Name: 2022 Joint Statistical Meetings
Start: 2022-08-06T07:00:00+00:00
End: 2022-08-11
Location: Walter E. Washington Convention Center

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All Times EDT

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CC = Walter E. Washington Convention Center M = Marriott Marquis Washington, DC
* = applied session ! = JSM meeting theme

Activity Details

4 * !	Sun, 8/7/2022, 2:00 PM - 3:50 PM	CC-151B
Recent Advancements in Prior Elicitation and Computational Tools for Bayesian Design and Analysis — Invited Papers
Section on Bayesian Statistical Science, Biometrics Section, Biopharmaceutical Section
Organizer(s): Joseph G Ibrahim, University of North Carolina
Chair(s): Ethan Alt, Harvard University
2:05 PM	Practical Considerations in Power Prior: Interpretation and Software Advancements Fang Chen, SAS Institute Inc.; Frank G. Liu, Merck & Co., Inc
2:30 PM	The Scale-Transformed Power Prior for Use with Historical Data from a Different Outcome Model Joseph G Ibrahim, University of North Carolina; Brady G Nifong, University of North Carolina; Matthew A. Psioda, University of North Carolina at Chapel Hill
2:55 PM	A Hierarchical Prior for Generalized Linear Models Based on Predictions for the Mean Response Matthew A. Psioda, University of North Carolina at Chapel Hill; Joseph G Ibrahim, University of North Carolina; Ethan Alt, Harvard University
3:20 PM	Flexible Conditional Borrowing Approaches for Leveraging Historical Data in the Bayesian Design of Superiority Trials Wenlin Yuan, University of Connecticut; Ming-Hui Chen, University of Connecticut; John Zhong, REGENXBIO Inc.
3:45 PM	Floor Discussion

12 * !	Sun, 8/7/2022, 2:00 PM - 3:50 PM	CC-206
Opportunities and Challenges in the Use of External Control Arms in Drug Development — Invited Papers
Biopharmaceutical Section, Biometrics Section, Society for Clinical Trials
Organizer(s): Antara Majumdar, GSK
Chair(s): Antara Majumdar, GSK
2:05 PM	Leveraging External Data to Augment the Control Arm in Randomized Clinical Trials Ram Tiwari, Bristol Myers Squibb
2:30 PM	Propensity-Score-Integrated Priors: A Novel Strategy for Leveraging Real-World and Historical Data Junjing Lin, Takeda Pharmaceuticals; Margaret Gamalo , Pfizer Inc.; Ram Tiwari, Bristol Myers Squibb
2:55 PM	Learnings from Regulatory Feedback on RWE in Regulatory Submissions Prashni Paliwal, Flatiron Health
3:20 PM	External Control Arm (ECA) in Oncology Studies Helen Zhou, GSK; Antara Majumdar, GSK; Andrew Smith, GSK; Brielle Forsthoffer, GSK; Nicky Best, GSK; Tai-Tsang Chen, GSK
3:45 PM	Floor Discussion

16 * !	Sun, 8/7/2022, 2:00 PM - 3:50 PM	CC-207A
Assessing Agreement and Reader Reliability in Medical Imaging Analysis — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Si Wen, Division of Imaging, Diagnostics and Software Reliability, FDA/CDRH/OSEL
Chair(s): Evangelos Hytopoulos, iRhythm Techonologies Inc.
2:05 PM	A Review on Assessing Agreement Huiman Barnhart, Duke University
2:25 PM	Sample Size Estimation for Overall Agreement for Multiple Raters with Replicated Measurements Tongrong Wang, Eli Lilly and Company; Huiman Barnhart, Duke University
2:45 PM	Exploring Pathologist-Pathologist Agreement as a Baseline for Algorithm-Pathologist Agreement Presentation Brandon D Gallas, US FDA, CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability
3:05 PM	Limits of Agreement for an MRMC Study Presentation Si Wen, Division of Imaging, Diagnostics and Software Reliability, FDA/CDRH/OSEL
3:25 PM	Floor Discussion

30	Sun, 8/7/2022, 2:00 PM - 3:50 PM	CC-204C
Statistical Considerations in Adaptive Designs — Contributed Papers
Biopharmaceutical Section
Chair(s): Meijing Wu, Sanofi
2:05 PM	Bayesian Empirical Balancing Calibration for Addressing Nonconcurrent Controls in Adaptive Platform Trials Evan Kwiatkowski, Rice University; Ying Yuan , the University of Texas MD Anderson Cancer Center; Ruitao Lin, MD Anderson
2:20 PM	Response-Adaptive Randomization for Precision Medicine Trials and the Pure-Exploration Contextual Bandit Problem John Sperger, University of North Carolina at Chapel Hill; Michael Kosorok, University of North Carolina at Chapel Hill
2:35 PM	Optimal Adaptive Promising Zone Designs Lingyun Liu, Vertex Pharmaceuticals; Cyrus Mehta, Cytel; Apurva Bhingare, Bristol Myers Squibb; Pralay Senchaudhuri, Cytel Corporation
2:50 PM	Generalized Conditional Power for Correlated Continuous Co-Primary Endpoints Zejiang Yang, Syneos Health
3:05 PM	A Note on Multiplicity Control for Trials with Adaptation Based on Intermediate Endpoint Wenjun Zheng, Regeneron Pharmaceuticals; Chenguang Wang, Regeneron Pharmaceuticals; Bret Musser, Regeneron Pharmaceuticals
3:20 PM	Overall Type I Error Control for Seamless 2/3 Adaptive Design Using Biomarkers Xin Wang, Bristol Myers Squibb; Rong Fan, Bristol Myers Squibb
3:35 PM	Adaptive Two-Stage Design with Count Data Yaohua Zhang, Vertex Pharmaceuticals; Bingming Yi , Vertex Pharmaceuticals; Lingyun Liu, Vertex Pharmaceuticals; Indrias Berhane, Vertex Pharmaceuticals

48 * !	Sun, 8/7/2022, 4:00 PM - 5:50 PM	CC-154B
Incorporating Ethical Thinking into Research and Innovation Through Education, Planning, Conduct, and Communication — Invited Panel
Committee on Professional Ethics, Statistics Without Borders, Committee on Scientific Freedom and Human Rights, Caucus for Women in Statistics, Biopharmaceutical Section
Organizer(s): Stephanie S Shipp, University of Virginia
Chair(s): Stephanie S Shipp, University of Virginia
4:05 PM	Incorporating Ethical Thinking into Research and Innovation Through Education, Planning, Conduct, and Communication
Panelists:	James Giordano, Georgetown University and US Naval War College Jeri Metzger Mulrow, Westat Jing Cao, SMU Momin Malik, Mayo Clinic Nathan Colaner, Seattle University Matthew D. Rotelli, Eli Lilly and Company
5:40 PM	Floor Discussion

53 * !	Sun, 8/7/2022, 4:00 PM - 5:50 PM	CC-143B
Considerations in Selection of the Appropriate Intercurrent Event Strategies for Estimands: Hypothetical vs. Composite vs. Treatment Policy — Topic Contributed Papers
Biopharmaceutical Section, ENAR, Biometrics Section
Organizer(s): Pilar Lim, Janssen Research & Development, LLC
Chair(s): Elena Polverejan, PhD, Janssen Research & Development, LLC
4:05 PM	Hypothetical Conversations: Which Estimand Strategies Are Clinically Relevant When Trial Participants Do Not Follow Clinically Relevant Protocol Guidelines? Bohdana Ratitch, Bayer Inc., Canada; Katrin Roth, Bayer
4:25 PM	Treatment Policy Estimation – Hidden Sources of Bias Michael Paul O'Kelly, IQVIA; Sylvia Siying Li, IQVIA
4:45 PM	Targeting Composite Estimands Using Trimmed Means Alex Ocampo, Novartis Pharma AG
5:05 PM	Discussant: Hsien-Ming 'James' Hung, PhD, U. S. FDA
5:25 PM	Discussant: Yongming Qu, PhD, Lilly
5:45 PM	Floor Discussion

54 * !	Sun, 8/7/2022, 4:00 PM - 5:50 PM	CC-152A
Recent Advances in Categorical Data Analytics — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, Committee on Applied Statisticians
Organizer(s): Krishna K Saha, Central CT State University
Chair(s): Krishna K Saha, Central CT State University
4:05 PM	Joint Analysis of Binary and Continuous Data via Joint Modeling of Jittered Binary and Continuous Outcomes: A New Approach Mili Roy, University of Calgary; Alexander R. de Leon, University of Calgary; Tolulope Sajobi, University of Calgary; Rob Deardon, University of Calgary
4:25 PM	Bayesian Network Meta-Regression for Aggregate Ordinal Outcomes with Missing Categories Yeongjin Gwon, University of Nebraska Medical Center; Ming-Hui Chen, University of Connecticut; May Mo, Amgen; Xun Jiang, Amgen; Amy Xia, Amgen; Joseph G Ibrahim, University of North Carolina
4:45 PM	Should We Use Discrete Variable to Estimate Semiparametric Functional Coefficient Fixed Effects Panel Data Model? Shaymal Chandra Halder, University of Pennsylvania; Emir Malikov, University of Nevada at Las Vegas
5:05 PM	High-Dimensional Fixed Effects Profiling Models: New Developments and Applications Danh Nguyen, University of California, Irvine; Jason Estes, Moutain View; Damla Senturk, University of California, Los Angeles; Esra Kurum, University of California, Riverside
5:25 PM	Analysis of the Relative Risk Associated with Clustering Binary Data Gopal Nath, Murray State University; Krishna K Saha, Central CT State University; Suojin Wang, Texas A&M
5:45 PM	Floor Discussion

