Dr Yili Pritchett,
Research Fellow, Director, Clinical Statistics, Global Stats & Data MgmtAbbott Laboratories
Dr. Yili L. Pritchett is a Research Fellow and a Director of Clinical Statistics in Global Pharmaceutical R&D at Abbott Laboratories. She has 15 years of experience in drug development from exploratory phase, confirmatory stage, to NDA filing. She is currently responsible for statistical aspects of drug development in Neuroscience, Pain Care, and Renal Care therapeutic areas. Prior to joining Abbott in 2006, Dr. Pritchett served as a research advisor at Eli Lilly and Company, where she assumed evolving roles in providing statistical leadership for the development of several brands (October 1994 – March 2006). She received her Ph.D. in Statistics from the University of Wisconsin at Madison (1994), and her Bachelor’s and Master degrees in Mathematics from Xiamen University, P.R. China. Dr. Pritchett is currently an active member of PhRMA Adaptive Trial Design Working Group. She has championed the use of adaptive designs in Abbott, and led the effort of designing and implementing a number of clinical trials with different types of adaptive design. Dr. Pritchett authored or o-authored 52 manuscripts or book chapters as well as over 120 presentations made at statistical, drug development, or medical conferences, including several invited presentations on adaptive design in the past two years.Appearing:
Pre-conference summit: Tuesday 18 May 2010
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
Dr Yili Pritchett,
Research Fellow, Director, Clinical Statistics, Global Stats & Data Mgmt,
Abbott Laboratories
Abbott Laboratories
Director, Safety and Risk Management,
Pfizer Inc
Pfizer Inc
Dr Orest Hurko,
Assistant Vice President, Discovery Translational Research,
Pfizer Inc
Pfizer Inc
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