Pharmacokinetics in Drug Discovery and Development

INTRODUCTION Pharmacokinetics and metabolism are now accepted as key disciplines in drug development providing an insight into differences in drug action within and between species. Unfortunately for many people it is also one of the more complex to understand and to put into practice, particularly with the new approaches such as in-vivo metabolism, genetic polymorphism, interaction studies, kinetic-dynamic modelling, bioavailability, population kinetics, biotechnology etc. The lecturers, who come from academia, industry and the regulatory agency, have many years’ experience in this area. They will provide information on the use and benefits of pharmacokinetics in drug development and how it affects drug discovery. Allowances have beenmade within the programme for discussion so that particular problems can be considered in detail. Please note: Delegate should bring a scientific calculator. WHO SHOULD ATTEND Directors and staff of pharmaceutical companies, particularly those in Clinical and Preclinical Research Departments, Regulatory Affairs, Registration, Licensing, including Product Managers and all those interested in the use of pharmacokinetics in drug development. This seminar is NOT aimed at the expert pharmacokineticist, although a knowledge of basic kinetic principles would be useful. The course provides information on the use and benefits of the application of Pharmacokinetics in Drug development and how it affects drug discovery including: Population PK/PD in drug development The changing role of ADME & DMPK Optimal use of in vitro data to predict ADME Kinetic/dynamic relationships & computer assisted trial design Applying Pharmacokinetics to enhance Drug Discovery Drug Switchability: The roles of Bioavailability, Bioequivalence & Biosimilarity in Drug Development Drug interactions in vivo Regulatory perspectives on pharmacokinetics: An aid to improving risk/benefit Pharmacokinetics of Biologics Chaired by: Professor Geoff Tucker Professor Emeritus, Academic Unit of Clinical Pharmacology, School of Medicine, University of Sheffield and Chairman Simcyp Ltd, Sheffield Alwyn Pidgen Independent Consultant to the Pharmaceutical Industry SPEAKERS Dr John Posner, Clinical Pharmacologist, Independent Consultant in Pharmaceutical Medicine Dr Rashmi Shah, Pharmaceutical Consultant and former Senior Clinical Assessor at the MHRA Don Walker, Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer Global R&D ATTENDANCE LIMITED TO 25 This limitation, a unique feature of all MANAGEMENT FORUM seminars, will give participants the opportunity for a thorough discussion of the complex issues to be covered by the programme.