57 * !	Sun, 8/7/2022, 4:00 PM - 5:50 PM	CC-151B
Recent Advancements in Multiple Comparison Methodology — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yeh-Fong Chen, Food and Drug Administration
Chair(s): George Kordzakhia, Astra Zeneca
4:05 PM	Computational Methods to Control Multiplicity in Nonstandard Settings of Confirmatory Clinical Trials Tianyu Zhan, Data and Statistical Sciences, AbbVie
4:25 PM	New Strategies in Controlling the Type I Error for Multiple Endpoints in Multiple Studies Qian Li, Statistics and Data Corporation
4:45 PM	On Dependence Assumption in P-Value Based Multiple Test Procedures Jiangtao Gou, Villanova University
5:05 PM	Modified Superchain Procedures for Exchangeable and Hierarchical Families with K-Out-of-N Success Criteria Qing Xie, FDA
5:25 PM	Discussant: John Lawrence, FDA
5:45 PM	Floor Discussion

63	Sun, 8/7/2022, 4:00 PM - 5:50 PM	CC-142
Statistical Methods in Precision and Personalized Medicine and Subgroup Analysis — Contributed Papers
Biopharmaceutical Section
Chair(s): Pin Li, Henry Ford Health System
4:05 PM	Exact Calculation for Curtailed One-Stage Binomial Random-Sized Subset Selection Procedures Yifang Zhang, Syracuse University; Pinyuen Chen, Syracuse University
4:20 PM	Matched cohorts applied propensity scores inverse probability of weighting - the association between home-based primary care in dementia patients and their hospital utilization In-Lu Amy Liu, Kaiser Permanente; Janet S Lee, Kaiser Permanente; Ernest Shen, Kaiser Permanente; Huong Q Nguyen, Kaiser Permanente
4:35 PM	Exploring Determinants of Treatment Response Lev S Sverdlov, Redmond Analytics LLC
4:50 PM	Identification of Immune Response Combinations Associated with Heterogeneous Infection Risk in the Immune Correlates Analysis of HIV Vaccine Studies CHAERYON KANG, Dept. of Biostatistics, University of Pittsburgh; Ying Huang, Fred Hutchinson Cancer Research Center
5:05 PM	A New Statistical Method to Adjust for Multiplicity in Confirmatory Subgroup Analysis QIQI DENG, Moderna; Naitee Ting, Boehringer-Ingelheim; Qian Li, Statistics and Data Corporation
5:20 PM	Sample Size and Levels of Treatment Effect Heterogeneity: Impact on the Estimation of Individualized Treatment Rules for Patients with Multiple Sclerosis Xiaotong Jiang, Biogen; Gabrielle Simoneau, Biogen; Bora Youn, Biogen; Changyu Shen, Biogen; Fabio Pellegrini, Biogen; Carl de Moor, Biogen
5:35 PM	Floor Discussion

76	Mon, 8/8/2022, 7:00 AM - 8:15 AM
CANCELED: Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section

223563	Mon, 8/8/2022, 8:00 AM - 12:00 PM	M-Archives
Biopharmaceutical Section Executive Committee Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Alan H Hartford, Takeda

CE_14C	Mon, 8/8/2022, 8:00 AM - 12:00 PM	CC-145A
Evidence-Based Approach in Pediatric Drug Development: Progress and Lessons Learned — Professional Development Continuing Education Course
ASA, Biopharmaceutical Section
Instructor(s): Satrajit Roychoudhury, Pfizer Inc; Margaret Gamalo , Pfizer Inc.; Robert ‘Skip’ Nelson, Johnson & Johnson
Evidence-based medicine is required for adults and nothing less so for the pediatric population. Pediatric trials are unique for several reasons: small number of patients, limited physiologic data, and ethical complexity increase the difficulty and costs of pediatric trials. Extrapolation of adult or other pediatric data has facilitated the conduct of pediatric product development trials, subsequent marketing approval, and labeling. This approach reduces the number of children that need to be enrolled and the type of clinical trials that need to be conducted for pediatric product marketing approval. During the first part of the short course, we will introduce the general scientific framework of extrapolation and provide overview of available design and analysis approaches. We’ll elaborate on the use of Bayesian hierarchical model (BHM) and discuss the practicality of the underlying assumptions associated with it. Finally, we’ll discuss extensions of BHM to handle possible deviations from underlying assumptions and implementation using the R. Later, we will focus on the regulatory aspects and case studies. A real-life case study will be included to illustrate the practical implementation and regulatory hurdles. The aim of the short course is to enable participants to apply the extrapolation techniques themselves in the real-life trial.

100 * !	Mon, 8/8/2022, 8:30 AM - 10:20 AM	CC-150B
Cross Trial Borrowing in Drug Development: The Promising Potentials — Topic Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, Section on Risk Analysis
Organizer(s): Qian Li, Statistics and Data Corporation
Chair(s): Qian Li, Statistics and Data Corporation
8:35 AM	Borrowing Information of a Surrogate Endpoint for Planning a Phase III Study Hui Quan, Sanofi; Zhixing Xu, Sanofi; Gautier Paux, Sanofi; Meehyung Cho, Sanofi; Xun Chen, Sanofi
8:55 AM	Implementation of Enrichment Designs in Platform Settings Yeh-Fong Chen, Food and Drug Administration ; Feiran Jiao, FDA
9:15 AM	Type I Error Control Strategies Using a Conditional Hybrid Control in Randomized Clinical Trials Hongyan Li, Statistics & Data Corporation ; Qian Li, Statistics and Data Corporation; Adam Hamm, Statistics & Data Corporation
9:35 AM	Discussant: Thomas Gwise, FDA/CDER
9:55 AM	Discussant: Qing Liu
10:15 AM	Floor Discussion

109	Mon, 8/8/2022, 8:30 AM - 10:20 AM	CC-204C
Innovative Approaches in Biomarkers Discovery and Subgroup Analyses — Contributed Papers
Biopharmaceutical Section
Chair(s): Jinyuan Liu, Vanderbilt University
8:35 AM	Controlling the False Discovery Rate in Benefiting Subgroup Identification Patrick M Schnell, The Ohio State University
8:50 AM	Joint Estimation of Multiple Mixed Graphical Models for Pan-Cancer Network Analysis Bochao Jia, Eli Lilly and Company
9:05 AM	A Targeted Simulation-Extrapolation Method for Evaluating Biomarkers Based on New Technologies in Precision Medicine Dong Wang, National Center for Toxicological Research/FDA; Sue-Jane Wang, FDA; Joshua Xu, National Center for Toxicological Research/FDA; Samir Lababidi, Office of Chief Scientist/FDA
9:20 AM	Network Analysis of RNA Sequence and Drug Safety Data Kao-Tai Tsai, BMS
9:35 AM	Compare and Combine Assays with a Different Limit of Detection Ying Huang, Fred Hutchinson Cancer Research Center; Yunda Huang, Fred Hutchinson Cancer Research Center
9:50 AM	Bayesian Image-on-Scalar Regression with a Spatial Global-Local Spike-and-Slab Prior Zijian Zeng, Rice University; Meng Li, Rice University; Marina Vannucci, Rice University
10:05 AM	Floor Discussion

131 *	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-159AB
Translating Health Outcome Data into Real-World Understanding and Policies — Topic Contributed Papers
Health Policy Statistics Section, Business and Economic Statistics Section, Biopharmaceutical Section
Organizer(s): Heejung Bang, Division of Biostatistics, University of California
Chair(s): Heejung Bang, Division of Biostatistics, University of California
10:35 AM	An Influence Function Based Instrumental Variable Estimator of Censored Medical Costs Nicholas Illenberger, New York University; Nandita Mitra, University of Pennsylvania; Luke Keele, University of Pennsylvania
10:55 AM	Optimizing Tailored Intervention in Cost-Effectiveness Analysis Shuai Chen, University of California, Davis
11:15 AM	The Diffusion of Health Care Fraud: A Network Analysis James O'Malley, Geisel School of Medicine at Dartmouth; Thomas Bubolz, Geisel School of Medicine at Dartmouth; Jonathan S Skinner, Dartmouth College
11:35 AM	Measuring Health Care Quality: Opportunities and Challenges for Addressing Social Determinants of Health Presentation Sophia Chan, Centers for Medicare and Medicaid Services (CMS)
11:55 AM	Floor Discussion

135 * !	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-203AB
The Use of Baseline Covariates and Early Read-Outs in Adaptive and Group Sequential Designs: Worth the Effort? — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Lisa Hampson, Novartis Pharma AG, Switzerland; Kelly Van Lancker, Johns Hopkins University, Bloomberg School of Public Health, US and Ghent University, Belgium
Chair(s): Lisa Hampson, Novartis Pharma AG, Switzerland
10:35 AM	Combining Covariate Adjustment with Group Sequential and Information Adaptive Designs to Improve Randomized Trial Efficiency Kelly Van Lancker, Johns Hopkins University, Bloomberg School of Public Health, US and Ghent University, Belgium; Joshua Betz, Johns Hopkins Bloomberg School of Public Health; Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health
10:55 AM	Using a Combination of Early and Primary Endpoint Data in Group-Sequential and Interrupted Clinical Trials Nigel Stallard, University of Warwick
11:15 AM	Use of Short-Term Outcomes in Adaptive Seamless Designs with Treatment or Subgroup Selection Presentation Tim Friede, University Medical Center Goettingen
11:35 AM	MIRROS: Planning a Phase 3 Trial with Time-to-Event Endpoint, a Cure Proportion, and a Futility Interim Analysis Using Response Presentation Kaspar Rufibach, F. Hoffmann-La Roche; Dominik Heinzmann, F. Hoffmann-La Roche; Annabelle Monnet, F. Hoffmann-La Roche
11:55 AM	Joint Modeling of Longitudinal and Time-to-Event Data Applied to Adaptive Clinical Trials Abigail Burdon, University of Cambridge
12:15 PM	Floor Discussion

