)Tomoyuki Yokobori, Quality Assurance, Takeda Pharmaceutical Company Ltd.; Japan
ssment5. Steve Nail, Baxter, and Linas Mockus, Purdue; USA; QbD for a Small Molecule Parenteral. II. A Case Study in Formulation and Pr

            

            

                                                                                    

pressor gene
CANCER DORMANCY, DISSEMINATED AND CIRCULATING TUMOR CELLS: NEW THERAPEUTIC APPROACHES
Klaus

ting of Antibody-Drug Conjugates‖; Lawrence Tamarkin, Ph.D., USA (CEO, CytImmune Sciences, Inc.) ―Safety of Tumor-targeted Pegylated




 rugs.
  anticancer drugs.
  selection. Yurong Lai, PhD, Pfizer Inc 4. Quantitative Atlas of Membrane Transporter Proteins: Tetsuya Terasaki Tohoku University, Japan o
 ation of particle surface using ultrasonic water mist.Daryl R. Williams; UK; Characterising the Surface Properties of Pharmaceutical Crystals.


, Italy,chitosan nanoparticles for peptide drug delivery applications;
ches to predict the impact of drug transport on disposition

                         

                                                                                      

                                                              Armin Rostami, Sheffield




 rs.




A 94158, USA.Significance of organic cation transporters such as OCT, OCTN and MATE in clinical pharmacotherapy;Niemi M (Finland)Univ
  
•

  
 Don Martin (Seagull technology Australia) Ultrasound guided drug delivery through nanotechnologies
   


                                                                                                           




                                                                                           

 New strategies in drug formulation to minimise the effect of intestinal efflux transporters
Prof. James McGinity

                                                                                             

                                                                                             
                   University of Texas, USA

                                                                                                                 
                       
St
 shire Ave., Silver Spring, MD 20993, USAConfirmed Speakers:(1) Richard L. Lalonde, Pharm.D.Vice President and Global Head of Clinical P

Drug metabolism and transporter effects on prediction of BA/BE"; Lawrence Yu, Ph.D., USA, "Current progress and future prospects on biow
 partment of Imaging WP44C-2, 770 Sumneytown Pike West Point, PA 19486-0004 , USASuggested presentation title: " The Functions of Mo
on.


 th, Texas Tech University, Amarillo, Texas, USA: Roles of active efflux transporters, passive permeability, and parenchymal binding on antica
 ncentrations as surrogate measurement for brain free concentrations.Margareta Hammarlund-Udenaes, Uppsala, Sweden: Structure-Brain E
  Model of Genotype 1 Hcv to Assess the Evolution of Protease-Inhibitor Resistant Variants;

hrani, Triboglide;Regulatory considerations for development of combination products,TBD
 , Uppsala University, Uppsala, Sweden: How well does rat data fit with human CNS exposure? Species differences and similarities in drug tr




 dictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX-2 Inhibitor; OR Thaddeus Grasela (US) The role of Populatio
adabushi (US) Integration of Pharmacometrics in Oncology Drug Development: FDA Perspective;


 innati Medical Center Generic AED Formulations: Current Standards and Future DirectionsYatindra Joshi, Ph.D.Teva Pharmaceuticals
 innati Medical Center Generic AED Formulations: Current Standards and Future DirectionsYatindra Joshi, Ph.D.Teva Pharmaceuticals
 innati Medical Center
 ticals


 innati Medical Center



   

   Samba Reddy, Ph.D., R.Ph.

 en
                        Texas A&M Health Science Center

                            
                              

 nt of the Metabolic Syndrome Christina Aquilante, Pharm.D.University of Colorado Denver School of Pharmacy Nonpharmacological Approa
, Ph.D.Merck Research Laboratories

 will be on the impact of these modifications (on aggregation, solubility, PK, PD and Immunogenicity) and not on the methods of achieving the




gement of Asthma and COPD;
(potentially another person from Genzyme, they are very strong in this area). 4. Ned Mozier, Pfizer (process-related) Host Cell Protein detect
                                                                 

                                                                 •

f visible particles on safety and efficacy--Gianni Torraca, Amgen
 Is it possible to have a particle free high concentration protein drug produc
n Relief with Nasal Spray Decongestant;J.D. Pipkin, PhD CyDex Pharmaceuticals, United States, A Novel Combination Product of Intranasal
s for Alzheimer‘s Disease.
   

ages for DNA and RNA products


or expediting oral development of oncology/biologics products.

 Utah OR TBD)4. Novel pH or Thermosensitive Block Copolymers for Triggered Drug-Delivery Systems(Christine Jerome, University of Lieg
and performance3. Proposed Speaker: Francois Menard / John Kirsch, Counrty of Origin: France / USA, Proposed Title: Industry Perspectiv
 le speakers:Otto Cars, Uppsala, Sweden ORUrsula Theuretzbacher, Vienna, Austria
 le speakers:Otto Cars, Uppsala, Sweden ORUrsula Theuretzbacher, Vienna, Austria


                                                                                      


                                                                                       

espina Solomonidou, PhD, Novartis Pharma AG; Basel, Switzerland; Global Technical R&D;
―Children are not Small Adults: Challenges in P

sisted crystallization : Dr, Graham Ruecroft, Prosonix, UKd) Ultrasound assisted melt extrusion of polymers: Professor Guo, The State Key L
m,
 
"Developments in Regulatory Matters on Herbal Medicinal Products in Europe"
 



h, or Ganga Sunkara or Hequn Yin of Novartis Shanghai;
rs, siRNA Gene Knockdown and miRNA Profiling: Fron Assay Development to Sample Analysis.




aceutics and Quality by Design.

                                                                                                                                     

or the New York Botanical Garden. USA, " Traditional Medicine and Dietary Supplements: Research Priorities and Lessons to be Learned"



yAnna Slater, PhDDirector, Intranasal Product Development DivisionGlaxoSmithKline, UK.




ries

uorescence;Owa Takashi,Eisai, Japan, Drug target validation and identification of secondary drug target effects using DNA microarrays;


omas Nicholai (Abbott)Silicone-free lubrication system - Vinay Sakhrani (Triboglide)US & EU regulatory perspectives on siliconization - Final
 ive-excipient, and preservative-package interactions: Otilia Koo (BMS)Preservative-free sterile products: Brian Rohrs (Bausch)Regulatory la
 ive-excipient, and preservative-package interactions: Otilia Koo (BMS)Preservative-free sterile products: Brian Rohrs (Bausch)Regulatory la
omas Nicholai (Abbott)Silicone-free lubrication system - Vinay Sakhrani (Triboglide)US & EU regulatory perspectives on siliconization - Final
omas Nicholai (Abbott)Silicone-free lubrication system - Vinay Sakhrani (Triboglide)US & EU regulatory perspectives on siliconization - Final
omas Nicholai (Abbott)Silicone-free lubrication system - Vinay Sakhrani (Triboglide)US & EU regulatory perspectives on siliconization - Final

 njury and mitochondria dysfunction;David W. Threadgill (University of North Carolina), USA, Mouse population-guided resequencing for eluc




 d Drug Administration,1114 Market St., St Louis, Missouri 63101, USA.Speaker 4: Xia Dong (TOF-SIMS/SEM/EDS imaging) Eli Lilly, Indiana
ersity of Tokyo, Japan; Impaired localization of hepatobiliary transporters in hepatotoxicityYukio Kato; Kanazawa University, Japan; Xenobiotic
 University of Washington, USA; Identification of the mitochondrial targeting signal of the human equilibrative nucleoside transporter 1 (hENT

Operations
uation for biotech-derived materials



cogenetics hypothesis.Speaker: David Goldstein, Duke University E-mail: d.goldstein@duke.edu4.Genetic factors in drug efficacy and toxici
e University, Division of Cellular Medicine and Davis Heart and Lung Research Institute, OH. E-mail: glen.cooke@osumc.edu;4. Pharmogen

bioavailability
s or Christopher Horvath,Amgen, USA; Robin Thorpe or Meenu Wadhwa, NIBSC, UK) 5.      Risk analysis (Paul Chamberlain, bioLOGICA C
                                   
 Sparreboom; St Jude Children‘s Hospital, USA; The pharmacogenetics of drug transporters in the
                                   Alex
orphisms from in vitro experiments;


 Danhof; Leiden University, The Netherlands; Incorporating Receptor Theory in Mechanism-Based PK/PD Modeling;William J. Jusko; Univer
e transporters;Matthias Reuss; University of Stuttgart, Germany; A quantitative understanding of dynamic cellular processes during detoxifica
 sorption by the inhibition of of drug efflux transporters;Richard Kim; University of Western Ontario, Canada; Clinical evidences on the active
 n, Pharmacoepigenetics of drug metabolism enzymes;Hiroyuki Kusuhara (The University of Tokyo), Japan, Tissue selective expression of tr
mor cells;Ikumi Tamai (Kanazawa University), Japan, Species difference in the drug-food interaction between rat and human;




                                                                                                                

z, Professor of Pharma Technology, University of Applied Sciences Northwestern Switzerland, Muttenz, Switzerland


wen N. Witte (University of California, Los Angeles), USA, Non-invasive prediction of tumor response;

                                                                                                   

d visions as regards appropriate delivery systems for protein therapeutics – what needs the market?




g cross flow injection: Case study 2" 5. Dr. Diane Burgess (USA)or Dr. Mansoor Khan (USA/FDA); "Quality by Design considerations for lipos
ent of Tuberculosis;


hD, Kyoto University Hospital, Japan, ―Impact of multidrug extrusion transporters (MATEs) and organic cation transporters (OCTs) on the effic
 4-0180Sheo B. SinghMedicinal ChemistryMerck Research Laboratories126 E. Lincoln Ave.Rahway, NJEmail: sheo_singh@merck.comJon S

                                                          
 Impurity Control Strategies for Global Clinical Trials
Panel discussion: 30
                                                           

                                                           

or Rapid Clinical Assessment of Experimental Dosage Forms
•
                                                      


                                                                                                                   

                                                             


                                                             
Moderators 
Majid Y. Moridani 

                                                              

76, Rm. 110, Frederick, MD 21702. E-mail: bobeg@mail.nih.gov 

            


                  Assistant Professor

                                                                                                
                    School of Pharmac
                                                                                                                     


tency of siRNA mediated knockdown in vivo. (35 min)Speaker: Kevin G. RiceCollege of Pharmacy, University of IowaIowa City, Iowa, tel: 319
ational Lab., USA)
                                                                                                        

ao Gobburu, PhD, FDA, USA, "Regulatory view on population modeling approaches to assess immunogenicity‖ 


  from different studies"
                                                                                                                                      


 oducts"; Wallace Adams, Ph.D., USA, "FDA research and current considerations in establishing in vivo approaches for BE evaluation". 




                                                                                                                                       


h Wilner, PhD, Pfizer Oncology La Jolla, CA2. Genetic Variation in drug transporters in ethnic populations. Kathy Giacomini, Department of

al Research, USA, Design of fit-for-purpose validation criteria for clinical biomarker measurement
                                          

nd other non-oral routes of administration

            


             

n Francisco
Speaker affiliation: Dry Powders of Stable Protein Formulations from Aqueous Solutions Prepared Using Supercritical CO2-As

g in relation to the quality of modified release products James G. Brasseur; USA; Prediction and reduction of risk of dose-dumping by model

ek-Gliszczynski, Eli Lilly, USA, Application of KO mice toestimating the fraction of clearance mediated by excretory transport andidentification
e moderators and previously presented to the speakers. Each speaker has prepared one answer slide per question; additional opportunities
philization process design and commercialization, Steve Nail, Baxter Healthcare, Bloomington, IndianaSpeaker affiliation: FDA Perspective
 ive-excipient, and preservative-package interactions: Otilia Koo (BMS)Process scale-up, manufacturing, and control issues: Final speaker (C
                             

                             


rked – what has failed?‖; 
Hyo-Kyung Han, College of Pharmacy, Chosun University, Korea;


     


                                                                                                 


                                                                                                



y development to scale-up and lifecycle management: Alan Royce (Country of origin: U.S.A) or Paul Dickinson or Gordon Muirhead (country

oo, MI 49009
 Amur, PhDFDAShashi.Amur@fda.hhs.govModeratorDr. Lawrence Fleckenstein University of IowaCollege of PharmacyS557 Pharmacy115


alatable Pharmaceuticals: Optimizing Sensory Attributes for Rx and OTC Drugs 4) Name: Robert Daines, PhDPosition: Director, Chemistry, R
alatable Pharmaceuticals: Optimizing Sensory Attributes for Rx and OTC Drugs 4) Name: Robert Daines, PhDPosition: Director, Chemistry, R

 SA.Speaker 3. Metabonomics in drug developmentJohn C. LindonDepartment of Biomolecular Medicine, Faculty of Medicine, Imperial Colle
                                                      
 Polyphenols as potential antioxidant therapeutic agents: mechanism and actions -
Amarillo, Texas, 79106, majid.moridani@ttuhsc.edu 
3. 


                                                       

 implications;
 er program will it replace PK and send back to empirical dosing days? Prasad Tata, St. Louis, MO.7 Title to be decided. Speaker TBD.8. Re




C-MS/MS method - Mario Rocci4. LC-MS/MS methods still rules when metabolism is there - Dary Dager- Kansas City.5. How to integrate anl


Quantum dot-FRET technology for enhanced intracellular gene and drug deliveryKam W. Leong, Ph.D.Duke University

rformance";Anette Mullertz, Denmark, "In Vitro Lipid Digestion Models for Design and Selection of Preferred Lipid Formulations";Marcus Bre




n strategies for pediatrics Speaker 4. Jeff Worthington, Senopsys, USATitle Palatability Assessment of Pediatric Formulation
wide Applications and Impacts of the BCS System on Drug Development, Clinical Outcome and Public Health. 4.Mansoor Khan, FDA, USA




ce, IncTopic: AMS - A Verstatile Quantiative Tool - From Carbon Dating to NDASpeaker 2:Industry Speaker to be IdentifiedTopic:Application o
ption: Usefulness of permeability and solubility classification in early MR candidate assessment;
of Predictive Models Integrating Dissoloution and Absorption: Challenges and Rewards;4. Jack Cook, Pfizer, US, Impacting Oral Drug Produ
macologyCDER, FDAPHONE: 301-796-3774EMAIL: ping.zhao@fda.hhs.gov FDA Perspective on the Evaluation of Complex Drug Interactio



 Co., Inc.Which equation to use in renal drug dosing? The CG or the MDRD eGFR?;Speaker 4:Lei Zhang, Ph.D.Office of Clinical Pharmacol

. (or Lei Zhang, Ph.D.)FDA Perspective
ion in Brazil.
 m the trench"


on), ―Rational Design of novel protein-protein interactions‖; Dr. Michael Owens (Professor, University of Arkansas Medical School), ―Rational


 tional Institutes of Health), ―Progress and challenges for malaria vaccines‖; Dr. Paul R. Kinchington (Associate Professor, University of Pitts

 nctions and stability of monoclonal antibodies‖.




utamate and COX2 signaling.
 o, CA 92121
 arlie Martin - Scale-up of the extrusion process from laboratory to production Joe Smith - Analytical Characterization of Extruded Materials
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
netics, Dynamics & Metabolism Pfizer Global Research and Development San Diego, CA 92121
             



 Capsules‖;
Bruno Hancock, USA, ―Mechanical Characterization, Tableting and Performance of Amorphous Spray Dried Dispersions‖;
Ron        


                                                                                                                                           


ationale for biotherapeutics and small drug molecule interaction studies. Yurong Lai, Pfizer Inc or Lewis Klunk, Biogen Idec, USA;    Alternativ


&#13;&#10;Steve Byrn, Purdue University, Talk entitled: Global Requirements for Drug Stability&#13;&#10;
                                                 
6f)
  D, Children‘s Hospital / Harvard Medical School
 Role of simulations in regulatory BE decisions, Suryanarayana Sista, Biovail Technologie
 IPL-CNRS, Marseille, France4.Experimental models for assessing the impact of in-vivo processes of lipid based formulations.Anette Mullertz



 f Cardiology Swiss Cardiovascular Center Division of Angiology Bern Universtiy Hospital, University of Bern Bern, Switzerland3. Clinical Deve
New Zealand;One speaker from FDA or WHO, to be named;

                                                                 

                                                                 Vince McCurdy, Ph.D., 

e of QbD and six-sigma in re-defining process validation approach
                     
Head, Right First Time Office, Pfizer.


                                                                                                                               


        

        
Dr.
roducts
 Yi Shi (Abbott)
3. Application of artificial stomach-duodenum model for ionic drugs and application in salt evaluation 
 Mich
                           


                            
                                                                                                    
Dr.

Kamal Midha, Ph.D., D.Sc., University of Saskatchewan, Canada;4. Quality-by-Design to Achieve Therapeutic Equivalence of Modified Relea
a ZenecaQbD: How it can help to set clinically meaningful specifications - Industry perspective

                                              

 y from industry: Speaker from Novartis or GSK



 s of Nk012, an Sn-38 Incorporating Micelle




Robert Havenaar – Netherlands – Predicting bioavailability with the TNO digestive system; James Brasseur – US- modeling the physical beha




rediction of Dissolution and Hardness of Tablets by NIR Person:M Otsuka, Ph.D.Organization: Musashino University, Tokyo, Japan

  the Biosimilar Products in the US?

 S/CDER/FDA (15 min)Multiphasic Products Chemistry & Manufacturing: Rakhi B. Shah, Ph.D., DPQR/OTR/OPS/CDER/FDA (15 min)
 rch FellowRegulatory CMC, PGRDPfizer, CT

 hese include, Prinicipal Investigators, Rex Rekaitis (Purdue Univ) and Robin Bogner (UConn), Fernando Muzzio (Rutgers), Jim Litster (Purd




Development"; Alyssa Morimoto, Genentech USA "Challenges of Pre-existing Anti-Cytokine Antibodies in Autoimmune Disease Sera"
              Speaker          Speaker                   Speaker       Speaker
              Company Presentation Speaker Company Presentation
                           Taste Masking ofJeff Worthington
             University of Mississippi                 Senopsys LLC  Sensory-Directed Taste Optimization of Pediatric Drug Technology
                                            Pediatric Solid Oral Formulations: Novel Opportunities Using Hot-melt ExtrusionProducts


                         An Overview of ICH Q11
            Johnson and Johnson                    Merck, Sharp Implementing ICH Q8, Ho Q10 and Q11 In Commercial Process Chara
                                         Gert Thurau             & Dohme       Kowid Q9, EMEA     Regulators Perspective on Quali
Biomarkers: Practice and Pitfalls

ory Perspective on Bioanalytical Harmonization
Special Dosage Forms Guideance
it and Sub-Standard Medicines
 of Nps: an Evidence Based Approach
ed from Implementing Quality Systems in China
e Enrichment of Phosphopeptides by Hydroxy Acid-Modified Metal Oxide Chromatography for Phosphoproteome Analysis



  Receptor Using a Reporter Gene Assay
buting to the Development of Successful Amorphous Dispersions: Supersaturation and Formulation Stability
acokinetic Aspects of Dbs: Pros & Cons
 ties In Aqueous Solutions

                          Physiological Modeling for Prediction of Target Exposure In PKPD
             Novartis Pharma AG

 ing Pharmacogenetics Into Practice?

 Principles and Practicalities from a Global Industry Perspective
on Requirements of New Excipients
 Health Authorities
naling Pathway as a Target for Human Disease
             Eli Lilly                         Joan Ruan Bristol-Myers Squibb
                            Stability Studies to Define a Design Space Oxidative Forced Degradation of Apis

n Therapeutic Products
d-Binding Immunoassay with Improved Sensitivity Relative to a Cell-Based Assay
etary Substances on the Intestinal First-Pass Extraction of Drugs
Create Multifunctional Agents


macology Approaches to Study Human Adrs
on and Training in a Global Perspective


omics of Drug Hypersensitivity Reactions
odelling of Drug Transport Processes from Cells to Whole Body for the Assessment of their Role in Drug ADME


tic Studies with Pet
ging of Film Coatings -from Research and Development to Real Time Process Control
 hogenic Coxsackievirus B3

 tibody Against Cell Membrane Carbohydrate Antigen as a Possible Cancer Treatment
sful Development Fixed Dose Combination of Three Drugs: Efavirenz, Tenefovir and Emtriva

                      Residual DNA
             CONFARMA France SARL : Technology, Latest Advances and Future Perspectives
                          Microarray Analysis as a Tool to Elucidate the Mechanism of Action of St. John's Wort
            University of Florida

 Neural Network Data Mining to Drug Delivery Systems


ications of Nanocrystals in Drug Delivery
y of Genetically Modified Foods

ndscape of Preservatives in Parenteral Drug Products
 ach In Clinical Investigation


 Metal Nanoparticles and Metal Nanorods Into Cells for Drug Delivery and Disease Diagnosis
sed on the Biopharmaceutics Drug Classification System
d Pharmacogenomics in Japan


Hepatic and Intestinal Drug Transporters
 pression and Anticancer Drug Distribution to Brain Tumors
ansporters During Drug Development: the Perspective from the FDA
Term Viral Kinetics to Long-Term Progression and Outcome



 s – Current Perspectives


oaches for Gene Drug Discovery and Gene Therapy

active Components of Pharmaceutical Excipients
zing, Cryoconcentration, and Impact on Stability
lobal Distribution of Avastin for Ocular Application
e In Human PK Prediction to Shorten the Cycle Time with Improved Efficiency for New Drug Development

 ormulation Performance

                          Can Sud 11      Mitsuru to Osaka University
                                                     Overcome Resistance In of 3d Tissue Infectious Diseases?
            University of Paris Nanomedicines HelpAkashi                        Nicholas Peppas
                                                                                             University of Texas
                                                                                                         Layer-by-Layer for Responsive
                                                                 Fabrication Cancer and Chips Using a NanotechnologyTechnique


itle to Be Determined



 Public[private Partnerships to Delivering Low-Cost Pharmaceuticals
ials Evaluating Tight Glycemic Control In Critically Ill Patients: Confirming Impact and Implementing Change
e Challenges of Regulatory Filing and Supplying Pharmaceuticals to Emerging Markets
Diversion Within the Global Supply Chain

us Vaccination System Using a Hydrogel Patch Formulation
                                                       
7.

 he dermal route. Dr. Joke Bouwstra (Leiden University)
 The intralymphatic route (allergy vaccines; the ultimate dose-sparing route?) Prof.




 e Netherlandsd) Novel-generation adjuvants for TB vaccines, EM Agger, Statens Serum Institut, Copenhagen, Denmarke) Modulating adjuv
 States and Larry Lesko, United States,Panel Discussion: - How can microdialysis help us in rational drug design?- What are the regulatory a




hington UniversityMaking the Case for Universities in Medical Innovation and Access for the Developing World Ashley Stevens, Boston Univ

 ed career in spectroscopy. Before he joined TeraView he was leading some of the laser research programmes at the Rutherford Appleton La
 nufacture of solid dosage products;Evdokia Korakianiti, Ph.D., EMEA, UK, Title: Current industry practices and regulatory requirements on b


 udy Juliano (USA); Endosomal escape and siRNA delivery design 7. Dr. John Rossi (USA) or Dr. Muthiah Manoharan (USA); Overview of si
 g responsibility for Pfizer Central Research, including Vice President of US Discovery Operations in 1993, Senior Vice President of Worldwid



                                                                                            

                                                                                            

Outsourcing- Sponsor Considerations‖ (Dr. Ajai K. Chaudhary, Lilly Research Laboratory, USA)






  

  


s:
Panos Macheras, (University of Athens, Greece) – Classical and non classical aspects of variability and heterogeneity in Biopharmaceuti




 elivery

                                                                                

                                                                                6.

of Michigan, President of the Organization for Study of Sex Differences (OSSD).
 Laurence A Bradley, Ph.D., Professor of medicine, Divisio
 Brian P. Booth, FDA, USA and Mr. Rodrigo Cristofoletti, ANVISA, BRAZIL);
ness and coating uniformity for multi-particulate dosage forms;Cetin Cetinkaya, Ph.D.,Clarkson University, US, Coating thickness estimation
nufacture Drugs ¨C What Issues Exist;Mansoor Khan, FDA, USA, The FDA Perspective of HME as a Means to Manufacture Drugs,
applications. In the last 5 years, he has worked in the Healthcare group developing silicone and silicone-acrylate hybrid PSA technologies fo
rithme Pharma, CANADA)WHO SHOULD ATTEND This session is for the numerous AAPS conference attendees who are involved in the re
arofolo, Algorithme Pharma, CANADA)4.General Guidelines on how to Chose Columns and Chromatographic Conditions to Handle Matrix E




 Felix Ecker (Fulda University of Applied Sciences, Germany). Alternate speaker: Prof. Jorg Breitkreuz (University of Dusseldorf, Germany);M
rminations including AIM



es for preclinical and Phase 0/Phase I human studies and analytical method challenges and specifications for radiolabeled test articles in sup
bility and efficacy of flavonoids. Robert Lee, Ohio State University, C. Demetzos, Department of Pharmaceutical Technology, School of Pharm

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD3.Regulation of ABCG2 expression and function: nuclear re
 sal cavity: in vitro and in vivo assessment. Newman SP. Pharmaceutical Profiles Ltd., Mere Way, Ruddington Fields, Nottingham NG11 6JS,
340. tristan_s_maurer@groton.pfizer.com
•
   


                                            
 Evaluation of CSF concentration and plasma free concentration as a surrogate measurement fo
                                                             

                                                             4.

oving target (Dr. Stephen Lowes, Advion BioServices, USA)
 Fit-for-purpose method development: choosing the appropriate sample prepa
 Perspective in Management of Asthma and COPD;
 ion on pharmacokinetics/pharmacodynamics: increasing recognition of its contribution to variability in response; Amin Rostami-Hodjegan: M



ends and Assessing the Impact of Outsourcing on Drug Development Performance and Economics - Rachael Zuckerman, Research Fellow,




th Tuomala (Harvard University, USA)or Edmund Capparelli (University of California - San Diego, USA) - Challenges in the Treatment of Pre




                      



roliferative disease‖;
Professor Nancy Zhang, PhD. School of Pharmaceutical Sciences, Shandong University, China (e-mail: zhangnancy9
uster, Ph.D., Director, Oncology, Eisai Medical Research, Inc.Ridgefield Park, NJ 07660Suggested presentation title: Marine Clinical Pipeline




SA, ―Formulation and processing aspects of developing a combination drug therapy‖; Dr. Pankaj Shah, Bristol-Myers Squibb, Director, Analy


ons for the Food Sector and Implications for Consumer Safety and Regulatory Controls, Dr. Qasim Chaudhry, Central Science Laboratory, Sa
livery systems for small molecules and macromolecules : Beyond the marketed emulsion and liposomal drug products, are nanoparticulates
nd Nanosafety, National Center for Nanoscience and Technology of China, Beijing, CHINA.
ogenicityDr. Christian Ross Petersen, NovoNordisk Bagsvaerd, Denmark



                                     
―Drug-Carrier Kinetics/Dynamics: Model This?‖ Jürgen B. Bulitta, Ph.D., Senior Scientist, Ordway
                                     :

 U.S., bsc@rx.uga.edu, (706) 542-3792





ith case studies.
erging for a solution?"




 Study in Formulation and Process Optimization for Sodium Ethacrynate

                

EUTIC APPROACHES
                                                                                                          

                                                                                                                           


                 Klaus Pantel, Institute of Tumor biology, University Medical Center Hamburg Eppendorf , Hamburg, Germany; 
NEW

of Tumor-targeted Pegylated Gold-TNF&#945; Nanoparticles in Men‖.
ki Tohoku University, Japan or Alternative speaker: Functional Analysis of Mouse and Monkey Multidrug Resistance-Associated Protein 2 (M
s of Pharmaceutical Crystals.Lian Yu; USA; Crystal growth kinetics exhibit a fragility-dependent decoupling from viscosity.




erapy;Niemi M (Finland)University of Helsinki, Department of Clinical Pharmacology, Helsinki University Central Hospital, PO Box 340, Helsin




                        

 University of Texas, USA
                                                                          

                                                                                                    

                          Strategies to increase the oral bioavailability of highly lipophilic drugs


and Global Head of Clinical PharmacologyHead of Clinical Pharmacology for Primary CarePfizer Inc.50 Pequot Avenue, MS# 6025-B2237Ne

and future prospects on biowaiver extensions: an FDA perspective".
on title: " The Functions of Molecular Imaging in Drug Discovery Process, Clinical Testing and Diagnosis of Disease".;Speaker 3: Dr. Christine



                                                                   

                                                                   


 renchymal binding on anticancer drug distribution in brain tumors.
Yuichi Sugiyama, Tokyo University, Tokyo, Japan (alt Hiroyuki Kusuhara)
 a, Sweden: Structure-Brain Exposure Relationships in Rat and Human of Unbound Drug Concentrations in the Brain Interstitial and Cerebro



                                                      

                                                      


ces and similarities in drug transport of model drugs.
Per Artursson, Uppsala University, Uppsala, Sweden: Cell culture models with human




ela (US) The role of Population PK/PD Analysis During the Implementation of a Bridging Strategy for Linezolid



.Teva Pharmaceuticals
.Teva Pharmaceuticals
Nonpharmacological Approaches for Decreasing the Risk of Metabolic SyndromeRajesh Krishna, Ph.D.Merck Research Laboratories


 the methods of achieving these.




ated) Host Cell Protein detection and characterization. 5. Xing Wang, Pfizer (process-related) Residual DNA analysis: current technology and
                                                    

                                                    •

entration protein drug product?--Ronald Smulders
 The regulatory concerns on the effect of visible particles on the safety and efficacy of pro
bination Product of Intranasal Steroid and Antihistamine for Treatment of Seasonal Allergic Rhinitis Studied in an Environmental Exposure Ch




 e Jerome, University of Liege, Belgium)
 ed Title: Industry Perspective on Pharmaceutical Development and a Case Study4. Proposed Speaker: Sivakumar Vaithiyalingam, Country




                                                                                        

                                                                                        


Small Adults: Challenges in Pediatric Dose Projection, PK/PD and Clinical Trial Design‖;
Jeffrey S. Barrett Ph.D., FCP, The Children‘s Hosp

fessor Guo, The State Key Laboratory, Sichuan University, China e) Sonochemical formation of co-crystals : Scott Childs Aptuit, USAModer




                          


                           

                           

 nd Lessons to be Learned"






using DNA microarrays;


 ives on siliconization - Final speaker (CMC-FG, RS-Section or FDA) TBD
Rohrs (Bausch)Regulatory landscape of preservatives in parenteral drug products: Final speaker (RS-Section, CMC-FG, or FDA) TBD
Rohrs (Bausch)Regulatory landscape of preservatives in parenteral drug products: Final speaker (RS-Section, CMC-FG, or FDA) TBD
 ives on siliconization - Final speaker (CMC-FG, RS-Section or FDA) TBD
 ives on siliconization - Final speaker (CMC-FG, RS-Section or FDA) TBD
 ives on siliconization - Final speaker (CMC-FG, RS-Section or FDA) TBD

guided resequencing for elucidating the mutation associated with drug-induced liver injury in humans;




DS imaging) Eli Lilly, Indianapolis, IN 46285Speaker 5: Deneen Hadden/Andreas Kaerner (NMR imaging) Eli Elilly, Indianapolis, IN 46285Mo
 University, Japan; Xenobiotic transporter-adaptor network.
cleoside transporter 1 (hENT1): implications for interspecies differences in mitochondrial toxicity of fialuridine.




ors in drug efficacy and toxicity: Emerging goal for pharmacogenetics and pharmacogenomics. Speaker: Wolfgang Sadée, Ohio State Univer
 @osumc.edu;4. Pharmogenomics of transporter mediated drug resistance Speaker: Alex Sparreboom, St Jude Children Hospital, Memphis


ul Chamberlain, bioLOGICA Consulting, France)6.     Formulation aspects of immunogenicity (Mary Cromwell, Genentech;Hanns-Christian
                                                  

 s of drug transporters in the cancer chemotherapy


ling;William J. Jusko; University at Buffalo, State University of New York, USA; Scaling Pharmacodynamics from In Vitro and Preclinical Anim
r processes during detoxification in human hepatocytes
 ical evidences on the active uptake and efflux transport in intestinal absorption
 ue selective expression of transporters involves DNA methylation;
t and human;




esign considerations for liposomal drug products6. Dr. Christian Phillips (USA) or Dr. S. Chrai (USA) or alternate; "Quality Control tools for lip



                                                                           

                                                                           


nsporters (OCTs) on the efficacy and toxicity of platinum antineoplastics‖;
4. Michael Gekle, PhD, University of Wuerzburg, Germany ―Dow
heo_singh@merck.comJon S. ThorsonSchool of PharmacyUniversity of Wisconsin777 Highland AvenueMadison, WI 53705Email: jsthorson

      


       
                           

 rials
Panel discussion: 30 minutes


                                    

         

Professor
                                          

                                                    Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@ttuhsc.edu 
R
          School of Pharmacy, & School of Medicine, 
                                                                            

                                                                                                                                 



 IowaIowa City, Iowa, tel: 319-335-9903, fax: 319-335-8766, email: kevin-rice@uiowa.eduOrganizer: Majid MoridaniAssistant ProfessorSchoo
                        


                        


                         


hes for BE evaluation". 


Giacomini, Department of Biopharmaceutical Sciences, University of California, San Francisco. Kathy.giacomini@ucsf.edu 3. Ethnic differe



                                                                                    

d Using Supercritical CO2-Assisted Aerosolization – Jim Searles, Aktiv Dry, Colorado


k of dose-dumping by modeling and computer simulationJoseph Reo; USA; Statistical models for correlating key excipient properties andpro

ry transport andidentification of relevant transport pathways as potential DDI sites; Yuichi Sugiyama, University of Tokyo, Japan, OR Keith H
ion; additional opportunities for the audience to ask questions are given.
affiliation: FDA Perspective on QBD for Lyophilized dosage Forms, QbD lifecycle regulatory strategies & Guidance for QbD filings, Mansoor
ntrol issues: Final speaker (CMC-FG, MSE-Section) TBD Preservative-free sterile products: Brian Rohrs (Bausch)Regulatory landscape of p

r Gordon Muirhead (country of origin: U.K.). Also, some of us may co-chair the symposium.


harmacyS557 Pharmacy115 S. Grand Ave Iowa City, IA 52242l-fleckenstein@uiowa.edu


osition: Director, Chemistry, Redpoint BioCountry: USATitle: Sweetness Enhancers: Amplifying Nutritive Sweeteners For the Taste-Signaling P
osition: Director, Chemistry, Redpoint BioCountry: USATitle: Sweetness Enhancers: Amplifying Nutritive Sweeteners For the Taste-Signaling P

y of Medicine, Imperial College London, Sir Alexander Fleming Building, South Kensington, London SW7 2AZ UK+44 (0)20 7594 3194. j.lind
ts: mechanism and actions - Okezie I. Aruoma, Professor and Chair of the Department of Pharmaceutical and Biomedical Sciences, Touro

decided. Speaker TBD.8. Regulatory perspectives on biomarker based drug development - CDER FDA speaker




s City.5. How to integrate anlytical strategy into drug development.6. topic tbd, speaker tbd7. topic tbd speaker tbd8. topic tbd speaker tbd


iversity

d Formulations";Marcus Brewster, Belgium/USA, "Case Studies of Formulation Design, Selection and Advancement of Novel Forms of Seve




 Formulation
4.Mansoor Khan, FDA, USA, Regulatory Approval Processes for Utilizing Dissolution Testing as the Clinical surrogate.




