June 24, 2011
11:30 – 1:00 pm EST

Course Description:
Adaptive design enables clinical trials to adapt to evolving information.  It is more powerful and cost effective than traditional design based on formal hypothesis in defining dose response curve and identifying optimal dose in exploratory drug development aiming to learn about pharmacology.  When multiple adaptive designs are plausible, clinical trial simulation is a powerful tool to evaluate and differentiate potential outcome of individual adaptive design.  It can model complicated dynamic process to evaluate key assumptions in trial design and their impacts on trial outcome.  Various types of clinical trial simulations may be conducted to visualize the dynamic trial process from patient recruitment, drug distribution, treatment administration to biomarker, PK/PD and clinical responses. 

Integrated with cumulative knowledge of PK/PD and biomarkers, Exposure Response (ER) based trial simulation could assess the validity and robustness of efficacy and safety findings, anticipate problems, project trial outcome.  In this presentation, advantages of exposure-response based trial simulations in dosing range phase II studies will be discussed via a case study.  Incorporating prior exposure variability and PK/PD information, trial simulations were conducted to:

• Evaluate potential adaptive designs via traditional statistical and exposure-response analysis
• Determine sample size and associated power in demonstrating either utility or futility
• Define decision criteria based on multiple endpoints
• Evaluate the robustness of efficacy and safety signals at various stages of study

Read this PDF for more course details.

Instructors:
Simon Zhou, Ph.D.,  Senior Director, Translational Medicine and Clinical Pharmacology, Daiichi-Sankyo Pharma Development

Simon Zhou holds Bachelor and Master degrees in Chemistry, a Ph.D. in Pharmaceutics and a Graduate Certificate on Modeling of Complex System from the University of Michigan.  Dr. Zhou is currently a senior director in translational medicine and clinical pharmacology of Daiichi-Sankyo Pharma Development, in Edision, NJ.  Prior to his current position, he has worked in preclinical and clinical drug development functions addressing biopharmaceutics, clinical pharmacology and clinical trial design issues at Pfizer, Bristol-Myers Squibb and legacy Wyeth.  He is experienced in kinetic/dynamic and statistical modeling and simulation to integrate and mine voluminous and complex data from clinical trials.  He has published manuscripts in biopharmaceutics, clinical pharmacology, drug delivery and pharmacokinetic and pharmacodynamic modeling.

Amit Roy, Group Director, Bristol-Myers Squibb