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Conference:
Pre-conference workshop
18 May 9am - 5pm
Day 1
19 May 8:30am - 6:30pm
Day 2
20 May 8:30am - 5:30pm
Post-conference workshop
21 May 9am - 5pm
Venue:
Hotel Sofitel London Heathrow, London, United Kingdom
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Baroness Susan Greenfield
CBE, Director
Royal Institution
Dr Eckhard von Keutz
SVP, Head Global Early Development
Bayer Schering Pharma AG
Dr Jackie Hunter
SVP Science Environment Development
GlaxoSmithKline
Professor Dr Michel Goldman
Executive Director
Innovative Medicines Initiative
Dr John Davis
Senior Director, Group Head Research Clinical Pharmacology
Pfizer
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Pre-conference summit: Tuesday 18 May 2010 Pre-conference summit: Tuesday 18 May 2010
Strategies to enable a smooth transition to early phase clinical trialsOutline: The safety of subjects in the transition to first-in-man studies presents particular risks with their safety being paramount. This practical and interactive session will provide a stimulating review on best practices used in safety management and early clinical development speeding products
to phase II clinical trials.
Objectives: This session will provide attendees with clinical view points. The speakers will provide structured content with attendees having the opportunity to discuss and add their own contributions. The meeting will begin at 9am and finish at 5pm. Lunch and refreshments will be provided.
09.00 MORNING SESSIONNon-clinical requirements and relevance of pre-clinical animal models
- Pharmacokinetics, pharmacodynamics and metabolism
- Demonstration of relevance of the animal model
- Toxicology
Transition from pre-clinical to first-in-human trials
- New paradigms in the exploratory phase I environment that are helping the transition into first-in-man
- Considerations when deciding clinical study design and subject Choice
Dose selection
- Calculation of the first dose in man
- Route and rate of administration
- Dose escalation scheme
13.00 AFTERNOON SESSIONRisk management plan
- Development of the safety review plan and targeted medical event list
- The risk management committee
- Development of the risk management plan
Review of safety requirements for early clinical trials
- How have recent regulatory guidelines affected early development trials?
- What are the challenges in FIH trials?
Adaptive trial design for early phase clinical trials
- Setting the scene: how to do statistics for early phase, adaptive trials
- Myth-busting: why many of the 'reasons not to be adaptive' do not hold water
- Use Bayesian probability to predict trial outcomes
- Consider testing POC for several compounds in the same study
Michèle Léonard, Senior Principal Scientist, UCB Pharma SA, Belgium Frederique Delannois, Senior Principal Scientist, UCB Pharma SA, Belgium Dr Orest Hurko, Assistant Vice President, Discovery Translational Research, Pfizer, Inc., United Kingdom Director, Safety and Risk Management, Pfizer, Inc., United Kingdom Research Fellow, Director, Clinical Statistics, Global Stats & Data Mgmt, Abbott Laboratories, United States of America
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