Pre-conference summit: Tuesday 18 May 2010
last modified: 10 May '10
Strategies to enable a smooth transition to early phase clinical trials
Outline: 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 SESSION
Non-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
12.00
Lunch
13.00
AFTERNOON SESSION
Risk 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
Frederique Delannois,
Senior Principal Scientist, UCB Pharma SA
Michèle Léonard,
Senior Principal Scientist, UCB Pharma SA
Research Fellow, Director, Clinical Statistics, Global Stats & Data Mgmt, Abbott Laboratories
Director, Safety and Risk Management, Pfizer Inc
Dr Orest Hurko,
Assistant Vice President, Discovery Translational Research, Pfizer Inc
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last modified: 10 May '10
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