 IdentifiedTopic:Application of Microdosing to Various Therapeutic Areas: Case Studies in Oncology and HIV/AIDSSpeaker 3:Industry/Acade
, Impacting Oral Drug Product Development and Regulatory Submissions by Simulations;
n of Complex Drug Interactions



.Office of Clinical PharmacologyCDER/FDAFDA Perspective and Update




s Medical School), ―Rational design of monoclonal antibodies for site-specific drug delivery‖.


Professor, University of Pittsburgh), ―Potential Prophylactic and Therapeutic Vaccines for HSV Infections‖.




ation of Extruded Materials




                       

                       

                                                                                                         

                                                                                                                                  

ray Dried Dispersions‖;
Ron Beyerinck or Brett Caldwell, USA, ―Controlled Release Dosage Forms Using Amorphous Solid Dispersions‖;



iogen Idec, USA;    Alternative speakers: Obstructive cholestasis induces TNF-alpha- and IL-1 -mediated periportal downregulation of Bsep a



ana Sista, Biovail Technologies Ltd., Chantilly, VA
 formulations.Anette Mullertz, Denmark



n, Switzerland3. Clinical Development of Plasmid DNA-based Pandemic Influenza Vaccines Dr. Alain Rolland, PhD, Pharm D Vical, Inc.San D



                    

                    Dr.                      

 in salt evaluation 
 Michael Hawley (Pfizer)
4. A two compartment dissolution test method and its application to BCS II drugs 
 Lyn
                                              

                                              
                                                                                

                                                                                                                               
Dr.

quivalence of Modified Release Products, Lawrence Yu, Ph.D., FDA, USA; 5. Panel Discussion
 - modeling the physical behavior of the human digestive system; Patrick Marroum – US- FDA perspective on dissolution testing and innovat




 rsity, Tokyo, Japan



S/CDER/FDA (15 min)


o (Rutgers), Jim Litster (Purdue Univ), Hamid Arastapoor (Illinois Inst. Tech.), Alberto Cuitino (Rutgers Univ), Raj Suryanaranan (UMinn), Eric




mmune Disease Sera"
of Pediatric Drug Products


                      Pharmaceutical Intellectual Resource Services LLC
            Nicholas Cappuccino Implementation of ICH Q8,q9,q10,q11 In Generic Industry, Challenges and Opportunities




teome Analysis
Nanotechnology for Responsive and Feedback-Controlled Systems for Protein and Drug Delivery
                                                                                         

                                                                                         8.

 timate dose-sparing route?) Prof. Thomas Kündig, Dr. P&#507;l Johansen (Zürich Hospital)
 Closing lecture: Vaccine delivery: routes to th




gen, Denmarke) Modulating adjuvant activity of particulate delivery systems with TLR and non-TLR ligands, Asso. Prof. Camilla Foged, Unive
esign?- What are the regulatory aspects?;




orld Ashley Stevens, Boston University, Incoming President of Association of University Technology ManagersGlobal Access and Infectious D

mes at the Rutherford Appleton Laboratry, UK. Dr Taday has been working on terahertz spectroscopy and imaging for almost ten years. He ha
 and regulatory requirements on blend uniformity testing in Europe and Japan;Albert W. Alexander, Ph.D., AstraZeneca, USA, Title: In-line de


Manoharan (USA); Overview of siRNA-based dosage forms in clinical trials 8. Dr. Mansoor Khan (USA/FDA); Prospective quality by design c
Senior Vice President of Worldwide Discovery Operations in 1998 and Senior Vice President of Worldwide Development in 1999.Dr. LaMattin




d heterogeneity in Biopharmaceutics PK and PD. Dr. Macheras is a leader in this area of approaches to heterogeneity in these systems and




                                                                                                                   

                                                                                                                   7.

 .D., Professor of medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham.
 Lori Mosca, Columb

 US, Coating thickness estimation using air-coupled acoustics;Andrew Birkmire, Ph.D., Niro Pharma Systems, GEA,USA, Monitoring and co
s to Manufacture Drugs,
crylate hybrid PSA technologies for transdermal applications.2) Dr. Paul Foreman of Hexcel Corp (National Starch):Paul Foreman is a Resea
endees who are involved in the regulated bioanalytical field and they are interested in getting an exhaustive update and discuss on industry s
hic Conditions to Handle Matrix Effect due to Phospholipids in LC-MS/MS (Dr. Steve E. UngerWyeth Pharmaceuticals, USA)




versity of Dusseldorf, Germany);Medication management tools in elderly: from implementation intention to automatic processes. Prof; John U




 or radiolabeled test articles in support of ADME studies
utical Technology, School of Pharmacy, Panepistimiopolis Zografou, Athens, Greece.4)Multiple flavonoid PK and PD interactions: Additive and

xpression and function: nuclear receptors and histone acetylation. Q. Mao, University of Washington or Susan Bates, National Cancer Institu
on Fields, Nottingham NG11 6JS, UK. steve.newman@pharmprofiles.co.uk
       

                                                                            

                                                                            

 n as a surrogate measurement for brain free concentration Liu X, Pfizer Global Research and Development, Groton, CT, USA xingrong.liu@
ing the appropriate sample preparation, separation conditions, and instrumentation for the desired applications: drug discovery, pre-clinical, a

onse; Amin Rostami-Hodjegan: Medical School, University of Sheffield, UK, Is the effect of disease on the PK/PD predictable?



ael Zuckerman, Research Fellow, Tufts CSDD, USA;




hallenges in the Treatment of Pregnant Women and Children;Proposed Speaker 5Chosen from submitted abstracts




                                                                                                

                                                                                                


rsity, China (e-mail: zhangnancy9@sdu.edu.cn). ―Improving delivery for non-viral gene therapy‖
Suggested chairpersons: Professor Gavin
ation title: Marine Clinical Pipeline: Development of Anti-cancer Marine Natural Products E7389 and E 7974. Speaker #3: William Kem, Ph.D




stol-Myers Squibb, Director, Analytical R&D, New Jersey, USA, ―Analytial hurdles in the development of a combination drug therapy and disc


ry, Central Science Laboratory, Sand Hutton, York, UK.
ug products, are nanoparticulates really the magic bullet? Dr. Rainer Muller, Free University, Berlin, GERMANY.
                                                                                                       

, Ph.D., Senior Scientist, Ordway Research Institute, U.S., jbulitta@ordwayreserach.org, (518) 641-6418





                         

                         


dorf , Hamburg, Germany; 
NEW STRATEGIES TO FIGHT CANCER METASTASIS: IN VITRO AND IN VIVO MODELS, AND CHARACTE
esistance-Associated Protein 2 (Mrp2). Toshiharu Horie, PhD Graduate School of Pharmaceutical Sciences, Chiba University, Japan, or sele
 rom viscosity.




ntral Hospital, PO Box 340, Helsinki, FIN-00029 HUS, Finland.Significance of organic anion transporting polypeptide (OATP) 1B1 in clinical p


quot Avenue, MS# 6025-B2237New London, CT 06320tel: 860-732-3007fax: 860-732-7026email: Richard.Lalonde@Pfizer.comTitle:Biomark


Disease".;Speaker 3: Dr. Christine AllenAssociate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Canada.Suggested pres



                                                                                                                       
 William Elm
                                                                                                                        OR

 yo, Japan (alt Hiroyuki Kusuhara): BCRP and Pgp transport – pharmacokinetic aspects on their combined roles at the BBB
 

 the Brain Interstitial and Cerebrospinal Fluids



                                                                                                               

                                                                                                               


n: Cell culture models with human or rodent transporters – differences and recommendations for oral absorption.
Certainly more speakers t




lid
rck Research Laboratories




A analysis: current technology and novel approaches. 6. Residual Protein A Analysis, speaker not identified.
                                                                                              

 s on the safety and efficacy of protein therapeutics--Barry Cherney, other FDA representative

 n an Environmental Exposure Chamber;Anne Marie Salapatek, MSc, PhD, Cetero International, United States, Development of a Novel Clin




ivakumar Vaithiyalingam, Country of Origin: IndiaProposed Title: Process Development and Control Strategy Moderators: Vilayat Sayeed, C




t Ph.D., FCP, The Children‘s Hospital of Philadelphia, Division of Clinical Pharmacology and Therapeutics, The University of Pennsylvania M

s : Scott Childs Aptuit, USAModerators; Professor Anant Paradkar, A.Paradkar1@Bradford.ac.uk            Dr. Graham Ruecroft, Graham.Rue




on, CMC-FG, or FDA) TBD
on, CMC-FG, or FDA) TBD
Eli Elilly, Indianapolis, IN 46285Moderator: Tim Wozniak




olfgang Sadée, Ohio State University Medical Center, Ohio. E-mail: wolfgang.sadee@osumc.edu
Jude Children Hospital, Memphis, TNE-mail: Alex.sparreboom@stjude.org;


well, Genentech;Hanns-Christian Mahler, Roche) 7.          Patient characteristics in unwanted immunogenicity (S.S. Zamvil,University of Califo


 from In Vitro and Preclinical Animal Studies to Humans




rnate; "Quality Control tools for liposomal drug products" 7. Dr. Liang Zhou (USA/FDA) or alternate;"CMC aspects of liposomal dosage form



                                                                                                                  

                                                                                                                  


 ity of Wuerzburg, Germany ―Downregulation of OATs and impaired PAH secretion after ischemic acute renal failure‖;
5. Invited presentation
adison, WI 53705Email: jsthorson@pharmacy.wisc.eduPhone: 608-262-3829Other Speakers:Frank E. KoehnNatural Products Discovery and


                           

                           

                

 majid.moridani@ttuhsc.edu 
Robert L. Chapman
Associate professor

                                                                 
                           

                                                                                             Midwestern University 
 31st S
                                                                  Chicago College of Pharmacy
                     555
                                                                                                                   


MoridaniAssistant ProfessorSchool of Pharmacy, & School of Medicine, Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@
acomini@ucsf.edu 3. Ethnic differences in drug metabolism and toxicity from Chemotherapy. Stephen J. Clarke,Dept of Medicine and Cance




g key excipient properties andprocess parameters with the performance of modified release productsXiao Yu Wu; Canada; Computational c

rsity of Tokyo, Japan, OR Keith Hoffmaster, Novartis, USADissecting competing pathways of transporter mediated elimination and distributio

uidance for QbD filings, Mansoor A. Khan, FDA
Bausch)Regulatory landscape of preservatives in parenteral drug products: Final speaker (CMC-FG, RS-Section or FDA) TBD




eeteners For the Taste-Signaling Pathways5)Name: Marcus BrewsterPosition: Distinguished Research Fellow, Johnson & JohnsonCountry: B
eeteners For the Taste-Signaling Pathways5)Name: Marcus BrewsterPosition: Distinguished Research Fellow, Johnson & JohnsonCountry: B

AZ UK+44 (0)20 7594 3194. j.lindon@imperial.ac.ukOrganizerMajid Y. Moridani, Pharm.D., Ph.D., DABCC, FACBDepartment of Pharmaceu
and Biomedical Sciences, Touro College of Pharmacy - 27-33 West 23 Street, New York, NY 10010, 212 851 1192 Ext 2121 okezie.aruoma@

aker




ker tbd8. topic tbd speaker tbd




ancement of Novel Forms of Several Low Solubility Compounds: Translation from In Vitro to In Vivo to the Clinic."




l surrogate.




 V/AIDSSpeaker 3:Industry/Academic Speaker to be IdentifiedTopicSpecial application of microdosing - biologicals (siRNA) to special popula
                             

                             

                                                                                               

Amorphous Solid Dispersions‖;
Gary Liversidge, USA, ―Processing Nanocrystalline Suspensions into Stable Tablets and Capsules‖;


eriportal downregulation of Bsep and zonal regulation. Markus Donner, Heinrich Heine Univ. Dusseldorf, Germany.




nd, PhD, Pharm D Vical, Inc.San Diego, CA4. Clinical Development of Plasmid DNA-based Genetic Vaccines for Treatment and Prevention o



                          

                          
Dr.                        


                                                       

plication to BCS II drugs 
 Lyn Hughes (Rohm and Haas)
5. Consideration of dissolution media and test method and its application to B
on dissolution testing and innovative approaches; Shinji Yamashita – Japan – dynamic dissolution system development and use; Kiyohiko S




, Raj Suryanaranan (UMinn), Eric Munson (UKentucky), Prabir Basu (NIPTE).
                                                              

 cine delivery: routes to the future. Rino Rappuoli (Novartis)





rof. Camilla Foged, University of Copenhagen, DenmarkModerators: Hanne Mørck Nielsen, Asso. Prof., University of Copenhagen, Denmark




al Access and Infectious DiseasesTom Kanyok, Senior Program Officer, Bill & Melinda Gates Foundation

or almost ten years. He has published the first paper applying the technology in the pharmaceutical sciences. Today he is leading the researc
eca, USA, Title: In-line detection of blend content uniformity. Primary Section: Manufacturing Science & EngineeringSupport Sections: 1. Form


ective quality by design considerations for emerging siRNA delivery systems and manufacturing process 9. Dr. Renee Thurmer (Germany) o
ment in 1999.Dr. LaMattina graduated cum laude from Boston College in 1971 with a B.S. in Chemistry. He attended the University of New H




                                                                           

                                                                           


 ity in these systems and represents a unique perspective on these issues.;
Unusual responses and adverse drug reactions resulting from i




  

  7.
                                             
8.

m.
 Lori Mosca, Columbia University Medical Center
 Susan Alpert, Ph.D. MD, Senior Vice President, Chief Regulatory Officer, Medtronic

A,USA, Monitoring and control of pellet layering and coating processes using in-situ particle characterization techniques;
Paul Foreman is a Research Fellow at Henkel Corporation, Adhesive Technologies Division where he has more than 25 years experience in
and discuss on industry standards in the evaluation of ion suppression and matrix effect.
als, USA)




 c processes. Prof; John Urquhart, AARDEX Group (Palo Alto CA);Geriatric Medicines as part of medication management by elderly and its




    interactions: Additive and Synergistic effects of multiple flavonoids. Marilyn Morris, University at Buffalo. OR 2 submitted abstract presentatio

s, National Cancer Institute, Bethesda MD4.In silico and in vitro methodology to identify substrates and inhibitors of ABCG2. T. Ishikawa, Tok

n, CT, USA xingrong.liu@roche.com
   

                                                                                    

g discovery, pre-clinical, and BA/BE (Dr. Fabio Garofolo, Algorithme Pharma, CANADA)


predictable?




s




ersons: Professor Gavin Brooks (GB) and Professor Robert Brodsky (USA)




er #3: William Kem, Ph.D., Dept of Pharmacology and Therapeutics University of Florida College of Medicine, Gainesville, FL 32610-0267Su




ion drug therapy and discussion on future trends‖.
                                                         

                                                         Lee
DELS, AND CHARACTERISTICS OF METASTASIS-PREVENTING AGENTS
 Jia, National Cancer Institute/ NIH, Bethesda, MD, USA;
 University, Japan, or selected from poster submissions




 e (OATP) 1B1 in clinical pharmacotherapy


 @Pfizer.comTitle:Biomarkers in clinical drug development: Quantitative applications;(2) Jasper Dingemanse, PhD, PharmD, FCPVP, Head C


  Canada.Suggested presentation title: "Image-guide Drug Delivery";Speaker 4: Mr. Mario KhayatVice President, Advanced Research Techno



        
 William Elmquist, University of Minnesota, Minneapolis, Minnesota, USA: The role of BCRP and Pgp co-function at the BBB an
         OR

  he BBB
 








Certainly more speakers that could cover information regarding different membranes (absorption, BBB etc).
velopment of a Novel Clinical Model to Study Non-Allergic Rhinitis (NAR): Insights in Patient Phenotype, Environmental Triggers of NAR and




erators: Vilayat Sayeed, Country of Origin: IndiaSusan Zuk: Country of Origin: USA




                                                                                       

                                                                                       


versity of Pennsylvania Medical School, Department of Pediatrics, Phildelphia, PA, USA;
―Global Lessons of Pediatric Trials and Drug Appr

 m Ruecroft, Graham.Ruecroft@prosonix.co.uk
Zamvil,University of California San Francisco) 8.   Industry view on the immunogenicity of biologics (name, J&J; name,Wyeth; name, Sano




 f liposomal dosage form manufacturing and the current status guidance document" 8. Panel discussion



   


    
                                                        

 ‖;
5. Invited presentation selected from contributed papers.

al Products Discovery and Discovery Analytical ChemistryWyeth Research401 North Middletown RoadPearl River, NY 10965Email: koehnf@


              

              555        

rn University 
 31st St, 

                         Downers Grove 

                                       

                                       (630) 969-4400

                                                     rchapm@midwestern.edu

                                                     
                    


s, 79106, majid.moridani@ttuhsc.edu Moderator: Majid MoridaniAssistant ProfessorSchool of Pharmacy, & School of Medicine, Texas Tech
 t of Medicine and Cancer Pharmacology Unit, Anzac Research Institute, Aoncord repatriation General Hospital, Australia.   Alternative speak




Canada; Computational controlled release for the QbD of modified releaseproducts

elimination and distribution: utility of knock out and mutant animals


 FDA) TBD




nson & JohnsonCountry: BelgiumTitle: Achieving Taste-masking Through the Use of Cyclodextrins
nson & JohnsonCountry: BelgiumTitle: Achieving Taste-masking Through the Use of Cyclodextrins

epartment of Pharmaceutical Sciences, School of PharmacyDepartment of Pediatrics, School of MedicineTexas Tech University Health Scie
                                   



                                   

Moderators 
Majid Y. Moridani 

Ext 2121 okezie.aruoma@touro.edu 




              

                                                    

               
Assistant Professor
 School of Pharmacy, & School of Medicine,
                                                                                           





 siRNA) to special population (pediatrics, pregnant women and other unique patient groups) Speaker 4:Speaker from the FDA to be Identified
eatment and Prevention of HIV Dr. David Weiner Department of Pahto9logy and Laboratory Medicine University of Pennsylvania, PAorDr. Ge



                                       

                                       
Dr.                   

                                                              Or
od and its application to BCS II drugs 
 David Sperry (Lilly) 
 Dr. Jennifer Dressman?
ment and use; Kiyohiko Sugano – UK – Simulating oral absorption using classical nucleation theory; Alex Avdeef – US – application of rotatin
of Copenhagen, Denmark, hmn@farma.ku.dk, Dennis Christensen, Statens Serum Institut, Copenhagen, Denmark, den@ssi.sk




he is leading the research into terahertz applications at TeraView Ltd in Cambridge, UK;Prof. Jim Drennen III (Duquesne University, PA, USA
Support Sections: 1. Formulation Design and Development2. Regulatory Sciences


nee Thurmer (Germany) or alternate from US FDA); Regulatory aspects for emerging siRNA delivery systems 10. Panel Discussion (question
 d the University of New Hampshire working with Professor Robert E. Lyle and received a Ph.D. from UNH in Organic Chemistry in 1975. He




                                                                        

                                                                        


 reactions resulting from innate nonlinearities in physiologic dynamics:
John Urquhart (UCSF, Maastricht, AARDEX, USA) – One of the few




                                  

                                  9.

gulatory Officer, Medtronics, Inc.
 Salma Lemtouni, MD, MPH, Medical Officer, Office of Women's Health, US Food and Drug Administratio

ues;
n 25 years experience in the research and development of pressure sensitive adhesives with particular emphasis on transdermal drug delive




gement by elderly and its importance for the future health care system. Dr. Sven Stegemann (Capsugel Belgium) Alternative Speaker: Mary R




mitted abstract presentations

 ABCG2. T. Ishikawa, Tokyo Institute of Technology, Yokohama, Japan.




 esville, FL 32610-0267Suggested presentation title: Marine Clinical Pipeline: Development of a Nicotinic Agonist GTS-21, for Improving Cog
IH, Bethesda, MD, USA;   

                         

                         


PharmD, FCPVP, Head Clinical PharmacologyActelion Pharmaceuticals Ltd.Gewerbestrasse 184123 AllschwilSwitzerlandtel +41-61-565 64 6


vanced Research Technologies, Montreal, Quebec, CanadaSuggested presentation title: "Monitoring therapy using softscan breast optical im



                                              

                                              


co-function at the BBB and in other membranes.
Robert G Thorne, New York University School of Medicine, New York, NY, USA: Character
 ntal Triggers of NAR and Testing of Putative Anti-NAR Therapeutics;




                                  

                                  


atric Trials and Drug Approvals‖; 
Dr. Dianne Murphy, or Dr. Hari Sachs, Office of Pediatric Therapeutics, FDA, or Dr. William Rodriguez, Sc
 ame,Wyeth; name, Sanofi-Aventis) Moderators: Eva Horn Møller, Marco van de Weert and/or Wim Jiskoot *    Primary Section: Physical




NY 10965Email: koehnf@wyeth.comLing YuanDepartment of Plant and Soil SciencesUniversity of KentuckyLexington, KY 40546Email: lyuan




 of Medicine, Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@ttuhsc.edu
stralia.   Alternative speakers: UGT1A1*6 polymorphism is most predictive of severe neutropenia induced by irinotecan in Japanese cancer p




ch University Health Sciences Center1406 S CoulterAmarillo, TX, 79106, USA.ModeratorDr. Lawrence Fleckenstein University of IowaColleg
                          

                          Texas Tech University HSC, Amarillo, Texas, 79106, majid.moridani@ttuhsc.edu 
Robert L. Chapman

cy, & School of Medicine, 
                                                                            

                                                                                                       

                     Associa
                                                                                                                              





m the FDA to be IdentifiedTopicRegulatory Evolution and Guidances - Exploratory IND/MIST (Metabolite in Safety Testing)
Pennsylvania, PAorDr. George PavlakisHuman Retrovirus SectionVaccine Branch, Center for Cancer Research, National Cancer Institute at
US – application of rotating disk dissolution experiments to assess dissolution performance of compounds; Douglas Flanagan – US – intrinsi
, den@ssi.sk




uesne University, PA, USA), PAT applications of terahertz imaging. Professor



anel Discussion (questions/answers with audience participation)
ic Chemistry in 1975. He then moved on to Princeton University as a National Instit




X, USA) – One of the few individuals sensitized to the need for adequate experimental design th




                           

                           10.                                                                 

                                                                                               

 d and Drug Administration.
 Emmanuel O. Fadiran, Ph.D., Health Programs Coordinator, OWH, FDA.

n transdermal drug delivery. His current research activities also include the d




ernative Speaker: Mary Roth (University of North Carolina NC); Moderators




TS-21, for Improving Cognitive Function.Speaker #4: Alejandro M.S. Mayer, Ph.D., Depa
erlandtel +41-61-565 64 63fax +41-61-565 66 96jasper.dingemanse@actelion.com


softscan breast optical imaging"



York, NY, USA: Characterization of mechanisms underlying the distribution of substances within the CNS usin
Dr. William Rodriguez, Science Director for Pediatrics, Office of New Drugs, or Pravi
Primary Section: Physical Pharmacy and Biopharmaceutics *   Secondary S




n, KY 40546Email: lyuan3@uky.eduPhone: (859) 257-4806Ben Shen
can in Japanese cancer patients. Ken-ichi Inui. Department of Pharmacy, Kyoto U




n University of IowaCollege of PharmacyS557 Pharmacy115 S. Grand Ave Iowa City, IA 5
ert L. Chapman
   Associate professor

                  
                  
Chicago College of Pharmacy

                                                                 

                                                                 Midwestern University 
 31st St, 

                                                                                       555
                                                                                       
          Do
                                                                                                  





esting)
tional Cancer Institute at Frederick Frederick, MD
Flanagan – US – intrinsic dissolution studies of co-crystals; Jonathan Miller – US – formulation de
Session
   #                Status                 Session Title                         Session Description
      10   Accepted                                                 PK/PD Modeling for Nucleic short synthetic, often chemicall
                                  Challenges and Application of RNA-based therapeutics are Acid Therapeutics
      12   Accepted               Concepts and Case Studies ofProcess Analytical Technology (PAT) has been gaining a lot
                                                                     PAT for Biopharmaceuticals
      14   Accepted               Bioanalytical Global Outsourcing INTRODUCTIONPharmaceutical and biotechnology compan
      15   Accepted                                                The purpose of this session is to discuss current and emergi
                                  Tissue Distribution of Biotherapeutics
      18   Accepted                                                There has been a recent increased focus
                                  Anomalous Results in Regulated Bioanalysis: Global Industry Standardsof regulatory agen
      26   Accepted                                                Comparability exercises are Studies Related to Drug Produc
                                  Comparability Exercises During Drug Development. Case a norm during biologics develop
      27   Accepted                                                ICH ―Q5E for Assessing Comparability of Biopharmaceutica
                                  Scientific and Regulatory ConsiderationsComparability of Biotechnological/Biological Produ
      32   Accepted                                                The focus Method Validation Guidelines
                                  Update on EMEA and FDA Bioanalyticalof the session will be on the application of regulato
      36   Accepted                                                This and Drug Delivery
                                  Biotechnology Innovations in Gene session will be extensively discussing the biotechnolog
      40   Accepted                                                The are We Now?
                                  The 21st Century LBA Lab: WhereAAPS 21st Century LBA workshop has just completed.
      44   Accepted                                                Unfavorable – Academic Pipe Dream or Commercially Viab
                                  Nanoparticle-Based Drug Delivery Systemsphysicochemical and pharmacokinetic propertie
      47   Accepted                                                One of the is
                                  Visible Particles in Biologics: How Clear itroutine lot release assays for therapeutics is the a
      48   Accepted                                                Use of pre-filled syringes and autoinjectors for biotechnology
                                  Biotechnology Product Development in Pre-Filled Syringes and Autoinjectors: Current Cha
      53   Accepted                                                We propose to host a the hours in length Symposium,
                                  Strategies for the Delivery of Biotherapeutics Across 2 ½ Blood Brain Barrier (Bbb). with 4
      59   Accepted               Cell Line Development 101 Biopharmaceutical products or Biologics are produced from
      61   Accepted                                                Many issues can Products
                                  A Forensic Approach to ‗particulates‘ in Biotecharise during the development of a pharmac
      66   Accepted                                                Predictive modelling and Lead Optimization to Phase 2
                                  Modelling & Simulation to Guide Decision Making: from simulation can optimise the drug de
      68   Accepted                                                Nowadays the Knowns like Unknowns
                                  PK of Biologics After Sc Administration – for biologics and monoclonal antibodies the impor
      71   Accepted                                                The past decade has seen a significant Drug Conjugates (A
                                  Clinical Pharmacology Considerations in the Development of Antibodyprogress in the deve
      75   Accepted                                                Immunoassay based Based Bioanalytical Methods for Biothe
                                  Mass Spectrometry as an Adjunct to Immunoassay methods predominate the bioanalysis o
      85   Accepted                                                Protein Drug Discovery and Development
                                  Computational Approaches to The lectures in this Sunrise session will demonstrate how sta
      89   Accepted                                                Monoclonal Antibodies (MAbs) are Antibody biotherapeutics
                                  Regulatory and Industry Perspectives on Fc Effector Functions ofimportant Therapeutics
      94   Accepted                                                Antibody-drug conjugate (ADC) represents an alternative an
                                  Development of Optimal Antibody-Drug Conjugates by Understanding Disposition
      97   Accepted                                                A Problems and Solutions
                                  Stability of Therapeutic Proteins:common problem for therapeutic proteins is the stability. R
     107   Accepted                                                Immunotherapy is of increasing interest in drug developmen
                                  Modeling and Simulation Strategies for Immune-Mediated Therapies: Infectious Diseases
     108   Accepted                                                Immunotherapy is of increasing interest in drug developmen
                                  Modeling and Simulation Strategies for Immune-Mediated Therapies: Oncology
     128   Accepted                                                  Technologies the most common platform for biomarker, im
                                  Advantages of Non-TraditionalELISA remainsfor Ligand-Binding Assay Development
     136   Accepted                                                 for Immunogenicity Risk Management discussion about ris
                                  Strategies and ConsiderationsIn the recent past there has been much(Pharmacovigilance)
     137   Accepted                                                This symposium will
                                  Advances in the Injectable Combination Products cover technical and regulatory advance
     140   Accepted               Comparability Practices – what are the Acceptable Limits? protocols have played an impor
                                                                   Comparability exercises and
     142   Accepted                                                This sunrise session will discuss fundamentals of these Met
                                  Fundamentals of Design of Experiments (Doe) Methods and Appropriate Use of DOE meth
     143   Accepted                                                Stability requirements for Well Characterized proteins is real
                                  Stability Challenges for Novel Biologic Products
     144   Accepted                                                The and Function: Past, (FcRn) plays a critical role in main
                                  Novel Concepts of FcRn Structure neonatal Fc receptorPresent and Future
     145   Accepted                                                In and the NIH held a for Biologics
                                  Update on Quantitative Systems 2008Disease Modelsworkshop to discuss quantitative syst
     147   Accepted                                                Recent years from -What?!
                                  You are Manufacturing Protein Therapeuticshave seen an emergence of companies develo
     149   Accepted                                                Extractables/Leachables studies provide critical data during
                                  Extractables / Leachables Studies for Biologics
     151   Accepted                                                Imaging platforms are becoming Right Tools
                                  Matching Imaging System(S) to Your Biologic -How to Pick thea major tool in the elucidati
     157   Accepted                                                The recent heparin contamination it
                                  The Heparin Contamination Incident-what We Have Learnt fromincident touched a lot of B
     163   Accepted                                                 Industry and the FDA for Biological Product Development -f
                                  Challenges to PharmaceuticalPreclinical pharmacology and toxicology studies play an imp
     164   Accepted                                                 Industry and the FDA studies play Product Development b
                                  Challenges to PharmaceuticalClinical pharmacology for Biologicalan important role during-f
     167   Accepted                                                This session highlights recent advances and application
                                  Emerging Biophysical Techniques in Biologics Formulation and Process Development of e
     168   Accepted                                                Formulation and a popular and effective
                                  Freezing Process in Biologics Frozen storage isProcess Development method to significa
     170   Accepted                                                The goal of this Symposium is to focus on of Protein Therap
                                  Impact of Immunogenicity on Pharmacokinetics and Pharmacodynamics understanding the
     176   Accepted                                                Biotec Section Open Observations
                                  Lessons Learned the Hard Way: Recent Inspection Forum - During recent FDA audits a nu
     177   Accepted               Oligonucleotide-Base TherapeuticsOligonucleotide-base compounds continue to hold great prom
     178   Accepted                                                The objective of this short course is to provide a general ove
                                  Preclinical Discovery and Development of Biotherapeutics
     179   Accepted                                                Ligand binding assays
                                  Reagents: the Foundation of Ligand Binding Assays are used to support drug developmen
     181   Accepted                                                 of a New Forum session will Therapeutic new AAPS Focu
                                  Introduction to the Challenges The OpenAAPS Focus Group:introduce the Protein Immunog
     187   Accepted                                                In December of 2009, FDA issued Immunogenicity Testing o
                                  New FDA Draft Guidance for Industry on Assay Development for a new guidance documen
     197   Accepted               Peptides as Drugs                The commercial success of such drugs as Forteo®, Byetta®
     198   Accepted                                                There is unprecedented for the in the
                                  Peptide R&d: a Historical Perspective as a Foundation interestFuture use of peptides as dru
     184                          Ask the
           Accepted-Pending Complete Data Industry Experts         Ask the Industry Experts- FDA and EMEA
     186                          Risk-based Product Development CMC Strategies: Pay Now or Pay Later!
           Accepted-Pending Complete Data                          In projecting the overall costs for product development, naïve
  8   Combined by Admin                                  In 2007 Bonnie in the Bioanalytical Laboratory
                          Defining the Qualification of Critical Reagents Rup and Denise O'Hara co-wrote a paper titl
 22   Combined by Admin                                                                               
of
                                                         RNA-based therapeutics hold the promise
 tremendously e
                          Review of Clinical Development of siRNA Drugs
 52   Combined by Admin                                  Biotec Section Open Observations
                          Lessons Learned the Hard Way; Recent Inspection Forum - During recent FDA audits a nu
 56   Combined by Admin                                  Oligonucleotide-base compounds continue to hold great prom
                          Oligonucleotide-Base Therapeutics
 84   Combined by Admin                                  Assay development and
                          Considerations for Critical Reagent Characterization maintenance is highly dependent on
106   Combined by Admin                                  Ligand binding assays
                          Reagents: the Foundation of Ligand Binding Assays are used to support drug developmen
121   Combined by Admin                                  A course of Biologics
                          Preclinical Discovery and Development dedicated to the early discovery and preclinical dev
141   Combined by Admin                                   Type Biotherapeutics
                          Preclinical Properties of NovelPreclinical evaluation of novel type biotherapeutics such as s
173   Combined by Admin                                  Review of recent 483s and warning letters pertaining to bioa
                          Lessons Learned: Review of Recent 483s and Warning Letters Pertaining to Bioanalysis o
  4   Rejected                                           Recently, a guideline for
                          Assessment of Human Allergenicity of Biotherapeutics the development and validation of a
  9   Rejected                                           Different and Clinical Implications
                          Testing for Immunogenicity: Preclinical types of bioanalytical assays need to be developed
 11   Rejected                                           Global Perspective on Technology Transfer Manufacturing
                          Global Perspective on Technology Transfer -Manufacturing and Analytical- Challenges
 13   Rejected                                            Therapeutic Proteins, Mechanism, Measurement and Implic
                          Reversible Self Association of Reversible self association in proteins that leads to apparent
 16   Rejected                                           Topical gene therapy through skin
                          Transcutaneous Gene Delivery-Opportunities and Challenges is attractive for the delvier
 17   Rejected            Mass Spectrometry as an Orthogonal Approach for Ligand Binding Bioanalysis of Macromo
                                                         Biological therapeutics and biomarkers are typically performe
 19   Rejected                                            Interpreting Ada Data Generated antibody (ADA) related inf
                          Reporting, Understanding andConsiderable amount of anti-drug During Clinical Study Supp
 20   Rejected                                           number of serious concerns with biotechnological product m
                          Common Phase 4 Commitments and Typical Pitfalls in Applications for Marketing Authoriz
 21   Rejected                                             of Recent BLA Approvals
                          Clinical Pharmacology ReviewClinical pharmacology guidance regarding the development
 23   Rejected                                           While it is common to scale across species allometrically the
                          Paediatric Development of Biotherapeutics
 24   Rejected                                           Changes to the PK/PD Evaluations in and the ensuing effe
                          Comparability of Biotherapeutics – Performingmanufacturing processDevelopment to Supp
 25   Rejected                                           Post translational modifications whether a part of the produc
                          Post Translational Modifications and their Impact on Aggregation, PK, PD and Immunogen
 28   Rejected                                           •
              
