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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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