137 * !	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-150A
Joint Modeling for Longitudinal and Survival Outcomes in Health Studies — Topic Contributed Papers
Section on Statistical Computing, WNAR, Biopharmaceutical Section
Organizer(s): Ying Lu, Stanford University School of Medicine
Chair(s): Ellen Snyder, Merck Research Laboratories
10:35 AM	Joint Model for Survival and Multivariate Sparse Functional Data with Application to a Study of Alzheimer's Disease Cai Li, St. Jude Children's Research Hospital; Luo Xiao, North Carolina State University; Sheng Luo, Duke University
10:55 AM	Efficient Algorithms and Implementation of a Semiparametric Joint Model for Longitudinal and Competing Risks Data, with Applications to Massive Biobank Data Presentation Shanpeng Li, UCLA; Gang Li, University of California, Los Angeles; Ning Li , UCLA; Hong Wang, Central South University; Jin Zhou, UCLA; Hua Zhou, UCLA
11:15 AM	A Robust Joint Model of Longitudinal Trajectories and Time-to-Event Data at Biobank Scale Hua Zhou, UCLA; Jin Zhou, UCLA; Gang Li, University of California, Los Angeles
11:35 AM	Joint Modeling in Presence of Informative Censoring in Palliative Care Studies Quran Wu, University of Florida; Michael Daniels, University of Florida; Zhigang Li, University of Florida
11:55 AM	Joint modeling of endpoints can be used to answer various research questions in randomized clinical trials Ruben van Eijk, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands
12:15 PM	Floor Discussion

138 * !	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-202B
Dose Optimization in Drug Development: Where We Are, and Where We Want to Be — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, Health Policy Statistics Section
Organizer(s): Bo Huang, Pfizer Inc.
Chair(s): Bo Huang, Pfizer Inc.
10:35 AM	A Bayesian Predictive Platform Design for Proof of Concept and Dose-Finding Using Early and Late Endpoints Ruitao Lin, MD Anderson; Li Wang, Abbvie; Peter Thall, The University of Texas MD Anderson Cancer Center; Ying Yuan , the University of Texas MD Anderson Cancer Center
10:55 AM	Statistical Methods for Dose Optimization in Oncology; One Size Does Not Fit All Roberto Bugarini, Pfizer Inc.; Wei Zhong, Pfizer Inc.; Christophe Le Corre, Pfizer Inc.; Cynthia Basu, Pfizer Inc.; Ray Li, Pfizer Inc.
11:15 AM	Dose-Finding in Retinal Gene Therapy Trials – Optical Illusion or Not? Jialin Xu, Janssen; George Capuano, Janssen
11:35 AM	Data-Informed Oncology Dosing Decisions: Trade-Off Between Efficacy/Safety/Convenience Including a Case Study with a Bi-Specific Immunotherapy Erik Rasmussen, Amgen
11:55 AM	Bayesian Approaches to Identify Multiple Recommended Phase 2 Doses Erik Bloomquist, Ph.D.; Jianjin Xu, FDA/CDER
12:15 PM	Floor Discussion

145	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-140B
Leveraging External Data in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Chris Holland, ImmunoCore
10:35 AM	BOREC: A Bayesian Optimal Design for Randomized Dose Expansion Cohorts in Oncology Trials Jinjie Chen, BMS; Rong Liu, BMS; Ruitao Lin, MD Anderson
10:50 AM	A Matching Design for Augmenting a Randomized Clinical Trial with External Control Jianghao Li, Eli Lilly and Company; Yu Du, Eli Lilly and Company; Yanyao Yi, Eli Lilly and Company; Huayu Liu, Eli Lilly and Company
11:05 AM	Evaluating Propensity-Score Augmentation of Real-World Controls in Clinical Studies Mingyang Shan, Eli Lilly and Company; Yang Ou, University of Pittsburgh; Tongrong Wang, Eli Lilly and Company; Ilya Lipkovich, Eli Lilly and Company; Douglas Faries, Eli Lilly & Company
11:20 AM	Dynamic Regularized Bayes Borrowing Leveraging Efficiency of Estimation Presentation Mohamad Hasan, Johnson & Johnson; Kate Stromberg, Janssen R&D, LLC
11:35 AM	BPAD: A Bayesian Basket Design for Pediatric Trials with Adult Data Yimei Li, University of Pennsylvania; Ying Yuan , the University of Texas MD Anderson Cancer Center
11:50 AM	Leveraging Information from Historical Trials: A Case Study in Pediatric Multiple Sclerosis Min Zhu, Bristol Myers Squibb; David Stivers, Bristol Myers Squibb; Judy Li, Bristol Myers Squibb
12:05 PM	Floor Discussion

153	Mon, 8/8/2022, 10:30 AM - 12:20 PM	CC-Hall D
Contributed Poster Presentations: Biopharmaceutical Section — Contributed Poster Presentations
Biopharmaceutical Section
Chair(s): Gyuhyeong Goh, Kansas State University
1:	Some Statistical Considerations in In-Vitro Data Analysis Dalong Huang, FDA/CDER; Jing Sun, FDA/CDER; Sheng Yuan, University of Kentucky
2:	Dynamic Prediction of Residual Life with Longitudinal Covariates Using Long Short-Term Memory Networks Grace Rhodes, North Carolina State University; Wenbin Lu, North Carolina State University; Marie Davidian, North Carolina State University
3:	Randomization Based Methods for Covariance and Stratified Adjustment of Win Ratios and Win Odds for Ordinal Outcomes Ann Marie K. Weideman, University of North Carolina at Chapel Hill, Chapel Hill, NC; Gary G. Koch, University of North Carolina at Chapel Hill, Chapel Hill, NC; Elaine K. Kearney, University of North Carolina at Chapel Hill, Chapel Hill, NC
4:	The Win Ratio Approach for Recurrent Events with an Associated Terminal Event - Simulations and Considerations Huihua Li, Pfizer Inc; Anqi Yin, Georgetown University; Ching-Ray Yu, Pfizer, Inc
5:	Statistical Methods for Selective Biomarker Testing Natalie DelRocco, University of Florida; Adam Ding, Northeastern University; Samuel Wu, University of Florida
6:	Projection in Site-Specific Participants Enrollment for Clinical Trials Wenjun He, EMMES LLC
7:	Adaptive Two-Stage Designs for One-Arm Binary Endpoint in Oncology Clinical Trials Yu Zhao, University of California, San Diego; Weichao Bao, Bayer U.S. LLC; Kui Shen, Bayer U.S. LLC
8:	A Unified Bayesian Framework for Assessing Predictive Probability of Trial Success Archie Sachdeva, University of Florida; Ming Zhou, Bristol Myers Squibb; Ram Tiwari, Bristol Myers Squibb
9:	A Single-Arm Multiple-Stage Bayesian-Frequentist Design with Efficacy and Futility Boundaries Bing Liu, KUMC; Jianghua He, University of Kansas Medical Center
10:	Jointly Assessing the Overall Treatment Effects Across Multiple Timepoints by a Global Test in the Paradigm of Longitudinal Analysis Hong Li, Takeda
11:	An Exact Confidence Interval of Observed Proportion with Stratified Factors ruji yao, Merck & Co., Inc.; Amarjot Kaur, Merck & Co; qing li, Merck & co., Inc.
12:	Multiple Imputation of COVID-19 Disease Progression Using a Markov Model Chaoran Hu, Eli Lilly and Company; Nathan Morris, Eli Lilly and Company; Sujatro Chakladar, Eli Lilly and Company; Brenda Crowe, Eli Lilly and Company
13:	Doubly-Robust Estimation for Interim Monitoring in Sequential Multiple Assignment Randomized Trials Cole Manschot, North Carolina State University; Marie Davidian, North Carolina State University; Eric Laber, Duke University
14:	Survey and Recommendations on the Use of P-Values Driving Decisions in Nonclinical Applications Stan Altan, Janssen R&D; Helena Geys, Janssen R&D ; Steven Novick, Astra Zeneca R&D
15:	Interim Presentation and Analysis of Multi-Protocol Clinical Trials Scott Diegel, University of Wisconsin-Madison; Melissa Schultz, University of Wisconsin-Madison; Nick Zaborek, University of Wisconsin-Madison
16:	Current Situation and Consideration on Sample Size Re-Estimation Shunichiro Orihara, Kyowa Kirin Co., Ltd.; Yuji Tanaka, Kyowa Kirin Co., Ltd.; Junji Moriya, Kyowa Kirin Co., Ltd.
17:	BACPAC Modified CDISC Standards Facilitate Characterization of Patient Populations and Integration of Data Across Multiple Back Pain Studies Anna Batorsky, University of North Carolina Chapel Hill; Micah McCumber, University of North Carolina Chapel Hill; Charity G. Patterson, Dept of Physical Therapy School of Health & Rehabilitation Sciences Univ of Pittsburgh; Matthew A. Psioda, University of North Carolina at Chapel Hill

161	Mon, 8/8/2022, 12:30 PM - 1:50 PM	CC-Ballroom Level South Prefunction
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
ML08:	Demonstration of Contribution of Component for Combination Drug Development Meihua Wang, Alkermes; Linda Sun, Merck & Co, Inc.
ML09:	The Tripartite Estimand Approach: When Is it Useful? Stephen J Ruberg, Analytix Thinking, LLC

174 * !	Mon, 8/8/2022, 2:00 PM - 3:50 PM	CC-202A
Patient Centricity at the Heart of Innovative Trial Design — Invited Papers
Biopharmaceutical Section, International Indian Statistical Association, Health Policy Statistics Section
Organizer(s): Satrajit Roychoudhury, Pfizer Inc
Chair(s): Satrajit Roychoudhury, Pfizer Inc
2:05 PM	The Predictive Individual Effect for Survival Data Kannan Natarajan, Pfizer
2:30 PM	The Impact of Complex Innovative Trial Designs: Past, Present, and Future Dionne Price, Food and Drug Administration
2:55 PM	Deliver Transformative Medicines to Patients by Leveraging Complex Innovative Designs Amy Xia, Amgen
3:20 PM	Innovations to Ascertain Predictive from Prognostic Targets Brian P Hobbs, The University of Texas
3:45 PM	Floor Discussion

