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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
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Activity Details

113 Mon, 8/4/2014, 8:30 AM - 10:20 AM CC-257B
Go/No-Go: The Practice for Developing Best-in-Class Product from Statistical Perspective — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Xuan Liu, AbbVie
Chair(s): Jun Zhao, AbbVie   
8:35 AM Futility Boundary Design Based on Probability of Success Under New Drug Development Paradigm Yijie Zhou, AbbVie ; Ruji Yao, Merck ; Bo Yang, AbbVie ; Ram Suresh, GlaxoSmithKline
8:55 AM Evaluation of Program Success for Programs with Multiple Trials in Binary Outcomes Meihua Wang, Merck ; Frank Liu, Merck ; Jerald Schindler, Merck
9:15 AM Selection of Development Pathways with Established or Exploratory Biomarkers Ming-Xiu Hu, Takeda ; Yi Liu, Takeda ; Feng Gao, Takeda
9:35 AM Go/No Go Criteria Based on a Joint Evaluation of Efficacy and Safety Using a Clinical Utility Index Theresa Ashton, GlaxoSmithKline ; Ohad Amit, GlaxoSmithKline ; Kert Viele, Berry Consultants
9:55 AM Discussant: Bo Yang, AbbVie
10:15 AM Floor Discussion

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