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262 * Tue, 8/4/2020, 1:00 PM - 2:50 PM Virtual
The FDA Complex Innovative Trial Design Pilot Program: Learning from Case Examples and Simulations for the Public Good — Topic Contributed Papers
Biopharmaceutical Section, ENAR, Section on Bayesian Statistical Science
Organizer(s): Dionne L Price, Food and Drug Administration
Chair(s): Dionne L Price, Food and Drug Administration
1:05 PM An Overview of Innovative Designs and Statistical Considerations: Lessons Learned
Laura Lee Johnson, FDA
1:25 PM A Bayesian Adaptive Trial in Duchenne Muscular Dystrophy
Stephen Lake, WAVE Life Sciences; Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants; Jennifer Panagoulias, Wave Life Sciences; Michael A. Panzara, Wave Life Sciences
1:45 PM The Design, Challenges, and Benefits of Evaluating Multiple Assets and Disease Types in a Master Protocol
JonDavid Sparks, Eli Lilly and Company; Saptarshi Chatterjee, Eli Lilly and Co; Karen L Price, Eli Lilly and Company
2:05 PM Floor Discussion