180 *	Mon, 8/8/2022, 2:00 PM - 3:50 PM	CC-152A
Machine Learning and Artificial Intelligence: Uses and Misuses! — Invited Panel
Section for Statistical Programmers and Analysts, Section on Statistical Computing, Biopharmaceutical Section
Organizer(s): Vipin Arora, Eli Lilly and Company
Chair(s): Vipin Arora, Eli Lilly and Company
2:05 PM	Machine Learning and Artificial Intelligence: Uses and Misuses!
Panelists:	Mark Van Der Laan, UC Berkeley Jingjing Chen, Takeda Pharmaceuticals Jaroslaw Harezlak, Indiana University Melvin Munsaka, AbbVie Inc
3:40 PM	Floor Discussion

198	Mon, 8/8/2022, 2:00 PM - 3:50 PM	CC-204A
Innovations in Patient-Focused Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): John Han, J&J
2:05 PM	Likelihood-Based Inferences for Hybrid Trials Incorporating Patient's Treatment Choice Rouba Chahine, RTI International; Inmaculada A Aban, The University of Alabama at Birmingham
2:20 PM	Innovative Basket Trails Design Using BIC (Bayesian Hierarchical Mixed Model, Patient Information, Clustering) Chenyang Duan, Oregon State University ; Zheyu Liu, Bayer; Christoph Neumann, Bayer
2:35 PM	Use and Potential Challenges of Consumer Wearable Devices in Clinical Trials T. Paulette Ceesay, Merck & Co; Vladimir Svetnik, Merck Research Labs
2:50 PM	Comparison of Estimand Strategies and Analysis Methods on Patient-Reported Outcome (PRO) Endpoint Saijuan (Sandra) Zhang, Bristol Myers Squibb
3:05 PM	A Comparison of K-Means and Consensus Clustering Algorithms in the Analysis of Wearable and Biosensor Data Vanja Vlajnic, Bayer; Steve Simske, Colorado State University
3:20 PM	Utility of Computerized Adaptive Testing for Measuring Endpoints in Clinical Trials Fraser Bocell, US FDA/CDRH; Weimeng Weng, US FDA/CDER; Xin Yuan, US FDA/CDER; Kevin Weinfurt, Duke University
3:35 PM	Approaches for Understanding Treatment Effects with Health Measures: The Meaningfulness of Expected Scores Versus Expected Differences in Scores Laura Lee Johnson, U.S. Food and Drug Administration; Fraser Bocell, US FDA/CDRH; Monica Morell, U.S. Food and Drug Administration; Kevin Weinfurt, Duke University

223571	Mon, 8/8/2022, 4:00 PM - 5:30 PM	M-Capitol
Leadership in Practice Committee (LiPCom): Early-Career Professionals Mixer — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Rakhi Kilaru, PPD, part of Thermo Fisher Scientific

210	Tue, 8/9/2022, 7:00 AM - 8:15 AM	CC-Ballroom Level South Prefunction
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
TL01:	Aggregate Safety Review, Analysis Planning, and Reporting Rosanne Lane, Janssen

217 * !	Tue, 8/9/2022, 8:30 AM - 10:20 AM	CC-150B
Theory and Algorithms for Adaptive Clinical Trial Design with Multiple Objectives — Invited Papers
WNAR, International Chinese Statistical Association, Biopharmaceutical Section
Organizer(s): Ying Lu, Stanford University School of Medicine
Chair(s): Ying Lu, Stanford University School of Medicine
8:35 AM	Grammar of Group Sequential Design Presentation Keaven M Anderson, Merck & Co., Inc.; Yilong Zhang, Merck & Co., Inc.; Nan Xiao, Merck & Co., Inc.; Yujie Zhao, Merck & Co., Inc.
9:00 AM	Tight, Rigorous, and Automated Type I Error Proofs with Simulation Michael Benjamin Sklar, Stanford University
9:25 AM	Optimizing Patient Enrollment in Global Clinical Trials by Metaheuristics Weng Kee Wong, UCLA; Mitchell Schepps, UCLA; Austin Matt, Amgen; Vlad Anisimov, Amgen
9:50 AM	Multi-Objective Approach to Assist in Selection of Efficient Clinical Trial Operation Design with Respect to Minimizing Expected Recruitment Time and the Geographic Site Footprint Austin Matt, Amgen; Vlad Anisimov, Amgen
10:15 AM	Floor Discussion

227 * !	Tue, 8/9/2022, 8:30 AM - 10:20 AM	CC-149AB
Moving the Needle on Innovation in Clinical Trial Designs and Strategies: Vignettes of Statistical Leadership and Lessons Learned from a Global Pandemic — Invited Panel
Biopharmaceutical Section, Section for Statistical Programmers and Analysts, Stats. Partnerships Among Academe Indust. & Govt. Committee
Organizer(s): Fanni Natanegara, Eli Lilly; Wei Shen, Eli Lilly
Chair(s): Wei Shen, Eli Lilly
8:35 AM	Moving the Needle on Innovation in Clinical Trial Designs and Strategies: Vignettes of Statistical Leadership and Lessons Learned from a Global Pandemic
Panelists:	Pandurang Kulkarni, Eli Lilly Chris Miller, AstraZeneca Wayne Wisemandle , Pfizer John Scott, FDA Lisa LaVange, U of North Carolina
10:10 AM	Floor Discussion

233 * !	Tue, 8/9/2022, 8:30 AM - 10:20 AM	CC-144B
Statistical Considerations for Adjusting Overall Survival in Randomized Trials with Treatment Switching — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, International Statistical Institute
Organizer(s): Songzi Li, BeiGene, Ltd.
Chair(s): Hongqian Wu, BeiGene
8:35 AM	A Simulation Study of Treatment Switching Considering Delay Treatment Effect Songzi Li, BeiGene, Ltd.; Jiang Li, Ph.D
8:55 AM	The Least Bad Option: A Simulation Approach to Minimizing Bias When Accounting for Treatment Switching in RCTs Daniel Leibovitz, Bristol Myers Squibb; Alessandro Previtali, Bristol Myers Squibb; Revathi Ananthakrishnan, Bristol Myers Squibb; James Lymp, Bristol Myers Squibb
9:15 AM	Estimation of Treatment Effects and Model Diagnostics with Two-Way, Time-Varying Treatment Switching Qingxia Chen, Vanderbilt University Medical Center; Fan Zhang, Pfizer Inc., Groton, CT. This work was done at University of Connecticut.; Ming-Hui Chen, University of Connecticut; Xiuyu Julie Cong, Everest Medicines, Shanghai, China. This work was done at Boehringer Ingelheim Pharma.
9:35 AM	Bayesian Model for Overall Survival Analysis Allowing Treatment Switching in Oncology Trials Zhou Feng, FDA; Erik Bloomquist, Ph.D.
9:55 AM	Discussant: Chi Song, FDA
10:15 AM	Floor Discussion

243	Tue, 8/9/2022, 8:30 AM - 10:20 AM	CC-144A
Operational Considerations in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Susan Mayo, Food and Drug Administration, Center for Drug Evaluation
8:35 AM	Sample Size Re-Estimation: Timing, Decision Rule, and Study Power David Li, Eisai; Yan Li , Washington University School of Medicine
8:50 AM	Statistical Power of Survival Trials Weakened by COVID-19 Pandemic Ping Xu, Merck & Co.; Gregory T Golm, Merck & Co.
9:05 AM	Efficient Parameter Estimation in Seamless Adaptive Group Sequential Designs Krishna Padmanabhan, Cytel; Cyrus Mehta, Cytel; Lingyun Liu, Vertex Inc; Pranab Ghosh, Pfizer Inc
9:20 AM	Power and Sample Size Calculation for Weighted Log-Rank Tests in Group Sequential Trials Kaifeng Lu, BeiGene
9:35 AM	Empirical Power of Adaptive Long-Term Restricted Mean Survival Time-Based Tests in Contemporary Phase III Cancer Immunotherapy Studies Miki Horiguchi, Dana-Farber Cancer Institute; Hajime Uno, Dana-Farber Cancer Insitute
9:50 AM	Statistical Comparison of Waterfall Plots in Oncology Drug Development Mo Huang, Merck & Co., Inc.; Linda Sun, Merck & Co, Inc.; Cong Chen, Merck & Co., Inc.
10:05 AM	Floor Discussion

271 * !	Tue, 8/9/2022, 10:30 AM - 12:20 PM	CC-207B
Recent Statistical Advances of Handling Nonproportional Hazards in Study Design and Data Interpretation — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section
Organizer(s): Philip He, Daiichi Sankyo
Chair(s): Xiaofei Chen, Sanofi
10:35 AM	Hypothesis Testing Under Non-Proportion Hazards: Methodologic Challenges and Interpretations Jianghua He, University of Kansas Medical Center; Huan Cheng, University of Kansas Medical Center
10:55 AM	Adaptive Extension of Group-Sequential Time-to-Event Trials in the Presence of Non-Proportional Hazards Yue Shentu, Daiichi Sankyo Inc.; Yu Li, Merck & Co; Xieyang Jia, Merck & Co
11:15 AM	Delayed Separation of OS and PFS Kaplan Meier Curves Occurs in the Majority of IO Trials: A Meta-Analysis of Phase III Studies with Anti-PD-(L)1 Therapy Magdalena Watras, AstraZeneca; Philip He, Daiichi Sankyo; Nana Rokutanda, AstraZeneca; Jennifer Stocks, AstraZeneca
11:35 AM	Testing and Estimating Treatment Effect in the Presence of Delayed Onset of the Effect for Cancer Immunotherapies Chang Yu, Vanderbilt University Medical Center; Xiang Huang, Vanderbilt University Medical Center; Hui Nian, Vanderbilt University Medical Center; Philip He, Daiichi Sankyo
11:55 AM	Discussant: ZHENZHEN XU, FDA
12:15 PM	Floor Discussion

