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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
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647 * Thu, 8/8/2013, 8:30 AM - 10:20 AM CC-514a
Decisionmaking in Biopharmaceutical Development — Contributed Papers
Biopharmaceutical Section
Chair(s): Maggie Wang, PPD Inc
8:35 AM Statistical Methods for Benefit Risk Assessment Lanju Zhang, Abbvie ; Bo Yang, Abbvie Inc
8:50 AM A Comparison of Sample Size Estimation Procedures Using Cost-Effective Methods Sibabrata Banerjee, Allergan, Inc
9:05 AM Evaluating Regression to the Mean of Treatment Effect from Phase II to Phase III Jianliang Zhang, Medimmune Inc.
9:20 AM A Novel Design for Decision Rules Based on Statistical Testing Strategies in a Definitive Go/No-Go Clinical Study — Ming Zhou, Amylin Pharma., LLC (a Bristol-Myers Squibb Co.) ; Larry Z. Shen, Amylin Pharma., LLC (a Bristol-Myers Squibb Co.)
9:35 AM Data-Monitoring Committees in China — Kent Koprowicz, Axio Research LLC ; Tingting Li, Axio Research ; Xiaohui Huang, Axio Research ; Ping Xu, Axio Research Coporation
9:50 AM Building Efficient Comparative Effectiveness Trials Through Adaptive Designs, Utility Functions, and Accrual Rate Optimization: Finding the Sweet Spot Byron Gajewski, Univ of Kansas-Medical Center ; Scott M. Berry, Berry Consultants ; Mamatha Pasnoor, University of Kansas Medical Center ; Mazen Dimachkie, University of Kansas Medical Center ; Laura Herbelin, University of Kansas Medical Center ; Richard Barohn, University of Kansas Medical Center
10:05 AM Floor Discussion



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