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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. Many upcoming companies want to venture into this area but lack of expertise or understanding leading them into resorting to the traditional pathways. In this presentation we will try to get a basic understanding of how to simulate and successfully design a clinical trial.
Moderator
Prasad N.V. 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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