Legend:
CC = Baltimore Convention Center,
H = Hilton Baltimore
* = applied session ! = JSM meeting theme
Activity Details
570 *
Wed, 8/2/2017,
2:00 PM -
3:50 PM
CC-319
More Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making — Topic Contributed Papers
Biopharmaceutical Section , Section on Risk Analysis
Organizer(s): Weili He, Merck & Co., Inc.
Chair(s): Xiaofei Hu, Merck & Co., Inc.
2:05 PM
On a Stepwise Quantitative Approach for Benefit-Risk Assessment
—
Weili He, Merck & Co., Inc. ; Yaxuan Sun, Department of Statistics, Iowa State University, Ames, IA, USA ; Qing Li, Merck & Co., Inc. ; Sabrina Wan, Merck & Co., Inc.
2:25 PM
DMCS and Benefit:Risk Assessment
—
Scott Evans, Harvard University ; Christy Chuang-Stein, Retired! ; Dave DeMets, Retired ; Paul Gallo, Novartis ; Weili He, Merck & Co., Inc. ; Qi Jiang, Amgen Inc. ; Frank Rockhold, Retired
2:45 PM
Using Patient Preference Information in Benefit-Risk Assessment
—
Xuefeng Li, FDA ; George Quartey , Genetech
3:05 PM
Rationale for the Use of Subject Level Information for Benefit-Risk Evaluations
—
Shihua Wen, Novartis ; Weili He, Merck & Co., Inc. ; Scott Evans, Harvard University ; Qi Jiang, Amgen Inc. ; Jonathan Norton, Takeda ; Xuefeng Li, FDA ; George Quartey , Genetech
3:25 PM
Discussant: Qi Jiang, Amgen Inc.
3:45 PM
Floor Discussion