AAPSPreliminary Program

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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 is leading them into resorting to the traditional pathways. In this presentation we will try to get a basic understanding how to simulate and successfully design a clinical trial.

Moderator

Prasad Tata, Ph.D., FCP

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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