JSM 2015 Online Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details

324 Tue, 8/11/2015, 8:30 AM - 10:20 AM CC-611
Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision-Making — Contributed Papers
Biopharmaceutical Section
Chair(s): John Han,
8:35 AM The Use of Adaptive Designs in Antiviral Drug Development Fraser Smith, FDA/CDER/OTS/OB/DBIV ; Karen Qi, FDA/CDER/OTS/OB/DBIV
8:50 AM Missing Data Handling for Composite Endpoints Sabrina Wan, Merck ; G. Frank Liu, Merck ; Weili He, Merck
9:05 AM Graphical Presentation of Benefit-Risk Profile Weili He, Merck ; Shihua Wen, AbbVie ; Scott R. Evans, Harvard University
9:20 AM What Is the Role of Statisticians in Benefit-Risk Adoption Within Our Companies? Susan P. Duke, GlaxoSmithKline ; Greg Anglin, Eli Lilly Corporation
9:35 AM Multiplicity and Subgroups in Benefit-Risk Assessment Jonathan Norton
9:50 AM Structured Benefit-Risk Assessment Across the Lifecycle of Products: Methods, Examples, and Challenges Chunlei Ke ; George Quartey, Roche ; Christy Chuang-Stein, Pfizer Inc. ; John Scott, FDA ; Qi Jiang, Amgen ; Weili He, Merck ; Ramin Aramin, AstraZeneca ; Guochen Song, Quintiles ; Kao-tai Tsai, Celgene ; Yujun Wu, Sanofi
10:05 AM Some Thoughts on Benefit-Risk Assessment for Drug Development Qi Jiang, Amgen

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