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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
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