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 development. 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: http://www.seerpharma.com.au/courses/6501.html 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 development ! 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) studies 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 techniques ! 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 Q&A Activity Prepare a product development checklist for CMC. Identify regulatory compliance risks and discuss mitigation 17:00 End of Workshop strategies 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.