Legend:
CC = Vancouver Convention Centre F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
Activity Details
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315
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Tue, 7/31/2018,
9:25 AM -
10:10 AM
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CC-West Hall B
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SPEED: Biopharmaceutical Applications: Trials, Biomarkers, and Enpoint Validation — Contributed Poster Presentations
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Biopharmaceutical Section
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Chair(s): Paul McNicholas, McMaster University
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Oral Presentations
for this session.
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21:
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Subgroup Mixable Exact Simultaneous Confidence Intervals for Logical Selection of a CDx Cut-Point
Jason Hsu, Ohio State University
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22:
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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
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24:
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Sample Size Calculation for Pilot Studies
Chi-Hong Tseng, UCLA; Danielle SIM, UCLA
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25:
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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
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26:
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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
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28:
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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,
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30:
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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
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32:
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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
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33:
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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
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34:
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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
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36:
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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
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