278	Tue, 8/9/2022, 10:30 AM - 12:20 PM	CC-140A
Multi-Stage and Seamless Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Inna Perevozskaya, GSK
10:35 AM	A 2-In-1 Seamless Phase II/III Design with Graphical Approach in Oncology Drug Development Presentation Linda Sun, Merck & Co, Inc.; Heng Zhou, Merck & Co., Inc.; Wen Li, Pfizer, Inc.; Calvin Jia, Merck & Co., Inc.
10:50 AM	A Bayesian Adaptive Two-Stage Design for Rare Disease Clinical Trials Xiaoqiang Xue, Syneos Health
11:05 AM	Two-Stage Design for Selecting Among Treatments with Two-Dependent Binary Endpoints Chishu Yin, Syracuse University; Pinyuen Chen, Syracuse University
11:20 AM	Two-Stage Designs with Dual Endpoints George Zhang, Bristol Myers Squibb; Olivia Tian, Bristol Myers Squibb
11:35 AM	Multi-Stage Transitional Seamless Trial Designs with Different Objectives and Endpoints Robert Anthony Tumasian III, Columbia University; Bin Cheng, Columbia University; Shein-Chung Chow, Duke University
11:50 AM	Dose Selection Based on Benefit-Risk Score in Seamless Phase 2/3 Adaptive Design Min Chen, BMS; Ivan Chan, BMS; Shuyu Chu, BMS
12:05 PM	Two-Stage in Restricted Mean Survival Time with Conditional Power in Clinical Studies Jingyu Huang, Rutgers University ; Yong Lin, Rutgers University; Weichung Joe Shih, Rutgers University; Shou-en Lu, Rutgers University; Kaifeng Lu, Allergan

296	Tue, 8/9/2022, 12:30 PM - 1:50 PM	CC-Ballroom Level South Prefunction
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
TL07:	The Use of Non-Concurrent Randomized Controls in Multi-Arm Adaptive Platforms Trials Ben Saville, Berry Consultants
TL08:	Dose Optimization for Early Hematology and Oncology Trials Shaoyi Li, BMS

323 * !	Tue, 8/9/2022, 2:00 PM - 3:50 PM	CC-201
Adaptive Enrichment Designs in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, ENAR
Organizer(s): Daniel Zhao, University of Oklahoma
Chair(s): Daniel Zhao, University of Oklahoma
2:05 PM	Adaptive Designs with Modified Testing Hierarchy at the Interim George Kordzakhia, Astra Zeneca; Cassie Dong, Takeda ; Eiji Ishida, Sunovion
2:25 PM	A Bayesian Group Sequential Enrichment Design with Adaptive Regression of Response and Survival Time on Baseline Biomarkers Presentation Peter Thall, The University of Texas MD Anderson Cancer Center; Yeonhee Park, University of Wisconsin-Madison; Suyu Liu, The University of Texas MD Anderson Cancer Center; Ying Yuan , the University of Texas MD Anderson Cancer Center
2:45 PM	Overview of Existing Methods for Biomarker-Driven Adaptive Designs Ilya Lipkovich, Eli Lilly and Company; Sarah Johnston, Bristol-Myers Squibb; Alex Dmitrienko, Mediana, Inc; Daniel Zhao, University of Oklahoma
3:05 PM	Decision Theoretic Approaches for the Design of Adaptive Enrichment and Umbrella Trials Martin Posch, Medical University of Vienna
3:25 PM	Discussant: Brian Wiens, ACELYRIN, INC.
3:45 PM	Floor Discussion

328 * !	Tue, 8/9/2022, 2:00 PM - 3:50 PM	CC-151A
Recent Development in Bayesian Dynamic Borrowing with Application to Clinical Trials — Topic Contributed Panel
Biopharmaceutical Section, Section on Bayesian Statistical Science, ENAR
Organizer(s): Lei Nie, U. S. FDA
Chair(s): Ming-Hui Chen, University of Connecticut
2:05 PM	Recent Development in Bayesian Dynamic Borrowing with Application to Clinical Trials
Panelists:	Ying Yuan , the University of Texas MD Anderson Cancer Center Margaret Gamalo , Pfizer Inc. Satrajit Roychoudhury, Pfizer Inc Hengrui Sun, FDA Ales Kotalik, AstraZeneca
3:40 PM	Floor Discussion

331	Tue, 8/9/2022, 2:00 PM - 3:50 PM	CC-202A
ASA Biopharmaceutical Section Student Paper Award Competition — Contributed Papers
Biopharmaceutical Section
Chair(s): Mingzhao Hu, University of California, Santa Barbara
2:05 PM	A New Clustering Method for Longitudinal Data Junyi Zhou, Amgen; Ying Zhang, University of Nebraska Medical Center; Wanzhu Tu, INDIANA UNIVERSITY
2:20 PM	A Synthetic Data Integration Framework to Leverage External Summary-Level Information from Heterogeneous Populations Tian Gu, Harvard Chan School of Public Health; Jeremy Taylor, University of Michigan; Bhramar Mukherjee, University of Michigan
2:35 PM	Learning Optimal Group-Structured Individualized Treatment Rules with Many Treatments Haixu Ma, University of North Carolina at Chapel Hill; Donglin Zeng, University of North Carolina; Yufeng Liu, University of North Carolina
2:50 PM	Semi-Supervised Mixture Multi-Source Exchangeability Model Approach for Incorporating Real World Data into Randomized Controlled Trial Analyses Lillian Moran Fitzmorris Haine, University of Minnesota; Thomas Murray , University of Minnesota ; Raquel Nahra, Cooper Medical School of Rowan University and Cooper University Health Care; Giota Touloumi, Department of Hygiene, Epidemiology Medical Statistics, Medical School, National; Eduardo Fernández-Cruz, Hospital General Universitario Gregorio Marañón, Servicio de Immunología Clínica, Madrid; Kathy Petoumenos, The Kirby Institute, University of New South Wales, Sydney, Australia; Joseph Koopmeiners, University of Minnesota - Minneapolis, MN
3:05 PM	BOB: Bayesian Optimal Design for Biosimilar Trials with Co-Primary Endpoints Xiaohan Chi, Shanghai Jiao Tong University; Zhangsheng Yu, Shanghai Jiao Tong University; Ruitao Lin, MD Anderson
3:20 PM	Longitudinal Monitoring of Antibiotics with Antimicrobial Susceptibility Testing Will Eagan, Vertex Pharmaceuticals; Bruce A. Craig, Purdue University
3:35 PM	Floor Discussion

223578	Tue, 8/9/2022, 5:30 PM - 7:30 PM	M-Liberty L
Biopharmaceutical Section Business Meeting and Mixer — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Alan H Hartford, Takeda

355	Wed, 8/10/2022, 7:00 AM - 8:15 AM	CC-Ballroom Level South Prefunction
Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee) — Roundtables AM Roundtable Discussion
Biopharmaceutical Section
WL01:	Diversity and Inclusion in the Pharmaceutical Industry T. Paulette Ceesay, Merck & Co; Darcy Hille, Merck & Co

223556	Wed, 8/10/2022, 7:30 AM - 9:00 AM	M-Gallery Place
Real-World Evidence Scientific Working Group Meeting — Other Cmte/Business
Biopharmaceutical Section
Chair(s): Weili He, AbbVie

361 * !	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-202B
Using Statistical Foundations to Demonstrate Effectiveness of ML/AI Algorithms for Clinical Utility — Invited Papers
Biopharmaceutical Section, Section on Statistical Learning and Data Science, Health Policy Statistics Section
Organizer(s): Charmaine Demanuele, Pfizer; Stephen J Ruberg, Analytix Thinking, LLC
Chair(s): Sandeep M Menon, Pfizer, Inc.
8:35 AM	Deep Learning for Image Analysis - Initial Development of Digital Diagnostic/Prognostic Algorithms: Analogies and Lessons Learned from Drug Development Chong Duan, Pfizer
9:00 AM	Optimizing Digital Diagnostic/Prognostics Algorithms: A New Framework and Approach Beyond Area Under the Receiver Operating Characteristic Curve Presentation Stephen J Ruberg, Analytix Thinking, LLC
9:25 AM	Clinical Trial Designs to Estimate the Effect of a Digital Diagnostic/Prognostic Algorithm in Clinical Practice: Application of Cluster-Randomized Designs Liz Turner, Duke University
9:50 AM	Discussant: John Quackenbush, Harvard T.H. Chan School of Public Health
10:15 AM	Floor Discussion

365 * !	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-207B
Causal Integration of Randomized Clinical Trials and Real-World Data: Challenges and Opportunities — Invited Papers
WNAR, Section on Statistics in Epidemiology, Biopharmaceutical Section
Organizer(s): Ting Ye, University of Washington
Chair(s): Yanyao Yi, Eli Lilly and Company
8:35 AM	Real-World Evidence: What’s in a Name? John Concato, Food and Drug Administration
8:55 AM	Counterfactual Controls for HIV Prevention Trials Deborah Donnell, Fred Hutchinson Cancer Research Center; Fei Gao, Fred Hutchinson Cancer Research Center
9:15 AM	Combining Randomized Clinical Trials and Observational Studies: An Anchored Transfer Learning Approach Ting Ye, University of Washington
9:35 AM	Improving the Power of Randomized Trials with Auxiliary Data in Education Research Johann A Gagnon-Bartsch, University of Michigan; Adam Sales, Worcester Polytechnic Institute
9:55 AM	Prognostic Covariate Adjustment: A Novel Method to Reduce Trial Sample Sizes While Controlling Type I Error David Walsh, Unlearn.AI; David Miller, Unlearn.AI; Diana Hall, Unlearn.AI; Jon Walsh, Unlearn.AI; Charles Fisher, Unlearn.AI; Alejandro Schuler, Unlearn.AI
10:15 AM	Floor Discussion

