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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

631 ! Thu, 8/2/2018, 8:30 AM - 10:20 AM CC-West 114
Clinical Trial Design- 7 — Contributed Papers
Biopharmaceutical Section
Chair(s): Yuqi Chen, Amgen
8:35 AM Impact of Clinical Center Effects on Objective Response Rate

Fang Liu, Merck & Co., Inc; Cong Chen, Merck & Co.
8:50 AM Utility and Challenges of Applying Quantitative Benefit-Risk Assessment for Regulatory Decision Making

Weili He, AbbVie; Bo Fu, Astellas Pharma Inc.; John Scott, FDA
9:05 AM Does it Pay to Repeat the Baseline?

Shiyang Ma, University of Rochester; David Oakes , University of Rochester
9:20 AM Extension to Signature Design

Xiting Yang, Food and Drug Administration
9:35 AM A Unified Framework for Weighted Parametric Multiple Test Procedures

Dong Xi, Novartis Pharmaceuticals; Ekkehard Glimm, Novartis; Willi Maurer, Novartis; Frank Bretz, Novartis Pharma AG
9:50 AM Target Toxicity Design for Phase 1 Dose-Finding: a Safe and Reliable Method
Bob Zhong, Johnson and Johnson; Wenchuan Guo, University of California Riverside
10:05 AM Bayesian Extrapolation in Pediatric Clinical Trials

Mehreteab F Aregay, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis Pharamceutical Corporation