–

                                                           Background
 An Therapeutics: the drug development pro
                          Prediction of Human Pharmacokinetics of Protein integral step inCurrent Practice and Futu
 29   Rejected                                           •
              
–

                                                           Background
 The disposition and pharmacokinetics of an
                          Role of Fc Receptor-Igg Interaction on the ADME and Pharmacokinetics of Protein Therap
 30   Rejected                                                                                              


                                                                                                             

                                                         Content of Conceptualo Framework and course
The topics
                          Conducting Forced Degradation Studies: the Forced Degradation short Laboratory Practice
 31   Rejected            Practical Applications of ISR This presentation will introduce the audience to recent repor
 33   Rejected                                           Background: Macromolecules represent endogenous
                          Microdialysis of Macromolecules-Significance, Challenges and Novel Approaches. agents
 34   Rejected                                           Pegylation of biological therapeutics has emerged Pharmac
                          Challenges and Approaches to Developing Quantitative Assays and Determiningas an effe
 35   Rejected                                           New Advance Bioanalytical Methods for Protein Therapeutic
                          Novel Technology and Reagents totechnology
       The
                                                                           
 atomic force microscope or AFM is a v
 37   Rejected                                           The use of
                          Bioresponsive Polymers in Biotechnology bioresponsive polymers in biotechnology and its i
 38   Rejected                                           INTRODUCTIONThe use
                          Dried Blood Spot (Dbs) Samples in Biomarkers Analysis of dried blood spots (DBS) is an e
 39   Rejected                                           INTRODUCTIONNew instruments and new techniques (suc
                          Impact of New Instruments and New Techniques in the Quantitative Analysis of Biologics &
 41   Rejected                                           The product-related and process-related impurities will bring
                          Novel Technologies in Process Control and Product Quality Assessment
 42   Rejected                                           Assessment of process-related Detection and Identification
                          Developments in Technologies for Process-Related Impuritiesimpurities is a critical compo
 43   Rejected                                           Protein folding and aggregation is a dynamic process that is
                          Therapeutic Protein Aggregation: Myths, Challenges and Concerns
 45   Rejected                                           Almost half of the biologics on teh market
                          Rational Development of Freeze-dried Protein Formulations for Biologicsare lyophiles. Furt
 46   Rejected                                           Lyohilization Process Development for Biologics
                          Advances in Lyophilization Formulation andis a critical technology that enable sthe develop
 49   Rejected                                            Manufacturing Facility: systems have Strategies
                          Introduction of Disposables in Disposable (single-use)Challenges andbeen recently used in
 50   Rejected                                           Conjugated antibody therapeutics are
                          Bioanalytical Considerations for Conjugated Antibody Therapeutics becoming more popul
 51   Rejected                                           With the increased emphasis on biotherapeutics that are typ
                          Characterization of Key Reagents in the Modern Bioanalytical Laboratory
 54   Rejected                                           With the advent of novel pharmaceutical and
                          Targeted Nanoparticulate Drug Delivery Systems: Where are We Headed? biopharmaceut
 55   Rejected                                           Oligonucleotides (ONs) have been studied extensively in rec
                          Bioanalytical Techniques in Support of Oligonucleotides Therapeutics and their Challenges
 57   Rejected                                           Goal: To arrive at an of Therapeutic Proteins During Clinical
                          Strategies to Address Drug-drug Interactions (DDI) industry/regulatory consensus on DDI s
 58   Rejected                                           Advancement in bioanalytical sciences for
                          Interference in Pharmacokinetic and Anti-Therapeutic Antibody Assays biopharmaceutics
 60   Rejected                                             Origin, of increasing concern Regulatory Implications
                          Metal Leachables in Biologics:An area Detection, Impact and and scrutiny is the potential ad
 62   Rejected                                           Many issues can : Techniques; Regulatory Implications and
                          Forensic Approaches to Biotech Product Issuesarise during the development of a biologic a
 63   Rejected            Delivery Technologies for Biotherapeutic Pharmaceutical Agents – Challenges and Opport
                                                         With the tremendous growth in the area of biotechnology pro
 64   Rejected                                           The Revisited
                          Excipients for Protein Formulationsnumber of excipients that can be used in protein formula
 65   Rejected                                           The past few Conjugates: the Challenges, Approaches dev
                          Analytical Characterization of Antibody-Drugyears have seen significant progress in theand
 67   Rejected                                           This roundtable Enhance will present an overview of strate
                          Shape Matters! Engineering Particle Shape todiscussionTargeted Deposition for Inhaled P
 69   Rejected                                           The talks Protein Drug Discovery and Development? Curren
                          What Can Computational Design Do for in this roundtable session give a brief overview of p
 70   Rejected                                           The Topical Delivery more and more for Respiratory Tract
                          Inhaled Antibiotics and Antivirals – lungs are getting of Potent Agentsattention as possible a
 72   Rejected            Epitope Mapping                An epitope is the part of the antigen which is recognized by t
 73   Rejected                                           Immunogenicity testing for biologics is a regulatory Biologic
                          State of the Art Approaches for Detection and Data Analysis of Immunogenicity ofrequirem
 74   Rejected                                           The talks in this Targeted Drug be focused on rational desig
                          Monoclonal Antibodies and Rational Design of symposium will Delivery
 76   Rejected                                           Ligand binding assay, LC-MS and cell-based Development
                          Overcome Interference in Bioanalytical Immunoassay During Biotherapeuticbioanalytical m
 77   Rejected                                   Label Free technologies Quantification
                 Label Free Methods for Biomarker and Biotherapeuticsare becoming a key element in LBA
 78   Rejected                                   Parallelism has long Use recognized and Tk/pk Methods.
                 Parallelism in Ligand Binding Assay Validations for beenin Biomarkeras a key analytical val
 79   Rejected                                    Safety Monitoring: potential biological mechanisms that cou
                 Clinical Laboratory Testing for Session will review Beyond Ada Testing for Biotherapeutics
 80   Rejected                                   The talks in this symposium will
                 Progress and Challenges in Vaccine Design and Developmentbe focused on the current pr
 81   Rejected                                   Accurate concentration measurement of biologic therapeutic
                 Antibody Interference in Bioanalytical Methods Used to Measure Biologic Therapeutics
 82   Rejected                                   Manufacturing process Nonclinical and Clinical Comparabili
                 ―outside the Box‖ Comparability: Novel Approaches toimprovements and expansion of man
 83   Rejected                                   The current White We Learned?
                 Immunogenicity Confirmatory Assays: what Havepapers provide better understatnding of d
 86   Rejected                                   Many studies have documented Safety Considerations
                 Pre-Existing Human Antibodies: Bioanalytical Challenges and the presence of naturally oc
 87   Rejected                                    Be talks to Predict the Corresponding be focused on the co
                 How Can In Vitro Activity DataThe Used in this roundtable session will In Vivo Activity of Pro
 88   Rejected                                   Tissue and plasma pharmacokinetics (PK) of anti-tumor mon
                 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Antibody Therapeutics: applica
 90   Rejected   PEGylation in Biotechnology This symposium would be devoted to current practices and c
 91   Rejected                                   Tissue and plasma pharmacokinetics (PK) of anti-tumor mon
                 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Antibody Therapeutics: applica
 92   Rejected                                   Maintaining high Environment
                 Maintaining High Quality Assays in a Compliantquality assays throughout the whole drug de
 93   Rejected                                   Tissue and plasma pharmacokinetics (PK) of anti-tumor mon
                 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Antibody Therapeutics: applica
 95   Rejected                                   With new technology development and
                 Considerations for Replacing Legacy Assays with New Technologies. with retirement of ass
 96   Rejected                                   Transferring to a Cro: Matrix Based assays from one lab to
                 Technology Transfers from a Sponsor Lab BiologicalIssues and Solutions from both Persp
 98   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProduc
                 Preservatives in Parenteral Products
 99   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProduc
                 Preservatives in Parenteral Products
100   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProduc
                 Preservatives in Parenteral Products
101   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProduc
                 Preservatives in Parenteral Products
102   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProdu
                 Siliconization for Parenteral Products
103   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProdu
                 Siliconization for Parenteral Products
104   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProdu
                 Siliconization for Parenteral Products
105   Rejected                                   This symposium proposal is Co-Sponsored by: SterileProdu
                 Siliconization for Parenteral Products
109   Rejected                                   With the discovery of several
                 Optimizing Delivery of Immune Potentiators for Vaccines new classes of novel Immune
110   Rejected                                   Gene Therapy
                 Gene Regulation for Effective Modulation of aberrant protein production offers great hope f
111   Rejected                                   Quantitation of Sample Extraction Differences for numerous
                 Quantitation of Oligonucleotides: Contrasting therapeutic oligonucleotides posessiRNA's, M
112   Rejected                                                  

                                                                


                 Application of Flow Cytometry Description:
Flow Cytometry (FC) has made significant imp
                                                 in Clinical Studies
113   Rejected   Peptide-Antibody Conjugates Peptide-monoclonal antibody conjugates are an effective wa
114   Rejected                                   A decade has
                 Adenovirus Gene Therapy: a Decade Later passed since the death of a young man enroll
115   Rejected   Got Flow? Got it Right?         Although many labs have flow cytometers, few are used corr
116   Rejected                                   There is a general impression that the development of nucle
                 Recent Development and Current Challenges in Nucleic Acid Therapies
117   Rejected                                   A survey of retrospective analysis of human Over the past fe
                 Retrospective Analysis of Human PK Predictions of Mabs
118   Rejected                                   During the development of new products, specially sterile pro
                 Rapid Microbiological Methodology (Rmm) as a Tool for QbD Product Development
119   Rejected                                   Case studies
                 Phase 0 Studies for Protein Therapeutics of Phase 0 studies for Protein biotherapeutics
120   Rejected                                   Advancement in HTS, development
                 High Throughput Formulation Development of Drug Candidates of genomics, proteomics
122   Rejected   Round Table                     Impact of Antibody Modifications on Disposition and Potentia
123   Rejected                                   Physiologically-Based Pharmacokinetic (PBPK) Modeling of
                 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Antibody Therapeutics: Applic
124   Rejected                                   In total five white
                 Immunogenicity White Papers: What's Next? papers have been written describing indust
125   Rejected                                   Tissue and plasma pharmacokinetics (PK) of anti-tumor mon
                 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Antibody Therapeutics: Applic
126   Rejected                                   Biotechnology derived drugs have become a Uncommon Pr
                 New Challenges in Development of Biologics: Understanding and Mitigatingsignificant prop
127   Rejected                                   Stability monitoring evaluates the Best Approach?
                 Monitoring Clinical Immunogenicity Sample Stability, what is assay performance under the
129   Rejected                                   In particular in the in Modern Biotech Manufacturing
                 The Bag Story -Practice of Disposable Systems biotechnology in practically all involved dis
130   Rejected   Intellectual Property – Follow-on Biologics (Biosimilairs
                                                 Congress continues to trace out the contours for a regulatory
131   Rejected                                   For the Monoclonal Antibodies and or intramuscular injectio
                 High Concentration Liquid Products ofapplication as subcutaneousTherapeutic Proteins
132   Rejected                                   Monoclonal antibodies are the fastest Mind-Engineering Opp
                 Engineering Monoclonal Antibodies with Critical Quality Attributes in growing class of drugs
133   Rejected   Parenteral Double Chamber Cartridges for Therapeutic Proteins – Double the Trouble user
                                                 In the last years a clear trend is registered toward more
134   Rejected                                    Individual Developments in Biotech
                 Platform Technologies VersusPlatform technologies since its infancy have been regarded t
135   Rejected                                   Cut Immunogenicity Cut Point Data
                 How to Work with Heterogeneous point is one of the most important parameters that need
138   Rejected                                   Symposium would address some of the following areas:Bioa
                 Preclinical Development of Protein Therapeutics Using Advanced Delivery Technologies
139   Rejected                                   The evaluation of an Immunogencity
                 Sampling Paradigms which Support Assessment ofimmunogenic response to a biologic tes
146   Rejected   Biologics Comparability Studies Comparability studies continue to present a challenge becau
148   Rejected   The Cut Point Challenge         The proper assignment of cut point is highly dependent on p
150   Rejected   Immune Responses in Normal1st speaker: Innate immunity in normal animals (a review)

                                                  vs. Genetically Altered Animals                            
2
152   Rejected                                   The biodistribution of a biologic has many chemical, physica
                 Biodistribution of Biologics: "Watching"pharmaceutical Disposition
153   Rejected                                                 The legislation which
                               A CMC Package for a Biosimilar Product in the us will allow Biosimilar approvals in the US
154   Rejected                                                 The new and Impoact on Biologics
                               The New Process Validation GuidelinesProcess Validation Guidelines document was publi
155   Rejected                                                 This course will address common stability data trending proc
                               Stability Data Trending, Early Phase to Commercial
156   Rejected                                                 Analysis in-Vivo Alterations and Metabolism
                               Issues of Analysis of Biotherapeutics – of the metabolism of biotherapeutics is a challengin
158   Rejected                                                 The new USP <67> is You?
                               Does the New USP Residual Solvent Section Impact became effective in June 2009. Curre
159   Rejected                                                 Conducting Biologics
                               Challenges in Clinical Trial Applications of clinical trials of biologics and biotech products pr
160   Rejected                                                 Growth and its Utility for Supply Chain in Third World Count
                               Predicting Stability for Biotherapeutics in development of biotherapeutic products have incre
161   Rejected                                                 At the last AAPS jamboree, it was felt that such a mock trial
                               Patenting Around the World -a Mock Trial
162   Rejected                                                 Safety assessment experience with biopharmaceuticals in co
                               Safety Considerations of Biopharmaceuticals When Designing and Conducting Developme
165   Rejected                 Nanotechnology in Theranostics  Mainly the session will focus in synthesizing multifunctional n
166   Rejected                                                 The Animal Rule is an FDA approach for approval of drugs a
                               The Animal Rule and Approval of Drugs and Biologics
169   Rejected                                                 The presence Formation: Do We Really Understand It?
                               Mechanism of Protein Particulate/aggregate of protein particulates in biologics dosage form
171   Rejected                 Peptides in Diabetes and ObesityPeptides are small proteins that play key roles in biochemica
172   Rejected                                                 No nonsense
                               Pharma Outsourcing: People on the Move access to inside tips to maximizing your outsou
174   Rejected                                                  as a Therapeutic
                               The Utility of Oligonucleotides The utility of oligonucleotides as a therapeutic were first reali
182   Rejected                                                 One of the the Haze
                               Visible Particulates in Biologics. Clearing assays typically used during GMP manufacturing
183   Rejected                                                  Therapeutic Proteins, Mechanism, Measurement and Implic
                               Reversible Self Association of Reversible self association in proteins that leads to apparent
185   Rejected                                                  Parenteral Products
                               Particles in BiopharmaceuticalThe quantification and characterization of subvisible and visi
188   Rejected                                                 Many studies have and Safety the presence for Monoclon
                               Pre-Existing Antibodies: Bioanalytical ChallengesdocumentedConsiderationsof naturally oc
189   Rejected                                                 The modern biopharmaceutical industry Antibodies
                               High Throughput Biophysical Analysis and Development of Monoclonalhas experienced a g
190   Rejected                                                 Abstract:This Hot Topic Roundtable will include presentation
                               Challenges to Applying Quality Risk Management (Qrm) to Biopharmaceuticals
191   Rejected                                                 Historically, the Superior Therapeutic Approach from target
                               Receptor– or Ligand– Targeting Biologics,small molecule drugs have predominantly a PK-P
193   Rejected                                                 Y27632 on the Electric Field-Directed Orientation of Vascula
                               Effects of Cytochalasin B and To investigate the effects of cytochalasin B and Y27632 on t
194   Rejected                                                 Y27632 on the Electric Field-Directed Orientation of Vascula
                               Effects of Cytochalasin B and To investigate the effects of cytochalasin B and Y27632 on t
195   Rejected                                                         

                                                               Scope:
Utility In Clinical Phase of Drug Development
                               Neutralizing Antibody Assays and theirNeutralizing antibody assays: Their necessity and ti
196   Rejected                                                 Purpose: To provide an overview of the physicochemical pro
                               Polyoxazoline (Poz): a Biopolymer for the Delivery of Proteins, Peptides and Small Molecu
192                            PK-PD Approaches to Aid Species Selection In Pre-Clinical Testing for Biologicsproteins) o
      Submitter/Organizer Approved                             Biologics (monoclonal antibodies and therapeutic
199   Successfully Submitted                                   Monitoring
                               Ultra-Sensitive Cytokine Quantification of low levels of cytokine requires appropriate dete
  Session      Primary    Additional    Primary         Additional       Additional       Additional
    Type       Section     Section   Focus Group Focus Group Focus Group Focus Group
Symposium CPTR           PPDM                        Population Pharmacokinetics & Pharmacodynamics
                                     Nucleic Acid Based Therapeutics
Symposium FDD            BIOTEC                      Freezing and Drying Technologies
                                     Process Analytical Technology
Mini-symposiumAPQ        PPDM                        Ligand Binding Assay Bioanalytical
                                     Contract Research Organization (CRO)
Symposium PPDM                       Please choose Please choose
                                                     an
                         Please choose an option below option belowan option below
Symposium APQ            RS          Bioanalytical Ligand Binding Assay Bioanalytical
Symposium BIOTEC         RS                          Chemistry, Manufacturing
                                     Protein Aggregation and Immunogenicity and Controls (CMC)
Short Course CPTR        PPDM        BioequivalenceChemistry, Manufacturing and Controls (CMC)
Symposium BIOTEC         PPDM                        Assay Bioanalytical
                                     Ligand Binding Bioanalytical
Roundtable BIOTEC        DDD                         N
                                     Nanotechnology ucleic Acid Based Therapeutics
Roundtable BIOTEC        APQ                         Assay Bioanalytical
                                     Ligand Binding Bioanalytical
Roundtable PPB           CPTR        Modified ReleaseNanotechnology
Mini-symposiumBIOTEC     RS                          Please choose an option
                                     Protein Aggregation and Immunogenicitybelow
              FDD
Sunrise Session          MSE         Sterile ProductsProcess Development
Roundtable BIOTEC        PPDM        Drug TransportTargeted Drug Delivery and Prodrug
              MSE
Sunrise Session          BIOTEC      Sterile ProductsAPI Manufacturing Technology
              MSE
Sunrise Session          FDD         Sterile ProductsChemistry, Manufacturing and Controls (CMC)
Mini-symposiumCPTR       PPDM                        Population Pharmacokinetics & Pharmacodynamics
                                     Modeling & Simulation
              PPDM
Sunrise Session          BIOTEC                      an option below
                                     Please choose Please choose an option below
Symposium CPTR           PPDM                        Population Pharmacokinetics & Pharmacodynamics
                                     Targeted Drug Delivery and Prodrug
Symposium APQ            BIOTEC      Bioanalytical Ligand Binding Assay Bioanalytical
              DDD
Sunrise Session          BIOTEC                      Please choose
                                     Computational Drug Design an option below
Symposium APQ            BIOTEC      Bioanalytical Chemistry, Manufacturing and Controls (CMC)
Symposium BIOTEC         PPDM                        M
                                     Drug Metabolism odeling & Simulation
Roundtable DDD           BIOTEC                      Please choose
                                     Computational Drug Design an option below
Symposium CPTR           PPDM                        Biomarkers in Translational Medicine
                                     Modeling & Simulation
Symposium PPDM           CPTR                        Biomarkers in Translational Medicine
                                     Modeling & Simulation
Symposium BIOTEC         APQ                         Assay Bioanalytical
                                     Ligand Binding Biomarkers in Translational Medicine
Symposium BIOTEC         APQ                         Assay Bioanalytical
                                     Ligand Binding Biomarkers in Translational Medicine
Symposium MSE            BIOTEC      Sterile ProductsChemistry, Manufacturing and Controls (CMC)
Roundtable PPDM          BIOTEC      BioequivalencePharmacogenomics (PGx)
              BIOTEC
Sunrise Session          APQ                         Assay Bioanalytical
                                     Ligand Binding Biomarkers in Translational Medicine
Symposium RS             APQ         Stability       Chemistry, Manufacturing and Controls (CMC)
Roundtable PPDM                      Please choose Please choose
                                                     an
                         Please choose an option below option belowan option below
Mini-symposiumPPDM       CPTR                        Please
                                     Modeling & Simulation choose an option below
              RS
Sunrise Session          APQ                         Process Development
                                     Chemistry, Manufacturing and Controls (CMC)
              RS
Sunrise Session          APQ                         Stability
                                     Chemistry, Manufacturing and Controls (CMC)
Roundtable PPDM          CPTR                        L
                                     Drug Metabolismipid-Based Drug Delivery Systems
Roundtable RS            BIOTEC                      Excipients
                                     Chemistry, Manufacturing and Controls (CMC)
Mini-symposiumPPDM       RS                          Generic Pharmaceuticals
                                     Animal Pharmaceutics & Technology
Mini-symposiumPPDM       RS          BioequivalenceModeling & Simulation
Symposium MSE            BIOTEC      Preformulation Sterile Products
Symposium PPB            BIOTEC      Preformulation Sterile Products
Symposium BIOTEC         PPDM                        an option below
                                     Please choose Please choose an option below
Roundtable BIOTEC        APQ                         Assay Bioanalytical
                                     Ligand Binding Bioanalytical
              BIOTEC
Sunrise Session                      Nucleic Acid Based Binding Assay Bioanalytical
                                                     Ligand
                         Please choose an option below Therapeutics
Short Course BIOTEC      CPTR        Bioanalytical Bioequivalence
Symposium BIOTEC                     Ligand Binding PleaseBioanalytical
                                                     Assay choose an option below
                         Please choose an option below
Open Forum BIOTEC                    Ligand Binding PleaseBioanalytical
                                                     Assay choose an option below
                         Please choose an option below
Hot Topic     BIOTEC     CPTR                        Assay Aggregation
                                     Ligand Binding ProteinBioanalytical and Immunogenicity
Symposium BIOTEC                     Please choose Please choose
                                                     an
                         Please choose an option below option belowan option below
Roundtable BIOTEC                    Please choose Please choose
                                                     an
                         Please choose an option below option belowan option below
Roundtable BIOTEC                    Please choose Please choose
                                                     an
                         Please choose an option below option belowan option below
Hot Topic     BIOTEC     RS                          Contract Research Organization
                                     Chemistry, Manufacturing and Controls (CMC) (CRO)
Symposium BIOTEC       APQ                         Assay choose anPlease below an option below an option below
                                   Ligand Binding PleaseBioanalyticaloption choose Please choose
              CPTR
Sunrise Session        RS                          an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Mini-symposiumBIOTEC   APQ                         Assay Bioanalytical
                                   Ligand Binding Bioanalytical                     Please choose
                                                                    Please choose an option below an option below
              BIOTEC
Sunrise Session                    Nucleic Acid Based Binding Assay BioanalyticalPlease choose an option below
                                                   Ligand
                       Please choose an option below Therapeutics Bioanalytical
Symposium BIOTEC                   Ligand Binding PleaseBioanalytical
                                                   Assay choose anPlease below an option below an option below
                       Please choose an option below                 option choose Please choose
Symposium BIOTEC                   Ligand Binding PleaseBioanalytical
                                                   Assay choose anPlease below an option below an option below
                       Please choose an option below                 option choose Please choose
Short Course BIOTEC    CPTR                        B
                                   Drug Metabolismioanalytical      Bioequivalence Protein Aggregation and Immunogeni
Short Course BIOTEC    PPDM                        B
                                   Drug Metabolismioanalytical      Drug Transport Targeted Drug Delivery and Prodrug
Roundtable BIOTEC      APQ                         an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC                   Ligand Binding PleaseBioanalytical
                                                   Assay choose anPlease below an option below an option below
                       Please choose an option below                 option choose Please choose
Symposium BIOTEC                   Protein Aggregation
                                                   Process Immunogenicity
                                                                    Please          Please choose
                       Please choose an option below andDevelopment choose an option below an option below
Roundtable BIOTEC      APQ                         an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC       MSE                         Preformulation Please            Please choose
                                   Protein Aggregation and Immunogenicitychoose an option below an option below
Roundtable PPB         BIOTEC                      Nucleic          NanotechnologyTargeted Drug Delivery and Prodrug
                                   DermatopharmaceuticsAcid Based Therapeutics
Symposium BIOTEC       APQ                         Assay Bioanalytical
                                   Ligand Binding Bioanalytical     Drug Metabolism Bioanalytical
Roundtable BIOTEC      APQ                         Assay choose anPlease below an option below an option below
                                   Ligand Binding PleaseBioanalyticaloption choose Please choose
Symposium CPTR         RS                          Population Pharmacokinetics & an option below an
                                                                    Please choose Please choose
                                   Chemistry, Manufacturing and Controls (CMC) Pharmacodynamics option below
Symposium CPTR         RS                          an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Symposium CPTR         PPDM                        Population Pharmacokinetics & Pharmacodynamics option below
                                   Modeling & Simulation                            Please choose an
                                                                    Special Population Studies
Symposium PPDM         BIOTEC                      Please choose anPlease below an
                                                                     option choose Please choose
                                   Population Pharmacokinetics & Pharmacodynamics option below an option below
Symposium BIOTEC       PPDM                        Chemistry, Manufacturing and Controls (CMC)
                                                                    Please          Please choose
                                   Protein Aggregation and Immunogenicitychoose an option below an option below
Symposium PPDM         BIOTEC                      M                Please          Please choose
                                   Drug Metabolism odeling & Simulation choose an option below an option below
Symposium PPDM         BIOTEC                      an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Short Course APQ                   Stability       Bioanalytical
                       Please choose an option below                                Please choose
                                                                    Please choose an option below an option below
Symposium BIOTEC       APQ                                          Bioanalytical
                                   Bioanalytical Ligand Binding Assay BioanalyticalPlease choose an option below
Symposium PPDM         CPTR                                         Ocular          Targeted Drug Delivery and Prodrug
                                   Microdialysis Dermatopharmaceutics Drug Delivery & Disposition
              BIOTEC
Sunrise Session                    Ligand Binding Process Analytical Technology
                                                   Assay Bioanalytical
                       Please choose an option below                Bioanalytical   Please choose an option below
              BIOTEC
Sunrise Session        PPDM                        Assay Bioanalytical
                                   Ligand Binding Bioanalytical                     Please choose
                                                                    Process Analytical Technology an option below
Poster/PodiumBIOTEC    DDD                         P                 option choose Please choose
                                   Nanotechnology lease choose anPlease below an option below an option below
Symposium APQ          BIOTEC                                       Biomarkers in Translational Medicine
                                   Bioanalytical Ligand Binding Assay BioanalyticalContract Research Organization (CRO
Symposium APQ          BIOTEC                      Assay Bioanalytical
                                   Ligand Binding Bioanalytical                     Please choose (CRO)
                                                                    Contract Research Organizationan option below
Symposium APQ          MSE                         an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Short Course APQ       MSE                         an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC       BIOTEC                      Stability        Bioanalytical
                                   Protein Aggregation and Immunogenicity           Please choose an option below
Short Course BIOTEC    MSE                         Freezing Immunogenicitychoose an option below
                                                                    Please
                                   Protein Aggregation and and Drying Technologies Please choose an option below
Symposium BIOTEC       MSE                         Freezing Immunogenicitychoose an option below
                                                                    Please
                                   Protein Aggregation and and Drying Technologies Please choose an option below
Symposium FDD          MSE         Sterile Products                 Please          Please choose
                                                   Process Development choose an option below an option below
Roundtable BIOTEC                  Ligand Binding Bioanalytical
                                                   Assay Bioanalytical
                       Please choose an option below                                Please choose
                                                                    Please choose an option below an option below
Roundtable BIOTEC      APQ                         Assay choose anPlease below an option below an option below
                                   Ligand Binding PleaseBioanalyticaloption choose Please choose
Symposium FDD          BIOTEC      Sterile Products                  Delivery Systems
                                                   Lipid-Based Drug NanotechnologyTargeted Drug Delivery and Prodrug
Symposium BIOTEC                   Ligand Binding Nucleic Acid Based Therapeutics Please choose an option below
                                                   Assay Bioanalytical
                       Please choose an option below                Bioanalytical
Short Course CPTR      PPDM                        an option below option choose Please choose
                                   Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC       APQ                         Assay Bioanalytical
                                   Ligand Binding Bioanalytical                     Population Pharmacokinetics & Pharm
                                                                    Protein Aggregation and Immunogenicity
Symposium MSE          FDD         Sterile ProductsStability                        Please choose an option below
                                                                    Chemistry, Manufacturing and Controls (CMC)
Symposium MSE          BIOTEC      Sterile Products                 Chemistry, Manufacturing and Controls (CMC)
                                                                                    Please
                                                   Protein Aggregation and Immunogenicity choose an option below
Symposium BIOTEC       FDD         Sterile ProductsDrug Transport Drug Transport Please choose an option below
Short Course BIOTEC                Protein Aggregation choose anPlease choose Please choose
                                                   Please            option
                       Please choose an option below and Immunogenicitybelow an option below an option below
Symposium BIOTEC       APQ                                          Chemistry, Manufacturing and Controls (CMC)
                                   Bioanalytical Targeted Drug Delivery and Prodrug Please choose an option below
Roundtable FDD         MSE                         Nanotechnology Please choose an option below an option below
                                   Inhalation Technology                            Please choose
Roundtable DDD         BIOTEC                      Please choose     option choose Please choose
                                   Computational Drug Design anPlease below an option below an option below
Roundtable FDD         PPB                         Generic          Please          Please choose
                                   Inhalation Technology Pharmaceuticals choose an option below an option below
Symposium BIOTEC                   Bioanalytical Ligand Binding Assay BioanalyticalPlease choose an option below
                       Please choose an option below                Please choose an option below
Symposium PPDM         BIOTEC                      Protein Aggregation and Immunogenicity choose an option below
                                                                    Ligand Binding Assay Bioanalytical
                                   Population Pharmacokinetics & Pharmacodynamics   Please
Symposium DDD          BIOTEC                      Please choose     option choose Please choose
                                   Computational Drug Design anPlease below an option below an option below
Roundtable BIOTEC      CPTR                                         Biomarkers in Translational Medicine
                                   Bioanalytical Ligand Binding Assay BioanalyticalPlease choose an option below
Roundtable BIOTEC                 Ligand Binding Biomarkers in Translational MedicineTechnology an option below
                                                  Assay Bioanalytical
                      Please choose an option below                                 Please choose
                                                                   Process Analytical
Roundtable BIOTEC                 Ligand Binding Biomarkers in Translational Medicine
                                                  Assay Bioanalytical
                      Please choose an option below                                 Please choose
                                                                   Please choose an option below an option below
Symposium BIOTEC      CPTR                        Assay choose anPlease below an option below an option below
                                  Ligand Binding PleaseBioanalyticaloption choose Please choose
Symposium DDD         BIOTEC                      Please choose     option choose Please choose
                                  Computational Drug Design anPlease below an option below an option below
Roundtable BIOTEC     APQ                         Assay Bioanalytical
                                  Ligand Binding Bioanalytical                      Please choose
                                                                   Please choose an option below an option below
Roundtable PPDM                   BioequivalencePlease choose anPlease below an option below an option below
                      Please choose an option below                 option choose Please choose
Roundtable BIOTEC                 Ligand Binding PleaseBioanalytical
                                                  Assay choose anPlease below an option below an option below
                      Please choose an option below                 option choose Please choose
Symposium BIOTEC                  Ligand Binding Bioanalytical
                                                  Assay Bioanalytical
                      Please choose an option below                                 Please choose
                                                                   Please choose an option below an option below
Roundtable DDD        BIOTEC                      Please choose     option choose Please choose
                                  Computational Drug Design anPlease below an option below an option below
Symposium PPDM        BIOTEC                      Please            option choose Please choose
                                  Modeling & Simulation choose anPlease below an option below an option below
Symposium BIOTEC                  Please choose Please choose
                                                  an                option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
Symposium PPDM        BIOTEC                      Please            option choose Please choose
                                  Modeling & Simulation choose anPlease below an option below an option below
Symposium BIOTEC      CPTR                        Assay Bioanalytical
                                  Ligand Binding Bioanalytical                      Please choose (CRO)
                                                                   Contract Research Organizationan option below
Symposium PPDM        BIOTEC                      Please            option choose Please choose
                                  Modeling & Simulation choose anPlease below an option below an option below
Roundtable BIOTEC     CPTR                        Assay Bioanalytical
                                  Ligand Binding Bioanalytical                      Please choose
                                                                   Please choose an option below an option below
Roundtable BIOTEC                 Ligand Binding Contract Research Organization (CRO) choose an option below
                                                  Assay Bioanalytical
                      Please choose an option below                                 Please
                                                                   Please choose an option below
Symposium FDD         BIOTEC      Sterile ProductsExcipients                        Chemistry, Manufacturing and Contro
                                                                   Ocular Drug Delivery & Disposition
Symposium BIOTEC      RS          Sterile Products                 Chemistry, Manufacturing
                                                  Ocular Drug Delivery & DispositionExcipientsand Controls (CMC)
Symposium RS          BIOTEC      Sterile Products                 Chemistry, Manufacturing
                                                  Ocular Drug Delivery & DispositionExcipientsand Controls (CMC)
Symposium MSE         BIOTEC      Sterile Products                 Ocular           Chemistry, Manufacturing and Contro
                                                  Process Development Drug Delivery & Disposition
Symposium FDD         BIOTEC      Sterile Products                 Process Development
                                                  Ocular Drug Delivery & DispositionChemistry, Manufacturing and Contro
Symposium BIOTEC      MSE         Sterile Products                 Chemistry, Manufacturing and Controls
                                                  Ocular Drug Delivery & DispositionProcess Development (CMC)
Symposium MSE         RS          Sterile Products                 Process Development
                                                  Ocular Drug Delivery & DispositionChemistry, Manufacturing and Contro
Symposium RS          BIOTEC      Sterile Products                 Ocular Drug Controls (CMC)
                                                                                    Process Development
                                                  Chemistry, Manufacturing and Delivery & Disposition
Symposium BIOTEC      PPDM                        Nanotechnology Protein Aggregation and Acid Based Therapeutics
                                  Targeted Drug Delivery and Prodrug                Nucleic Immunogenicity
Symposium BIOTEC                  Nucleic Acid Based
                                                  Nanotechnology                    Please choose
                      Please choose an option below Therapeutics Please choose an option below an option below
Roundtable PPDM                   Nucleic Acid Based
                                                  Bioanalytical                     Please choose
                      Please choose an option below Therapeutics Please choose an option below an option below
Symposium BIOTEC      CPTR                                         Please choose an option below an option below
                                  Bioanalytical Biomarkers in Translational MedicinePlease choose
Poster/PodiumBIOTEC               Please choose Please choose
                                                  an                option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
Symposium BIOTEC      CPTR                        Nanotechnology                    Please
                                  Nucleic Acid Based Therapeutics Process Development choose an option below
Roundtable BIOTEC                 Ligand Binding PleaseBioanalytical
                                                  Assay choose anPlease below an option below an option below
                      Please choose an option below                 option choose Please choose
Symposium BIOTEC      CPTR                        Please choose an option choose Please choose
                                  Nucleic Acid Based Therapeutics Please below an option below an option below
Roundtable BIOTEC     CPTR                        Ligand           Drug Metabolism
                                  Modeling & Simulation Binding Assay BioanalyticalPopulation Pharmacokinetics & Pharm
Symposium MSE         BIOTEC      Sterile Products                 API Manufacturing Technology
                                                                                    Please choose
                                                  Chemistry, Manufacturing and Controls (CMC) an option below
Roundtable BIOTEC     CPTR                        an option below option choose Please choose
                                  Please choose Please choose anPlease below an option below an option below
Symposium FDD         BIOTEC                                                        Please choose
                                  Preformulation Sterile Products Please choose an option below an option below
Symposium PPDM        BIOTEC                      an option below option choose Please choose
                                  Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC      PPDM                        Drug Metabolism Drug Transport Please choose an option below
                                  Modeling & Simulation
Roundtable BIOTEC     CPTR                        Assay choose anPlease below an option below an option below
                                  Ligand Binding PleaseBioanalyticaloption choose Please choose
Symposium PPDM        BIOTEC                      Please            option choose Please choose
                                  Modeling & Simulation choose anPlease below an option below an option below
Symposium BIOTEC      PPB         Sterile ProductsStability        Excipients       Protein Aggregation and Immunogeni
Roundtable BIOTEC                 Ligand Binding Bioanalytical
                                                  Assay Bioanalytical
                      Please choose an option below                                 Please choose
                                                                   Please choose an option below an option below
Symposium BIOTEC      RS                          Sterile Products Protein Aggregation andchoose an option below
                                  Freezing and Drying Technologies                  Please Immunogenicity
Symposium RS          BIOTEC                      Generic Pharmaceuticals
                                  Intellectual Property            Bioequivalence API Manufacturing Technology
Symposium BIOTEC      MSE                         Stability        Process
                                  Protein Aggregation and Immunogenicity DevelopmentBioanalytical
Symposium BIOTEC      FDD                                          Chemistry, Manufacturing and Controls (CMC)
                                                                                    Please
                                  Preformulation Protein Aggregation and Immunogenicity choose an option below
Symposium BIOTEC      PPB                         Sterile Products Protein          Process Development
                                  Protein Aggregation and Immunogenicity Aggregation and Immunogenicity
Symposium BIOTEC      FDD                         Stability
                                  Process Development                               Protein Aggregation and Immunogeni
                                                                   API Manufacturing Technology
Symposium BIOTEC                  Ligand Binding PleaseBioanalytical
                                                  Assay choose anPlease below an option below an option below
                      Please choose an option below                 option choose Please choose
Symposium BIOTEC                  Please choose Please choose
                                                  an                option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
              PPDM
Sunrise Session       CPTR                                          option choose Please choose
                                  Bioanalytical Please choose anPlease below an option below an option below
Symposium RS          BIOTEC                      Process DevelopmentManufacturing Technology
                                                                   API
                                  Chemistry, Manufacturing and Controls (CMC) Please choose an option below
Roundtable BIOTEC                 Ligand Binding ProteinBioanalytical and Immunogenicity choose an option below
                                                  Assay Aggregation
                      Please choose an option below                Bioanalytical    Please
              PPDM
Sunrise Session       BIOTEC                      Animal Pharmaceutics & Technology
                                                                   Drug
                                  Non-clinical Dose Formulation AnalysisMetabolism  Protein Aggregation and Immunogeni
Symposium PPDM        CPTR                        Drug Metabolism Special Population Studies Dose Formulation Analys
                                  Biomarkers in Translational Medicine              Non-clinical
Short Course RS       BIOTEC                       Process Development
                                                                   Protein Aggregation and
                                  Chemistry, Manufacturing and Controls (CMC) Stability Immunogenicity
Roundtable RS         BIOTEC                       Process Development
                                                                   Process Analytical Technology
                                  Chemistry, Manufacturing and Controls (CMC) Please choose an option below
Short Course RS       APQ         Stability                        Please          Please choose
                                                   Process Development choose an option below an option below
Roundtable PPDM       APQ         BioequivalenceStability          NanotechnologyTargeted Drug Delivery and Prodrug
Symposium RS          APQ                          Excipients      Please choose Please choose
                                  Chemistry, Manufacturing and Controls (CMC) an option below an option below
Symposium RS                      Please choose Please choose
                                                   an               option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
Symposium BIOTEC      FDD         Sterile Products                 Stability
                                                   Computational Drug Design       Please choose an option below
Roundtable RS                     Intellectual below
                                                   Please           option choose Please choose
                      Please choose an option Property choose anPlease below an option below an option below
Symposium APQ                     Bioanalytical Please choose anPlease below an option below an option below
                      Please choose an option below                 option choose Please choose
Symposium BIOTEC      CPTR                         T               Please choose anPlease choose
                                  Nanotechnology argeted Drug Delivery and Prodrug option below an option below
Roundtable RS         CPTR                         Population Pharmacokinetics & Pharmacodynamics (PGx)
                                  Modeling & Simulation                            Pharmacogenomics
                                                                   Biomarkers in Translational Medicine
Symposium BIOTEC      FDD                          Preformulation Please           Please choose
                                  Protein Aggregation and Immunogenicitychoose an option below an option below
Symposium BIOTEC      CPTR                         an option below option choose Please choose
                                  Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC      CPTR                         an option below option choose Please choose
                                  Please choose Please choose anPlease below an option below an option below
Symposium BIOTEC                  Please choose Please choose
                                                   an               option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
Open Forum BIOTEC                 Protein Aggregation choose anPlease choose Please choose
                                                   Please           option
                      Please choose an option below and Immunogenicitybelow an option below an option below
Open Forum BIOTEC                 Protein Aggregation choose anPlease choose Please choose
                                                   Please           option
                      Please choose an option below and Immunogenicitybelow an option below an option below
Hot Topic    BIOTEC   MSE         Sterile Products                 Protein Aggregation and Immunogenicity
                                                   Process Development             Stability
Hot Topic    BIOTEC               Bioanalytical Ligand Binding Assay BioanalyticalPlease choose an option below
                      Please choose an option below                Please choose an option below
Hot Topic    BIOTEC   FDD                          Preformulation Stability
                                  Process Development                              Please choose an option below
Hot Topic    BIOTEC   MSE                          Please choose anPlease below Please choose
                                                                    option choose
                                  Chemistry, Manufacturing and Controls (CMC) an option below an option below
Hot Topic    PPDM     CPTR                         an option below option choose Please choose
                                  Please choose Please choose anPlease below an option below an option below
Hot Topic    BIOTEC   BIOTEC                                        option choose Please choose
                                  BioequivalencePlease choose anPlease below an option below an option below
Hot Topic    BIOTEC   BIOTEC                                        option choose Please choose
                                  BioequivalencePlease choose anPlease below an option below an option below
Hot Topic    BIOTEC               Please choose Please choose
                                                   an               option choose Please choose
                      Please choose an option below option belowanPlease below an option below an option below
Hot Topic    BIOTEC   FDD                          Nanotechnology Protein Aggregation and Immunogenicity
                                  Targeted Drug Delivery and Prodrug               Modified Release
Hot Topic    BIOTEC               Please choose Please choose
                                                   an               option below Genentech Inc
                      Please choose an option below option belowanFrank-Peter Theil
Poster/PodiumPPDM     BIOTEC                       Assay choose anPlease below an option below an option below
                                  Ligand Binding PleaseBioanalyticaloption choose Please choose
             Proposed                       Organizer 1 Organizer 1 Organizer Organizer 2 Organizer 2
             Speakers        Organizer 1     Affiliation         Email           2      Affiliation     Email
codynamics              Richard Geary                       rgeary@isisph.com
                                           ISIS Pharmaceuticals, Inc.
                        Rakhi Shah         FDA              rakhi.shah@fda.hhs.gov
                        Fabio Garofolo                      fgarofolo@algopharm.com
                                           Algorithme Pharma Inc.
                        Yulia Vugmeyster                    yvugmeyster@wyeth.com
                                           Pfizer-Research and Development
                        Fabio Garofolo                      fgarofolo@algopharm.com
                                           Algorithme Pharma Inc.
                        Satish Singh       Pfizer, Inc.     satish.singh@pfizer.com
                        Wendy Putnam       Genentech, Inc.wputnam@gene.com
                        Marian Kelley                       mmk48@comcast.net
                                           MKelley Consulting, LLC
                        Darin Furgeson                      darin.furgeson@utah.edu
                                           University of Utah
                        Chad Ray                            caray@radixbiosolutions.com
                                           Radix BioSolutions
                        Giovanni Pauletti                   gm.pauletti@uc.edu
                                           University of Cincinnati
                        Satish Singh       Pfizer, Inc.                     Linda NarhiAmgen, Inc
                                                            satish.singh@pfizer.com                 lnarhi@amgen.com
                        Parag Kolhe                         parag.kolhe@pfizer.com
                                           Pfizer Global Biologics Pharmaceutical
                        Manoj Rajadhyaksha Pfizer Inc.      manojrajadhyaksha@msn.com
                        Lavinia Lewis                       lavinia.m.lewis@pfizer.com
                                           Pfizer Global Biologics Pharmaceutical
                        Maria Toler                         maria.r.toler@pfizer.com
                                           Pfizer Global Biologics Pharmaceutical
codynamics              Steven Martin      Pfizer           steven.martin@pfizer.com
                        Wolfgang Richter                     Roche, Ltd.
                                           F. Hoffmann-Lawolfgang.richter@roche.com
codynamics              Sandhya Girish     Genentech/Roche  sandhyag@gene.com
                        Surinder Kaur      Genentech, Inc.skaur@gene.com
                        Chang-Guo Zhan                      zhan@uky.edu
                                           University of Kentucky
                        Shan Chung         Genentech, Inc.chung.shan@gene.com
                        Leslie Khawli      Genentech/Roche  khawli.leslie@gene.com
                        Chang-Guo Zhan                      zhan@uky.edu
                                           University of Kentucky
                        Paolo Vicini                        paolo.vicini@pfizer.com
                                           Pfizer Global Research and Development
                        Paolo Vicini                        paolo.vicini@pfizer.com
                                           Pfizer Global Research and Development
                        Joleen White                        joleen.white@bms.com
                                           Bristol-Myers Squibb
                        Lakshmi Amaravadi BiogenIdec        lakshmi.amaravadi@biogenidec.com
                        Sandeep Nema       Pfizer, St. Louissandeep.nema@pfizer.com
                        Mei-Ling Chen      FDA              meiling.chen@fda.hhs.gov
                        Lakshmi Amaravadi BiogenIdec        lakshmi.amaravadi@biogenidec.com
                        Nanda Subbarao                      nsubbarao@bcg-usa.com
                                           Biologics Consulting Group, Inc.
                        Tracey Clark                        tracey.clark@pfizer.com
                                           Pfizer Global Research & Development
                        Mark Peterson      Biogen Idec      mark.peterson@biogenidec.com
                        Nanda Subbarao                      nsubbarao@bcg-usa.com
                                           Biologics Consulting Group, Inc.
                        Nanda Subbarao                      nsubbarao@bcg-usa.com
                                           Biologics Consulting Group, Inc.
                        Brian Moyer                         bmoyernh@gmail.com Covidien
                                           BRMoyer & Associates, LLC Narayan Cheruvu                Narayan.Cheruvu@covidien.
                        Nanda Subbarao                      nsubbarao@bcg-usa.com
                                           Biologics Consulting Group, Inc.
                        Hong Zhao          FDA              hong.zhao@fda.hhs.gov
                        Hong Zhao          FDA              hong.zhao@fda.hhs.gov
                        Tapan Das          Pfizer, St. Louistapan.k.das@pfizer.com
                        Tapan Das          Pfizer, St. Louistapan.k.das@pfizer.com
                        Narendra Chirmule Amgen             chirmule@amgen.com
                        Jeffrey Sailstad                    sailstad@aol.com
                                           Sailstad and Associates Inc.
                        Philip Oldfield                     philip.oldfield@crl.com
                                           Charles River Laboratories
                        Shefali Kakar                       shefali.kakar@novartis.com
                                           Novartis Pharmaceuticals Corporation
                        Denise O'Hara      Wyeth            dohara@wyeth.com
                        Boris Gorovits     Wyeth            gorovib@wyeth.com
                        Valerie Quarmby    Genentech/Roche  quarmby@gene.com
                        Mira Admin                          abstracts@aaps.org
                                           Mira Digital Publishing
                        Mira Admin                          abstracts@aaps.org
                                           Mira Digital Publishing
                        Prabu Nambiar      Vertex, Inc      prabu_nambiar@vrtx.com
                        nadine ritter                       nritter@bcg-usa.com
                                           Biologics Consulting Group, Inc.
Bonnie Rup, USA, TBDBinodh DeSilva, USA, TBDAdrienne Clements-Egan, Centecor, USA, TBD
Speaker fron Isis or novartis to speak on fomivirsen.Speaker from OPKO Health to speak about Bevasiranib.possibly regulator t
Jeffrey Sailstad, USA, organizer and speaker, title of talk to be determined.
John S. Grundy; USA; Mode of Action - From Antisense to siRNA.Page Bouchard; USA; Aptamer Therapeutics.
1.Reagent Characterization: evaluation for quality and consistency: Kaz Reynhardt(Wyeth)2. CRO perspective for reagent chara
To be determined from the reagent focus group, suggested title life cycle managment of critical reagents; to be determined sugg
Tracey Clark: Pfizer or Jenny Liras: Pfizer - Preclinical PK and PD package Bonny Rupp: Wyeth: Immunogenicity risk strategyso
Leo Kirkovsky, USA, ADME properties of novel peptide therapeutics;Scott Fountain, USA, ADME properties of hybrids of small m
A Review of Recent 483s and Warning Letters - Speaker TBD; Industry, CRO and Regulatory Perspective - Speaker TBD
1. Robert Hamilton, Ph.D., D.ABMLI, (USA)Drug induced human allergic disease (pathophysiology and clinical manifestations) 2
Chairperson: Larry Callahan, Ph.D., Chemist, Office of the Commissioner, FDA, UNITED STATES
         
