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

Activity Details

315 Tue, 7/31/2018, 9:25 AM - 10:10 AM CC-West Hall B
SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Paul McNicholas, McMaster University
Oral Presentations for this session.
21: Subgroup Mixable Exact Simultaneous Confidence Intervals for Logical Selection of a CDx Cut-Point
Jason Hsu, Ohio State University
22: A Location-Adjusted Approach to the Covariate-Adjusted Response-Adaptive Allocation Design in Multi-Center Trials
Brian S Di Pace, Virginia Commonwealth University; Roy T Sabo, Virginia Commonwealth University; David C. Wheeler, Virginia Commonwealth University
24: Sample Size Calculation for Pilot Studies
Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
25: Determine Appropriate Sample Size for a Biomarker Signature Discovery Problem Using Penalized Regression
Xiang Li, Statistics and Decision Sciences, Janssen Research & Development, LLC; Hong Tian, Janssen Pharmaceutical; Liang Xiu, Janssen Research & Development, LLC
26: Statistical Considerations for Using Multiple Databases to Build a Biomarker Probability Tool
Feng Gao; Shijia Bian, Biogen; Wenting Wang, Biogen; Nancy Maserejian, Biogen; Judith Jaeger, Albert Einstein College of Medicine; Robert Robert Engle , Biogen; Timothy Swan, Biogen; James McIninch, Alnylam Pharmaceuticals; Feng Gao, Biogen
28: Phase I Designs That Allow for Uncertainty in the Attribution of Adverse Events
Alexia Iasonos, Memorial Sloan Kettering Cancer Center; John O'Quigley, Universit'e Pierre et Marie Curie,
30: A Bayesian Analysis of Small N Sequential Multiple Assignment Randomized Trials (SnSMARTs)
Boxian Wei, University of Michigan, Ann Arbor; Kelley M Kidwell, University of Michigan; Thomas M Braun, University of Michigan; Roy N Tamura, University of South Florida
32: Pre-Specified Bias Evaluation of ECG Measurements for Assay Sensitivity Assessment
Xiaoli Hou, Merck; Nancy Kim, Merck; Wei Gao, Merck; Leticia Arrington, Merck; Kajal Larson, Merck
33: Improvements to the Escalation with Overdose Control Design and a Comparison with the Restricted Continual Reassessment Method
Lingyun Ji, University of Southern California; Richard Sposto, University of Southern California; Juan Pablo Lewinger, University of Southern California; Mark Krailo, University of Southern California; David Conti, University of Southern California; Susan Groshen, University of Southern California; Shahab Asgharzadeh, University of Southern California
34: Statistical Approaches for Assessing the Utility of Urinary Glycosaminoglycans as a Surrogate Endpoint in Clinical Trials
Di Xiao, The Food and Drug Adminstration; Yeh-Fong Chen, US FDA; Min Min, U.S. Food and Drug Administration, CDER/OTS/OB
36: Statistical Considerations for Bridging Studies in Precision Medicine Programs with Drug-Device Co-Development
Shunguang Wang, Novartis Analytics; Meijuan Li, FDA; Xiaohong Li, Novartis Analytics; Jincao Wu, CDRH/US. Food and Drug Adminstration; Robinson Douglas, Novartis Pharmaceuticals