Stream 4: MODELLING AND TRANSLATIONAL MEDICINE
last modified: 10 May '10
15.25
Opening remarks from the chair
15.30
Safety testing of drug metabolites
• When and how to identify, characterise and evaluate metabolites
• Identifying metabolites to better understand the ADME of a drug
• Impact of regulatory guidelines
Dr Gareth Shackleton,
Assistant Research Director, Global Metabolism and Pharmacokinetics, Sanofi-Aventis
16.00
The dogma of metabolites
• What do we know about pharmacologically active metabolites?
• Reactive toxic metabolites and the impact of dose and duration
• Exploring and addressing safety implications
Academic Research Fellow, Pfizer Inc
16.30
Application of PK/PD modelling and simulation to aid early development
• PK/PD modelling to provide answers on efficacy and safety of new drugs faster
• The role of mechanism-based PK/PD modelling and simulation in translational research
Dr Mendel Jansen,
Director, Modelling & Simulation, DAIICHI SANKYO DEVELOPMENT LTD.
17.00
Forecasting clinical utility in early development by translational pharmacometrics
• Quantification of biomarker response
• Model-based integration with animal efficacy to enhance decision making
• How a strong focus yields awareness and organizational changes
Modelling & Simulation Expert, Schering-Plough Research Institute
17.30
Closing remarks
17.30
Networking drinks reception
Join your fellow phase I peers and relax after a busy conference day
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last modified: 10 May '10
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