Alternate Chairperson: Joy C
Pejman ParhamiMedImmune, (AstraZeneca Biologics)Maryland, USA2010 Roundtable on:Global Perspective on Technology Tr
Sathish Hasige; USA; Mechanism of Reversible Self-Association of a full length mAb
1.Dr. Marianna Foldvari, University of Waterloo,Canada. Tentative Title: Novel lipid based carriers for gene delivery through skin
M Hall, US, Mass spectrometric method to investigate protein drug biotransformation and corroboration with immunoassays; So
Gopi Shankar, CNTUSBonita Rup, WyethBoris Gorovits
FDA Speaker Monica Hughes (RPM team leader in Biologics Oncology Division)EU Speaker Gabriele Schäffner-Dallmann (PEI
FDA Speaker Angela Man EU Speaker Gabriele Schäffner-DallmannJapan Speaker TBD
;Willem de Winter on his recent research into more appropriate methods of allometry.Nich Holford - on his standard allometric a
Graham Jang [Amgen] Steve W, Martin [Pfizer] and Angela Men [FDA]
Case Study Lenercept (Speaker from Genentech); Glycosylation and Biophysical characteristics/aggregation: Kai Griebenow or
 

 –


 Rong Deng, PhD, Scientist, PKPDB, Genentech
         

                                                       Title: Novel approaches to predict human pharmacokinetics 
 TBD 

                                                                                                                    
–
     
Title:
–
TBD
  
                                                                                                       

         Title: Introduction to FcRn and FcgR and their role in antibody pharmacokinetics: where are we today
 TBD
 TBD 

                                                                                                                 –
     
–
      Po
                                                                                                                                 

Dr. Tarik Veysoglu, PresidentAntioch Analytical IncorporatedDr. Tarik Veysoglu is the founder and currently the president of Antio
Moderators: Marian Kelley, USA and Bindh DeSilva USA;Dr. Michaela Golob, Merck-Serono, Germany Title: Comparison of the
Moderators;Grazia StagniSuggested Speakers;1. Hartmut Derendorf ; Overview of importance of microdialysis of             macromol
Jenny Wang, USA: Development and validation of an immunoassay for a pegylated adnectinHaiqing Wang, USA: PK profile of
Murli Krishna, USA: Comparative bioanalytical data to quantify an adnectin using antibodies and aptamersLinda Obenauer-Kutn
David Oupicky, Ph.D.Justin Hanes, Ph.D.Sung Wan Kim, Ph.D.Hamid Ghandehari, Ph.D.Ananth Annapragada, Ph.D.Rainer H.
SPEAKERS & TOPICS 1.Advantages/Disadvantages of using Dried Blood Spot Samples in Biomarker analysis (Dr. Neil Spoone
SPEAKERS & TOPICS 1.Advantages/Disadvantages of using UPLC-MS/MS in Biologics analysis (Dr. Mohammed Jemal, Bristo
1. Thomas M. Dillon, Amgen. Tdillon@Amgen.com (product-related), disulfide bond characterization of IgG2. 2. Arthur J. Chirino
4. Ned Mozier, Pfizer (process-related) Host Cell Protein detection and characterization. 5. Xing Wang, Pfizer (process-related)
Tentative titles Protein refolding in down stream processing-OpenHydrophobic ligand binding: A novel method to evalaute aggre
John Carpenter, Mike Pikal, Steven Nail
Carpenter, Pikal, Randolphi, Cicerone, dePablo etc
Designing facility with the use of disposable system: Challenges and Considerations: Mirium Mong, Stedim Biotech, France;Met
Peter Senter, Ph.D. Seattle Genetics, USA, TBD
Russell J. Sanders, Ph.D.; USA, organizer and speaker, Title of talk to be determined.
1) Dr. Dan Cromelin, Top Institute Pharma, Netherlands2) Dr. Alex Biris, Chief scientist at the UALR Nanotechnology Center, Litt
Sandra Carrieo; Canada; Hybridization Methods for the quantitation of Various Classes of Oligonucleotides in Biological Matrice
1.
Hong Zhao (To be confirmed) Division of Clinical Pharmacology CDER (USA): Current regulatory perspectives on drug-drug i
Sally Fisher, USA -Interference observed in PK and ATA assays and various strategies to reduce or overcome effect in assays;M
Christian Schöneich, USA; Professor and Dean of Department of Pharmaceutical Chemistry, University of Kansas; Impact of Me
Gretchen Shearer; USA; State of the Art techniques and instrumentation used in trace analysisScott Aldrich (Independent Consu
1) Sandeep Nema, USA, Overview of delivery technologies for biotherapeutic molecules; 2) David Nowotnik, USA, Cobalamin m
 Regulatory considerations for excipients – FDA person?
 Buffers for protein formulations revisited – Amgen?
 Sucrose in pro
•
                                                            •

                                                              
                                                   •

                                                                                                                  

Speaker from Seattle Genetics, name to be determined; speaker from ImmunoGen, name to be determined; speaker from Gen
Dr. Joseph DeSimone, University of North Carolina, United States;Dr. William R. Kenan, Jr., North Carolina State University, Uni
Dr. Michael Owens (Professor, University of Arkansas Medical School), ―Vaccines and Monoclonal Antibodies Developed throug
Dr. Michael Newhouse, Mcmaster University, Canada, Inhaled Antibiotics: Why TOBI and Other Aminoglycosides Have Such Cli
Yoshitomo Hamuro, ExSAR Corporation; Wang LF, CSIRO Livestock Industries, Australian Animal Health Laboratory, PO Bag 2
1. Shalini Gupta, PhD, Amgen, USA, "Latest improvements in traditional immunogenicity detection methods"; 2. a speaker from
Dr. Bin Liu (Associate Professor, Department of Anesthesia, University of California-San Francisco), ―Targeted drug delivery to m
Jean Lee, Ph.D. Amgen;Jihong Yang, Ph.D. Genentech;Hendrik Neubert, Ph. D. Pfizer;Hossein Salimi-Moosavi, Ph.D. Amgen.
Y.Lin/J.F. Houle, USA/Canada, Quantification of pM levels of biomarker by Diffractive Optics Technology;Speaker TBD,USA, Qu
Speaker 1: J. Lee, USA Similarity in Biomarker Assay Validation; Speaker 2: J. Dunn, USA, Statistical Methods for Analysis of Si
1. Meena Subramanyam, USA - Potential Mechanisms for adverse events2. Yuanxin Xu, USA - Strategies for detection of IgE a
Dr. Christopher M. Walker (Director, Center for Vaccines and Immunity, Nationwide Children‘s Hospital), ―Challenges and oppor
Philip Oldfield, CRL, Canada, Risk-based evaluation of immunogenicity on therapeutic concentration bioanalysis;Jeffrey Sailstad
Dr. Kerry Culm-Merdek of Genzyme, USA, Preclinical PK Assessment;Dr. Honghui Zhou of Centocor, USA, Clinial PK Assessme
1.V. Devanarayan, USA - Statistical considerations for confirmatory assays and cutpoints 2. Mike Moxness, USA - Case study (A
Beloo Mirakhur, Bristol Myers Squibb, USA "Hypersensitivity Considerations: IgE Antibodies to Cetuximab"; Deborah Finco-Ken
Dr. Donald Landry (Professor and Chair of Medicine, Columbia University), ―Factors affecting in vivo activities of protein drugs‖;
David Z. D'Argenio, Ph.D. (USC)Ivan A. Nestorov (Amgen)Joseph P. Balthasar (SUNY Buffalo)Greg Ferl (Genentech)Lu Xu (Ge
Speakers TBD.
David Z. D'Argenio, Ph.D. (USC);Ivan A. Nestorov (Amgen);Joseph P. Balthasar (SUNY Buffalo);Greg Ferl (Genentech);Lu Xu (
Audra Meyer, USA, Genentech Inc, Long term assay strategy and maintenance of ADA assays;Binodh DeSilva, USA, Amgen, A
David Z. D'Argenio, Ph.D. (USC), Ivan A. Nestorov (Amgen), Joseph P. Balthasar (SUNY Buffalo), Greg Ferl (Genentech), Lu X
Robert Hendricks, USA, Genentech, Inc., Analytical Challenges of changing the assay format or platform of an Immunogenicity
Renuka Pillutla, USA, Tandem Laboratories, CRO Perspective: Understanding the customer‘s needs and expectations.
To be     


                                                                                                                            

Committed topics and speakers:Overview of current preservative use in parenteral drug products: Sandeep Nema/Parag Kolhe
Committed topics and speakers:Overview of current preservative use in parenteral drug products: Sandeep Nema/Parag Kolhe
Committed topics and speakers:Overview of current preservative use in parenteral drug products: Sandeep Nema/Parag Kolhe
Committed topics and speakers:Overview of current preservative use in parenteral drug products: Sandeep Nema/Parag Kolhe
Committed topics and speakers:Introduction: importance, technology review, and current industry status - Mike Akers (Baxter U
Committed topics and speakers:Introduction: importance, technology review, and current industry status - Mike Akers (Baxter U
Committed topics and speakers:Introduction: importance, technology review, and current industry status - Mike Akers (Baxter U
Committed topics and speakers:Introduction: importance, technology review, and current industry status - Mike Akers (Baxter U
Dr. Lamine Mbow or Derek O'Hagan, Novartis Vaccines;Dr. Geert Vanden Bossche, GATES Foundation;Prof. Stanley Hem, Pur
                              
•                                                                                           


                                                                                                                            

The symposium will discuss: 
 Gene Regulation by Transcription Factors (Kathy Flanders, National Institutes of Health)
• Zinc
J. Shawn Roach - USA; Michael Beverly - USA; Mark Sanseverino - USA; Pam Pavco - USA; Renta Hutabarat - USA; Mark Hai
Shabnam Tangri, Director, Clinical Science and Technology Biogen Idec Inc. David Parrish, Executive Director, Bioinformatics, T
Wei Liao
 Adenovirus p53 gene therapy: Success, failure, and status. Robert E. Sobol, MD, Forward Ventures, USA;
•

•
                                                                                                                 

                                                                                                                   

                                                                                                                  
 Development o
Joseph Trotter, USA, An Approach for Truly Optimal Setup for Digital Cytometers; Mario Roederer, Ph.D., USA, Designing and
Bristol-Myers Squibb or ISIS, USA, Nucleic Acid Therapeutics Classes- Overview; Lilly, USA, Antisense Oligonucleotide Develop
Shefali Kakar Novartis USA: A retrospective analysis of PK and dose predictions for Oncology mAbs - Novartis experience.M
1.Real time Air and Water Monitoring for Microbes.TBD2.Fast Identification of Bacteria, Yeast and Molds in environment, excipie
Shefali Kakar Novartis USA Comp differences in the use of Ph 0 studies in biologics vs. small molecules.Jin Chen and Rhett Be
1.High throughput screening of protein formulation stability: Practical considerations, Tudor Arvinte, University of Geneva 2.Rapi
Potential Moderators:Ben Shen, Genentech Inc.Leslie Khawli, Genentech, Inc.Potential Speakers and titles:Joe Balthasar The
David Z. D'Argenio, Ph.D. (USC); Ivan A. Nestorov (Amgen); Joseph P. Balthasar (SUNY Buffalo); Greg Ferl (Genentech); Lu X
1. Steve Swanson, USA- Antibody & NAb assessments2. Gopi Shankar, USA - Risk based strategies and case examples3. Sus
David Z. D'Argenio, Ph.D. (USC);Ivan A. Nestorov (Amgen);Joseph P. Balthasar (SUNY Buffalo);Greg Ferl (Genentech);Lu Xu (
                            

                            


Topics/Possible Speakers: 
(1) Computational Approaches in Identifying Degradation ―Hotspots‖ 
Berhard L. Trout, PhD

                                                                                                     


                      Dep
                                                                                                                              

Case studies of monitoring clincial ADA sample stability in long term clinical studies.Dong GengPrincipal ScientistBioanalytical S
Jan Feuser, Germany, Smart approaches to controlled freeze/thaw and transport of frozen bulk Karoline Bechtold-Peters, Germ
James Kelly, Esq. USA, Eli Lilly, No title at this time; Mercedes Meyer, Esq., USA Drinker Biddle, No title at this time.
Nick Warne, USA, Opalescence – an inherent property? How to set the specifications;
     
N.N., Issues with processing high conce
Dr. Jim Thomas (Amgen) invited to co-host symposium; TBD (Eli Lilly & Company;TBD (Genentech/ Roche);TBD Centocor or M
Markus Hemminger, Germany, Control, in-line monitoring and characterization of double-chamber cartridge siliconization;
     Chris
                                                                                                                             

Hanns-Christian Mahler, Generic formulation approaches;Michael Thierolf, Platform analytical characterization technologies;Hel
Hong Zhao, USA, Case study of pre-existing ADA;Eric Wakshull, USA, Assay interference by soluble medidators in immunogen
TBD
Academic speaker on Immunogenicity principlesIndustry speaker on methodologies for detecting immune responses and their l
1. Steven Martin, USA, 'The Pfizer model Comparability Protocol'2. Speaker from Industry, 'Case studies of Comparability Stud
Holly SmithRobin Marsden(more to be announced later)
Speaker 1- TBA. an expert in the biology and expression of innate immunity in animalsSpeaker 2 - TBA. an expert in the modif
Speaker 1. USA; Biodistribution of biologics over time: How drugs and biologics move through and are eliminated from the body
Blair Fraser, Ex- US FDA, (Author of FDA Biosimilar Guidance Document), Regualtory Requirements for Bioimilars in the US.
Jim Agalloco, USA, 'Overview of the new Process Validation Guidelines'FDA Speaker, 'Agencies expectations for Process Valida
Tim Schoefield, USA, 'Stability data trending procedures- statistical procedures';Nanda Subbarao, USA, 'OOT in Stability Studie
speaker 1. USA; MR and MRS technologies: applications and limits for drug assessmentsSpeaker 2. USA; MRS and Choline:
USP speaker: Current expectation for USP <67> Residual SolventsIndustry Speaker. Case Study: Implementing Residual Sol
Noemi Guma, sanofi-aventis USA, title - tbd; Kamali Chance, Quintiles, USA, title - tbd; Jeannine Brussiere, Amgen, USA, title -
1)Sandeep Kumar, USA, Use of computational tools to aid in predictive stability of monoclonal antibodies 2)Pierre Baldi, USA, P
TBD
S. Arrol
Santaneel Ghosh; USA; "Multifunctional Nanostructures for Theranostics".Santaneel Ghosh, PhDAssistant ProfessorDepartmen
All US government speakers:Speaker 1. TBA (FDA rep) The FDA and the Animal RuleSpeaker 2. (TBA (HHS rep) National and
Steve Shire (Genentech)John Philo (Alliance)Sambit Kar (Pfizer formulation group)John carpenter (Colorado)Sylvia Kiese (Roch
A Review of Peptides of Recent Interest in the Treatment of Diabetes and Obesity - Speaker TBD; Regulatory Requirements in
A Review of Best Practices Related to Maximizing Outsourcing Efficiencies - Speaker TBD; Global Pharmaceuticals - Speaker T
Dr. Richard Gary, Vice president of Research and Development at Isis will present results on DNA based oligonucleotide therap
•
                                                                                 
•

  Visible particle assessment according to the UPS method--USP representative
 Visible inspection for particles according to th
Characterizing associations in concentrated or crowded media (Allen Minton, NIH)Proximity Energies: A Framework for Underst
Moderators/Organizers:Vinay Radhakrishnan, PfizerBrian Rhodes, GSK_______________________1. John G. Shabushnig, Pfi
IgE Antibodies to Cetuximab: Beloo Mirakhur, Bristol Myers Squib; Anti-galactose-alpha 1,3 galactose Antibodies and PK Assay
Steven Jacobs, Ph.D., Centocor Research & Development, Radnor, PA, USA
        
Title: ―Cross-Interaction Chromatography: A Rapid
Kristin Murray, Senior Manager, Global Regulatory Affairs, Pfizer USA;Stephen Reich, Risk Management Principal, Quality Assu
Maria Fuentes PhD, USA, Roche, [Tentative Title]: Receptor vs. Ligand – Zoom in at the Molecular Biology Level;
   
David Morris
YING XIAN,P.R.C
YING XIAN,P.R.C
Potential speakers: Susan Kirshner, FDA; USA, Shalini Gupta (Amgen) USA; Eric Wakshull, (Genentech/Roche) USA; Ago Ahe
Remy Gross, Tacey Viegas, Michael Bentley and Milton HarrisSerina Therapeutics, Inc., 601 Genome Way, Huntsville, AL 35806
theil.frankpeter@gene.com
Mark Spengler; Germany; ULTRA-SENSITIVE CYTOKINE QUANTIFICATION
                         Organizer 3    Organizer 3                  Moderator 1 Moderator 1
           Organizer 3    Affiliation     Email     Moderator 1 Affiliation              Email        Moderator 2
                                                                                    rgeary@isisph.com
                                                    Richard GearyISIS Pharmaceuticals, Inc.
                                                    Rakhi Shah FDA                                  Feroz Jameel
                                                                                    rakhi.shah@fda.hhs.gov
                                                                                    fgarofolo@algopharm.com
                                                    Fabio GarofoloAlgorithme Pharma Inc.
                                                                   Pfizer-Research and Development
                                                    Yulia Vugmeyster                yvugmeyster@wyeth.com
                                                                                    fgarofolo@algopharm.com
                                                    Fabio GarofoloAlgorithme Pharma Inc.
                                                    Satish Singh Pfizer, Inc.       satish.singh@pfizer.com
                                                    Wendy Putnam                    w
                                                                   Genentech, Inc. putnam@gene.com  Joy Cavagnaro
                                                                   Solvay           peter.vanamsterdam@solvay.com
                                                    Peter Van AmsterdamPharmaceuticals
                                                    Darin Furgeson                  darin.furgeson@utah.edu
                                                                   University of Utah
                                                    Chad Ray                        caray@radixbiosolutions.com
                                                                   Radix BioSolutions
                                                                   University of Cincinnati
                                                    Giovanni Pauletti               gm.pauletti@uc.edu
rhi@amgen.com                                       Satish Singh Pfizer, Inc.                       Linda Narhi
                                                                                    satish.singh@pfizer.com
                                                                                    parag.kolhe@pfizer.com
                                                    Parag Kolhe Pfizer Global Biologics Pharmaceutical
                                                                   Pfizer
                                                    Manoj RajadhyakshaInc.          manojrajadhyaksha@msn.com
                                                    Satish Singh Pfizer, Inc.       satish.singh@pfizer.com
                                                                                    maria.r.toler@pfizer.com
                                                    Maria Toler Pfizer Global Biologics Pharmaceutical
                                                    Steven Martin Pfizer                            Mark Peterson
                                                                                    steven.martin@pfizer.com
                                                                   F.                 Roche, Ltd. Frank-Peter Theil
                                                    Wolfgang RichterHoffmann-Lawolfgang.richter@roche.com
                                                    Sandhya Girish Genentech/Roche                  Mark Dresser
                                                                                    sandhyag@gene.com
                                                                                    s
                                                    Surinder Kaur Genentech, Inc. kaur@gene.com
                                                    Chang-Guo Zhan                  zhan@uky.edu
                                                                   University of Kentucky
                                                    An Song                         s
                                                                   Genentech, Inc. ong.an@gene.com  Marjorie Shapiro
                                                    Kedan Lin                       l
                                                                   Genentech, Inc.ink@gene.comAndy Boswell
                                                    Chang-Guo Zhan                  zhan@uky.edu
                                                                   University of Kentucky
                                                                                    paolo.vicini@pfizer.com
                                                    Paolo Vicini Pfizer Global Research and Development
                                                                                    paolo.vicini@pfizer.com
                                                    Paolo Vicini Pfizer Global Research and Development
                                                                                    joleen.white@bms.com
                                                    Joleen White Bristol-Myers Squibb               Paul Rhyne
                                                                   BiogenIdec
                                                    Lakshmi Amaravadi                               Bonita (Bonnie) Rup
                                                                                    lakshmi.amaravadi@biogenidec.com
                                                                   P
                                                    Sandeep Nema fizer, St. Louissandeep.nema@pfizer.com
                                                    Mei-Ling ChenFDA                                Raja Velagapudi
                                                                                    meiling.chen@fda.hhs.gov
                                                                   BiogenIdec
                                                    Lakshmi Amaravadi               lakshmi.amaravadi@biogenidec.com
                                                    Nanda Subbarao                  nsubbarao@bcg-usa.com
                                                                   Biologics Consulting Group, Inc.
                                                                                    tracey.clark@pfizer.com
                                                                                                    Nicole Piche-Nicholas
                                                    Tracey Clark Pfizer Global Research & Development
                                                    Mark PetersonBiogen Idec        mark.peterson@biogenidec.com
                                                    Nanda Subbarao                  nsubbarao@bcg-usa.com
                                                                   Biologics Consulting Group, Inc.
                                                    Nanda Subbarao                  nsubbarao@bcg-usa.com
                                                                   Biologics Consulting Group, Inc.
rayan.Cheruvu@covidien.com                          Narayan CheruvuCovidien         Narayan.Cheruvu@covidien.com
                                                    Nanda Subbarao                  nsubbarao@bcg-usa.com
                                                                   Biologics Consulting Group, Inc.
                                                    Anne Pilaro FDA                 anne.pilaro@fda.hhs.gov
                                                    Hong Zhao      FDA                              Amita Joshi
                                                                                    hong.zhao@fda.hhs.gov
                                                    Tapan Das                                       Suanne
                                                                   Pfizer, St. Louistapan.k.das@pfizer.comMahabir
                                                    Tapan Das                                       Amrita Banerjee
                                                                   Pfizer, St. Louistapan.k.das@pfizer.com
                                                                   Amgen
                                                    Narendra Chirmule               chirmule@amgen.com
                                                                   Sailstad and Associates Inc.
                                                    Jeffrey Sailstad                sailstad@aol.com
                                                    Steven Martin Pfizer            steven.martin@pfizer.com
                                                                                    shefali.kakar@novartis.com
                                                                                                    Leo Kirkovsky
                                                    Shefali Kakar Novartis Pharmaceuticals Corporation
                                                    Denise O'HaraWyeth                              Susan
                                                                                    dohara@wyeth.com Richards
                                                    Boris Gorovits Wyeth                            Bonita
                                                                                    gorovib@wyeth.com (Bonnie) Rup
                                                    Valerie QuarmbyGenentech/Roche  quarmby@gene.com
                                                                   Indiana University
                                                    Richard DiMarchi                rdimarch@indiana.edu
                                                                   Indiana University
                                                    Richard DiMarchi                rdimarch@indiana.edu
siranib.possibly regulator to talk about clin pharm package expectations for such molecules.