374 * !	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-201
Bayesian Clinical Trial Designs with Heterogeneous Patient Subgroups — Topic Contributed Papers
Biopharmaceutical Section, International Chinese Statistical Association, Section on Bayesian Statistical Science
Organizer(s): Kentaro Takeda, Astellas Pharma Global Development, Inc.
Chair(s): Kentaro Takeda, Astellas Pharma Global Development, Inc.
8:35 AM	Dose Finding with Heterogeneous Patient Subgroups ANASTASIA IVANOVA, UNC at Chapel Hill; Pooja Saha, Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan
8:55 AM	Group-Sequential Enrichment Designs Based on Adaptive Regression of Response and Survival Time on High-Dimensional Covariates Yeonhee Park, University of Wisconsin-Madison; Suyu Liu, The University of Texas MD Anderson Cancer Center; Peter Thall, The University of Texas MD Anderson Cancer Center; Ying Yuan , the University of Texas MD Anderson Cancer Center
9:15 AM	BAGS: A Bayesian Adaptive Group Sequential Trial Design with Subgroup-Specific Survival Comparisons Ruitao Lin, MD Anderson; Peter Thall, The University of Texas MD Anderson Cancer Center; Ying Yuan , the University of Texas MD Anderson Cancer Center
9:35 AM	Bayesian Divide-and-Conquer Propensity Score–Based Approaches for Leveraging Real-World Data in Randomized Control Trials Eric Baron, University of Connecticut; Jian Zhu, Servier Pharmaceuticals; Sammi Tang, Servier Pharmaceuticals; Ming-Hui Chen, University of Connecticut
9:55 AM	Incorporating Historical Information for Randomized Clinical Trials: Dynamic Borrowing with Bias Control Masataka Taguri, Yokohama City University
10:15 AM	Floor Discussion

375 * !	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-203AB
Causal Estimand in Clinical Trials — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, Health Policy Statistics Section
Organizer(s): Lei Nie, U. S. FDA
Chair(s): Frank Bretz, Novartis
8:35 AM	Covariate Adjustment and Missing Data in Clinical Trials Daniel Rubin, U.S. Food and Drug Administration
8:55 AM	Estimating the Average Treatment Effect in Randomized Clinical Trials with All-or-None Compliance Zhiwei Zhang, National Cancer Institute/National Institutes of Health; Zonghui Hu, National Institutes of Health; Dean Follmann, National Institute of Allergy and Infectious Diseases; Lei Nie, U. S. FDA
9:15 AM	Estimands and Their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic Kelly Van Lancker, Johns Hopkins University, Bloomberg School of Public Health, US and Ghent University, Belgium; Sergey Tarima, Division of Biostatistics, Medical College of Wisconsin; Jonathan Bartlett, University of Bath; Madeline Bauer, Division of Infectious Diseases, Keck School of Medicine, University of Southern Californi; Bharani Bharani-Dharan, Novartis Pharmaceuticals; Frank Bretz, Novartis; Nancy Flournoy, University of Missouri; Hege Michiels, Ghent University; Camila Olarte Parra, University of Bath; James Landis Rosenberger, Penn State and NISS; Suzie Cro, Imperial Clinical Trials Unit, Imperial College London
9:35 AM	Discussant: Wanjie Sun, The US FDA
9:55 AM	Discussant: Tianmeng Lyu, Novartis
10:15 AM	Floor Discussion

385	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-140A
SPEED: Statistical Methods and Applications in Medical Research, Risk Analysis, and Marketing Part 1 — Contributed Speed
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Section on Statistics in Imaging, IMS, International Chinese Statistical Association, Section on Risk Analysis, Section on Statistics in Marketing
Chair(s): Michael Higgins, Kansas State University
8:35 AM	Near Real-Time Surveillance of COVID-19 Vaccine Safety in the U.S. Food and Drug Administration Biologics Effectiveness and Safety (BEST) Initiative Data Network Mao Hu, Acumen LLC; Patricia Lloyd, US Food and Drug Administration; Cindy Ke Zhou, US Food and Drug Administration; An-Chi Lo, Acumen LLC; Yoganand Chillarige, Acumen LLC; John Hornberger, Acumen LLC; Jeffrey Kelman, Centers for Medicare & Medicaid Services; Anne Marie Kline, Aetna; Cheryl N McMahill-Walraven, Aetna; Kandace L. Amend, Optum Epidemiology; John D Seeger, Optum Epidemiology; Daniel Beachler, HealthCore, Inc.; Alex Secora, IQVIA; Christian Reich, IQVIA; Azadeh Shoaibi, US Food and Drug Administration; Hui Lee Wong, US Food and Drug Administration; Steven Anderson, US Food and Drug Administration
8:40 AM	Integration of Efficacy Biomarkers Together with Toxicity Endpoints in Immuno-Oncology Dose Finding Studies Yiding Zhang, Sanofi; Zhixing Xu, Sanofi; Ji Lin, Sanofi; Hui Quan, Sanofi
8:45 AM	Practical Implementation of Randomization in a Complex Site-Level Stepped-Wedge Cluster Pragmatic Randomized Trial Wen Wan, Section of General Internal Medicine, University of Chicago; Linda Rosul, Access community health network; Theodore Karrison, University of Chicago; Neda Laiteerapong, Section of General Internal Medicine, University of Chicago
8:50 AM	A Two-Stage Method to Minimize the Expected Sample Size of a Single-Arm Study Under the Alternative Hypothesis Xiaobo Zhong, Bristol Myers Squibb; Qian Li, Biostatistics and Strategic Consulting
8:55 AM	Improving Dose-Escalation Design with Historical and Concurrent Trial Data Abhishek Kumar Dubey, Bristol Myer Squibb; Arun Kumar Kumar, Bristol Myer Squibb; Kaushal Kumar Mishra, Bristol Myer Squibb
9:00 AM	BGLAM: A Bayesian General Logistic Autoregressive Model for Correlated Binary Outcomes Ahmad Hakeem Abdul Wahab, Janssen Pharmaceuticals; Arman Sabbaghi, Purdue University; Maggie O'Haire, Purdue University
9:05 AM	Practical Guidance on Mixture Priors Specification in Oncology Dose Escalation Models Frank Shen, Bristol Myers Squibb; Yanping Chen, Bristol Myers Squibb; Rong Liu, BMS
9:10 AM	Overlap Weight-Based Adaptive Bayesian Commensurate Prior for Augmenting the Control Arm of a Randomized Controlled Trial Yeonil Kim, Merck & Co., Inc. ; Erina Paul, Merck & Co., Inc.
9:15 AM	Power Analysis for Longitudinal Cluster Randomized Trials with Binary Outcomes Jijia Wang, UT Southwestern Medical Center
9:20 AM	Association of COVID Vaccine Hesitancy and Vaccine Misinformation Using Google Trends Analytics Vaccine Hesitancy Lan Gao, The University of Tennessee at Chattanooga
9:30 AM	Extending the Weighted Generalized Score Statistic for Comparison of Correlated Means Aaron D. Jones, Duke University; Andrzej S. Kosinski, Duke University
9:35 AM	Can Cutaneous Squamous Cell Carcinoma Be Properly Graded? Investigation of the Differentiation Grading Among Dermatopathologists Yevgeniya Gokun, The Ohio State University; Xueliang Pan, The Ohio State University; David Carr, The Ohio State University; Katie Shahwan, The Ohio State University; Jessica Nash, The Ohio State University
9:45 AM	Homogeneity Test for Ordinal ROC Regression and Application to Facial Recognition Ty Nguyen, University of Central Florida; Larry Tang, University of Central Florida
9:50 AM	Club Exco: Clustering Brain Extreme Communities from Multi-Channel EEG Data Matheus Bartolo Guerrero, King Abdullah University of Science and Technology; Raphael Huser, King Abdullah University of Science and Technology (KAUST); Hernando Ombao, King Abdullah University of Science and Technology
9:55 AM	Large-Scale Correlation Screening Under Dependence for Brain Functional Connectivity Inference Hanâ LBATH, Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP, LJK; Alexander Petersen, Brigham Young University; Sophie ACHARD, Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP, LJK
10:00 AM	Correcting Under-Reporting in Cyber Incidents Seema Sangari, Kennesaw State University; Eric Dallal, Verisk
10:05 AM	Outcome-Dependent Sampling on Posterior Estimates of Salesperson Rankings Neil Mercer, Google LLC; Frank Yoon, Google LLC; Ignacio Martinez, Google LLC
10:10 AM	A Framework for Measuring Influencer Marketing Gary Cohen, Amazon.com; Vanja Dukic, Amazon.com

10:15 AM	Floor Discussion

388	Wed, 8/10/2022, 8:30 AM - 10:20 AM	CC-204A
Statistical Methods in Handling Longitudinal Data and Temporal Effect — Contributed Papers
Biopharmaceutical Section
Chair(s): Dayu Sun, Emory University
8:35 AM	The Bayesian Time Machine: Accounting for Temporal Drift in Multi-Arm Platform Trials Ben Saville, Berry Consultants
8:50 AM	Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults Gail Potter, National Institutes of Health / NIAID; Tyler Bonnett, National Institutes of Health/ NIAID; Kay Tomashek, National Institutes of Health/ NIAID; Pablo Tebas, University of Pennsylvania
9:05 AM	Representation Learning with Gaussian Processes in Sparse Irregularly Sampled Longitudinal Metabolomics Allen Ross, George Washington University; Ali Rahnavard, George Washington University; Jason Lloyd-Price, Google
9:20 AM	A Rank-Based Test for Clinical Trials with Multivariate Longitudinal Endpoints Presentation Xiaoming Xu, Duke University; Sheng Luo, Duke University
9:35 AM	A Rshiny Applet for Sequential, Multiple Assignment, Randomized Trials with a Survival Final Endpoint Sasha Kravets, Division of Epidemiology and Biostatistics, University of Illinois; Amy Ruppert, Eli Lilly and Company; Jennifer Le-Rademacher, Mayo Clinic; Sumithra Mandrekar, Mayo Clinic
9:50 AM	Conditional Independence Graphical Modeling for Multivariate Longitudinal Data Yafei Zhang, AbbVie; Pang Du, Virginia Tech
10:05 AM	Floor Discussion

