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385 Thu, 8/12/2021, 12:00 PM - 1:50 PM Virtual
Biomarkers, Endpoint Validation and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Susan Wang, Boehringer Ingelheim
12:05 PM Statistical Design and Methodology for Validating a Multiplex Electrochemiluminescent Assay Detecting Multiple Endpoints in Human Sera Samples
Mohammad Lutfur Rahman, Sanofi Pasteur; Lingyi Zheng, Sanofi Pasteur
12:10 PM Validating Surrogate Endpoints with Longitudinal Outcomes
Emily Roberts, University of Michigan; Michael R. Elliott, University of Michigan; Jeremy M.G. Taylor, University of Michigan
12:15 PM A Generalized Linear Mixed Model Framework for Calculating Inter-Rater Reliability
Jonathan D Mahnken, The University of Kansas Medical Center; Katelyn A McKenzie, The University of Kansas Medical Center
12:20 PM On Appropriate Use of Fold Change in Immunogenicity Studies
Ting Zeng, University of Kentucky; Kerry W Go, Sanofi Pasteur; Anthony Homer, Medtronic
12:25 PM Digital Endpoints and Digital Therapeutics in RCTs, PCTs, and RWE
Kelly H. Zou, Viatris
12:30 PM Using Statistical Methods to Modify and Repurpose the Composite Assessment of Index Lesion Severity Scoring System in Cutaneous Lichen Planus
Nan Zhang, Mayo Clinic; Caitlin Brumfiel, Mayo Clinic; Meera Patel, Mayo Clinic; Amylou Dueck, Mayo Clinic; Mark Pittelkow, Mayo Clinic; Aaron Mangold, Mayo Clinic
12:35 PM A Simulation-Based Evaluation of Statistical Methods for Hybrid Real-World Control Arms in Clinical Trials
Mingyang Shan, Eli Lilly and Company; Douglas Faries, Eli Lilly and Company; Andy Dang, Eli Lilly and Company; Zhanglin Cui, Eli Lilly and Company; Xiang Zhang, CSL Behring; Kristin Sheffield, Eli Lilly and Company
12:40 PM Standardized mortality ratio-weighted power prior approach for covariate-adjusted borrowing of historical control data
Ryo Sawamoto, The University of Tokyo; Yutaka Matsuyama, The University of Tokyo
12:45 PM Statistical Design and Data Analysis for the Effect of the Multiple Doses of a Treatment on Renal Functions Using a Pharmacodynamic Biomarker
Meiyu Shen, Office of Biostatistics CDER, FDA; Kimberly Smith, FDA
12:50 PM Integrated Propensity Score-Power Prior Approach for Augmenting the Control Arm of a Randomized Controlled Trial
Yeonil Kim, Merck & Co., Inc.; Erina Paul, Merck & Co., Inc.; Santosh Sutradhar, Merck & Co., Inc.
1:00 PM P-Value Distribution with Historical Data Borrowing
Jasmine Zhang, University of Illinois at Urbana Champaign
1:05 PM Up-Front Matching: An Ongoing Recruitment Method for Prospective Observational Studies That Mimics Randomization for Selected Baseline Covariates
Ibrahim Turkoz, Janssen Research and Development, LLC; William H Olson, WHO Statistical Consulting, LLC
1:10 PM Optimal Dose Finding Using Bayesian Utility with Toxicity and Efficacy Endpoints
Haolun Shi, Simon Fraser University; Ruitao Lin, The University of Texas MD Anderson Cancer Center; Ying Yuan, Department of Biostatistics, University of Texas MD Anderson Cancer Center; Jiguo Cao, Simon Fraser University
1:15 PM Flexible Use of Copula-Type Model for Dose-Finding in Drug Combination Clinical Trials
Koichi Hashizume, Graduate School of Engineering, Tokyo University of Science; Jun Tsuchida, Doshisha University; Takashi Sozu, Faculty of Engineering, Tokyo University of Science
1:20 PM Using a Piecewise Model to Account for Treatment Gaps When Evaluating Continuous Outcomes
Xiaolei Zhou, RTI Health Solutions
1:25 PM Impact of Informative Follow-Up Visits on Longitudinal Real-World Data and Evidence Studies of Comparative Effectiveness: An Application in Multiple Sclerosis
Paramita Saha Chaudhuri, University of Vermont; Gabrielle Simoneau, Biogen; Shirley Liao, Biogen; Changyu Shen, Biogen; Fabio Pellegrini, Biogen; Carl de Moor, Biogen
1:30 PM Statistical Consideration of Extrapolation of Adult Efficacy Data to Pediatric Population
Cassie Dong, Takeda; Yulia Sidi, Takeda
1:35 PM Practical Guidance for Successful BLA Submissions from a Statistician’s Perspective
tulin shekar, Merck