All Times EDT
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Activity Details
166
Tue, 8/10/2021,
10:00 AM -
11:50 AM
Virtual
Non-Clinical Statistics, Personalized Medicine, and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Vivien Yin, Mayo Clinic
10:05 AM
A Meta-Inference Framework to Integrate Multiple External Models into a Current Study
Tian Gu, Department of Biostatistics, University of Michigan ; Jeremy M.G. Taylor, University of Michigan; Bhramar Mukherjee, University of Michigan
10:10 AM
Best Practices of Double Score Matching for Estimating Causal Effects
Yunshu Zhang, NC State University ; Shu Yang, North Carolina State University; Wendy Ye, Eli Lilly and Company; Douglas Faries, Eli Lilly and Company; Ilya Lipkovich, Eli Lilly; Zbigniew Kadziola, Eli Lilly and Company
10:15 AM
In Vitro Dissolution Profile Comparison Using Bootstrap Bias Corrected Similarity Factor, F2
Xiaoyu Cai, U.S. Food and Drug Administration ; Shaobo Liu, U.S. Food and Drug Administration; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:20 AM
Quadratic Slope-Ratio Model for Nonlinear Dose-Response of CBPA Assay
Ming Luo, AbbVie
10:25 AM
Statistical Approaches for Shelf Life Determination of a Drug Product
Xutong Zhao, CDER, US FDA ; Tengfei Li, Georgetown University; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:30 AM
Practical Conformal Prediction Methods for QSAR
Yuting Xu, Merck & Co., Inc. ; Andy Liaw, Merck & Co., Inc.; Vladimir Svetnik, Merck & Co.
10:35 AM
Power and Sample Size Estimation in Stability and Analytical Comparability
Qianqiu Li, Janssen Research & Development
10:40 AM
Comparing the Means of Continuous Measurements for Noninferiority and Equivalence
Shaobo Liu, U.S. Food and Drug Administration ; Xiaoyu Cai, U.S. Food and Drug Administration; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
10:45 AM
Risk Difference, Relative Risk, and Odds Ratio for Noninferiority Clinical Trials: Assessment with Negative Event Rate Endpoint
Jingwei Wu, Temple University ; Quanji Yu, Nanjing Medical University; Jianling Bai, Nanjing Medical University; Hao Yu, Nanjing Medical University
10:50 AM
WITHDRAWN: Challenges and Strategies of Handling of PKPD Data in CDISC Standards
11:00 AM
A Principal Stratification Approach to Estimating the Effect of Continuing Treatment After Observing Early Outcomes
Patrick Schnell, The Ohio State University College of Public Health ; Richard Baumgartner, Merck Research Laboratories; Shahrul Mt-Isa , MSD; Vladimir Svetnik, Merck & Co.
11:05 AM
Utility-Based Approach in Individualized Optimal Dose Selection Using Machine Learning Methods
Pin Li, University of Michigan ; Jeremy M.G. Taylor, University of Michigan; Philip Boonstra, University of Michigan; Theodore S. Lawrence, University of Michigan; Matthew J. Schipper, University of Michigan
11:10 AM
Addressing Covariate Unbalance in Subgroup Identification for Censored Survival Data via Weighted Gradient Tree Boosting
JINCHUN ZHANG, Merck & Co. ; PINGYE ZHANG, MERCK & Co.; Yue Shentu, Merck Sharp & Dohme; JUNSHUI MA, Merck & Co.
11:15 AM
A Comparison of Precision Medicine Methods for Count Outcomes: A Simulation Study and a Case Study in Multiple Sclerosis
Xiaotong Jiang, Biogen ; Gabrielle Simoneau, Biogen; Bora Youn, Biogen; Changyu Shen, Biogen; Fabio Pellegrini, Biogen; Carl de Moor, Biogen
11:20 AM
Finding Associations in a Heterogeneous Setting: Novel Statistical Test for Aberration Enrichment. The Signal Is in the Tails
Mohamed Aziz Mezlini, Evidation Health Inc, University of Toronto, Harvard Medical school
11:25 AM
Model-Robust Inference for Clinical Trials That Improve Precision by Stratified Randomization and Covariate Adjustment
Bingkai Wang, Johns Hopkins Bloomberg School of Public Health ; Ryoko Susukida, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; Ramin Mojtabai, Johns Hopkins Bloomberg School of Public Health; Masoumeh Amin-Esmaeili, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; Michael Rosenblum, Johns Hopkins University
11:30 AM
WITHDRAWN: Calibrated Dynamic Borrowing Using Capping Priors
11:35 AM
Bayesian Multivariate Probability of Success Using Historical Data with Family-Wise Error Rate Control
Ethan Alt, University of North Carolina at Chapel Hill ; Matthew Psioda, UNC Chapel Hill; Joseph G Ibrahim, UNC
11:40 AM
Innovations in the Use of External Data to Augment Controls in Clinical Trials
Frank Shen, Bristol Myers Squib ; Rong Liu, Bristol Myers Squibb
