Conference Program Home
My Program
All Times EDT
Legend:
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.
|
