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conference details
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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our speakers
Speaker photo
Baroness Susan Greenfield
CBE, Director
Royal Institution
Speaker photo
Dr Eckhard von Keutz
SVP, Head Global Early Development
Bayer Schering Pharma AG
Speaker photo
Dr Jackie Hunter
SVP Science Environment Development
GlaxoSmithKline
Speaker photo
Professor Dr Michel Goldman
Executive Director
Innovative Medicines Initiative
Speaker photo
Dr John Davis
Senior Director, Group Head Research Clinical Pharmacology
Pfizer
 

 

 

Pre-conference summit: Tuesday 18 May 2010

Pre-conference summit: Tuesday 18 May 2010
 

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
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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