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CC = Walter E. Washington Convention Center   M = Marriott Marquis Washington, DC
* = applied session       ! = JSM meeting theme

Activity Details

467 * ! Wed, 8/10/2022, 2:00 PM - 3:50 PM CC-144B
Alternative Data Sources Utilization in Clinical Development — Topic Contributed Papers
Health Policy Statistics Section, Social Statistics Section, Biopharmaceutical Section
Organizer(s): Freda Cooner, Amgen
Chair(s): Judy Li, Bristol Myers Squibb
2:05 PM Achieving Regulatory Approval Using Real-World Evidence: Challenges and Considerations
Tae Hyun (Ryan) Jung, US FDA
2:25 PM Bridging the Gap Between Clinical Trial and Real World Data: A Framework for Working with Real-World Data in Clinical Development
Laura L Fernandes, COTA Healthcare
2:45 PM Industry Applications of RWD to Advance Drug Development and Inform Regulatory Decision-Making
May Mo, Amgen
3:05 PM Illustration of Propensity Score Weighted External Control with Single Arm Phase 2 Trial and Hybrid Randomized and External Control in Phase 3 Design in Recurrent Glioblastoma
Ruthie Davi, Acorn AI by Medidata
3:25 PM Discussant: Yueqin Zhao, Food and Drug Administration
3:45 PM Floor Discussion
Video Available to all JSM Registered Attendees. Please login to view.