 apeutics.
spective for reagent characterization: Lynne LeSauteur (Charles River)
nts; to be determined suggested title LBA support through the ages
unogenicity risk strategysomeone from Covance: Radiolabeled distribution studies in animals.Phil Lowe: PK/PD and PBPK models for PK Pre
erties of hybrids of small molecules or peptides and antibodies with CovX body as an example
ctive - Speaker TBD
d clinical manifestations) 2. Connie Cullen, Ph.D. (USA) Unique Design Characteristics of Human IgE anti-Drug Assays 3. Michael Moxness,
ernate Chairperson: Joy Cavagnaro, Ph.D., DABT, RAC, President, Access Bio LC, UNITED STATES;

       

                                                                                                     
Next Generation Biologics: Deimmu
spective on Technology Transfer - Manufacturing and Analytical Challenges

gene delivery through skin2. Spekaer-TBD, Inovio Biomedical Corporation San Diego, CA. Tentative title: DNA vaccine delivery through skin u
 n with immunoassays; Someone from Novartis, Sweden, Pharmacokinetic assessment of monoclonal antibody therapeutics using LC/MS; H

 Schäffner-Dallmann (PEI)Japan Speaker TBD

n his standard allometric approaches.;Dr Anja Henningsson or Dr Siv JönssonMedical Products Agency, Sweden. Regulatory experience of p

egation: Kai Griebenow or Ricardo Sola from Univ of Puerto Rico
              

              –

 cokinetics 
 TBD 
    Title: Prediction of human pharmacokinetics using PBPK modeling
 TBD, Division of Monoclonal Antibodies, Office of B
                       
                                                                    
–

          
–
    
–

e today
 TBD
 TBD 
        

                           Potential Title: Structure-ADME/PK relationships for FcRn and FcgR: an understanding of the key residues. 
 TBD

                                                                                                                                          
–
     

ently the president of Antioch Analytical Incorporated. In this capacity, he has provided training and consultation especially in the area of analy
y Title: Comparison of the EBF view of ISR to the AAPS Workshop Report View; Dr Laurie Nyer, "Case Studies on Implementation of the ISR
 odialysis of     macromolecular therapeutics.2.Monty Reichert; Mass transport models for microdialysis of macromolecules 3.S.N.Murthy; N
Wang, USA: PK profile of a pegylated domain antibody in a cynomolgus modelHeather Myler, USA: Site specific pegylation as a means to e
mersLinda Obenauer-Kutner, USA: Atomic force Microscopy - a new tool to characterize protein therapeuticsStuart Lindsay, USA: Apatame
  pragada, Ph.D.Rainer H. Müller, Ph.D.
r analysis (Dr. Neil Spooner, GlaxoSmithKline, UK) 2.Challenges in Validation of Biomarkers by using Dried Blood Spot Analysis (Dr. Richard
  Mohammed Jemal, Bristol-Myers Squibb, USA) 2.Emerging techniques in the Analysis of Biologics: LC-MS/MS coupled with LBA (Dr. Jean L
 f IgG2. 2. Arthur J. Chirino, Xencor. art@xenor.com (product-related) product-related impurities in general. 3. Daotian Fu. Genzyme. Daotian
 , Pfizer (process-related) Residual DNA analysis: current technology and novel approaches. 6. Residual Protein A Analysis, speaker not iden
method to evalaute aggregation propensity of protein biologics-Bilikalahalli Muralidhara- Pfizer Stability of protein biologics in frozen state-Op


edim Biotech, France;Methods and implementation challenges for use of disposables in biotech manufacturing: Adam Goldstein, Genentech


anotechnology Center, Little Rock, Arkansas3) Dr. N.K. Jain, Professor, Department of Pharmaceutical Sciences, Sagar University, India.4) D
 tides in Biological Matrices, Advantages, Limitations and Challenges.Renta Hutabarat; USA; Quantitation of Apatmers in Biological Matrices:
                                                                         
 Min
                                                                         


erspectives on drug-drug interaction strategies for therapeutic proteins
2.
 Zhu (Amgen, USA) Informative study designs, logistical const
ercome effect in assays;Mauricio Maia, USA- Impact of various interfering molecules on PK assays; Kate Peng, USA- Impact of various inter
 y of Kansas; Impact of Metal ions on BiologicsArthur J Shaw, Associate Research Fellow, Department of Parenteral Development and Analy
  drich (Independent Consultant); UltraMikron; USA; Regulatory implications of particulate matter in dosage formsMaria Toler; USA; Case Stu
wotnik, USA, Cobalamin mediated delivery technology for the oral delivery of proteins;3) Wei-Chiang Shen, USA,Transferrin receptor-mediat
            

            •
                                                                                       
•

 Amgen?
 Sucrose in protein formulations & glycation? – C.Quan Genentech or S Fischer, Roche
 Trehalose in protein formulations – T. P
mined; speaker from Genentech, name to be determined; speaker from FDA, name to be determined
 olina State University, United States;Dr. Stephanie Gratton, University of North Carolina, United States;
 tibodies Developed through Integrated Computational-Experimental Studies‖; Dr. Donald Landry (Professor and Chair of Medicine, Columbia
  glycosides Have Such Clinical Importance;Dr. Sally-Ann Cryan, Royal College of Surgeons, Ireland, Respiratory Antivirals - Drugs, Vaccines
alth Laboratory, PO Bag 24, Geelong, Victoria 3220, Australia;Gershoni M, Department of Life Sciences and National Institute of Biotechnolo
 thods"; 2. a speaker from non-ligand binding technology flat-form company (TBD), USA , "Novel technology flat-forms for immunogenicity tes
Targeted drug delivery to mesothelioma cells using functionally selected internalizing human single-chain antibodies‖; Dr. Duxin Sun (Associa
  -Moosavi, Ph.D. Amgen.
gy;Speaker TBD,USA, Quantification of mAbs on Biacore; Current and Future utility; M. Dysinger, USA, Quantification of Biotherapeutics wit
 Methods for Analysis of Similarity: Speaker 3: L.King, USA, Similarity in Biotherapeutic assay Development and Validation
egies for detection of IgE antibodies3. Sally Fischer, USA - Clinical case study on developing a drug specific IgE assay4. Crystal Sung, USA
al), ―Challenges and opportunities for development of new generation of safe, protective vaccines against infection, cancer, and allergy‖; Dr. W
 ioanalysis;Jeffrey Sailstad, Sailstad and Associates , US, Case studies of immunogenicity impact on measuring therapeutic concentration
 USA, Clinial PK Assessment;A speaker from FDA (TBD), USA, Regulatory Perspective
ness, USA - Case study (Amgen)3. Eric Wakshull, USA - Case study (Genentech)
 mab"; Deborah Finco-Kent, Pfizer, USA "Anti-galactose-alpha 1,3 galactose Antibodies and PK Assay Development"; Human Genome Scien
 ctivities of protein drugs‖; Dr. James Woods (Professor, University of Michigan), ―Development of a promising long-lasting enzyme therapy: I
 erl (Genentech)Lu Xu (Genentech)Peter Kletting (Ulm University, Germany)

 Ferl (Genentech);Lu Xu (Genentech);Peter Kletting (Ulm University, Germany);
  DeSilva, USA, Amgen, Appropriate Approach to maintain high quality PK assays for long term support of Clinical Trials;Chris Behrs, Canada
eg Ferl (Genentech), Lu Xu (Genentech), Peter Kletting (Ulm University)
rm of an Immunogenicity assay between Clinical Trials.Valerie Quarmby, USA, Genentech, Inc., Replacement of legacy assays with new tec
                    

                    


and expectations.
To be determined, USA, Amgen, Sponsor Perspective: Lessons learned and Solutions for a successful technology trans
 deep Nema/Parag Kolhe (Pfizer USA); Mechanism and advantages/disadvantages of various commonly used preservatives: Brian Meyer (M
 deep Nema/Parag Kolhe (Pfizer USA); Mechanism and advantages/disadvantages of various commonly used preservatives: Brian Meyer (M
 deep Nema/Parag Kolhe (Pfizer USA); Mechanism and advantages/disadvantages of various commonly used preservatives: Brian Meyer (M
 deep Nema/Parag Kolhe (Pfizer USA); Mechanism and advantages/disadvantages of various commonly used preservatives: Brian Meyer (M
 us - Mike Akers (Baxter USA); Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly USA); Sil
 us - Mike Akers (Baxter USA); Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly USA); Sil
 us - Mike Akers (Baxter USA); Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly USA); Sil
 us - Mike Akers (Baxter USA); Analysis of silicone layer on glass containers by FTIR, Rap-ID and ICP - Fangdong Yin et al (Eli Lilly USA); Sil
on;Prof. Stanley Hem, Purdue Univ.;Dr. Alexander K. Andrianov, Apogee Inc., Boston;
                    


                     
                                                                                                                             

 stitutes of Health)
• Zinc finger protein as an artificial transcription factors (Carlos F. Barbas, III, Scripps Research Institute, La Jolla, CA)


                                                                                                                                                    

 utabarat - USA; Mark Hail - USA; Marc Lemaitre - USA; Paul Winkler - USA;
Director, Bioinformatics, The immune Tolerance Network.Diana Wu, Principal Scientist, Clinical Biomarkers, Bristol-Myers Squibb CoJaya G

 , USA;
•
 

           

          
 Development of CerePro (rAd-TK) for the treatment of glioblastoma. Nigel Parker, PHD, CEO, Ark Therapeutics, UK;
•
     

                                                                                                                                    

                                                                                                                                   
 Developm
h.D., USA, Designing and Implementing Multicolor Flow Cytometric Assays; Jennifer Wilshire Ph.D., USA, Multiparametric Flow Cytometry D
 e Oligonucleotide Development; Merck or Alnylam, siRNA Development; Archemix, USA, Aptamers Development; Open Discussion
bs - Novartis experience.Megan Gibbs Amgen USA: Amgen experienceShasha Jumbe                    Genentech USA: Phil Lowe Novartis USA:
 ds in environment, excipients and API.Claudio Denoya, Pfizer3.RMM options for microbiological cleaning validation for DS and DP. Michael M
 les.Jin Chen and Rhett Behrji: Case studies of the use of Ph0 for go/no-go decision making.Colin Garner USA (Xeleron): Use of Microdosing
niversity of Geneva 2.Rapid Vaccine Formulation Screening, Russ Middaugh, University of Kansas 3.Automated Solubility Screen for Rapid F
d titles:Joe Balthasar The State University of New York, Buffalo, New York, USA. Impact of antibody modification on PK and PD;Henry Lowm
eg Ferl (Genentech); Lu Xu (Genentech); Peter Kletting (Ulm University)
and case examples3. Susan Kirshner, USA - Regulatory perspective
  Ferl (Genentech);Lu Xu (Genentech);Peter Kletting (Ulm University)
 erhard L. Trout, PhD
 
                                          

                        Department of Chemical Engineering, MIT;
(2) Disulfides and their Stability in Peptides and Proteins
Terhuna Siahaa
                                                                   

                                                                   
                                                         


                                                                                                                              

 al ScientistBioanalytical SciencesBristol Myers SquibbUSA;Adrienne Clements-EganPrincipal ScientistClinical Pharmacology SciencesJohns
ne Bechtold-Peters, Germany, Waste not wash - disposable fill& finish systems;Ingrid Markowic, USA, FDA/CDER), Particulate matter, leach
  e at this time.
                                                       

                                                       Michael Adler, Switzerland, Formulation tool box for high concentration liquid formulatio
  th processing high concentration liquid formulations;

Roche);TBD Centocor or Medimmune
                      

                      Christina Lichtblau, Germany, Comparison of two siliconization procedures including particulate matter characterization;
 ridge siliconization;

erization technologies;Helmut Hoffmann: Platform purification approaches; N.N.., Objective review of success of platform approaches in Biot
 medidators in immunogenicity testing;Zhiyan Liang, USA, Tool kit of reducing matrix intereference in immunogenicity assays;Meena Subram

une responses and their limitations and assumptions.
dies of Comparability Studies gone bad'3. Kathleen Clouse, US FDA, 'Current Regulatory Expectations for Biologics Comparability Protocols

BA. an expert in the modification of the immune response in genetically altered animals. The PPDM strongly recommends this session on the
e eliminated from the bodySpeaker 2. USA; MR systems for measuring metabolic change in-vivoSpeaker 3. Nuclear medicine systems and
for Bioimilars in the US.
ctations for Process Validation'Audience feedback about the implementation of the new Guidelines
A, 'OOT in Stability Studies, - from the Chemistry/Biochem angle'
  USA; MRS and Choline: an example of MRS applications in prostate cancer therapy Speaker 3. USA; Diagnostic methods using array plat
mplementing Residual Solvent testing as per the new USP <67>Industry Speaker.Case study: Challenges of obtaining vendor certificaion to
 siere, Amgen, USA, title - tbd; Serge Mathonet, Sanofi-aventis, France, title - tbd; Sid Advant, Tunnel Consulting, USA, title - tbd.
ies 2)Pierre Baldi, USA, Prediction of Protein Stability Changes for Single-Site Mutations for biiotherapeutic agents3)Chris Roberts, USA, De


stant ProfessorDepartment of Physics and Engineering PhysicsSoutheast Missouri State UniversityCape Girardeau, MO, 63701.
A (HHS rep) National and International Preparedness and the US Government's PHEMCE: Public Health Emergency Medical Countermeasu
olorado)Sylvia Kiese (Roche)
 gulatory Requirements in the EU, Canada, and US - Speaker TBD; Industry and Acadmic Perspective and Issues: Examples - Speaker TBD
 armaceuticals - Speaker TBD; Emerging Pharma, Top Tier Pharma and CRO Perspectives - Speaker TBD
sed oligonucleotide therapies; Dr. JT den Dunnen from the University of Leiden will present on the development of DNA oligonucleotides for t
or particles according to the European pharmacopeia (Parenteral Preparations, Visible Particles, mAb monograph) --EP representative 
 EF 
•

 A Framework for Understanding Concentrated Biological Solutions(Tom Laue)Methods to study high concentration / self associating protein
 . John G. Shabushnig, Pfizer - Proposal to Revise USP General Chapter Injections 2. Cristy Dougherty, GSK - Analytical techniques for mea
  Antibodies and PK Assay Development: Deborah Finco-Kent, Pfizer;Anti-IFN Antibodies and IFN Drug Development: HGS or Roche speak
                                                                                                  

                                                                                                  


  Chromatography: A Rapid Method to Identify Highly Soluble Monoclonal Antibody Candidates‖;
Sathish Hasige, Ph.D., MedImmune Inc., G
ent Principal, Quality Assurance, Pfizer USASuggested Presentation Title: Challenges to Applying Quality Risk Management (QRM) to Biopha
 logy Level;
 David Morris MD, Switzerland, Novartis, [Tentative Title]: Receptor vs. Ligand – The Learning from an Early Clinical Developmen
              



ech/Roche) USA; Ago Ahene (Roche) USA; Lakshmi Amaravadi (Biogen Idec) USA.Eric Wakshull and Lakshmi Amaravadi and Ago Ahene h
 Way, Huntsville, AL 35806, USA
           Frank-Peter TheilGenentech Inc theil.frankpeter@gene.com
            Moderator 2 Moderator 2                        Moderator 3     Moderator 3                         Speaker
             Affiliation  Email            Moderator 3      Affiliation      Email            Speaker         Company
                                                                                                          Charles River Laboratories
                                                                                             Philip Oldfield
            Amgen, Inc        fjameel@amgen.com                                              Rakhi ShahFDA
                                                                                                          Algorithme Pharma Inc.
                                                                                             Fabio Garofolo
                                                                                                          Pfizer-Research and Development
                                                                                             Yulia Vugmeyster
                                                                                                          Algorithme Pharma Inc.
                                                                                             Fabio Garofolo
                                                                                                          Human
                                                                                             Thomas Spitznagel Genome Sciences
            access bio        jcavagnaro@accessbio.com                                       Joy Cavagnaroaccess bio
@solvay.com                                                                                               Bayer Schering
                                                                                             Margarete Brudny-KloeppelPharma
                                                                                                          University of Houston
                                                                                             Mohamed Ismail Nounou
                                                                                             Ago Ahene PHARMARGO, LLC
                                                                                                          University of Cincinnati
                                                                                             Giovanni Pauletti
            Amgen, Inc        lnarhi@amgen.com                                               Deborah ShnekAmgen, Inc
                                                                                                          Abbott
                                                                                             Thomas Nikolai Laboratories
                                                                                                          University of Toronto
                                                                                             Kullervo Hynynen
                                                                                                          Pfizer
                                                                                             Kunle Onadipe Global Biologics Pharmaceutic
                                                                                                          U
                                                                                             Scott Aldrich ltramikro, LLC
            Biogen Idec mark.peterson@biogenidec.com                                                      Pfizer
                                                                                             Piet van der Graaf
            Genentech Inctheil.frankpeter@gene.com                                                        F. Hoffmann-La Roche, Ltd.
                                                                                             Wolfgang Richter
            Genentech/Roche   dresser.mark@gene.com                                          Aakanksha FDA Khandelwal
                                                                                             Surinder KaurGenentech, Inc.
                                                                                                           Zhan
                                                                                             Chang-GuoUniversity of Kentucky
            FDA               marjorie.shapiro@fda.hhs.gov                                                G
                                                                                             Shan Chung enentech, Inc.
            Genentech/Roche                  Ben Shen
                              boswell.charles@gene.com                      shen.ben@gene.com
                                                              Genentech/Roche                Stephen AlleySeattle Genetics
                                                                                                           Zhan
                                                                                             Chang-GuoUniversity of Kentucky
                                                                                                          Los
                                                                                             Alan Perelson Alamos National Laboratory
                                                                                                          Massachusetts General Hospital
                                                                                             Thomas Deisboeck
            BMS               paul.rhyne@bms.com                                                          G
                                                                                             Jihong Yang enentech, Inc.
            Pfizer            brup@wyeth.com                                                              Amgen,
                                                                                             Steven Swanson Inc
                                                                                                          Wyeth
                                                                                             Terri DeAngelo Biotech
                              rvelagapudi@barrlabs.com
            Teva Pharmaceuticals, USA                                                        Barry CherneyFDA
biogenidec.com                                                                               Chad Ray Radix BioSolutions
                                                                                                          Biologics Consulting Group, Inc.
                                                                                             Nanda Subbarao
                              npiche@wyeth.com
            Pfizer Global Research & Development                                                          Ut
                                                                                             E. Sally Ward Southwestern Medical Center At D
                                                                                             Mark PetersonBiogen Idec
                                                                                             Ruth Wolff Biologics Consulting Group, Inc.
                                                                                                          Biologics Consulting Group, Inc.
                                                                                             Nanda Subbarao
ovidien.com                                                                                               University
                                                                                             Laura Boles Ponto of Iowa
                                                                                                          U
                                                                                             Anita Szajek nited States Pharmacopeia
                                                                                             Anne PilaroFDA
                              joshi.amita@gene.com
            Genentech, Inc., South San Francisco, CA                                         Hong Zhao FDA
                              smahabi2@uwo.ca
            University of Western Ontario                                                    Tapan Das Pfizer, St. Louis
                              abaner4@uic.edu
            University of Illinois, Chicago                                                               Pfizer
                                                                                             Stanley Speaker Global Research & Developm
                                                                                             Hong Zhao FDA
                                                                                                          Sailstad and Associates Inc.
                                                                                             Jeffrey Sailstad
                                                                                                          Isis
                                                                                             John Grundy Pharmaceuticals
            Pfizer            leonid.kirkovsky@pfizer.com                                                 Pfizer
                                                                                             Bonita (Bonnie) Rup
                              susan.richards@genzyme.com Pfizer, Inc.
            Genzyme Corporation              Franklin Spriggs                                Michelle Schroeder
                                                                            franklin.spriggs@pfizer.comAmgen, Inc
            Pfizer                           Gopi                                            Boris
                              brup@wyeth.com Shankar Centocor, Inc. gshanka3@its.jnj.comGorovits          Wyeth
                                                                                                          FDA
                                                                                             Susan Kirshner
                                                                                                          Indiana
                                                                                             Richard DiMarchi University
                                                                                                          7
                                                                                             Andrew Vick th Wave Labs
D and PBPK models for PK Predictions.Shefali Kakar: Clinical Development Plan. How to tailor the plan for your compound.would/could be


 g Assays 3. Michael Moxness, PhD, DABCC (USA)Consensus on Validation Methods for Human IgE anti-Drug Assays: Michael Moxness, P
                                                                                                                        
Clinical
                                                                                                                         

 Generation Biologics: Deimmunization and Tolerance Induction: Annie De Groot, M.D., CEO/CSO EpiVax, Inc. UNITED STATES;




 vaccine delivery through skin using electroporation3. Dr. Nadine Smith, Penn State University, USA. Tentative Title: Transutaneous ultrasoun
 y therapeutics using LC/MS; H Neubert, UK, LC/MS quantification of protein targets of monoclonal antibody therapeutics – differentiating to



en. Regulatory experience of paediatric data - focusing on modelling aspects.;FDA presenter - if EU regulators unable to present.


 noclonal Antibodies, Office of Biotechnology Products, FDA-CDER
       

                        
–

g of the key residues. 
 TBD
   
                                                                                     

                                 Potential Title: Role of FcRn in the transport of IgG across the blood brain barrier 

n especially in the area of analytical method development and validation and analytical problem solutions to the pharmaceutical industry. Boe
s on Implementation of the ISR process"; Dr. Martin Ullman, " Comparison of ISR for small and large molecule; Chris Beaver, "Best Practices
 cromolecules 3.S.N.Murthy; Novel strategies and technological advances to improve recovery of macromolecules. 4.Dale Conner Or Edwa
 fic pegylation as a means to enhance the PK profile of hGH.Mark Rose: LC-MS/MS method development and validation for PEGylated ther
Stuart Lindsay, USA: Apatamer reagents: challenges and progress to date

ood Spot Analysis (Dr. Richard Hooker, Pfizer, UK)3.Dried Blood Spots (DBS) Assays for Determination of Various Biomarkers in Whole Bloo
 S coupled with LBA (Dr. Jean Lee, Amgen, USA)3.Immunoaffinity Liquid Chromatography Tandem Mass Spectrometry: an Innovative Emerg
Daotian Fu. Genzyme. Daotian.Fu@genzyme.com (product-related) Protein glycosylation (potentially another person from Genzyme, they ar
in A Analysis, speaker not identified.Academia and othe rindustry speakers
ein biologics in frozen state-OpenRegulatory concenrs of therapuetics protein aggregation-Open (FDA member)Determination of subvisible/


g: Adam Goldstein, Genentech


 es, Sagar University, India.4) Dr. Jackie Fairley, COO, Starpharma, Melbourne, Australia.
patmers in Biological Matrices: HPLC to HLIHA.To be Determined; USA; Analysisof a Biomarker and Immunogenicity Testing.Hewei Li; USA;
                                                                      
 Sandhya Girish (Genentech, USA) Review of PK based DDI's in onco
                                                                      


  study designs, logistical constraints in the conduct of DDI studies 
3.

 g, USA- Impact of various interfering molecules on ATA assays; Mark Ma, USA- Title TBD (accepted);Kay Stubenrauch, TBD, Germany (TBD
 nteral Development and Analytics, Pfizer Inc; Regulatory Guidance and Analytical Tools to detect Metal LeachablesThomas Schoenknecht; U
msMaria Toler; USA; Case Study 1 TBD speaker from Genentech (US) or Amgen (US) or GSK (UK) Case Study 2
SA,Transferrin receptor-mediated transcytosis in protein drug delivery4) Ajay Banga, USA, Electrically assisted transdermal and topical delive
                                                     
•

e in protein formulations – T. Patapoff, Genentech
 Polysorbates in protein formulations – HC Mahler, Roche
   



nd Chair of Medicine, Columbia University), ―Therapeutic Enzymes from Computational Design‖; Dr. David Baker (Professor, University of W
ory Antivirals - Drugs, Vaccines and Novel Therapies;Dr. David Edwards, Harvard University, United States, Inhaled Large Porous Particles of
 ational Institute of Biotechnology (NIBN), Ben-Gurion University of the Negev, Beer-Sheva, Israel;Reineke U,Lead Discovery Biology Departm
at-forms for immunogenicity testing under development"; 3. Gopi Shankar, PhD. MBA, Centocor, USA , "Data analysis techniques to assess i
bodies‖; Dr. Duxin Sun (Associate Professor, University of Michigan), ―Targeted Drug Delivery in Cancer Therapy‖; Dr. David Baker (Professo
 tification of Biotherapeutics with Octet and comparison to ELISA for IVT sample analysis;
 d Validation
gE assay4. Crystal Sung, USA - Safety assessment for Myozyme, an ERT
  tion, cancer, and allergy‖; Dr. Wayne Koff, ―AIDS Vaccine Development: Challenges and Opportunities‖; Dr. Allan Saul (Malaria Vaccine Dev
ng therapeutic concentration


pment"; Human Genome Sciences or Roche speaker TBD, USA, "Anti-IFN Antibodies and IFN Drug Development"; Industry Speaker TBD, U
 long-lasting enzyme therapy: In vitro and in vivo studies‖; Dr. Michael Owens (Professor, University of Arkansas Medical School), ―In vitro an



 cal Trials;Chris Behrs, Canada, MDS Pharma, Maintaining consistent performance of assays from Sponsor to CRO.Moderator: Joo-Hee Yi/

 of legacy assays with new technologies: strategy and case studies.Moderator: Patrick Liu/Suzanne Brignoli
                                      



r a successful technology transfer
Moderator: Suzanne Brignoli/Joo-Hee Yi, Genentech Inc.

         


                                                                                                    


                                                                                                   


d preservatives: Brian Meyer (Merck USA); Screening methods and selection criteria for preservatives in parenteral drug products: Qiang Ye
d preservatives: Brian Meyer (Merck USA); Screening methods and selection criteria for preservatives in parenteral drug products: Qiang Ye
d preservatives: Brian Meyer (Merck USA); Screening methods and selection criteria for preservatives in parenteral drug products: Qiang Ye
d preservatives: Brian Meyer (Merck USA); Screening methods and selection criteria for preservatives in parenteral drug products: Qiang Ye
 ong Yin et al (Eli Lilly USA); Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jose Casillas (Amylin Pharmaceut
 ong Yin et al (Eli Lilly USA); Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jose Casillas (Amylin Pharmaceut
 ong Yin et al (Eli Lilly USA); Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jose Casillas (Amylin Pharmaceut
 ong Yin et al (Eli Lilly USA); Siliconization of vials and dual-chamber cartridges (case study) - John Fan & Jose Casillas (Amylin Pharmaceut

                              


                               
                                                                             


                                                                                                              

earch Institute, La Jolla, CA)
• Stimuli-Responsive Gene Regulation (Minhyung Lee, Hanyang University, Korea)
• Gene regulation by RNA

 ristol-Myers Squibb CoJaya Goyal, Associate Director, Clinical Science and Technology Biogen Idec Inc.

                    
 Development of TNFerade (rAd-TNF&#61537;) for the treatment of pancreatic cancer. Paul H. Fischer, PHD, Presiden
                    

 Therapeutics, UK;
•


ultiparametric Flow Cytometry Data Analysis: Case Studies;
ment; Open Discussion
 A: Phil Lowe Novartis USA: Xolair (or Llaris) a case study.
 ation for DS and DP. Michael Miller, Eli Lilly4.Rapid In-process and Release Microbiological Testing: Where we are? Genzyme or GSK
A (Xeleron): Use of Microdosing in biologics. Someone from FDA/EMEA: Thoughts on microdosing (There is a sig difference in the EMEA an
 d Solubility Screen for Rapid Formulation Selection of Ophthalmic Candidates- An AGILE approach, Michelle Marra, Pfizer 4.Advances in Hi
 on on PK and PD;Henry Lowman Genentech, Inc., USA Current strategies in modifying antibody for developing better biotherapeutics;Greg



              


               

 and Proteins
Terhuna Siahaan, PhD
    

                                       Department of Pharmaceutical Chemistry, University of Kansas;
(3) Formulation Considerations for
                                                                                                         

                                                                                                         

                                                                                                         

 Pharmacology SciencesJohnson & JohnsonUSA;Regulatory experiences of submitting ADA sample stability data in BLA filingGopi Shankar
DER), Particulate matter, leachables and integrity of bags - the safety aspect;Kirsten Lauber, Germany, Recent innovations in disposable fluid

                                    

                                    Karoline Bechtold-Peters, Germany, High concentration liquid SUSPENSIONS – an alternative approach
  concentration liquid formulations;


                                
 Presser, Germany, Novel holding system for lyophilization and transport of double chamber cartridges;

                                Ingo
 culate matter characterization;
                                                                                                      

 of platform approaches in Biotech
 enicity assays;Meena Subramanyam, USA, Novel statistical approach for ADA assay cut point;


ologics Comparability Protocols'4. Natalie Cohen, Teva Israel, 'Comparability from the view of a Biosimilar Product'

ecommends this session on the basis that it will be highly instructional and introduce the audience to more sessions on the topic of immuno-m
 Nuclear medicine systems and radiolabling of proteins, Mabs, peptides, sugars and lipids for following drug disposition.Speaker 4. How you
nostic methods using array platforms and interpretive pattern recognition algorithms for array mappingSpeaker 4. MRS and solid tumor biolo
 btaining vendor certificaion to comply with the new USP <67>.
ng, USA, title - tbd.
 ents3)Chris Roberts, USA, Development of models of protein aggregation kinetics to design and/or predict in vitro and in vivo behavior4)Tom


rdeau, MO, 63701.
 rgency Medical Countermeasure EnterpriseSpeaker 3. (TBA, BARDA CBRN rep)Ionizing radiation exposure injuries (pancytopenia, GI Synd

 ues: Examples - Speaker TBD

nt of DNA oligonucleotides for treatment of muscular dystrophy; Dr. Elena Feinstein from Quark Pharmaceutical will present on preclinical an
                             

                             •

aph) --EP representative 
 EFPIA and PhRMA comments on Requirements for Visible Particulates in Biotherapeutics—member of industry c
 ation / self associating protein systems (TBD)Mechanism of Reversible Self-Association of a full length mAb (Sathish Hasige, Medimmune)
 - Analytical techniques for measuring subvisible particles in protein solutions3. Maria Toler, Pfizer - Challenges in quantifying and characteriz
 opment: HGS or Roche speaker TBD;RF Antibodies and Impact on Assay Development: Industry speaker TBD;Challenges of pre-existing a
 ge, Ph.D., MedImmune Inc., Gaithersburg, MD, USA
      Title: ―Quantitative High Throughput Screening of Conformational and Colloidal Stabilit
                                                        