410 * !	Wed, 8/10/2022, 10:30 AM - 12:20 PM	CC-154A
Bayesian Adaptive Designs and Novel Strategies for Dose Optimization in Cellular Therapy Drug Development — Topic Contributed Papers
Biopharmaceutical Section, International Society for Bayesian Analysis (ISBA), Stats. Partnerships Among Academe Indust. & Govt. Committee
Organizer(s): Yunqi Zhao, Takeda Pharmaceutical
Chair(s): Yunqi Zhao, Takeda Pharmaceutical
10:35 AM	The Ji3+3 Design for Cell/Gene Therapy Dose-Finding Trials with Joint Efficacy and Toxicity Outcomes Yuan Ji, The University of Chicago; Xiaolei Lin, Fudan University
10:55 AM	PMED: Optimal Bayesian Design for Platform Trials with Multiple Endpoints Rachael Liu, Takeda Pharamaceuticals; Tian He, Indiana University Purdue University Indianapolis; Meizi Liu, Takeda pharmaceuticals; Jianchang Lin, Takeda Pharmaceuticals
11:15 AM	A Sequential Basket Trial Design Based on Multi-Source Exchangeability with Predictive Probability Monitoring Alexander Kaizer, University of Colorado Anschutz Medical Campus; Emily Zabor, Cleveland Clinic; Lei Nie, U. S. FDA; Brian P Hobbs, The University of Texas
11:35 AM	GBOIN-ET: A Generalized Bayesian Optimal Interval Design for Optimal Dose-Finding Accounting for Ordinal Graded Efficacy and Toxicity in Early Clinical Trials Presentation Kentaro Takeda, Astellas Pharma Global Development, Inc.
11:55 AM	Discussant: Shuqi Wang, Georgetown University
12:15 PM	Floor Discussion

411 *	Wed, 8/10/2022, 10:30 AM - 12:20 PM	CC-158AB
Addressing Key Issues to Promote the Uptake of Using RWE/D for Regulatory Decisions — Topic Contributed Papers
Biopharmaceutical Section, Stats. Partnerships Among Academe Indust. & Govt. Committee, Health Policy Statistics Section
Organizer(s): Yixin Fang, AbbVie
Chair(s): Hana Lee, FDA
10:35 AM	Estimands in Real-World Studies Jie Chen, Overland Pharmaceuticals
10:55 AM	Statistical Consideration for Fit-For-Use Real-World Data to Support Regulatory Decision Making in Drug Development Weili He, AbbVie
11:15 AM	Sensitivity Analyses for Unmeasured Confounding: A Path Forward? Douglas Faries, Eli Lilly & Company
11:35 AM	Examples of Applying Causal Inference Framework in Real-World Settings Presentation Yixin Fang, AbbVie
11:55 AM	Discussant: Mark Levenson, FDA
12:15 PM	Floor Discussion

421	Wed, 8/10/2022, 10:30 AM - 12:20 PM	CC-144A
Missing Data Handling and Consideration — Contributed Papers
Biopharmaceutical Section
Chair(s): Deepak Khatry, Westat
10:35 AM	Treatment Effect Estimation in the Analysis of Count and Recurrent Event Data Sarah Conner, Vertex Pharmaceuticals; Yijie Zhou, Vertex Pharmaceuticals; Jason Yuan, Vertex Pharmaceuticals; Tu Xu, Vertex Pharmaceuticals
10:50 AM	Handling Intercurrent Events and Missing Data for Longitudinal Binary Data Under the Estimand Framework Cuihong Zhang, The University of Texas Health Science Center at Houston; Yunxia Sui, AbbVie Inc.; Yihan Li, AbbVie Inc.; Xin Wang, Bristol Myers Squibb
11:05 AM	A Hybrid Estimand to Account for Different Types of Intercurrent Events in Clinical Trials for Atopic Dermatitis Zhuqing Liu, Eli Lilly and Company; Jingyi Liu, Eli Lilly and Company
11:20 AM	Direct Likelihood Estimation for the Commonly Used Pattern Mixture Models in Clinical Trials Jitong Lou, Eli Lilly and Company; Yongming Qu, PhD, Lilly
11:35 AM	Doubly Robust Methods for Censored Covariates: An Application to Huntington Disease Marissa C. Ashner, University of North Carolina at Chapel Hill; Tanya P. Garcia, University of North Carolina at Chapel Hill
11:50 AM	Definition of Missing Value Within Estimand Framework – a Source for Confusion in the Statistical Practice Ulker Aydemir, Syneos Health
12:05 PM	Floor Discussion

443	Wed, 8/10/2022, 10:30 AM - 11:15 AM	CC-Hall D
SPEED: Statistical Methods and Applications in Medical Research, Risk Analysis, and Marketing Part 2 — Contributed Poster Presentations
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Section on Statistics in Imaging, IMS, International Chinese Statistical Association, Section on Risk Analysis, Section on Statistics in Marketing
Chair(s): Michael Higgins, Kansas State University
01:	Near Real-Time Surveillance of COVID-19 Vaccine Safety in the U.S. Food and Drug Administration Biologics Effectiveness and Safety (BEST) Initiative Data Network Mao Hu, Acumen LLC; Patricia Lloyd, US Food and Drug Administration; Cindy Ke Zhou, US Food and Drug Administration; An-Chi Lo, Acumen LLC; Yoganand Chillarige, Acumen LLC; John Hornberger, Acumen LLC; Jeffrey Kelman, Centers for Medicare & Medicaid Services; Anne Marie Kline, Aetna; Cheryl N McMahill-Walraven, Aetna; Kandace L. Amend, Optum Epidemiology; John D Seeger, Optum Epidemiology; Daniel Beachler, HealthCore, Inc.; Alex Secora, IQVIA; Christian Reich, IQVIA; Azadeh Shoaibi, US Food and Drug Administration; Hui Lee Wong, US Food and Drug Administration; Steven Anderson, US Food and Drug Administration
02:	Dose Finding via Efficacy Biomarkers and Toxicity Endpoints in Immuno-Oncology Clinical Trials Yiding Zhang, Sanofi; Zhixing Xu, Sanofi; Ji Lin, Sanofi; Hui Quan, Sanofi
03:	Practical Implementation of Randomization in a Complex Site-Level Stepped-Wedge Cluster Pragmatic Randomized Trial Wen Wan, Section of General Internal Medicine, University of Chicago; Linda Rosul, Access community health network; Theodore Karrison, University of Chicago; Neda Laiteerapong, Section of General Internal Medicine, University of Chicago
04:	A Two-Stage Method to Minimize the Expected Sample Size of a Single-Arm Study Under the Alternative Hypothesis Xiaobo Zhong, Bristol Myers Squibb; Qian Li, Biostatistics and Strategic Consulting
05:	Improving Dose-Escalation Design with Historical and Concurrent Trial Data Abhishek Kumar Dubey, Bristol Myer Squibb; Arun Kumar Kumar, Bristol Myer Squibb; Kaushal Kumar Mishra, Bristol Myer Squibb
06:	BGLAM: A Bayesian General Logistic Autoregressive Model for Correlated Binary Outcomes Ahmad Hakeem Abdul Wahab, Janssen Pharmaceuticals; Arman Sabbaghi, Purdue University; Maggie O'Haire, Purdue University
07:	Practical Guidance on Mixture Priors Specification in Oncology Dose Escalation Models Frank Shen, Bristol Myers Squibb; Yanping Chen, Bristol Myers Squibb; Rong Liu, BMS
08:	Overlap Weight-Based Adaptive Bayesian Commensurate Prior for Augmenting the Control Arm of a Randomized Controlled Trial Yeonil Kim, Merck & Co., Inc. ; Erina Paul, Merck & Co., Inc.
09:	Power Analysis for Longitudinal Cluster Randomized Trials with Binary Outcomes Jijia Wang, UT Southwestern Medical Center
10:	Association of COVID Vaccine Hesitancy and Vaccine Misinformation Using Google Trends Analytics Vaccine Hesitancy Lan Gao, The University of Tennessee at Chattanooga
11:	Extending the Weighted Generalized Score Statistic for Comparison of Correlated Means Aaron D. Jones, Duke University; Andrzej S. Kosinski, Duke University
12:	Can Cutaneous Squamous Cell Carcinoma Be Properly Graded? Investigation of the Differentiation Grading Among Dermatopathologists Yevgeniya Gokun, The Ohio State University; Xueliang Pan, The Ohio State University; David Carr, The Ohio State University; Katie Shahwan, The Ohio State University; Jessica Nash, The Ohio State University
13:	Evaluation of Patient-Reported Outcomes Using Kappa Statistics Saryet Kucukemiroglu, Food and Drug Administration; Manasi Sheth, Food and Drug Administration
14:	Statistical Considerations When Evaluating Diagnostic Devices with Categorical Output Manasi Sheth, Food and Drug Administration
15:	Homogeneity Test for Ordinal ROC Regression and Application to Facial Recognition Ty Nguyen, University of Central Florida; Larry Tang, University of Central Florida
16:	Club Exco: Clustering Brain Extreme Communities from Multi-Channel EEG Data Matheus Bartolo Guerrero, King Abdullah University of Science and Technology; Raphael Huser, King Abdullah University of Science and Technology (KAUST); Hernando Ombao, King Abdullah University of Science and Technology
17:	Large-Scale Correlation Screening Under Dependence for Brain Functional Connectivity Inference Hanâ LBATH, Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP, LJK; Alexander Petersen, Brigham Young University; Sophie ACHARD, Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP, LJK
18:	Correcting Under-Reporting in Cyber Incidents Seema Sangari, Kennesaw State University; Eric Dallal, Verisk
19:	Outcome-Dependent Sampling on Posterior Estimates of Salesperson Rankings Neil Mercer, Google LLC; Frank Yoon, Google LLC; Ignacio Martinez, Google LLC
20:	A Framework for Measuring Influencer Marketing Gary Cohen, Amazon.com; Vanja Dukic, Amazon.com

