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Activity Details
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