 Management (QRM) to Biopharmaceuticals
                                               

                                               Yue
m an Early Clinical Development Perspective;
 Huang PhD, USA, Roche-Genentech, [Tentative Title]: The role TMD Plays in Impacting P


mi Amaravadi and Ago Ahene have already accepted

                                            Anne Pilaro      FDA              Tbd              Peter LloydNovartis Horsham Research Centre
    Speaker                         Speaker          Speaker                        Speaker        Speaker
 Presentation Speaker              Company        Presentation Speaker            Company       Presentation Speaker
                   John Grundy Pharmaceuticals
                                 Isis           Antisense Oligonucleotide Translational Challenges
                                                                  Renta Hutabarat
                                                                               Alnylam Pharmaceuticals
                                                                                               siRNA Translational and
                                                                                                                 Bal Pk/pd: Application
Measuring Nucleic Acid Based Therapeutics In Biological Samples: Application andPK and PD: Application BhatChallenges a
                    for Freeze-drying of Biopharmaceutical Products
PAT ApplicationsJim Stout Amgen, Inc PAT ApplicationsBryan RileyFDA                                              Mansoor Khan
                                                                   for Biopharmaceutical APIPAT Applications for Rapid Microbiology
                                                                                               What‘s Unique About a Case Study
What Drives the Decision to Amgen, Incand what Molecules Offshore Outsourcing -Sponsor Considerations: Ligand Binding Ass
                   Han Gunn Outsource                             John and Challenges
                                                Large are the Benefits AllinsonIcon
                   [125i]-Labeled Therapeutic Proteins: Application In Protein LLC
                                 SLOAN          Imaging and Pharmacokinetics of Theranostic Carbon Nanotubes In Mice
                                                                  Eric                         Quantitative Whole-Body Autoradiograph
Biodistribution of David Scheinberg KETTERING INSTITUTE, Solon QPSDrug Development BeyondEric Stefanich           Oncology<sup><sup><
                   Margarete Brudny-KloeppelPharma
                                 Bayer Schering Biotherapeutics Case Studies from BioServices Pharmaceutical Companies Inve
                                                                  Esme Farley
When and How Much Do Anomalous Results Need to Be Investigated? Advionthe EuropeanInc                            Out of Marini
                                                                                               Case Studies In JosephSpecification
                   Jamie Moore   Genentech, Inc.Comparability Assessment: Product
                                                                  Nicholas Changing from Drug Sc During ClinicalWei Case Studie
Comparability Strategies When Making Changes to the Finished DrugWarne                         IV to Development Ziping Development
                                                                               Pfizer-Research and Product Comparability:
                   Hong Zhao FDA                Regulatory Perspective on Comparability Assessment of Biopharmaceuticals During
                                                                  Steven MartinPfizer          Comparability Yow-Ming Wang
Comparability Assessment of Biopharmaceuticals: Characterizing Differences that Make a Difference Toolkit for Teams to Asses
                    on the KelleyMKelley Guideline
EBF PerspectiveMarian EMEA Draft Consulting, LLC                  Michaela Golob
                                                                               Application     Comparison of EMEA the us Environme
                                                                                                                 Jan Welink
                                                LBABFG Perspective on the Merck KGaAof the EMEA Guideline Inand FDA Recomm
                   Darin FurgesonUniversity of Utah
                                                Genetically Engineered Multi-Targeted DrugTbd Gene Carriers
                                                                  Dana
Novel Lysine-Based Bioreducible Nonviral Gene Delivery System Crouse           Sigma Aldrich and
                   Franklin Spriggs
The Road to Plug and Play Pfizer                                    the Ideal 21st
                                                                               Pfizer
                                                Characteristics ofSheldon LeungCentury PlatformProgress Towards a Standardized Immu
                   Nakissa Sadrieh
                                 FDA            Regulatory        Neil Desai Abraxis BioScience Nanoparticle Albumin Bound (Nab) P
                                                                                               The
Engineering of Smart Colloidal Drug Delivery Systems Framework Driving Clinical Development of Nanoparticle Drug Delivery S
                   Jack Ragheb   FDA            Focus on and Automated Seneviratne
                                                                  Ananda Inspection
                                                                               Allergan        Visible Particles In Protein Therapeutics:
Visible Particle Analysis During Lot Release: Manual Visible and Sub-Visible Aggregates and their Potential Impact on Immunog
                   of Prefillled MedImmune Formulation Strategies in the Development of Pre-Filled Syringe Presentations of Hig
                                  Syringe
Characterization Mariana Dimitrova Functionality for Autoinjector Applications
                   William Pardridge
                                 Armagen, Inc Re-Engineering Biopharmaceuticals for Targeted Delivery Across the Human Blood-B
                                                                  Brian Macromolecular Delivery Delivery Crossing the Blood Brain
                                                                               The              University Brain
Focused Ultrasound Technology for Blood Brain Barrier DisruptionKaspar Ohio StateGenein theSchool of Medicine
Cell Line Development 101: How to Create Productive Stable Cell Lines
                   Gretchen Stability Associates
                                 McCrone         Investigation of Isolation
Clean and Stable: Product Shearer and theExamination andParticles of Foreign Particles in Pharmaceutical and Biotech Sample
                   Portfolio Decision            Using PreclinicalSameer Doshi is Early and When is Likelihood of to Guide Disco
                                                                   M&s: How Amgen, Inc
                                                                               Early           Use of Prior Too Late?
Influencing Early Mike Smith Pfizer Making Enhanced Quantitative Decision Making -Reducing the itClinical Data Incorrect Decis
                   Biologics -Principles, Non-clinical Models Mabtheir Translation to Man
Sc Absorption of Joseph Balthasar               Sc Absorption
                                 University at Buffalo, SUNY of and -Investigations with Knockout Mice, Engineered Mab, and PB
                   John Lambert  ImmunoGen, Inc. from Promise to Reality
                                                Adcs:             Tae Han Seattle Genetics linical Pharmacology ofGupta
Challenges of Antibody-Drug Conjugate Development-a Regulatory Perspective                     C                 Manish Brentuximab V
                   Hendrik Neubert
                                 Pfizer          Measuring the Pharmacokinetics of Antibody-Drug Conjugates Spectrometry to Inv
                                                                  Assessment   Amgen, Inc      Ligand-Binding Mass Henion
Mass Spectrometry and Immunoassays forPharmacokinetic Michael Hall of Antibody Therapeutics by LC-MS/MS          Jack
                   Sheldon Park  University at Through Computational Design as a Protein Engineering Tool
                                                Molecular Dynamics Simulation
Protein Drug Discovery and DevelopmentBuffalo, SUNY
                   Jaya Goyal Biogen Idec Bioanalytical Methods for Shapiro    FDA             Regulatory Perspectives and Expectation
Impact of Igg Glycoform Variations on Fc Effector Functions Marjorie Evaluation of Fc Effector Functions
                   Claude Meares University of California, AntibodyTargeted Imaging.
                                                The Chemistry        and Drug ImmunoGen, Inc. and Disposition. Polakis
Antibody-Auristatin Conjugates for Cancer Therapy: Davis ofHans Erickson       Pharmacokinetics                  Paul
                                                                                               Antibody-Maytansinoid Conjugates for C
                   Ho Cho        Ambrx, Inc
Rational Design of Protein Drug Stabilization   Using an Expanded Genetic Code to Optimize the Pharmacology of Protein Drugs
                   Dominik WodarzUniversity of California, the Dynamics Between
                                                Modeling                       University of Immune Clinical Trials: a Way to Assess D
                                                                                               Virtual
Modeling Hepatitis C Virus Infection and Treatment Irvine Simeone MarinoHiv and MichiganResponses with Implications for T
                   Peter Lee                                      Lisette de Pillis
                                                                               Harvey the Immune System Modeling of Cancer-Immun
Multiscale Cancer Modeling Stanford Univ.Modeling Regulation Mechanisms InMudd College         Mathematical
                    Resonance Based Inc
                                 Amgen, Assays: Additional Data to Drive Drug AssayLivermore Nationalof Luminex-Based Applicat
                                                                  Ligand Binding
Surface PlasmonHossein Salimi-Moosavi High Throughput John Dzenitis Development                Development Laboratory
                                                                                                                 Laure Moller
                                                                               Lawrence for Therapeutic Antibodies and Biomarkers U
                   Susan Impact on
                                 Genzyme Corporation
                                                Perspectives on Post Approval Related to Monitoring Erythropoietin Immunogenicity
                                                                  Meena Subramanyam
                                                                               Biogen Idec Immunogenicity Assessment for a Marke
Immunogenicity Has an Richards Safety-Considerations and ChallengesImmuosurveillance for Myozyme                 Susan Kirshner
                   Robin Hwang   Halozyme Theraputics
                                                Large Volume Subcutaneous Injection and Devices Learned fromDaddona
Scale Up to Manufacturing for Autoinjectors -Lessons Learned                   Pfizer
                                                                  Jessica Ballingeer           Lessons           Peter Drug-injector Pro
                   Jean and Amgen, Inc Industry Perspective on Comparability Assessment of Protein Products
                                                                  Angela Men   FDA             Regulatory Experience Perspective
Regulatory ExperienceLee Acceptance Limits for Physicochemical/biological Assays In Comparability: an FDAand Acceptance L
                   Alvydas Mikulskis
                                 Immunoassay Optimization
DoE a Solution for Multiplex Biogen Idec An Introduction to DoE Methods and their Use In Bioanalytical Assay Development
                    for Cell Therapy Products
Stability ProgramEmily Shacter   FDA                               for Biosimilars
                                                                               FDA
                                                Stability Program Katherine Tyner              Stability Program for Nanoparticle Drugs
                   William Dall'Acqua
                                  Properties on Modulating the the Subcellular Lilly
                                                                  Amita Datta-Mannan
                                                                               Eli Properties of Therapeutic IgGs via Fc Engineering: t
The Impact of FcRn Binding MedImmune IgG Behavior atPharmacokineticand In Vivo Levels          Pharmacokinetics of Variant Humanized
                   Matthew to Build Institute
                                 Metrum
A Review of Global EffortsRiggs Qspcol Models                     Hao Zhu FDA                  Disease Models at the FDA
                                                Multiscale Modeling: the Quantitative Integration of Systems Biology, Clinical Pharma
                   Elizabeth Murray
                                 SemBioSys for Novel Cell
                                                The Production of Therapeutic Proteins In Plants: the Story of Insulin and Apo A1
Overview and Regulatory ConsiderationsGenetics, Inc. Substrates
Analytical Methods for Testing Extractables/leachables
                   Mary Spilker  Pfizer Global Research & Development Using Imaging Southern California
Pet Diagnostics and Imaging Animals                               Peter ContiUniversity of Pet Imaging in Drug Development with N
                                                Biotranslational Research
                   Edwin
USP Tests for Heparin Moore                     The               Ali Al-Hakim FDA
                                 Baxter Healthcare Heparin Incident-what the Industry Learnt   Presentation Title Tbd
Regulatory Challenges for Biological Product Development -from a Preclinical Perspective
                   Steven Martin Pfizer         First In Human -from a Clinical Biological Challenges to the Industry for Biological
                                                                  Mark Peterson Pharmacology Perspective
                                                                                 of
Regulatory Challenges for Biological Product DevelopmentStudy DesignBiogen Idec Products
                   John Carpenter of Colorado
                                 Univ           Roles of Subvisible Particles rap-ID
Emerging Biophysical Techniques In Biologics DevelopmentMarkus Lankers                         Pathways for Therapeutic Silicone
                                                                                                                 Monica Pallitto
                                                                                In Aggregation The Relationship Between Proteins Laye
                   Jim SearlesAktiv-Dry         Latest a Pre-Filled Syringe University of Minnesota
                                                                  Alptekin Aksan
Freezing Step Considerations for Lyophilization InDevelopments In Freezing and Annealing                         Freezing-Induced
                                                                                               Desiccation and W. Aaron Pruett Micro
                   Steven Swanson                                 Peiming Ma
Regulatory Considerations Amgen, Inc Immunogenicity of Therapeutic Proteins    Amgen, Inc                        Chad Ray
                                                                                               Overview of Population Pharmacokinetic
                   Andrew -Presentation of Case Studies
                                 7
Organization of Session Vick th Wave Labs
                   Page Bouchard Archemix
Mode of Action -from Antisense to siRNA Aptamer Therapeutics
Immunogenicity Shefali Kakar                    Human PK Corporation
                                                                  Leo Projections
                                                                               Pfizer          Biotherapeutics Jennifer Liras
                                 Novartis Pharmaceuticals and Dose Kirkovsky of Protein Overview of Biologics
                   Meena Subramanyam
                                 Biogen Idec                      Pankaj Oberoi Scale Discovery Reference Standards in Quantitat
Reagent Inventory Systems and ProcessesLife Cycle Management of Reagents       Meso            Use of            Valerie Theobald
                   Bonita (Bonnie) Rup
                                 Pfizer          Data Presentation Based on Case Study in The Need for Standard Analytical Approa
                                                                  Gopi Shankar   Gaps Exist Examples             TBD TBD
One Company Perspective on Clinical Ada Intro: what Opportunities andCentocor, Inc. the Quest to Reliably Predict, Understand
Overview of the New FDA Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins
                   Claudio SchteingartResearch Institute Degarelix: Miljanich
                                 Ferring        Once a Month George Engineering the Physicochemical Properties Obesity
                                                                               AIRMID          Conotoxin-Based Peptides: Peptides
                                                                                                                 Richard Houghten
Discovery of Glucagon-Based Peptides with Broaden Molecular Pharmacology for the Treatment of Diabetes and ofPrialt® as a
Panel Discussion                 Indiana        Panel                          Torrey          Panel Discussion
                   Richard DiMarchi University DiscussionRichard Houghten Pines Research Institute Ronald Bowsher
 our compound.would/could be many more and I'll have to think about it further if accepted.


ug Assays: Michael Moxness, PhD, DABCC4. Per Matsson, Ph.D. (Sweden) Recommendations for pharmaceutical companies, academic ce
c. UNITED STATES;

  

                    
Clinical Experiences on Impact of Immunogenicity on Safety and Efficacy of Protein Therapeutics: Naren Chirmule, P


e Title: Transutaneous ultrasound mediated delivery of liposome encapsualted siRNA.
therapeutics – differentiating total vs. free drug/target; Someone from Genentec, US, Challenges and opportunities in the mass spectrometri



 s unable to present.




he pharmaceutical industry. Boehringer Ingelheim Roxanne Laboratories, Targacept, Inc., Bayer, and Wyeth are among his most recent clien
e; Chris Beaver, "Best Practices for conducting an event resolution".
cules. 4.Dale Conner Or Edward Bashaw Regulatory Perspectives on Microdialysis of macromolecules
nd validation for PEGylated therapeutic proteins and comparison to ELISA methods


 rious Biomarkers in Whole Blood (Dr. Xiarong Liang, Covance Laboratories, USA)4.DBS in Regulated Bioanalysis: an Overview (Dr. Fabio G
ectrometry: an Innovative Emerging Technique for Biologics Quantification (Dr. Huifen Faye Wang, Pfizer, USA)4.Evaluation of FAIMS, HRES
  person from Genzyme, they are very strong in this area). 4. Ned Mozier, Pfizer (process-related) Host Cell Protein detection and characteriz

ber)Determination of subvisible/visible aggregates in protein formulations-- OpenProtein folding pathways and theories- Kevin Plaxco- UCSD




 genicity Testing.Hewei Li; USA; Quantitationof mRNA Biomarkers, siRNA GeneKnockdown and miRNA Profiling: From Assay Development t
                                                                                                                                 
 ET
                                                                                                                                  

                                                                                                                                  

eview of PK based DDI's in oncology setting: case studies to illustrate study designs/acceptance criteria and clinical relevance 
4.
 Morga
ubenrauch, TBD, Germany (TBD)
hablesThomas Schoenknecht; USA;Amgen; Case Study: Tungsten Leachable from pre-filled syringeORShuxia Zhou: USA; Global Biologics,
udy 2
d transdermal and topical delivery of proteins;



aker (Professor, University of Washington), ―Stabilization of Protein Drugs through Computational Design‖.
 haled Large Porous Particles of Capreomycin for Treatment of Tuberculosis;
 Lead Discovery Biology Department, Jerini AG, Invalidenstr. 130, D-10115 Berlin, Germany;Shibata T,Biometal Science Laboratory, RIKEN S
 analysis techniques to assess immunogenicity"; 4. Jogarao Gobburu, PhD, FDA, USA "Regulatory view on population modeling approaches
 apy‖; Dr. David Baker (Professor, University of Washington), ―Rational Design of novel protein-protein interactions‖; Dr. Michael Owens (Pro
Allan Saul (Malaria Vaccine Development Unit, NIAID, National Institutes of Health), ―Progress and challenges for malaria vaccines‖; Dr. Pau



pment"; Industry Speaker TBD, USA "RF Antibodies and Impact on Assay Development"; Alyssa Morimoto, Genentech, USA " Challenges of
sas Medical School), ―In vitro and in vivo studies on the functions and stability of monoclonal antibodies‖.



 o CRO.Moderator: Joo-Hee Yi/Patrick Liu Genentech Inc.



 nteral drug products: Qiang Ye (Otonomy USA); Preservative-drug, preservative-excipient, and preservative-package interactions: Otilia Koo
 nteral drug products: Qiang Ye (Otonomy USA); Preservative-drug, preservative-excipient, and preservative-package interactions: Otilia Koo
 nteral drug products: Qiang Ye (Otonomy USA); Preservative-drug, preservative-excipient, and preservative-package interactions: Otilia Koo
 nteral drug products: Qiang Ye (Otonomy USA); Preservative-drug, preservative-excipient, and preservative-package interactions: Otilia Koo
se Casillas (Amylin Pharmaceuticals USA); Prefilled syringe Case Study - Thomas Nicholai (Abbott USA); Silicone-free lubrication system - V
se Casillas (Amylin Pharmaceuticals USA); Prefilled syringe Case Study - Thomas Nicholai (Abbott USA); Silicone-free lubrication system - V
se Casillas (Amylin Pharmaceuticals USA); Prefilled syringe Case Study - Thomas Nicholai (Abbott USA); Silicone-free lubrication system - V
se Casillas (Amylin Pharmaceuticals USA); Prefilled syringe Case Study - Thomas Nicholai (Abbott USA); Silicone-free lubrication system - V

     


      
                                                                                        


                                                                                                

orea)
• Gene regulation by RNAi for cancer gene therapy (Ram I Mahato, University of Tennessee)
• Tissue specific and artificial promoter



                                                           
 Adenovirus gene therapy – lessons for the future. James Wilson, MD, PH
                                                           


 Paul H. Fischer, PHD, President and CEO, GenVec, Inc. USA;
•




we are? Genzyme or GSK
 a sig difference in the EMEA and FDA guidances).
  Marra, Pfizer 4.Advances in High Throughput formulation Development: Future direction, David Putnam, Cornell
 ing better biotherapeutics;Greg Adams Fox Chase Cancer Center, USA Do antigen binding affinity and molecular matter on tumor targetpen



                                                                         


                                                                          

 Formulation Considerations for Proteins Susceptible to Asp Isomerization
Aditya Wakankar or Steve Shire, PhD

                                                                                                             

                                                                                                             Genentech, Inc.;
(4) Co
                                                                                                                             

                                                                                                                             


 data in BLA filingGopi ShankarDirectorClinical Pharmacology SciencesJohnson & JohnsonUSA
nt innovations in disposable fluid handling technologies

                               

 ONS – an alternative approach?


                              

                              N.N., Future directions and visions as regards appropriate delivery systems for protein therapeutics – what ne
 of double chamber cartridges;





oduct'

 ssions on the topic of immuno-modification.
disposition.Speaker 4. How you can follow your drug or biologic in-vivo - watching pharmaceutic disposition in real time.
er 4. MRS and solid tumor biology - A way to witness physiologic change in tumor chemistry


 vitro and in vivo behavior4)Tom Saylor, UK, Use of formulation technologies to stabilize proteins and vaccines for supply to third world coun



injuries (pancytopenia, GI Syndrome, Lung fibrosis and cutaneous injuries: Medical Countermeasures that can make a difference in surviva



cal will present on preclinical and clinical development of siRNA for treatment of AMD; Dr. Daniel Anderson of MIT will present the developm
                                               
•

 apeutics—member of industry consortium 
 The regulatory concerns on the effect of visible particles on the safety and efficacy of protein th
  (Sathish Hasige, Medimmune)Self Association and the manufacture of high concentration products (TBD)Self association and its implicatio
es in quantifying and characterizing visible particles in biopharmaceutical formulations4. Nitin Rathore, Amgen - Particles in biopharmaceutica
 BD;Challenges of pre-existing anti-cytokine Antibodies in Autoimmune Disease Sera: Alyssa Morimoto
                                                                                                                            


                                                                                                                             

 ormational and Colloidal Stability of Therapeutic Proteins: Application and Challenges during Formulation development‖;
Vladimir Razinkov

 role TMD Plays in Impacting PK-PD Profile of a Novel Biologic Candidate.




             Tbd
               Speaker       Speaker                    Speaker        Speaker                     Speaker      Speaker
              Company Presentation Speaker Company Presentation Speaker                           Company Presentation
                          MicroRNA
            Regulus Therapeutics Antogomir PK/PD; Application and Challenges
            FDA           Science and Regulatory Aspects of PAT In Biopharmaceuticals
 About Ligand Binding Assay Bioanalysis and what Have We Learned from Outsourcing?
                          Investigation of Factors Parry
            Genentech/Roche                           Varian       In Vivo Biodistribution, Pet Imaging,
                                           Renate Influencing Biodistribution of Protein Therapeutics and Tumor Accumulation of Enginee
                          Biotherapeutics Case Inc
            Centocor Research & Development, Studies from the North American Pharmaceutical Companies
            MedImmune Comparability Assessment of Biopharmaceutical Products: Strategy and Practice
                                                                                     – Challenges and Utility The 80-125 Rule In PKPD Co
            Amgen, Inc PKPD Comparability Assessment of Biopharmaceuticals Kerry Culm-Merdek Development and Post-approval
                                                      Genentech, Comparability Study Packages During
                                           Kathleen Francissen Inc.                              Genzyme
                          Overview of the Recent EMEA Guideline on BMV
            Dutch Medicines Evaluation Board

rds a Standardized Immunoassay Data Format
le Albumin Bound (Nab) Platform for Drug Delivery: Targeting Gp60 and Sparc
  In Protein Therapeutics: Physical Nature, Origin, Detection and Solutions
 inge Presentations of High-Concentration Monoclonal Antibodies
Crossing the Blood Brain Barrier for Treating Neurological Disorders

 utical and Biotech Samples
 nical Data to Guide Discovery and Development of Second Generation Biologics
 Engineered Mab, and PBPK
                           Clinical Pharmacology Strategies In the Development of T-Dm1
              Genentech/Roche
                           The Use
              Advion BioServices Inc of Mass Spectrometry for Detecting and Characterizing Biospecific Non-Covalent Interactions

spectives and Expectations on Fc Effector Function Assessment
                           Adc
              Genentech, Inc. Development
 ology of Protein Drugs
Trials: a Way to Assess Differences in Reactivation of Tuberculosis Induced from Anti-Tnf Treatment
Modeling of Cancer-Immunology Dynamics
                           The ABCs
              Meso Scale Discovery of ECL -Best Practices for Ligand Binding and Immunogenicity Assays on the MSD Platform
              FDA          A Regulatory Perspective on Immunogenicity Surveillance Considerations In the Post Approval Phase of Biothera
              Zosano PharmaMicroneedle Patch Delivery System Development: Where are We Now?
 erience and Acceptance Limits for PK/PD Studies In Comparability: an FDA View
cal Assay Development
 m for Nanoparticle Drugs
 cs of Variant Humanized Monoclonal Antibodies with Improved FcRn Binding Properties
s at the FDA
 of Insulin and Apo A1

Drug Development with Novel Biomarkers


he Industry for Biological Product Development -from a Clinical Pharmacology Perspective
             Amgen, Inc Protein Interactions with Primary Packaging Surfaces
                             Impact of Freeze-Thaw Parameters and Frozen Storage Temperature on Protein Formulations
             Human Genome Sciences
                             Bioanalytical Assay to Measure PK of Tennessee Health of Protein Therapeutics
             Radix BioSolutions                         University Pharmacokinetics Science Center
                                             Bernd Meibohm


             Pfizer                           Binodh DeSilva
                            Candidate Selection Criteria                            Eric Ezan Assay Methods
                                                                                                          Lcms-Based Assays and their
                                                        Amgen, Inc Overview of Ligand Binding CEA (Commissariat a l'Energie Atomique
             Genzyme        Reagent Integrity and Long Term Stability (Focus on Non-Ab Reagents)
                            Clinical
             University of Florida Perspectives: what Can We Learn About Risk Prediction and Management Using Products with Establish
  Therapeutic Proteins
             Torrey Pines Research Vivo Discovery Using Mixtures Intracellular Peptide Drug Targets – Pkc
                                              Daria Mochly-Rosen Univ.
                            Direct In Institute         Stanford
                            Panel             P         Ferring Research Institute
             Millipore CorporationDiscussion ierre Riviere           Panel Discussion
 companies, academic centers and regulators
                                                                                             
Adnectins – Case Study from the Clinic
                                                                                              

eutics: Naren Chirmule, Ph.D., Executive Director, Clinical Immunology, Amgen, UNITED STATES;





 in the mass spectrometric quantification of antibody-drug conjugates; Someone from Isis or Amgen, US, Quantification of therapeutic oligon




 ong his most recent clients. In his prior position as the Senior Director for Pharmaceutical Development at Targacept Inc., he was in charge




 an Overview (Dr. Fabio Garofolo, Algorithme Pharma, CANADA)
aluation of FAIMS, HRES and MS3 Techniques to Increase Specificity in LC-MS/MS Method Development of Biologics and Biomarkers (Dr. F
detection and characterization. 5. Xing Wang, Pfizer (process-related) Residual DNA analysis: current technology and novel approaches. 6. R

 es- Kevin Plaxco- UCSD, USA




 om Assay Development to Sample Analysis.
           
 ET
            

            

 relevance 
4.
 Morgan (Emory University, USA)Impact of Infectious and Inflammatory: Disease on Cytochrome P450–Mediated Drug M

u: USA; Global Biologics, PfizerCase Study 2: Effect of Chelators in Monoclonal Antibody Formulations




ence Laboratory, RIKEN SPring-8 Center, Hyogo, Japan;Säfsten P,Department of Systems and Applications, Biacore AB (a GE Healthcare C
 on modeling approaches to assess immunogenicity‖ 
  

  Dr. Michael Owens (Professor, University of Arkansas Medical School), ―Rational design of monoclonal antibodies for site-specific drug deli
malaria vaccines‖; Dr. Paul R. Kinchington (Associate Professor, University of Pittsburgh), ―Potential Prophylactic and Therapeutic Vaccines



ech, USA " Challenges of Pre-existing Anti-cytokine Antibodies in Autoimmune Disease Sera"




 ge interactions: Otilia Koo (BMS USA); Process scale-up, manufacturing, and control issues: Final speaker (CMC-FG, MSE-Section) TBD (U
 ge interactions: Otilia Koo (BMS USA); Process scale-up, manufacturing, and control issues: Final speaker (CMC-FG, MSE-Section) TBD (U
 ge interactions: Otilia Koo (BMS USA); Process scale-up, manufacturing, and control issues: Final speaker (CMC-FG, MSE-Section) TBD (U
 ge interactions: Otilia Koo (BMS USA); Process scale-up, manufacturing, and control issues: Final speaker (CMC-FG, MSE-Section) TBD (U
 ree lubrication system - Vinay Sakhrani (Triboglide USA); US & EU regulatory perspectives on siliconization - Final speaker (CMC-FG, RS-S
 ree lubrication system - Vinay Sakhrani (Triboglide USA); US & EU regulatory perspectives on siliconization - Final speaker (CMC-FG, RS-S
 ree lubrication system - Vinay Sakhrani (Triboglide USA); US & EU regulatory perspectives on siliconization - Final speaker (CMC-FG, RS-S
 ree lubrication system - Vinay Sakhrani (Triboglide USA); US & EU regulatory perspectives on siliconization - Final speaker (CMC-FG, RS-S

                                                                                                

 ific and artificial promoters for effective gene therapy (Savio Woo, University of Pittsburgh) 




 . James Wilson, MD, PHD John Herr Musser Professor of Research Medicine, Professor, Department of Pathology and Laboratory Medicin




matter on tumor targetpenetration?;Amita Datta-Mannan Lilly Research Laboratories, Lilly Corporate Center, USA Improving FcRn binding a





Genentech, Inc.;
(4) Contribution of Excipients in Protein Degradation
Bruce A. Kerwin, PhD


               

                

                                                    


                                                                       
                   Amgen, Inc.;
(5) Panel Discussion

                                                                                           
           

                                                                                                       

                   





                                         

ein therapeutics – what needs the market?





 ime.
supply to third world countries



ke a difference in survival Speaker 4. TBA, BARDA Emerging Diseases rep) The Swine Flu, the CDC, NIH, BARDA and National Preparedne



will present the development of siRNA delivery vehicles using candidates identified from random screening of these libraries; Dr. Ian MacLac
                                                                                   

                                                                                   •

 and efficacy of protein therapeutics--Barry Cherney, or other FDA representative 
 Effect of visible particles on safety and efficacy—Tony M
ociation and its implication for in vivo performance (PK, PD, potency and efficacy)Novel self interaction nanoparticles to study weak protein in
icles in biopharmaceutical parenteral products - Impact of manufacturing5.TBD Speaker from FDA, Particles in biopharmaceutical parentera

     

     

                                                     

                                                            Title: ―High Throughput Biophysical Characterization of Monoclonal Antibodi
ent‖;
Vladimir Razinkov, Ph.D., Amgen Inc., Seattle, WA, USA

r Accumulation of Engineered Antibody Fragments In Tumor-Bearing Nude Mice


e 80-125 Rule In PKPD Comparability Analysis: what is It? Why Do We Need It? Can We Avoid It?




ent Interactions




he MSD Platform
 pproval Phase of Biotherapeutics




                       Novartis Pharmaceuticals Corporation Species SelectionLorinCurrent Guidance PK/PD of Biotherapeutics Perspect
            Jennifer Sims                     Anne Package:
                                  Preclinical SafetyPilaroFDA                 and RoskosMedImmune
                                                                  Nonclinical Development of Biologic Therapeutics: U.S. FDA

ng Products with Established Immunogenicity Profiles?
Case Study from the Clinic of the Impact of Immunogenicity: Eric Furfine, Ph.D., Senior Vice President, Research & Preclinical Development



ation of therapeutic oligonucleotides and metabolite identification by LC/MS.




ept Inc., he was in charge of the chemical and formulation development functions as well as pharmaceutical and bioanalytical method develo




gics and Biomarkers (Dr. Fabio Garofolo, Algorithme Pharma, CANADA)
and novel approaches. 6. Residual Protein A Analysis, speaker not identified.




                                                    
 Steven Martin (Pfizer, UK): Discuss DDIs for therapeutic proteins in combina
                                                     

                                                     

e P450–Mediated Drug Metabolism and Pharmacokinetics
5.





re AB (a GE Healthcare Company), Rapsgatan 7, 754 50 Uppsala, Sweden

s for site-specific drug delivery‖.
and Therapeutic Vaccines for HSV Infections‖.




FG, MSE-Section) TBD (USA); Preservative-free sterile products: Brian Rohrs (Bausch USA); Regulatory landscape of preservatives in pare
FG, MSE-Section) TBD (USA); Preservative-free sterile products: Brian Rohrs (Bausch USA); Regulatory landscape of preservatives in pare
FG, MSE-Section) TBD (USA); Preservative-free sterile products: Brian Rohrs (Bausch USA); Regulatory landscape of preservatives in pare
FG, MSE-Section) TBD (USA); Preservative-free sterile products: Brian Rohrs (Bausch USA); Regulatory landscape of preservatives in pare
 speaker (CMC-FG, RS-Section or FDA) TBD (USA)
 speaker (CMC-FG, RS-Section or FDA) TBD (USA)
 speaker (CMC-FG, RS-Section or FDA) TBD (USA)
 speaker (CMC-FG, RS-Section or FDA) TBD (USA)




                                                          

gy and Laboratory Medicine University of Pennsylvania, USA





 Improving FcRn binding and its impact on disposition and potential therapeutic application
A and National Preparedness for pandemics



e libraries; Dr. Ian MacLachlan will present siRNA pharmacokinetic and pharmacodynamic profiles for parenteral administration of siRNA for
                                                              

                                                              •

fety and efficacy—Tony Mire-sluis or Jennifer Mercer, Amgen
 Alternatives to manual inspection for visible particle assessment--Deborah S
es to study weak protein interactions (Peter Tessier)Talk by Peter Schuck
opharmaceutical parenteral products - Regulatory perspective

                              

ion of Monoclonal Antibodies‖.

Biotherapeutics
                                                                                        
Immunogenicity Considerations for Bioph
                                                                                         

& Preclinical Development, Adnexus, a Bristol – Myers Squibb R&D Company, UNITED STATES;






oanalytical method development, testing and outsourcing. He founded the Analytical Method Development Department and was the head of t




                                                                                          
 Speaker (To be identified) Preclinical Tool
                                                                                           

                                                                                           

eutic proteins in combination with immunosuppressant drugs targeting inflammatory diseases
6.

e of preservatives in parenteral drug products: Final speaker (CMC-FG, RS-Section or FDA) TBD (USA)
e of preservatives in parenteral drug products: Final speaker (CMC-FG, RS-Section or FDA) TBD (USA)
e of preservatives in parenteral drug products: Final speaker (CMC-FG, RS-Section or FDA) TBD (USA)
e of preservatives in parenteral drug products: Final speaker (CMC-FG, RS-Section or FDA) TBD (USA)
ministration of siRNA formulated in Techmira‘s oligonucleotide delivery system.
                                       
•
                                             

                                                                                       •

assessment--Deborah Shnek (Amgen)
 Visible inspection during manufacturing (US speaker)
 Identification and characterization of visible
Considerations for Biopharmaceuticals: Harald Kropshofer, Ph.D., Global Coordinator Immunosafety, F Hoffmann La Roche AG, SWITZERL




ent and was the head of the department at the AVENTIS Kansas City site for several years when he was promoted to the position of Aventis




dentified) Preclinical Tools and in vitro test systems to assess DDI potenial for therapeutic cytokine antagonists/cytokines in combination with
                                                                                                                      
•

characterization of visible particles in drug product (Scott Aldrich or Stefan Fischer/Roche or Gianni Torraca, Amgen)
 Proteinaceous partic
                         
In
                          

La Roche AG, SWITZERLAND;

 Vitro Immunogenicity Assessment: Thomas Kleen, Ph.D., Co-Founding Scientist, Director, Business and




o the position of Aventis Technology Transfer Liaison for North and South America and the UK. His experience in the pharmaceutica




                                          
 Honghui Zhou (Centocor): Exploratory Population PK approaches to assessing potential
                                          


kines in combination with small molecules 
7.

