Drug Discovery and Preclinical Development by lindayy


Drug Discovery and Preclinical Development

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									                      Drug Discovery and
                  Preclinical Development
                   Two Day Comprehensive & Interactive Seminar
                               & Workshop with Subject Expert

               Aims and Objectives

  !     Take home with you a set of successful strategies for integrating
        the science, regulatory and business aspects of drug                                Course Content
After the course you will be able to;
  !     Identify and manage critical factors when developing a drug
  !     Select relevant tools to identify drug candidates and their         !   Drivers for drug discovery and development
        targets                                                             !   Building a drug development program through integrating
  !     Know what to do after you’ve identified leading candidate               scientific processes with regulatory & business requirements
        molecule(s)                                                         !   Selecting relevant tools for high throughput screening and
  !     Design an integrated drug development strategy and avoid                preclinical testing
        common mistakes from product discovery to first in man study        !   Role of patent management in the product life cycle
  !     Conduct gap analyses in data to optimize use of resources           !   Quintessential steps after lead candidate identification
  !     Identify the relevant pre!clinical studies to support the first     !   Application of biopharmaceutics to prototype formulation
        study in man                                                            design
  !     Understand requirements for successful scale!up and validation      !   Toxicology and safety pharmacology requirements for First in
  !     Apply best practices to the development of new product                  Man Study
        initiatives                                                         !   Guidelines for dose selection
  !     Identify, assess and manage potential risks associated with non!    !   Regulatory issues
        compliance during development                                       !   Applying principles of pharmaceutical GXP to ensure
  !     Map a product life cycle for your product                               compliance

                                             About the Course Presenter

Dr Philip Marshall BSc (Hons) PhD, FRACI CChem has 30 years                 !   Founded his consultancy company, Pharmchem Technical
international experience in the biotech and pharmaceutical industry.            Services Pty Ltd, in 1991 which has provided independent
     !    Actively involved in over 1000 medicinal products at one or           advice to over 100 companies spanning small business to
          more stages of product life cycle.                                    multinationals across Europe, the Americas and the Asia!
     !    Experience and expertise in                                           Pacific region.
          !    all dosage forms                                             !   In partnership with TGA conducted product compliance
                                                                                analysis of around 200 products
          !    drug development and design of delivery systems
                                                                            !   Provides scientific and technical advice on
          !    pre!clinical and clinical trials design and management,
                                                                                !    drug discovery and development
          !    scale!up and technology transfer
                                                                                !    due diligence for product acquisition
          !    manufacturing
                                                                                !    drug delivery systems
          !    quality assurance
                                                                                !    GXP audits and gap analysis for leading drug companies
          !    risk management
                                                                                     in Europe and Asia!Pacific including Australia, New
          !    patent matters                                                        Zealand, Bangladesh, China, India, Indonesia, Korea and
          !    international regulatory affairs.                                     Taiwan

   For more information please visit:

                                                                                     Melbourne | UK | Singapore | Korea
                                                    Day One                                                                      Day Two

09:00      !   Drug Discovery and Development                             09:00             Preclinical ! Safety Pharmacology & Toxicology
           !   Major milestones in getting the product to market                            Evaluation
           !   Revenue expansion as driver for drug development,                            ! In vitro and in vivo studies
               others                                                                       ! Animal Species and Dose Selection for studies
           !   Understand how scientific disciplines such as                                ! What is “toxicity”
               medicinal chemistry, pharmaceutical sciences,                                ! Safety pharmacology studies
               regulatory affairs, marketing, clinical, legal, business                     ! Study design
               development and project management are brought
                                                                          Activity          !    Outline the basic requirements for a pre!clinical
               together for drug discovery & development
                                                                                                 study program to pre!FIM or
           !   Strategic approaches to small and large molecule
                                                                                            !    Case study in toxicology
           !   Regulatory compliance                                      10:40             Morning Refreshments
           !   Target product profile (TPP)
                                                                          11:00             Phase I Clinical Studies
           !   Pros and cons of contracting CROs
           !   Product life cycle: The impact of
                                                                                             !   starting dose and regimen for first in man (FIM)
                           o     Medical needs
                           o     Use of patents
                                                                                             !   Interspecies scaling

                           o     Pharmacovigilance                                           !   Safety Factors
Activity   !   What’s in a dose                                                              !   Maximum recommended starting dose (MRSD)
           !   Create a target product profile for your product and                          !   No Observed Adverse Event Levels (NOAEL)
               determine the best path to regulatory approval.                                   calculations
10:40      Morning Refreshments                                                              !   Regulatory compliance
                                                                          Activity          Critical analysis of a hypothetical protocol
11:00      Drug Discovery – Applying the General Principles in the
           Commercial Environment                                         12:45             Lunch
           ! Medicinal chemistry and structure activity
               relationships                                              13:30             Regulatory Affairs
           ! Target selection and validation                                                 !   Regulatory strategies and pathways
           ! Molecular targeting
                                                                                             !   Critical Regulatory Milestones and go/no go
           ! Screening: High!throughput, in vitro and in vivo                                    decision points
                                                                                            !    Pre!IND strategies as example for FIM
           ! Candidate selection and optimisation
           ! Limitations of various methods and techniques                                  !    The IND dossier and submissions
                                                                                            !    Regulatory compliance
           !   Drug developability assays
                                                                                            !    Risk analysis and mitigation strategies
           !   Requirements for clinically useful products
                                                                                            !    Pharmacovigilance
Activity   !   How to determine structure!activity relationships          Activity          !    Identify the key issues and risks of drug
           !   Develop a decision tree and or matrix for lead                                    developability and develop a plan to overcome
               candidate selection and 5 key selection criteria                                  and/or manage potential difficulties

12:45      Lunch
                                                                                            !    Launching a product – what’s involved?
                                                                          15:00             Afternoon Refreshments
13:30      Pre!clinical ! Key Pharmaceutics, Formulation and CMC
           Issues                                                         15:20             Emerging Trends as Development Drivers
           !   Pre!formulation and Formulation                                              !    emerging technologies in drug discovery
           !   Physicochemistry                                                             !    pro!drugs
           !   API characterization                                                         !    molecular targeting
           !   Drug Delivery Systems                                                        !    drug delivery systems
           !   Stability                                                                    !    Changing face of patents in generic
                                                                                                 pharmaceutical development
           !   GMP compliance and risk management
Activity   Prepare a product development checklist for CMC. Identify
           regulatory compliance risks and discuss mitigation
                                                                          17:00             End of Workshop

15:00      Afternoon Refreshments
                                                                          Training Dates:
15:20      Pre!clinical ! Pharmacokinetics; ADME
           !   Principles of PK and ADME                                  Melbourne Jul 28, Jul 29
           !   Bioavailability
                                                                          Sydney     Aug 4, Aug 5
           !   Dose selection and species selection
           !   Role of metabolites in safety                              Brisbane   Jun 30, Jul 1
           !   Pro!drugs
                                                                          Short Course Fees: $1095+ GST
Activity   Identify the key desirable ADME characteristics for a
           theoretical lead compound eg peptide with in vitro anti!       Register by 3rd July and receive a 10% discount.
           cancer properties
                                                                          Register for this course and SP6502 by 3rd July and receive a 15%
17:00      End of Day 1                                                   discount.

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