Sessions Were Renumbered as of May 19.
Legend:
CC-W = McCormick Place Convention Center, West Building,
CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,
UC = Conference Chicago at University Center
* = applied session ! = JSM meeting theme
597 *
Wed, 8/3/2016,
2:00 PM -
3:50 PM
CC-W185bc
Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians , Section on Risk Analysis
Organizer(s): Weili He, Merck
Chair(s): Jonathan Norton, MedImmune
2:05 PM
Practical Considerations for Benefit Risk Assessment and Implementation: Vorapaxar TRA-2P TIMI 50 Case Study
—
Weili He, Merck
2:25 PM
Patient Preference in Benefit-Risk Analysis in Medical Device Trials
—
Xuefeng Li, FDA
2:45 PM
Benefit-Risk Assessment via Case Studies
—
George Quartey, Genentech ; Qi Jiang, Amgen ; Weili He, Merck
3:05 PM
Some Consideration on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment in Pharmaceutical Drug Development
—
Haijun Ma ; Qi Jiang, Amgen
3:25 PM
Discussant: Martin Ho, FDA/CDRH
3:45 PM
Floor Discussion