  
•
                                                                                                      

n)
 Proteinaceous particles and is it possible to have a particle free protein drug products? (Discussion) 

st, Director, Business and Technology Development, Cellular Techno




e pharmaceutica
           Session                       Sponsoring    Additional     Primary       Additional
  Status      #        Session Type        Section      Section     Focus Group    Focus Group
Accepted         16   Sunrise Session   MSE
Accepted         32   Short Course      FDD           MSE                          Generic Pharmaceuticals
                                                                    Modified Release
Accepted         35   Roundtable        APQ           RS            Bioanalytical Contract Research Organization (CRO)
Accepted         37   Mini-symposium    MSE           RS            Modeling & Simulation
Accepted         44   Sunrise Session   FDD           PPB           Excipients     Preformulation
Accepted         52   Symposium         FDD           MSE                          Lipid-Based Drug Delivery Systems
                                                                    Modified Release
Accepted         72   Roundtable        PPDM                        Drug MetabolismDrug Transport & Uptake
Accepted         74   Symposium         PPDM          APQ           Drug MetabolismDrug Transport & Uptake
Accepted         77   Roundtable        PPB           PPDM
Accepted         79   Symposium         AAPS/ACCP     PPDM                          Prodrug
                                                                    Biomarkers in Translational Medicine
Accepted         82   Symposium         APQ           RS            Bioanalytical Contract Research Organization (CRO)
Accepted         87   Symposium         PPDM          BIOTEC                        Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted         92   Short Course      PPDM          CPTR                          & Uptake
                                                                    Drug Transport Oral Absorption
Accepted         94   Roundtable        APQ           FDD                            & Dissolution Testing
                                                                    In Vitro ReleaseModified Release
Accepted         96   Roundtable        RS            PPDM          Bioequivalence Generic Pharmaceuticals
Accepted         97   Mini-symposium    FDD           PPB                           Prodrug
                                                                    Lipid-Based Drug Delivery Systems
Accepted         98   Roundtable        PPDM          CPTR                          Pharmacogenetics/Pharmacogenomics
                                                                    Pharmacogenetics/Pharmacogenomics
Accepted         99   Roundtable        MSE
Accepted        105   Short Course      APQ           FDD                            & Dissolution Testing
                                                                    In Vitro ReleaseModified Release
Accepted        108   Symposium         RS            FDD                           Bioequivalence
                                                                    Generic Pharmaceuticals
Accepted        112   Sunrise Session   CPTR          PPDM                          Population
                                                                    Special Population Studies Pharmacokinetics & Pharmac
Accepted        114   Roundtable        CPTR          PPDM                          Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        115   Symposium         CPTR          PPDM                          Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        118   Sunrise Session   PPDM          CPTR                          Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        119   Short Course      BIOTEC        PPB                           Prodrug
                                                                    Biomarkers in Translational Medicine
Accepted        120   Symposium         CPTR          PPDM                          Population
                                                                    Special Population Studies Pharmacokinetics & Pharmac
Accepted        125   Symposium         CPTR          PPDM                          Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        126   Symposium         CPTR          BIOTEC                        Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        129   Roundtable        FDD                         Preformulation Excipients
Accepted        133   Roundtable        CPTR          PPDM                          Biomarkers in Translational Medicine
                                                                    Modeling & Simulation
Accepted        152   Sunrise Session   FDD           MSE                           In
                                                                    Modified Release Vitro Release & Dissolution Testing
Accepted        171   Symposium         MSE           FDD           Sterile ProductsProcess Analytical Technology
Accepted        172   Sunrise Session   BIOTEC        MSE           Sterile ProductsExcipients
Accepted        181   Symposium         FDD           BIOTEC        Sterile ProductsProcess Development
Accepted        186   Roundtable        BIOTEC        PPB           Prodrug         Pharmacogenetics/Pharmacogenomics
Accepted        202   Symposium         FDD           MSE           Modified ReleaseLipid-Based Drug Delivery Systems
Accepted        205   Roundtable        SPOD Cmte
Accepted        206   Roundtable        PPDM                                         Population Pharmacokinetics & Pharmac
                                                                    Modeling & Simulation
Accepted        209   Symposium         FDD                         Inhalation and Nasal Technology
Accepted        210   Roundtable        CPTR          PPDM          Modeling & Simulation
Accepted        213   Symposium         BIOTEC        PPDM                           Bioequivalence
                                                                    Ligand Binding Assay Bioanalytical
Accepted        218   Roundtable        FDD                                          Nanotechnology
                                                                    Ocular Drug Delivery & Disposition
Accepted        220   Symposium         PPDM          CPTR                           Modeling & Simulation
                                                                    Population Pharmacokinetics & Pharmacodynamics
Accepted        223   Sunrise Session   FDD                         Ocular Drug Delivery & Disposition
Accepted        234   Roundtable        PPDM          BIOTEC                         & Uptake
                                                                    Drug Transport Drug Metabolism
Accepted        235   Roundtable        PPB           PPDM          Prodrug          Computational Drug Design
Accepted        238   Roundtable        APQ           FDD                             & Dissolution Testing
                                                                    In Vitro ReleaseModified Release
Accepted        240   Roundtable        DDD           BIOTEC        Intellectual Property
Accepted        246   Symposium         APQ           FDD           Nutraceutical In Vitro Release & Dissolution Testing
Accepted        258   Symposium         PPDM          CPTR          Drug Transport & Uptake
Accepted        259   Short Course      DDD           PPDM          Drug Metabolism  Drug Transport & Uptake
Accepted        293   Sunrise Session   BIOTEC                      Protein Aggregation and Immunogenicity
Accepted   294   Sunrise Session   PPDM        PPB                     & Uptake
                                                        Drug Transport Oral Absorption
Accepted   299   Roundtable        PPB         FDD      Preformulation Nanotechnology
Accepted   300   Roundtable        SPOD Cmte
Accepted   304   Roundtable        PPDM        RS       Drug Metabolism
Accepted   320   Symposium         PPB         FDD      Preformulation Excipients
Accepted   321   Roundtable        MSE         FDD                       Process
                                                        Process Development Analytical Technology
Accepted   322   Roundtable        DDD         BIOTEC                    Prodrug
                                                        Computational Drug Design
Accepted   324   Symposium         BIOTEC      DDD      Sterile ProductsModified Release
Accepted   334   Roundtable        BIOTEC      DDD                       Drug Metabolism
                                                        Pharmacogenetics/Pharmacogenomics
Accepted   349   Roundtable        CPTR        PPDM     Special Population Studies
Accepted   356   Roundtable        BIOTEC      APQ                       Contract Research
                                                        Ligand Binding Assay Bioanalytical Organization (CRO)
Accepted   357   Sunrise Session   PPDM        PPB      Prodrug          Computational Drug Design
Accepted   358   Sunrise Session   APQ         PPDM                      Animal Pharmaceutics
                                                        Non-clinical Dose Formulation Analysis& Technology
Accepted   360   Symposium         MSE         APQ                       Process
                                                        Process Development Analytical Technology
Accepted   363   Mini-symposium    DDD         CPTR     Intellectual Property
Accepted   365   Sunrise Session   DDD         PPDM                      & Uptake
                                                        Drug Transport Drug Metabolism
Accepted   368   Symposium         APQ         MSE                       Chemistry, Manufacturing, and Controls (
                                                        Process Analytical Technology
Accepted   371   Symposium         DDD                                   Natural Products Chemistry
                                                        Computational Drug Design
Accepted   374   Symposium         DDD         CPTR     Drug Metabolism
Accepted   385   Roundtable        PPB         FDD      Prodrug          Nanotechnology
Accepted   386   Roundtable        RS          APQ                       Chemistry, Manufacturing,
                                                        Contract Research Organization (CRO) and Controls (
Accepted   388   Symposium         PPDM        DDD      Drug Metabolism
Accepted   393   Sunrise Session   PPB         FDD      Preformulation
Accepted   396   Sunrise Session   PPDM        CPTR                      Population Pharmacokinetics & Pharmac
                                                        Modeling & Simulation
Accepted   403   Symposium         BIOTEC      APQ      Preformulation Process Development
Accepted   407   Symposium         RS          MSE                       Process Development
                                                        Chemistry, Manufacturing, and Controls (CMC)
Accepted   420   Sunrise Session   CPTR        PPDM                      Drug Metabolism
                                                        Pharmacogenetics/Pharmacogenomics
Accepted   421   Short Course      PPB         FDD
Accepted   422   Roundtable        RS          APQ
Accepted   423   Roundtable        PPB
Accepted   424   Roundtable        BIOTEC
Accepted   425   Roundtable        RS          APQ
Accepted   426   Symposium         PPB
Accepted   427   Symposium         FDD         RS       Excipients     Preformulation
Accepted   428   Symposium         PPB
Accepted   429   Symposium         APQ
Accepted   430   Symposium         PPB         APQ      Microdialysis Dermatopharmaceutics
Accepted   432   Open Forum        RS          APQ                    Process Development
                                                        Chemistry, Manufacturing, and Controls (CMC)
Accepted   439   Open Forum        APQ         RS
Accepted   440   Open Forum        PPDM
Accepted   443   Open Forum        CPTR
Accepted   444   Open Forum        BIOTEC      RS
Combined    13   Symposium         BIOTEC      CPTR                     Bioanalytical
                                                        Ligand Binding Assay Bioanalytical
Combined    30   Symposium         APQ         RS       Stability       Chemistry, Manufacturing, and Controls (
Combined    31   Symposium         APQ         FDD      Stability       Lipid-Based Drug Delivery Systems
Combined    38   Roundtable        RS          APQ      Stability
Combined    53   Symposium         RS          FDD      Excipients      Preformulation
Combined    88   Mini-symposium    APQ         RS                        & Dissolution Testing
                                                        In Vitro ReleaseChemistry, Manufacturing, and Controls (
Combined   130   Symposium         APQ         RS
Combined   135   Roundtable        RS          APQ                    Stability
                                                        Generic Pharmaceuticals
Combined   136   Symposium         APQ         RS       Stability     Generic Pharmaceuticals
Combined   139   Roundtable        RS          APQ      Stability     Contract Research Organization (CRO)
Combined   140   Sunrise Session   CPTR        PPDM                   Drug Metabolism
                                                        Pharmacogenetics/Pharmacogenomics
Combined   142   Sunrise Session   CPTR        PPDM                   Drug Metabolism
                                                        Pharmacogenetics/Pharmacogenomics
Combined   163   Roundtable        PPDM        PPB      Microdialysis Dermatopharmaceutics
Combined   174   Roundtable        FDD      MSE      Excipients      Preformulation
Combined   237   Short Course      PPB      FDD      Oral AbsorptionChemistry, Manufacturing, and Controls (
Combined   244   Symposium         MSE               Excipients
Combined   250   Roundtable        PPB      FDD      Preformulation Oral Absorption
Combined   269   Symposium         PPB      PPDM                     Microdialysis
                                                     Dermatopharmaceutics
Combined   278   Symposium         PPB      PPDM                     Microdialysis
                                                     Dermatopharmaceutics
Combined   297   Symposium         PPB      CPTR     Oral Absorption
Combined   303   Symposium         PPB      PPDM
Combined   308   Roundtable        FDD      APQ                     Stability
                                                     Chemistry, Manufacturing, and Controls (CMC)
Combined   314   Symposium         APQ      FDD      Stability      Chemistry, Manufacturing, and Controls (
Combined   316   Roundtable        PPB      FDD      Preformulation Oral Absorption
Combined   330   Roundtable        BIOTEC   APQ                     Contract Research
                                                     Ligand Binding Assay Bioanalytical Organization (CRO)
Combined   337   Symposium         APQ      RS                      Excipients
                                                     Chemistry, Manufacturing, and Controls (CMC)
Combined   338   Symposium         RS       APQ                     In Vitro Release & Dissolution Testing
                                                     Chemistry, Manufacturing, and Controls (CMC)
Combined   372   Symposium         PPB      FDD      Nanotechnology Oral Absorption
Combined   392   Short Course      PPB      FDD      Preformulation Stability
Combined   398   Symposium         PPB
Accepted    58   Roundtable        RS       APQ                     Stability
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected     5   Poster/Podium     FDD      PPB                     Contract Research Organization (CRO)
                                                     Modified Release
Rejected     6   Symposium         PPB      FDD                     Nanotechnology
                                                     Modified Release
Rejected     7   Symposium         BIOTEC   CPTR
Rejected     8   Sunrise Session   PPDM     DDD                      Drug Metabolism
                                                     Contract Research Organization (CRO)
Rejected     9   Symposium         DDD      PPDM                     & Uptake
                                                     Drug Transport Pharmacogenetics/Pharmacogenomics
Rejected    14   Mini-symposium    FDD      BIOTEC   Nucleic Acid Based Therapeutics
Rejected    15   Symposium         BIOTEC            Bioanalytical
Rejected    17   Symposium         APQ      PPDM     Bioanalytical
Rejected    19   Symposium         APQ      FDD      In Vitro Release & Dissolution Testing
Rejected    20   Symposium         BIOTEC            Bioanalytical Process Development
Rejected    21   Symposium         APQ      RS
Rejected    22   Symposium         FDD      MSE                     Process Development
                                                     Modified Release
Rejected    23   Short Course      APQ      PPDM     Bioanalytical Contract Research Organization (CRO)
Rejected    24   Roundtable        RS       PPDM                    Bioequivalence
                                                     Generic Pharmaceuticals
Rejected    25   Symposium         RS       FDD                     Bioequivalence
                                                     Generic Pharmaceuticals
Rejected    26   Short Course      FDD      MSE                     Modeling & Simulation
                                                     Modified Release
Rejected    27   Symposium         RS       APQ                     Process Development
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected    28   Symposium         RS       APQ                     Bioequivalence
                                                     Generic Pharmaceuticals
Rejected    29   Symposium         RS       APQ                     Process Development
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected    33   Sunrise Session   APQ      RS       Bioanalytical Contract Research Organization (CRO)
Rejected    34   Roundtable        RS       APQ      Stability
Rejected    36   Roundtable        MSE
Rejected    39   Roundtable        APQ      RS                        & Dissolution Testing
                                                     In Vitro ReleaseGeneric Pharmaceuticals
Rejected    40   Symposium         APQ      RS                       Excipients
                                                     Generic Pharmaceuticals
Rejected    41   Symposium         FDD      RS       Excipients      Nutraceutical
Rejected    42   Symposium         FDD      RS       Excipients
Rejected    43   Short Course      FDD      RS       Excipients      Chemistry, Manufacturing, and Controls (
Rejected    45   Symposium         APQ      FDD      Stability       Generic Pharmaceuticals
Rejected    46   Symposium         APQ      FDD      Bioanalytical Generic Pharmaceuticals
Rejected    47   Symposium         APQ      RS                       Generic Pharmaceuticals
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected    48   Symposium         APQ               Bioanalytical
Rejected    49   Symposium         APQ      PPDM     Bioanalytical Drug Metabolism
Rejected    50   Symposium         APQ      FDD                      Bioequivalence
                                                     Generic Pharmaceuticals
Rejected    55   Symposium         RS       FDD      Excipients      Generic Pharmaceuticals
Rejected    56   Symposium         BIOTEC            Bioanalytical Ligand Binding Assay Bioanalytical
Rejected    57   Symposium         BIOTEC   PPDM     Bioanalytical Ligand Binding Assay Bioanalytical
Rejected    59   Roundtable        RS
Rejected    60   Symposium         MSE      PPB                      Modeling
                                                     Process Development & Simulation
Rejected    61   Mini-symposium    DDD      PPB                      Excipients
                                                     Lipid-Based Drug Delivery Systems
Rejected    62   Mini-symposium    FDD               Oral Absorption
Rejected    64   Roundtable        PPB               Oral Absorption
Rejected    65   Roundtable        FDD               Oral Absorption
Rejected    66   Roundtable        APQ      PPB
Rejected    67   Poster/Podium     APQ               Animal Pharmaceutics & Technology
Rejected    68   Poster/Podium     APQ               Animal Pharmaceutics & Technology
Rejected    69   Symposium         BIOTEC   APQ                     Protein Aggregation
                                                     Ligand Binding Assay Bioanalytical and Immunogenicity
Rejected    71   Mini-symposium    BIOTEC   PPDM                    Lipid-Based Drug Delivery
                                                     Protein Aggregation and Immunogenicity Systems
Rejected    73   Symposium         BIOTEC   DDD                     Pharmacogenetics/Pharmacogenomics
                                                     Biomarkers in Translational Medicine
Rejected    75   Roundtable        DDD      CPTR
Rejected    76   Symposium         PPB      FDD
Rejected    78   Roundtable        BIOTEC   PPB                     Prodrug
                                                     Biomarkers in Translational Medicine
Rejected    80   Symposium         APQ      BIOTEC                  Bioanalytical
                                                     Ligand Binding Assay Bioanalytical
Rejected    81   Sunrise Session   PPB      PPDM     Prodrug        Protein Aggregation and Immunogenicity
Rejected    83   Sunrise Session   APQ      DDD      Bioanalytical Contract Research Organization (CRO)
Rejected    84   Short Course      PPDM     RS
Rejected    86   Poster/Podium     FDD      PPB                       Lipid-Based Drug Delivery Systems
                                                     Lipid-Based Drug Delivery Systems
Rejected    90   Symposium         CPTR     RS       Biomarkers in Translational Medicine
Rejected    91   Symposium         CPTR     RS       Biomarkers in Translational Medicine
Rejected    93   Symposium         RS       PPDM     Bioequivalence Generic Pharmaceuticals
Rejected    95   Symposium         PPDM     CPTR                      & Uptake
                                                     Drug Transport Animal Pharmaceutics & Technology
Rejected   100   Sunrise Session   DDD      PPDM                      Bioanalytical
                                                     Intellectual Property
Rejected   101   Symposium         MSE
Rejected   102   Short Course      PPDM     CPTR     Drug Metabolism Biomarkers in Translational Medicine
Rejected   103   Symposium         RS       APQ                      Process Development
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected   104   Roundtable        RS       MSE                      Process Development
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected   106   Symposium         APQ      RS                        & Dissolution Testing
                                                     In Vitro ReleaseBioequivalence
Rejected   107   Sunrise Session   PPDM     DDD                      & Uptake
                                                     Drug Transport Drug Metabolism
Rejected   109   Short Course      FDD      PPB      Excipients      Chemistry, Manufacturing, and Controls (
Rejected   111   Mini-symposium    DDD      PPDM     Drug Metabolism
Rejected   116   Roundtable        CPTR     RS       Biomarkers in Translational Medicine
Rejected   117   Symposium         MSE      FDD
Rejected   121   Roundtable        CPTR     PPDM                    Population
                                                     Special Population Studies Pharmacokinetics & Pharmac
Rejected   122   Short Course      CPTR     PPDM                    Population Pharmacokinetics & Pharmac
                                                     Modeling & Simulation
Rejected   123   Roundtable        FDD      PPDM     Oral AbsorptionLipid-Based Drug Delivery Systems
Rejected   124   Poster/Podium     PPDM              Prodrug
Rejected   127   Mini-symposium    FDD      MSE      Stability      In Vitro Release & Dissolution Testing
Rejected   128   Sunrise Session   MSE      FDD
Rejected   131   Symposium         PPB      FDD      Dermatopharmaceutics
Rejected   132   Roundtable        APQ      PPDM     Bioanalytical Ligand Binding Assay Bioanalytical
Rejected   134   Sunrise Session   RS       APQ      Stability     Generic Pharmaceuticals
Rejected   137   Symposium         RS       APQ                    Stability
                                                     Contract Research Organization (CRO)
Rejected   141   Symposium         APQ      RS                     Process Technology
                                                     Animal Pharmaceutics &Development
Rejected   143   Symposium         CPTR
Rejected   144   Roundtable        APQ      RS                     Stability
                                                     Contract Research Organization (CRO)
Rejected   145   Roundtable        CPTR
Rejected   146   Sunrise Session   DDD      PPDM     Prodrug        Drug Metabolism
Rejected   147   Roundtable        DDD      PPDM     Prodrug        Natural Products Chemistry
Rejected   148   Roundtable        DDD      BIOTEC   Prodrug        Nucleic Acid Based Therapeutics
Rejected   149   Symposium         FDD      PPB      Preformulation Chemistry, Manufacturing, and Controls (
Rejected   150   Symposium         APQ               Bioanalytical
Rejected   151   Symposium         BIOTEC   APQ                     Nucleic Acid Based
                                                     Ligand Binding Assay Bioanalytical Therapeutics
Rejected   153   Roundtable        PPB      PPDM                    & Uptake
                                                     Drug Transport Inhalation and Nasal Technology
Rejected   154   Short Course      FDD      MSE      Excipients     Modified Release
Rejected   156   Roundtable        CPTR     PPDM
Rejected   157   Symposium         CPTR     PPDM
Rejected   158   Symposium         PPDM
Rejected   159   Symposium         RS
Rejected   160   Roundtable        PPDM     CPTR     Microdialysis Drug Transport & Uptake
Rejected   161   Symposium         PPDM     CPTR     Microdialysis Modeling & Simulation
Rejected   162   Symposium         FDD                              Nanotechnology
                                                     Lipid-Based Drug Delivery Systems
Rejected   164   Symposium         APQ      RS       Chemistry, Manufacturing, and Controls (CMC)
Rejected   166   Symposium         CPTR     DDD      Pharmacogenetics/Pharmacogenomics
Rejected   167   Symposium         DDD      CPTR     Pharmacogenetics/Pharmacogenomics
Rejected   168   Symposium         CPTR     DDD      Pharmacogenetics/Pharmacogenomics
Rejected   169   Symposium         FDD      MSE                     Sterile Products
                                                     Nucleic Acid Based Therapeutics
Rejected   170   Symposium         MSE      FDD                     Chemistry, Manufacturing, and Controls (
                                                     Lipid-Based Drug Delivery Systems
Rejected   173   Roundtable        FDD      MSE      Excipients
Rejected   175   Sunrise Session   PPDM     CPTR     Drug MetabolismDrug Transport & Uptake
Rejected   176   Symposium         PPDM     CPTR     Drug MetabolismPharmacogenetics/Pharmacogenomics
Rejected   177   Roundtable        CPTR     PPDM     Pharmacogenetics/Pharmacogenomics
Rejected   178   Roundtable        CPTR     PPDM     Pharmacogenetics/Pharmacogenomics
Rejected   179   Sunrise Session   PPDM     CPTR     Drug MetabolismDrug Transport & Uptake
Rejected   180   Symposium         MSE      RS                      Excipients
                                                     Process Analytical Technology
Rejected   182   Mini-symposium    PPDM
Rejected   183   Symposium         DDD      PPDM     Nanotechnology  Ocular Drug Delivery & Disposition
Rejected   184   Symposium         FDD      MSE                      Excipients
                                                     Process Development
Rejected   185   Roundtable        PPB      PPDM     Prodrug         Drug Transport & Uptake
Rejected   187   Symposium         CPTR     PPDM                     Population Pharmacokinetics & Pharmac
                                                     Modeling & Simulation
Rejected   188   Symposium         CPTR     PPDM                     Population Pharmacokinetics & Pharmac
                                                     Modeling & Simulation
Rejected   189   Symposium         FDD      MSE      Sterile Products
Rejected   190   Sunrise Session   PPDM     DDD      Drug Metabolism Drug Transport & Uptake
Rejected   191   Symposium         CPTR     CPTR                     Population Pharmacokinetics & Pharmac
                                                     Modeling & Simulation
Rejected   192   Poster/Podium     CPTR     PPDM                     Population Pharmacokinetics & Pharmac
                                                     Modeling & Simulation
Rejected   193   Symposium         MSE      FDD
Rejected   194   Roundtable        FDD      APQ      Preformulation Oral Absorption
Rejected   195   Sunrise Session   APQ      BIOTEC                  Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   196   Sunrise Session   APQ      PPDM                    Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   197   Sunrise Session   APQ      BIOTEC                  Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   198   Roundtable        PPB      APQ                     Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   199   Roundtable        APQ      BIOTEC                  Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   200   Mini-symposium    PPB      APQ                     Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   201   Symposium         PPB      FDD      Prodrug        Modified Release
Rejected   203   Roundtable        PPDM     PPB      Oral AbsorptionDrug Transport & Uptake
Rejected   204   Roundtable        APQ      RS       Bioanalytical Ligand Binding Assay Bioanalytical
Rejected   207   Symposium         APQ
Rejected   208   Sunrise Session   PPDM              Drug Transport & Uptake
Rejected   211   Symposium         BIOTEC   PPDM                     Population Pharmacokinetics & Pharmac
                                                     Pharmacogenetics/Pharmacogenomics
Rejected   212   Symposium         PPB      RS       Nanotechnology
Rejected   215   Symposium         APQ      PPB      In Vitro Release & Dissolution Testing
Rejected   216   Symposium         CPTR     BIOTEC                   Bioanalytical
                                                     Ligand Binding Assay Bioanalytical
Rejected   217   Sunrise Session   APQ      BIOTEC                   Bioanalytical
                                                     Contract Research Organization (CRO)
Rejected   219   Symposium         FDD                               Sterile
                                                     Process Development Products
Rejected   221   Short Course      FDD      MSE      Preformulation Modified Release
Rejected   222   Sunrise Session   PPDM     CPTR                     Modeling & Simulation
                                                     Population Pharmacokinetics & Pharmacodynamics
Rejected   224   Roundtable        PPDM     CPTR     Population Pharmacokinetics & Pharmacodynamics
Rejected   225   Symposium         PPDM     CPTR                     Modeling & Simulation
                                                     Population Pharmacokinetics & Pharmacodynamics
Rejected   226   Symposium         FDD      BIOTEC
Rejected   227   Roundtable        PPB      FDD      Preformulation
Rejected   228   Symposium         FDD                              Sterile
                                                     Process Development Products
Rejected   229   Roundtable        APQ      BIOTEC   Bioanalytical
Rejected   230   Symposium         APQ      BIOTEC   Bioanalytical Ligand Binding Assay Bioanalytical
Rejected   231   Sunrise Session   FDD                              Sterile
                                                     Process Development Products
Rejected   232   Mini-symposium    CPTR     PPDM                    Biomarkers in Translational Medicine
                                                     Modeling & Simulation
Rejected   233   Sunrise Session   FDD                              Sterile
                                                     Process Development Products
Rejected   236   Roundtable        RS       FDD                     Generic Pharmaceuticals
                                                     Ocular Drug Delivery & Disposition
Rejected   239   Roundtable        DDD               Natural Products Chemistry
Rejected   241   Symposium         FDD      MSE                     Process Analytical Technology
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected   242   Symposium         PPDM              Drug Transport & Uptake
Rejected   243   Symposium         APQ      MSE                     Chemistry, Manufacturing, and Controls (
                                                     Process Analytical Technology
Rejected   245   Roundtable        FDD      PPB      Nanotechnology Chemistry, Manufacturing, and Controls (
Rejected   247   Symposium         BIOTEC
Rejected   248   Roundtable        APQ                               Ocular Drug Delivery & (CMC)
                                                     Chemistry, Manufacturing, and ControlsDisposition
Rejected   249   Roundtable        FDD      PPB                      Oral
                                                     Modified Release Absorption
Rejected   251   Symposium         FDD      MSE      Modified ReleaseLipid-Based Drug Delivery Systems
Rejected   252   Roundtable        PPB      FDD      Oral Absorption
Rejected   253   Symposium         APQ      DDD      Nutraceutical Natural Products Chemistry
Rejected   254   Roundtable        FDD      PPB                      Oral
                                                     Modified Release Absorption
Rejected   255   Symposium         FDD      APQ                      In
                                                     Modified Release Vitro Release & Dissolution Testing
Rejected   256   Mini-symposium    CPTR                              Special
                                                     Modeling & Simulation Population Studies
Rejected   257   Symposium         FDD      RS       Modified ReleaseExcipients
Rejected   260   Poster/Podium     PPDM                              Modeling & Simulation
                                                     Population Pharmacokinetics & Pharmacodynamics
Rejected   261   Poster/Podium     DDD      DDD      Preformulation Process Development
Rejected   262   Roundtable        CPTR     PPDM
Rejected   263   Roundtable        FDD      APQ      Excipients      Preformulation
Rejected   264   Symposium         BIOTEC   MSE      Bioanalytical Drug Metabolism
Rejected   265   Symposium         RS       CPTR                     Special Population Studies
                                                     Generic Pharmaceuticals
Rejected   266   Symposium         PPDM     FDD                      Population Pharmacokinetics & Pharmac
                                                     Animal Pharmaceutics & Technology
Rejected   267   Symposium         RS       CPTR                     Generic Pharmaceuticals
                                                     Special Population Studies
Rejected   268   Symposium         RS       PPDM                     Biomarkers in Translational Medicine
                                                     Pharmacogenetics/Pharmacogenomics
Rejected   270   Symposium         PPB               Dermatopharmaceutics
Rejected   271   Symposium         FDD      DDD                      Oral Absorption
                                                     Lipid-Based Drug Delivery Systems
Rejected   274   Symposium         RS       FDD                      Modified Release
                                                     Lipid-Based Drug Delivery Systems
Rejected   277   Symposium         PPB               Dermatopharmaceutics
Rejected   279   Symposium         CPTR     PPDM                     Pharmacogenetics/Pharmacogenomics
                                                     Population Pharmacokinetics & Pharmacodynamics
Rejected   280   Roundtable        DDD      PPB                      Prodrug
                                                     Computational Drug Design
Rejected   281   Symposium         RS       CPTR                     Modeling & Simulation
                                                     Population Pharmacokinetics & Pharmacodynamics
Rejected   282   Mini-symposium    MSE      FDD                      Process
                                                     Process Development Development
Rejected   283   Symposium         PPDM              Drug Metabolism Drug Transport & Uptake
Rejected   284   Roundtable        CPTR     PPDM     Special Population Studies
Rejected   285   Symposium         FDD      PPB      Stability       Oral Absorption
Rejected   286   Symposium         BIOTEC   RS                       Stability
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected   287   Symposium         PPDM     CPTR                     Computational Drug Design
                                                     Modeling & Simulation
Rejected   288   Symposium         CPTR     PPDM                     Population
                                                     Special Population Studies Pharmacokinetics & Pharmac
Rejected   289   Symposium         PPB               Dermatopharmaceutics
Rejected   290   Roundtable        APQ      MSE      Nutraceutical Process Analytical Technology
Rejected   291   Mini-symposium    PPDM              Drug Transport & Uptake
Rejected   292   Symposium         FDD      MSE      Sterile ProductsExcipients
Rejected   295   Sunrise Session   DDD      FDD                      Stability
                                                     Chemistry, Manufacturing, and Controls (CMC)
Rejected   296   Roundtable        PPB      APQ
Rejected   298   Symposium         PPB      FDD      Bioequivalence Modified Release
Rejected   301   Roundtable        PPB
Rejected   302   Roundtable        FDD      MSE
Rejected   305   Mini-symposium    BIOTEC                              Nanotechnology
                                                        Lipid-Based Drug Delivery Systems
Rejected   306   Roundtable        SPOD Cmte
Rejected   307   Sunrise Session   DDD         BIOTEC                   Prodrug
                                                        Computational Drug Design
Rejected   309   Symposium         CPTR                 Special Population Studies
Rejected   310   Roundtable        APQ                  Bioanalytical
Rejected   311   Symposium         BIOTEC               Protein Aggregation and Immunogenicity
Rejected   312   Symposium         FDD         MSE                      Excipients
                                                        Inhalation and Nasal Technology
Rejected   313   Mini-symposium    FDD         MSE                      Modified
                                                        Process Development Release
Rejected   315   Roundtable        DDD         BIOTEC   Computational Drug Design
Rejected   319   Symposium         PPDM                 Drug Transport & Uptake
Rejected   323   Short Course      BIOTEC      APQ                      Sterile Products
                                                        Protein Aggregation and Immunogenicity
Rejected   325   Symposium         CPTR        PPDM     Special Population Studies
Rejected   326   Roundtable        CPTR        PPDM                     Population Pharmacokinetics & Pharmac
                                                        Modeling & Simulation
Rejected   327   Roundtable        PPDM        CPTR     Modeling & Simulation
Rejected   328   Roundtable        DDD         BIOTEC                   Prodrug
                                                        Computational Drug Design
Rejected   329   Short Course      BIOTEC      RS       Protein Aggregation and Immunogenicity
Rejected   331   Symposium         FDD         PPB                      Excipients
                                                        Lipid-Based Drug Delivery Systems
Rejected   332   Sunrise Session   CPTR        PPDM                     Population Pharmacokinetics & Pharmac
                                                        Modeling & Simulation
Rejected   333   Roundtable        FDD                  Animal Pharmaceutics & Technology
Rejected   335   Roundtable        RS          MSE      Chemistry, Manufacturing, and Controls (CMC)
Rejected   336   Roundtable        BIOTEC      PPDM                     Bioanalytical
                                                        Ligand Binding Assay Bioanalytical
Rejected   339   Roundtable        BIOTEC                               Protein Aggregation and
                                                        Protein Aggregation and ImmunogenicityImmunogenicity
Rejected   340   Symposium         MSE         FDD      Process Development
Rejected   341   Roundtable        APQ
Rejected   344   Roundtable        APQ
Rejected   345   Roundtable        BIOTEC      APQ                      Bioanalytical
                                                        Ligand Binding Assay Bioanalytical
Rejected   346   Symposium         FDD         PPB      Inhalation and Nasal Technology
Rejected   347   Symposium         PPDM                                 & Uptake
                                                        Drug Transport Drug Metabolism
Rejected   348   Roundtable        PPDM
Rejected   350   Symposium         MSE         FDD                     Excipients
                                                        Process Development
Rejected   351   Symposium         PPDM        CPTR                    & Uptake
                                                        Drug Transport Drug Metabolism
Rejected   352   Roundtable        BIOTEC      APQ                     Contract Research
                                                        Ligand Binding Assay Bioanalytical Organization (CRO)
Rejected   353   Sunrise Session   DDD         BIOTEC                  Prodrug
                                                        Computational Drug Design
Rejected   354   Sunrise Session   DDD         BIOTEC   Computational Drug Design
Rejected   355   Symposium         MSE         FDD                     Process
                                                        Process Development Analytical Technology
Rejected   359   Symposium         APQ         PPDM     Bioanalytical Contract Research Organization (CRO)
Rejected   361   Symposium         PPDM                 Drug Transport & Uptake
Rejected   362   Roundtable        BIOTEC      RS       Bioequivalence Chemistry, Manufacturing, and Controls (
Rejected   364   Symposium         APQ
Rejected   366   Symposium         CPTR        BIOTEC                   Ligand Binding Assay Bioanalytical
                                                        Pharmacogenetics/Pharmacogenomics
Rejected   367   Sunrise Session   DDD         CPTR                     Drug Transport &
                                                        Inhalation and Nasal Technology Uptake
Rejected   369   Sunrise Session   DDD                  Computational Drug Design
Rejected   370   Roundtable        DDD         PPDM                     Drug Metabolism
                                                        Biomarkers in Translational Medicine
Rejected   373   Symposium         BIOTEC      APQ                      Bioanalytical
                                                        Ligand Binding Assay Bioanalytical
Rejected   375   Short Course      MSE         FDD      Excipients      Modified Release
Rejected   376   Short Course      DDD         CPTR                     Oral Absorption
                                                        Biomarkers in Translational Medicine
Rejected   377   Symposium         DDD         CPTR                     Nucleic Acid
                                                        Computational Drug Design Based Therapeutics
Rejected   378   Sunrise Session   DDD         PPDM     Oral AbsorptionDrug Transport & Uptake
Rejected   379   Roundtable        APQ                  Bioanalytical Drug Metabolism
Rejected   380   Sunrise Session   MSE                                  Process Development
                                                        Process Analytical Technology
Rejected   381   Roundtable        CPTR        PPDM                     Population Pharmacokinetics & Pharmac
                                                        Modeling & Simulation
Rejected   383   Roundtable        CPTR        PPDM                     Biomarkers in Translational Medicine
                                                        Pharmacogenetics/Pharmacogenomics
Rejected   384   Roundtable        MSE                                  Process Development
                                                        Process Analytical Technology
Rejected   387   Roundtable        PPDM        RS       Prodrug
Rejected   389   Symposium         FDD         PPB
Rejected   390   Symposium         FDD         BIOTEC       Sterile ProductsExcipients
Rejected   391   Roundtable        MSE                      Process Analytical Technology
Rejected   394   Symposium         CPTR        PPDM                         Special
                                                            Modeling & Simulation Population Studies
Rejected   395   Symposium         PPB         FDD          Preformulation Contract Research Organization (CRO)
Rejected   397   Roundtable        PPB         FDD
Rejected   399   Roundtable        CPTR        DDD                         Inhalation and Nasal Technology
                                                            Population Pharmacokinetics & Pharmacodynamics
Rejected   400   Symposium         FDD         PPB          Preformulation Sterile Products
Rejected   401   Roundtable        DDD         PPB                         Prodrug
                                                            Computational Drug Design
Rejected   402   Symposium         PPDM                                    Biomarkers in Translational Medicine
                                                            Modeling & Simulation
Rejected   404   Symposium         BIOTEC      PPB          Preformulation Protein Aggregation and Immunogenicity
Rejected   405   Sunrise Session   DDD
Rejected   406   Mini-symposium    DDD         BIOTEC       Preformulation Sterile Products
Rejected   408   Symposium         RS          APQ                         Chemistry, Manufacturing, and Controls (
                                                            Process Analytical Technology
Rejected   409   Symposium         BIOTEC      RS
Rejected   410   Symposium         CPTR        PPDM                       Special Population Studies
                                                            Drug Metabolism
Rejected   411   Symposium         BIOTEC      RS
Rejected   412   Roundtable        PPB         FDD          Oral AbsorptionBioequivalence
Rejected   413   Mini-symposium    BIOTEC
Rejected   414   Mini-symposium    BIOTEC
Rejected   415   Roundtable        MSE         APQ                         Process Development
                                                            Process Analytical Technology
Rejected   416   Mini-symposium    BIOTEC
Rejected   417   Mini-symposium    BIOTEC
Rejected   418   Mini-symposium    BIOTEC
Rejected   419   Symposium         RS                       Chemistry, Manufacturing, and Controls (CMC)
Rejected   431   Open Forum        PPDM
Rejected   433   Open Forum        FDD         PPB                         Nanotechnology
                                                            Modified Release
Rejected   434   Open Forum        MSE
Rejected   435   Open Forum        BIOTEC                Ligand Binding Assay Bioanalytical
Rejected   436   Open Forum        MSE         FDD                      Inhalation and Nasal Technology
                                                         Process Development
Rejected   437   Open Forum        BIOTEC      RS
Rejected   438   Open Forum        AAPS/ACCP   AAPS/ACCP Nanotechnology
Rejected   441   Open Forum        BIOTEC
Rejected   442   Open Forum        PPB         PPB          Bioequivalence Generic Pharmaceuticals
               Additional  Additional
              Focus Group Focus Group          Session Title                           Session Description
                                                                     Reliable sterility assurance through sterile filtration of liquid products i
                                        Sterile Filtration -Principles and Case Studies
 eric Pharmaceuticals                                                The Delivery
                                        Recent Advances in Oral Drug program focus is on new technologies and various aspects of for
 ract Research Organization (CRO)                                    Sunrise in Lc-Ms/ms Bioanalytical Methods
                                        Evaluation of the Regression Type Session Proposal supported by Contract Research Organizat
                                                                     A key
                                        Role of Models in Design Space element of the Quality by Design (QbD) paradign of drug develo
                                                                      Using Excipients for Drug Testing in Early Tox Studies
                                        Practical Considerations inDrug candidates are becoming more challenging to formulate in early
 -Based Drug Delivery Systems                                        The advent of high throughput screening in the drug discovery proces
                                        Hot-Melt Extrusion: a Novel Oral Solids Processing Technology
   Transport & Uptake                                                Prediction of drug-drug Interactions
                                        In Vivo Animal Models for Prediction of Drug-Drug interactions from in vitro studies is difficult. Co
   Transport & Uptake                                                Proteins are intimately responsible for modulating
                                        Pharmacoproteomics: Targeted Absolute Quantitative Proteomics in ADME drug disposition, as
                                                                     Finding a safe and effective compound amongst the hoards of availab
                                        Predicting Oral Drug Absorption: Fiction and Facts
                                                                     Recent implementation for Treating Diseases in 0-4 from the labels
                                        Aaps/accp Joint Symposium: Strategic Biomarkersof removing children agesYounger Children S
 ract Research Organization (CRO)                                    Symposium Proposal supported by Contract Bioanalysis
                                        Impact of Unstable Metabolites During Drug Quantification in RegulatedResearch Organization a
ulation Pharmacokinetics & Pharmacodynamics                          Pharmacokinetic-Pharmacodynamic (PKPD) modeling is being increa
                                        Mechanism-Based Pkpd Modeling: its Role in Discovery and Early Development of Biologics
                                                                     It is widely recognized that membrane transporters play an important
                                        Transporter Mediated Drug-Drug Interactions: Possible Criteria that Warrant In Vivo Transporter
  fied Release                                                       In vitro release dissolution testing plays a dual role in the drug develop
                                        Ivivc for Establishing Clinically Relevant Specifications
 eric Pharmaceuticals                                                The Challenges in Global Drug Development and Harmonization
                                        Bioequivalence Requirements: pharmaceutical drug industry has become increasingly global. Bio
                                                                     Lipid-drug complexes arise from non-covalent association of a drug w
                                        Intestinal Delivery of Lipidic Drug Complexes and Conjugates : Case Studies
 macogenetics/Pharmacogenomics                                       This
                                        First Time in Human Dosing roujnd table discuss the rational approach of desing regimen in f
                                                                     This symposium will focus on the ever increasing
                                        Critical Role of CMC-Project Management in the Drug Development Processcomplexity of the pr
  fied Release                                                       Abstract: Biorelevant dissolution testing on QbD
                                        Developing Biorelevant Dissolution Test Methods with an Emphasisis playing a critical role in gui
                                                                     With the Establish Pharmaceutical Equivalence and Bioequivalence
                                        Using Quality-by-Design Principle toadvances in pharmaceutical science and technology, there is
                                                                     Background
Determining the most appropriate dose for a new pharm
                                                                                     

