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

Activity Details

238 Mon, 7/30/2018, 2:00 PM - 3:50 PM CC-West 209
SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation — Contributed Speed
Biopharmaceutical Section
Chair(s): Jiawei Wei, Novartis
Poster Presentations for this session.
2:05 PM Subgroup Mixable Exact Simultaneous Confidence Intervals for Logical Selection of a CDx Cut-Point

Jason Hsu, Ohio State University
2:10 PM 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
2:15 PM Sample Size Calculation for Pilot Studies

Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
2:20 PM 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
2:25 PM 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
2:35 PM 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,
2:40 PM 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
2:50 PM 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
3:00 PM 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
3:05 PM 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
3:15 PM 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