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Clinical Trial Simulations: Many Questions, Few Answers
Monday, November 12
8:00 am – 10:00 am
Roundtable
ACPE #073-999-07-538-L04
Clinical Trial Simulation is a fascinating area of clinical research. It is currently not uncommon for dosing recommendations and labeling decisions to be made on the basis of modeling and simulation (pharmacometric) analyses. Upcoming companies may wish to venture into this area to realize the promised, inherent efficiencies but lack the expertise to execute these efforts effectively. In this roundtable session, we will present and discuss a basic understanding of model-based clinical trial simulation approaches, how to successfully implement such strategies, and position them for favorable regulatory decision making.
Moderators
Prasad Tata, Ph.D., FCP
Mallinckrodt, Inc.
Road Map to Clinical Trial Simulations – Conceptualization, Design, and Execution
Sandra Allerheiligen, Ph.D.
Eli Lilly and Company
Overcoming Obstacles in Delivering M&S Results for Drug Development and Regulatory Decision-making
Ted Grasela, Pharm.D., Ph.D.
Cognigen Corporation
Clinical Trial Simulations in the Critical Path Initiative and Regulatory Decision-making
Lawrence Lesko, Ph.D., FCP
U.S. Food and Drug Administration
Panel Discussion
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