ulation Pharmacokinetics & Pharmacodynamics Story of the Three Bears: Too Big, 
 Small, Just Right! Size Issues in Drug Development
                                        The                                         Too
                                        Evaluating Fit-for-Purpose Disease/PK/PD/Trial or Controversy being increasingly used to aid d
ulation Pharmacokinetics & Pharmacodynamics                           Models. Consensus Models are now
                                        Using                        Obesity has reached Dose Regimens for Obese Patients
ulation Pharmacokinetics & Pharmacodynamics Modeling and Simulation to Safely Adjust epidemic proportions worldwide. Obesity presen
                                        Physiologically Based Pharmacokinetic Modeling:To discuss and generic framework ofDiscovery
ulation Pharmacokinetics & Pharmacodynamics                          Goals and Objectives: Concepts the Applications in Drug physiolog
                                                                     The use of oligonucleotides as therapeutic agents has elicited a great
                                        Rna-Targeting Therapeutics: Issues and Advances
                                                                     Development 
 FDA Guidance for Industry for the study of drugs li
                                                                                    
 The
ulation Pharmacokinetics & Pharmacodynamics Graying Globe -Drug Background
in the Elderly
                                        The
                                        Leveraging Prior Quantitative Knowledge in Guiding Pediatric renewed their call for innovative m
ulation Pharmacokinetics & Pharmacodynamics                          The FDA and EMEA have recently Drug Development
                                        The                          Goals and Objectives: 1. To better understand how Adaptable, and E
ulation Pharmacokinetics & Pharmacodynamics Modeling and Simulation Frontier: Multi-Level, Multi-Scale, Multi-Attribute,multi-level, multi-s
                                                                     Study of drug excipient interactions provides the basis for the design o
                                        Role of Excipient Impurities in Drug-Excipient Interactions
markers in Translational Medicine                                     in the Value of is intended 1 Studies to address the following contro
                                        Myths and MisconceptionsThis roundtable Early Phaseto specificallyPredict Risk of QT Prolonga
 tro Release & Dissolution Testing                                   Inflammatory bowel a Case can affect both the small Temporal Gast
                                        Innovative Colonic Drug Delivery Systems with disease Study in Formulation and and large intest
 ess Analytical Technology                                           Freeze-drying is a preferred and established way of stabilizing molecu
                                        Freeze-Drying of Biologics/small Molecules: Case Studies that Touch on Formulation, Process a
                                                                     Approaches to freeze-dried formulations are often empirical or semi-e
                                        Rational Design of a Freeze-Dried Formulation for a Biologic
 ess Development                                                      Combination Products
                                        Advances in the Injectable This symposium will cover technical and regulatory advances in the in
 macogenetics/Pharmacogenomics                                       It has been increasingly evident that
                                        Latest Developments of Drug Targeting to Cancer Stem Cells cancer probably be initiated from
 -Based Drug Delivery Systems                                        Full Description:Sustained-release (SR) oral
                                        Novel Sustained Release Formulation Techniques with Lipid Excipients drug delivery is of great i
                                                                     There is a growing demand for pharmaceutical
                                        Individualizing a Postdoctoral Position Based on your Career Aspirations and biomedical scient
                                        Facilitating the Transition to Model-Based Drug Development
ulation Pharmacokinetics & Pharmacodynamics                          Roundtable: Facilitating the Transition to Model-Based Drug Developm
   Technology                                                        Discovery and development of inhaled lung-targeted
                                        Pharmacokinetic-Pharmacodynamic Aspects of Inhaled Lung-Targeted Agents therapeutic agen
                                                                     • The unique complexities associated with the
                                        Translational Challenges in Pk/pd/td of Biotechnology-Derived Products PK and PK/PD of biote
                                                                     Ligand Binding PK Assays frequently introduced during the Assessm
                                        Impact of the Variability of Manufacturing changes areon the Outcome of Comparability lifecycles
                                                                     ―Nanoparticle‖ has been a drug delivery buzz word for years, yet the te
                                        Nanoparticles – are They Ever Going to Amount to Anything?
 eling & Simulation                                                  Discussing pros and and of some of the emerging methods and softw
                                        Pros and Cons of Emerging Methods in Pop PKcons Exposure/response Analysis
y & Disposition                                                       Delivery and models for
                                        Modeling Ophthalmic DrugSophisticated Disposition ocular drug disposition are becoming availab
   Metabolism                                                        Therapeutic proteins (cytokines, interleukins, and monoclonal antibod
                                        Biotherapeutics and Modulation of Drug Transporters
  putational Drug Design                                             The identification and and Clinical of new drug candidates Stories"o
                                        Optimization of Systemic Exposure in Preclinical developmentDevelopment: "Success with a des
  fied Release                                                        Extend Roundtable that is design Products
                                        Alcohol Dose Dumping for This is aRelease Solid Oral Dosageto stimulation discuss and question
                                                                     Regarding been continuous changes implemented by the Claims‘, a
                                        Navigating the New Rules There havePatents Law: Decodifying ‗obviousness‘, ‗limitedUS PTO to
 tro Release & Dissolution Testing                                   The complexity of Testing Nutraceuticals, in herbal dietary and Trad
                                        Challenges and Application of Dissolution for phytochemical mixtures Natural Productssuppleme
                                                                     ATP Binding Cassette Tissue Defense and Organ Regeneration
                                        The Role of Atp Binding Cassette Transporters in(ABC) transporters are membrane proteins pre
   Transport & Uptake                                                The main goal Interface Process
                                        Learning the Drug Discovery and Deliveryof this Short Course is to provide scientists with an ove
 and Immunogenicity                     Protein-Based Vaccines An introduction to protein-based vaccines platform and the challenges
                                                                       This sunrise session will provide up to date information on the state o
                                          Humanized Transgenic Transporter Models-Update on State of the Art
                                                                       In the past the most common approach was How to Pick the Winner
                                          Salts, Cocrystals, Polymorphs/solvates, Nanoparticles, or Amorphous: to choose the most stabl
                                                                       Pharmaceutical industry and academia provide the most common em
                                          Paths Less Traveled: Opportunities for Pharmaceutical Scientists Beyond Industry and Academi
                                                                       This session is Approaches for the FDA Guidance
                                          To Test or Not to Test? Risk Assessment intended to takeHuman Metabolites on Metabolite in S
                                                                       Many common and others Fail
                                          Excipient Variability: Why some Lots Passmacromolecular excipients such as celluloses are der
 ess Analytical Technology                                             Lean manufacturing is to Improve the efficiency. Efficiency of Pharm
                                          The Application of Lean Manufacturing Principles a philosophy of Quality and By applying Lean pr
                                                                       The talks for Drug Discovery and Development? Current State of the
                                          What Can Computational Design Doin this roundtable session give a brief overview of drug disco
 fied Release                                                           Advances & Challenges in Pegylation and a significant proportion of
                                          New Frontiers in Biologics:Biotechnology derived drugs have become Alternatives to Pegylation
  Metabolism                                                           Pharmacogenomics has emerged as an important tool
                                          Impact of Pharmacogenomics on Drug Development: an Industrial Perspective for discovering
                                                                       Women were Drug excluded from clinical research due to liability co
                                          Inclusion of Women in Clinical Trials andinitiallyDevelopment -How Far Have We Gone
 ract Research Organization (CRO)                                      With of increasing number of macromolecular therapeutic candidate
                                          Strategies for the Determinationthe a Robust Cut Point in Immunogenicity Assays: Impact of Imm
 putational Drug Design                                                  of Early Human Dose Predictions: Getting parameters in humans
                                          Eliminating the GuessworkThe accurate prediction of pharmacokinetic it Right the First Time! an
mal Pharmaceutics & Technology                                         There seems to be a never ending interest on how Go? Gmp or Glp?
                                          Dosage Form Release Testing for Non Clinical Studies-How Far We Have to to qualify or what t
 ess Analytical Technology                                             What can the pharmaceutical industry learn about process developme
                                          What Can the Pharmaceutical Industry Learn About Process Development and Manufacturing fr
                                                                          takes too
                                          Repurposing Old Drugs forItNew Uses long and costs too much to bring new drugs to market. De
  Metabolism                              The Blood Brain Barrier Pharmacokinetic assessment in early drug discovery is now a commo
                                                                       Process Analytical Chemometrics in Applied Chemometrics in Monito
mistry, Manufacturing, and Controls (CMC) Process Analytical Technologies and Applied Technologies and Monitoring Crystallization of Api
 ral Products Chemistry                                                In the quest for new chemical entities and new drugs to treat Drug De
                                          State of the Art Approaches to Drug Design: Case Studies of Successful Applications ofdiseases
                                                                       Longer development times, costly late-stage by Applying Rational Dru
                                          Toxicological Considerations in Early Drug Discovery: Avoiding Failuresfailures and recent withd
                                                                       The method of delivery plays an important role
                                          Tumor Targeting Using Nanotechnology-Based Drug Delivery Systems in ensuring that the dru
                                                                       In this session we share the expereinces of FDA
mistry, Manufacturing, and Controls (CMC) How to Face and Successfully Defend FDA and Other Regulatory Audits officers and clients e
                                                                       Safety-related issues continue
                                          Reactive Metabolites in Drug Discovery and Developmentto significantly contribute to overall attr
                                                                       Too many variables to control in your experiments? What is the optim
                                          Solve your Problems in a Smarter Way: Use Design of Experiments
                                          Today, Tomorrow and Beyond: Approaches and Challenges a comprehensive summary of empi
ulation Pharmacokinetics & Pharmacodynamics                            Goals and Objectives: To provide in Modeling Pharmacodynamic Effe
 ess Development                                                       Pharmaceutical industry is facing rising challenges of enormous drug
                                          Leaner Development Strategies to Enrich Drug Pipeline
 ess Development                                                       Critical Quality the right and Critical Process Parameters in Success
                                          Regulatory Significance of Identification of Attributescritical quality attributes (CQA) of pharmaceu
  Metabolism                              Please Create New Title Dear Majid,The two sessions (Clinical Applications of Pharmacogenet
                                                                       Hello,Please work together to organize the session details.
                                          Rational Design and Development of Solid Dispersions with Amorphous Drug for Improving Oral
                                          Please Create New Title Please work together to combine all proposals into one.
                                          Please Create New Title Please work together to creat new session information, utilizing both o
                                          Please Create New Title Dear Session Organizers,Please work together to combine/create new
                                          Please Create New Title Session Organizers,Please work together to create new session deta
                                          Please Create New Title Dear Session organizers,Please work together to create new session
                                          Please Create New Title Dear Session Organizers,Please work together to create new session
                                          Please Create New Title Dear Session Organizers,Please work together to creat new session d
                                                                       Dear Session Organizers,Please work together to and new session d
                                          Effective Stability Strategies for Evaluating QbD Design Space and Scientific creatRisk-Based Ap
matopharmaceutics                                                      Dear Session Organizers,Please work together to creat
                                          Microdialysis Role in the Development and Optimization of Drug Topical Delivery new session d
 ess Development                                                       Controlling the quality of medicines is one of the critical aspects of ass
                                          Global Regulatory Challenges for Genotoxic Impurities
                                                                       Counterfeits have penetrated our global marketplace, compromising t
                                          Analytical Challenges in Detecting and Preventing Counterfeits in Global Environment
                                          An Evolution or RevolutionCritical aspects and fundamentals for understanding
                                                                        in Drug Metabolism: When, Where, Why, What, How?
                                          Adequacy of PK/PD ModelAs PK/PD modeling (M) and clinical trial simulation (S) are becoming
                                                                        Validation and Simulation
                                                                       As global sales for Future products
                                          Biosimilars-Development Considerations and biologicDirections is on the rise, this market represe
                                                                       Theme/Background:In May
                                          My Incurred Sample Reanalysis Failed...now What? of 2006, at Crystal City III in Arlington, VA
                                                                       In 2003 the to Api and Drug Product Stability guidance document out
mistry, Manufacturing, and Controls (CMC) Scientific and Risk-Based Approaches ICH endorsed Q1A(R2), a quality to Support Clinical and R
 -Based Drug Delivery Systems                                          This session will discuss the use of alternate Formulations
                                          Alternate Stability Conditions for the Rapid Development of Challenging accelerated conditions a
                                                                       Pharmaceutical Shelf-Life are faced with Clinical Studies
                                          Challenges with Establishing Drug Product companiesfor World-Wide substantial regulatory ame
                                                                       Excipients facilitate manufacture,
                                          How Does Excipient Functionality Apply in a QbD World? enhance or support stability, and/or
                                                                       This symposium
mistry, Manufacturing, and Controls (CMC) Dissolution Testing of Blinded Comparatorswill share both industry experience and regulatory pe
                                                                       This session intends to bring experts from the health authority and the
                                          QbD Approach to Analytical Research and Development
                                                                       Comparator products Products
                                          Development Strategies for Testing Comparator play a significant role in the drug development p
 eric Pharmaceuticals                                                  Based degradation studies
                                          Predicting Product Quality Forced on Stress Studies and stress studies are conducted to gain
 ract Research Organization (CRO)                                      In current Products Globally
                                          Challenges in Developing New Drug environment, API and drug products are manufactured, pac
  Metabolism                                                           Level of presentation: Basic to IntermediateThe level of the sunrise is
                                          Clinical Applications of Pharmacogenetics
  Metabolism                                                             of Clinical Medicine
                                          Pharmacogenomics Tools Level of presentation: Basic to intermediateThe level of the sunrise is
matopharmaceutics                                                      The rapid and efficient development and evaluation
                                          Microdialysis in the Development and Optimization of Topical Drug Delivery of topical delivery
                                                                        QbD World
                                          Excipient Functionality in aExcipients facilitate manufacture, enhance or support stability, and/or
                                                                       It Dispersions for Improving Oral Absorption of chemical entities (NC
mistry, Manufacturing, and Controls (CMC) Amorphous Solids and Solidhas been estimated that over 50% of the new Poorly Soluble Drugs
                                                                       Excipients for Global Applications
                                          Managing the Use of New The objective of this proposed symposium is to increase awareness a
                                                                       Discussions on recent exploration of amorphous pharmaceutical solid
                                          Characterization of Amorphous Pharmaceutical Solids and Solid Dispersions
                                                                       Cutaneous and Optimization of Drug Topical Delivery
                                          Microdialysis Role in the Developmentmicrodialysis provides a tremendous tool to optimize drug
                                                                       Cutaneous and Optimization of Drug Topical Delivery
                                          Microdialysis Role in the Developmentmicrodialysis provides a tremendous tool to optimize drug
                                                                       In recent years, finding a Well to Bridge Preclinical Data to Predict a
                                          Serving as an Interface -what is Required and How safe and effective compound has becomeHu
                                                                       Absorption to Human: Understanding and Practice.
                                          Extrapolation from Animal Screening, optimizing and understanding of the in vivo performance o
                                                                       Controlled temperature shipping of commercial pharmaceutical produ
                                          Strategies for Controlled Temperture Shipping of Clinical Supplies and Commecial Products
                                                                       This Evaluating will Design Space
mistry, Manufacturing, and Controls (CMC) Effective Stability Strategies for symposiumQbDdiscuss strategies and case studies for effective
                                                                       This proposed symposium will focus on the fundamental understandin
                                          Structure, Relaxation and Molecular Dynamics: Toward the Fundamental Understanding of the G
ract Research Organization (CRO)                                       Typically to matrix spiked controls
                                          ISR Failure Investigation: Strategiesthe Avoid the Quagmire. at low, medium and high concentr
                                                                       Quality by Product Variability -Excipient Functionality Testing by Co
                                          Characterization and Control of Drug Design (QbD) is a concept that has been embracedandthe
tro Release & Dissolution Testing                                      Global Sourcing of Comparators for later phases of development (Ph
                                          Regulatory Challenges for Conducting global clinical studiesfor Use in Clinical Studies
                                                                       In recent years, in the Development of Oral Dosage Forms for of nan
                                          Application of Nanoparticulate Technology there has been much interest in the applicationPoorly
                                                                       The increase in the number of
                                          Characterization and Stability of Amorphous Dispersions poorly soluble drugs in pharmaceutical
                                                                       The structure and properties of nanoparticles can
                                          Route-Specific Nanoparticle Design: Impact on Drug Product Performance be finely tailored to
                                                                       An open Post-Approval Regulators from North America and Europe
                                          Impact of Changing Regulations on discussion withCMC Changes: U.S. and E.U. Perspectives w
ract Research Organization (CRO)                                       The rapidly developing for of ―Smart‖ polymeric materials, which res
                                          Recent Advances in Stimuli-Responsive Polymersfield Controlled Drug Delivery
                                                                       The rapidly developing for of ―Smart‖ polymeric materials, which res
                                          Recent Advances in Stimuli-Responsive Polymersfield Controlled Drug Delivery
                                                                       The past decade Development of Antibody Drug Conjugates (Adc)
                                          Clinical Pharmacology Considerations in thehas seen a significant progress in the development
  Metabolism                                                           The addition Studies
                                          Use of Radiotracers in Early Human PKof nano Curie amounts of 14C to early clinical trials enab
macogenetics/Pharmacogenomics                                          Purpose/ Impact: and export pumps are encoded by
                                          ABC Transporters: Regulation of ExpressionABC Pharmacological Significance ~48 human gen
Therapeutics                                                           Successful
                                          Development of DNA Therapeutics development of DNA therapeutics remains to be a challen
                                                                        Assays
                                          Interference in PK and AtaScope: There are multiple types of molecules found in serum and plas
                                                                       Describe the current challenging business conditions for bioanalysis a
                                          The Commoditizing Bioanalytical Business
issolution Testing                                                     With the in Dosage Form Development
                                          Applications of Imaging Technologyincreased use of imaging technology, a greater understandin
ess Development                                                        The Biopharmaceuticals
                                          Advances in Lc/ms Analysis of requirements for bio-therapeutic characterization are stringent du
                                                                       Drug counterfeiting is becoming a Infringement
                                          Mitigating Pharmaceutical Counterfeiting and Process Patentmore a more significant issue to the
ess Development                                                        There is a Solid Formulation minimize consumption of drug substanc
                                          Drug Sparing Scaleable Strategies in continuing drive to Development
ract Research Organization (CRO)                                       In Development for Bioanalytical Program
                                          Lc-Ms/ms and Uplc Methods developing bionalaytical methods careful selection of analytical met
                                                                       Over the decades, concerns have been expressed and recognized re
                                          Use of Scaled Average Bioequivalence Approach for Highly Variable Drug Products
                                                                       Many inhaled drug products such as Inhaler and Metered Dose Inha
                                          Recent Progress in Bioequivalence Assessment for Dry Powderdry powder inhalers (DPI) and m
eling & Simulation                                                      Qulity-by-Design FDA‘s initiative of Quality by
                                          Mathematical Tools for theImplementation ofof Modified Release ProductsDesign (QbD) requires
ess Development                                                        Although ICH Q8 Expect ICH Q11 to Change Api Development and R
                                          How Do Industry and Regulatory Authorities (Pharmaceutical Development) and the ICH Q8 Ann
                                                                       In
                                          Biowaivers: When and How? vivo bioavailability (BA) or bioequivalence (BE) studies are generall
ess Development                                                        Controlling the quality of medicines is just as important as demonstrat
                                          Global Regulatory Challenges for Genotoxic Impurities
ract Research Organization (CRO)                                        Effect Session Proposal
                                          Impact of Lc-Ms/ms MatrixSunrisein Glp Bioanalysis supported by Contract Research Organizat
                                                                       Outsourcing - the current mantra of pharmaceutical industry - is being
                                          Advantages and Disadvantages to Outsourcing Analytical Testing Abroad
                                                                       This roundtable would bring together some Here?
                                          The Future of Pharmaceutical Manufacturing -Where Do We Go from stalwarts in the field of pha
eric Pharmaceuticals                                                   The calibration of dissolution testers for stood the test of time for dec
                                          Performance Verification of Dissolution Testers :-the Challengehas the Industry with Conflicting R
                                                                       USP is replacing the OVI chapter with residual solvent chapter<467>.
                                          Impact Current us and European Regulations on Analysis and Qualification of Residual Solvents
                                                                        Raw Materials: Apis, Excipients and Adulteration
                                          Integrity of PharmaceuticalRecent events concerning glycerin, pet food, heparin and milk have s
                                                                       Safety
                                          Counterfeiting and Patient Counterfeiting has become a serious problem in many parts of the wo
                                                                       In the current environment Case Studies
mistry, Manufacturing, and Controls (CMC) Managing Excipient Functionality: Considerations andof risks assessments and quality by design
eric Pharmaceuticals                                                   To lower rising in the Fast Paced Drug Development Based doing eve
                                          Role of Automation of Analytical Methods healthcare costs pharamaceutical industry is on QbD.
eric Pharmaceuticals                                                   Analytical Update and Current Industry Trend
                                          Analytical Instrument Qualification aninstruments are essential tools for the pharmaceutical indus
eric Pharmaceuticals                                                   Sub-standard and counterfeit medicines
                                          Quality Assurance of Medicines and the Detection of Counterfeits are a great threat to public he
                                                                       Metabonomics or metabolomics is Metabolite how the endogenous s
                                          Technological Advancements for Endogenous and Xenobioticthe study of Identification and Quan
  Metabolism                                                           Safety Testing of Drug Metabolites: LC-MS
                                          Safety Testing of Drug Metabolites: Lc-Ms Solutions and Challenges Solutions and Challenges
                                                                       About 20 billion dollar
                                          Generic Drugs:-Challenges and Opportunities worth of branded drug will be coming off patent
eric Pharmaceuticals                                                   The
                                          Global Excipient Supply Chain pharmaceutical global environment is changing rapidly and the aw
nd Binding Assay Bioanalytical                                         Protein therapeutics are capable of inducing an antibody response tha
                                          Immune Complexes with Biological Therapeutics: Formation, Distribution, Disposition
nd Binding Assay Bioanalytical                                         Detection Specific Reactivity: Alternative to be hindered by the prese
                                          Measuring B and T Cells for Antigen of anti-drug antibodies (ADA) can Immunoassays for Anti-D
                                                                       A brief overview of the regulations in North America
                                          Internation Regulations and Processes for Pediatric Development Programs and Europe regar
 eling & Simulation                                                   Roller Roller Compaction Process Using First Principles
                                          Understanding and Modelling thecompaction has gained increasing importance in the pharmace
                                                                      The purpose of this symposium is to share an academic and Soluble
                                          Industrial Versus Acedemic View of the Current Status of Lipidic Formulations for Poorlyindustria
                                                                       Tastemasking and Orally industry representatives (Eurand, Catalent,
                                          Compare/contrast Various A discussion from various Disintegrating Tablet Technologies
                                                                      A discussion from industry representatives
                                          Strategies for Delivery of Drugs or Compounds with Solubility Issues regarding various approac
                                                                      Discussion with various Combination Products
                                          Development Challenges When Formulating Drug industry leaders regarding formulation and pr
                                                                      Regulatory guidance for for an FDA Guidance?
                                          Non-Clinical Dose Formulation Analysis – is it Timethe validation of analytical procedures has be
 cs & Technology                                                      This abstract contains screening of BIP-1 5-HT2A antagonist for their
                                          Anti-Depressant-Like Effect of a Novel 5-Ht2a Receptor Antagonist in Rodents: Approaching Fas
 cs & Technology                                                      The involvement of Receptor Antagonist in Rodents: Approaching Fas
                                          Anti-Depressant-Like Effect of a Novel 5-Ht2a the 5-HT 2A receptors in rodent depressive-like b
ein Aggregation and Immunogenicity                                    Incurred sample reanalysis (ISR) is an approach to assess the consis
                                          Incurred Sample Reanalysis -Challenges and Strategies
 -Based Drug Delivery Systems                                         This session will
                                          Emerging Vaccine Delivery Technologies cover new technolgies that have emerged in the last
 macogenetics/Pharmacogenomics                                         for Molecular Therapeutics and for Discovery
                                          Micro-R N As: Novel ToolsMicroRNAs: Novel Cellular ToolsBiomarkers of Therapeutic Target
                                                                       Drug Discovery and Development
                                          Neurosteroid-Based NovelNeurosteroid-based Drug Discovery and Development Moderator D. S
                                                                      The QbD Initiative: Why it is Important and yet Not development. It in
                                          Product Design in Quality by Design is a systemic approach to pharmaceuticalOften Discussed m
                                                                      Can the Brain: Use of Genetic Arsenals
                                          A New Era of Drug Targeting towe use new genetic technologies to disable the efflux machinerie
                                                                      Symposium Proposal supported by Ligand Binding Assay Bioanalytica
                                          Bioanalytical Global Outsourcing of Chromatographic and Ligand Binding Assay Methods
ein Aggregation and Immunogenicity                                    Clopidogrel is a prodrug Do a Better prevention of heart attacks. Pos
                                          Expensive Prodrug Lesson Learned: How Can We indicated forJob?
 ract Research Organization (CRO)                                     Background The ability to develop a rugged and reliable method in the
                                          Strategies for Developing Rugged and Reliable Quantitative Bioanalytical Methods for Small Mol
                                                                      Bioequivalence of Bioequivalence to Ensure Product Equivalence an
                                          Emerging Scientific and Regulatory Issuesstudies are conducted by drug manufactures to confir
 -Based Drug Delivery Systems                                         This session will
                                          Innovative Oral Drug Delivery Technologiesbe given annually, on a recurring basis, at the AAPS
 lational Medicine                        Orphan Vaccines             Healthcare worldwide has been impacted by the growing emergence
 lational Medicine                                                     New Drug stage clinical Using Adaptive Study Designs
                                          Improving the Efficiency in Rising late Development trial failures have resulted in several compan
 eric Pharmaceuticals                                                 Locally acting drug products include topical dermatological products, o
                                          Bioequivalence of Locally Acting Drug Products
mal Pharmaceutics & Technology                                        Preclinical pharmacokinetic and in vitro studies characterize and com
                                          Do you Select Right Models?--Proteomics Absolute Quantifications for Predictive Adme-Tox
                                                                      Writing is integral Writing -How Well We are and profesional growth.
                                          Stimulative and Thought Provoking Scientificpart of scientific community Training
                                                                      This symposium Lab Scale to Commercialization -Challenges
                                          Active Pharmaceutical Ingredients from Kilowill focus on the complexity of taking API synthesis f
markers in Translational Medicine                                     In this short courrse we would like to present a walk through of differe
                                          Integration of Preclinical Work, Modeling in Designging Clinical Drug Development Program
 ess Development                                                      Technology transfer R&D to as a process of conveying Roles of or
                                          Establishing Efficient Technology Transfer fromis viewedCommercial Manufacturing:expertise IC
 ess Development                                                      The purpose of this Quality is to underline the
                                          Risky Business: are We Risking it by Avoiding sessionRisk Management important role that qua
                                                                      This symposium will the present an Test
                                          Use of the Disintegration Versus Dissolution as first Regulatory overview Disintegration as a test
   Metabolism                                                         This Sunrise School Bench to Bedside
                                          The Role of Drug Transporters on Admet: from is designed to provide a comprehensive overview
                                                                      Excipients are considered as Case Studies and Current Developmen
mistry, Manufacturing, and Controls (CMC) Definitions of a New Excipient: Practical Considerations,ingredients, other than the active pharm
                                                                      Learning Objectives: Recognize how off-label use of adult medication
                                          The Need for Pediatric Labeled Medications
 lational Medicine                                                    In the recent past, there have been New Drug stage drug failures, th
                                          Do We Have Adequate Clinical Risk Management Strategy forseveral lateCandidates?
                                                                      Many times when process optimization studies are to be performed at
                                          Roller Compaction -Scale-Up Challenges and the Role of PAT
                                                                      Background The kidney
ulation Pharmacokinetics & Pharmacodynamics Development in Subjects with Renal Disease is of crucial importance to drug and metabolit
                                          Drug
                                          Optimal Sampling Using Winpopt integration of quantitative clinical pharmacology approaches
ulation Pharmacokinetics & Pharmacodynamics                           With the
 -Based Drug Delivery Systems                                         Many Universities and Pharmaceutical Companies are developing
                                          Developing New Technologies for Negelected Diseases as Part of the Global Health Initiativestr
                                                                      This poster describes Prodrugs
                                          A Novel Approach for the Use of Acetaminophena novel approach for the use of acetaminophen
 tro Release & Dissolution Testing                                    Efficaceous medicines to treat illnesses in space are of Topical avoi
                                          Effect of Space Shuttle and International Space Station Environment on Stabilityessential toPatc
                                                                      This sunrise session will provide
                                          The Basics and Recent Advances in Softgel Technology a basic overview of softgel technolog
                                                                      More than 35 transdermal patch Delivery
                                          Current and Future Skin Permeation Technologies for Drugproducts have been approved in US
 nd Binding Assay Bioanalytical                                        Metabonomics
                                          Stability in Bioanalysis andStability in Bioanalysis and Metabonomics: Stability of analytes or inte
 eric Pharmaceuticals                                                 Stability Stability mandated to demonstrate a pharmaceutical produc
                                          Stability Program to Support Globaltesting is Requirements
                                                                      Billion Global Outsourcing toward outsourcing analytical testing. Com
                                          Practical Approaches to Improve dollars are budgetedStrategies
 ess Development                                                      New Support Drug Development
                                          New Analytical Technologies to analytical technologies are developed in recent years has brough
                                                                      Many Translational Research
                                          Opportunities and Challenges in drugs fail in drug development because animal pharmacology r
                                                                      With current economic systems, pharmaceutical companies depend o
                                          Selecting a Outsourcing Services Providers
                                          What is Proof-of-Concept?Due to the exorbant high cost of drug development, there is increasin
   Metabolism                                                         Level of presentation: Basic to advanced The level of this sunrise is b
                                          Enzyme Directed Prodrug Bioactivation
 ral Products Chemistry                                               In this roundtable we Drug Delivery
                                          Polyphenol Based Prodrugs for Organ Targeted will discuss natural plant products polyphonols a
 eic Acid Based Therapeutics                                          small Opportunities
                                          siRNA Delivery: Challenges and interfering RNA (siRNA) is gaining increasing popularity both as
                                                                      A eutectic mixture is a physical ensemble of two or more solid substa
mistry, Manufacturing, and Controls (CMC) Understanding and Application of Eutectic Mixtures
                                                                      Since the Understanding of Bioanalytical Procedures and Regulations
                                          Achieving Global Harmonization and release of the Bioanalytical Method Validation Guidance by
 eic Acid Based Therapeutics                                          Oligonucleotides (ONs) have Therapeutics and their Challenges
                                          Bioanalytical Techniques in Support of Oligonucleotides been studied extensively in recent years
  ation and Nasal Technology                                          The importance of Respiratory Tract?
                                          How Relevant is Active Drug Transport in the active transp