446	Wed, 8/10/2022, 12:30 PM - 1:50 PM	CC-Ballroom Level South Prefunction
Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee) — Roundtables PM Roundtable Discussion
Biopharmaceutical Section
WL06:	Challenges and Opportunities in Safety Monitoring and Analysis of Clinical Trials Philip He, Daiichi Sankyo
WL07:	Meet and Greet with the Biopharmaceutical Section Chairs Alan H Hartford, Takeda

467 * !	Wed, 8/10/2022, 2:00 PM - 3:50 PM	CC-144B
Alternative Data Sources Utilization in Clinical Development — Topic Contributed Papers
Health Policy Statistics Section, Social Statistics Section, Biopharmaceutical Section
Organizer(s): Freda Cooner, Amgen
Chair(s): Judy Li, Bristol Myers Squibb
2:05 PM	Achieving Regulatory Approval Using Real-World Evidence: Challenges and Considerations Tae Hyun (Ryan) Jung, US FDA
2:25 PM	Bridging the Gap Between Clinical Trial and Real World Data: A Framework for Working with Real-World Data in Clinical Development Laura L Fernandes, COTA Healthcare
2:45 PM	Industry Applications of RWD to Advance Drug Development and Inform Regulatory Decision-Making May Mo, Amgen
3:05 PM	Illustration of Propensity Score Weighted External Control with Single Arm Phase 2 Trial and Hybrid Randomized and External Control in Phase 3 Design in Recurrent Glioblastoma Ruthie Davi, Acorn AI by Medidata
3:25 PM	Discussant: Yueqin Zhao, Food and Drug Administration
3:45 PM	Floor Discussion

475 * !	Wed, 8/10/2022, 2:00 PM - 3:50 PM	CC-202B
Advancing Innovative RWE Analytics in Drug Development — Topic Contributed Papers
Biopharmaceutical Section, Section on Bayesian Statistical Science, Committee on Applied Statisticians, Text Analysis Interest Group
Organizer(s): Haijun Ma, .
Chair(s): Haijun Ma, .
2:05 PM	Defining Causal Questions for a Single-Arm Trial with an External Control Arm: An Application of the Target Trial Framework in Oncology Lisa Hampson, Novartis Pharma AG, Switzerland; Evgeny Degtyarev, Novartis Pharma AG
2:25 PM	Causal Effect Machine Learning Analyses Using Model Averaging Alan Brnabic, Eli Lilly; Anthony Zagar, Eli Lilly
2:45 PM	Applying Bayesian Modeling for Reproducibility Issues Between RCT and RWE Xiang Zhang, CSL Behring; James Stamey, Baylor University
3:05 PM	Analysis of Biosimilar Regulatory Review and Approval Texts from the FDA and the EMA Akash Jayesh Gosai, Viatris; Joseph Cook, Viatris
3:25 PM	Discussant: Samiran Ghosh, The University of Texas Health Science Center at Houston
3:45 PM	Floor Discussion

481	Wed, 8/10/2022, 2:00 PM - 3:50 PM	CC-140B
Dose Finding, Dose Selection, and Early-Phase Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Na Hu, BI
2:05 PM	A Comparative Study of in Vitro Dose-Response Estimation Under Extreme Observations Presentation Xinying Fang, Pennsylvania State University; Shouhao Zhou, Pennsylvania State University
2:20 PM	Machine Learning in Pharmacogenomics Jackson Lautier, University of Connecticut; Junghi Kim, Food and Drug Administration (FDA); Jessica Kim, U.S. Food and Drug Administration; Stella Grosser, U.S. Food and Drug Administration
2:35 PM	Early Completion of Model-Assisted Designs for Dose-Finding Trials Masahiro Kojima, Kyowa Kirin Co, Ltd.
2:50 PM	A Non-Parametric Bayesian Approach for Monotonic Dose-Response Model Nairita Ghosal, Merck & Co., Inc.
3:05 PM	Comparison of Dose Limiting Toxicity Rates for Bayesian Dose Escalation Designs Presentation Richard John McNally, Labcorp
3:20 PM	Justifying a Sample Size in Phase 2 Dose Selection Study Using a Bayesian Meta-Analytic-Predictive Approach with a Robust Prior Component Presentation Mehreteab Aregay, Daiichi Sankyo Inc
3:35 PM	Floor Discussion

491 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-102A
Bridging Causal Inference and Clinical Trials — Invited Papers
Society for Clinical Trials, Biometrics Section, Biopharmaceutical Section
Organizer(s): Fan Li, Duke University
Chair(s): Fan Li, Duke University
8:35 AM	Model-Assisted Analyses of Cluster-Randomized Experiments Peng Ding, University of California Berkeley
9:00 AM	Combining Trial and Population Data to Estimate Population Average Treatment Effects Elizabeth Stuart, Johns Hopkins University
9:25 AM	Sensitivity of Causal Estimands in Clinical Trials with Imperfect Compliance Heng Chen, Gilead Sciences, Inc.; Daniel F. Heitjan, Southern Methodist University
9:50 AM	Clarifying Selection Bias in Cluster Randomized Trials: Estimands and Estimation Presentation Fan Li, Yale School of Public Health; Georgia Papadogeorgou, University of Florida; Fan Li, Duke University
10:15 AM	Floor Discussion

497 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-201
Implementation of the Estimand Framework: Next Steps for Steady and Consistent Progress? — Invited Papers
Biopharmaceutical Section, ENAR, Biometrics Section
Organizer(s): Pilar Lim, Janssen Research & Development, LLC
Chair(s): Pilar Lim, Janssen Research & Development, LLC
8:35 AM	Lessons from Implementation of the Estimand Framework Across Projects Presentation Elena Polverejan, PhD, Janssen Research & Development, LLC
9:00 AM	Estimands and Complex Innovative Designs Presentation Frank Bretz, Novartis
9:25 AM	Discussant: Lei Nie, U. S. FDA
9:40 AM	Discussant: Catherine Njue, Health Products and Food Branch / Health Canada / Government of Canada
9:55 AM	Discussant: Yuki Ando, Pharmaceuticals and Medical Devices Agency (PMDA)
10:10 AM	Floor Discussion

499 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-203AB
Recent Issues in the Design and Analysis of Clinical Trials in Neurodegenerative Disorders — Invited Papers
ENAR, Mental Health Statistics Section, Biopharmaceutical Section
Organizer(s): Pilar Lim, Janssen Research & Development, LLC
Chair(s): Akiko Okamoto, ScD, Janssen Research & Development, LLC
8:35 AM	Identifying Disease-Modifying Treatments in Progressive Diseases Through Delayed Failure Time Models and Delayed Longitudinal Progression Models Suzanne Hendrix, Pentara; Newman Knowlton, Pentara; Nathaniel Hogan, Pentara; Jessie Johnson, Pentara; Samuel Dickson, Pentara
8:55 AM	A Case Study Evaluating Alternative Analysis Methods in Longitudinal Alzheimer’s Disease Study, with Variable Subject Follow-Up Yevgen Tymofyeyev, Janssen RD of J&J
9:15 AM	The Chronic Progressive Repeated Measures (CPRM) Model for Longitudinal Data Steven Edland, University of California San Diego
9:35 AM	Understanding and Accounting for Rapidly Progressing Patients in Alzheimer’s Clinical Trials Craig Mallinckrodt, Cortexyme
9:55 AM	Discussant: Barbara Wendelberger, PhD, Berry Consultants
10:15 AM	Floor Discussion

505 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-202B
Generalized Pairwise Comparisons and Win Statistics (Win Ratio, Win Odds, and Net Benefit): A Ten-Year Journey — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, Lifetime Data Science Section
Organizer(s): Yodit Seifu, Bristol Myers Squibb
Chair(s): Kaifeng Lu, BeiGene
8:35 AM	On the Intransitivity of the Win Ratio DAVID OAKES, University of Rochester,; Changyong Feng, University of Rochester
8:55 AM	Win Odds: An Adaptation of the Win Ratio to Include Ties Tobias Mütze, Novartis Pharma AG; Tianmeng Lyu, Novartis
9:15 AM	The Net Benefit as a Measure of Treatment Effect for Generalized Pairwise Comparisons Vaiva Deltuvaite-Thomas, IDDI; Marc Buyse, IDDI
9:35 AM	Impact of Follow-Up Time and a Comparison of Win Statistics on Time-to-Event Outcomes James Song, BeiGene; Gaohong Dong, BeiGene
9:55 AM	Evidence Synthesis in Oncology Clinical Trials: A Generalized Pairwise Comparison Approach Bo Huang, Pfizer Inc.; Ying Cui, Emory University; Gaohong Dong, BeiGene
10:15 AM	Floor Discussion

508 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-202A
Innovative Statistical Methods for Preclinical to Clinical Translatability in Drug Development — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, International Chinese Statistical Association
Organizer(s): Dean Li, Pfizer
Chair(s): Dean Li, Pfizer
8:35 AM	Predicting Clinical Response Rate of BRAF Inhibitors in BRAF-Mutant Melanoma Using Preclinical Data Shibing Deng, Pfizer Inc; Douglas Robinson, Pfizer Inc
8:55 AM	A Bayesian Approach for MRE Back Translation Based Decision Making with the Attenuation Ratio Metric Thomas Bradstreet, Bristol-Myers Squibb; Haiying Tang, CHDI Management, Inc.; Matthew Fronheiser, Bristol-Myers Squibb; Thomas Petrone, Bristol-Myers Squibb; Lei Zhao, Bristol-Myers Squibb
9:15 AM	A Bayesian Gene Network Reveals Insight into the JAK-STAT Pathway in Systemic Lupus Erythematosus Yushi Liu, Eli Lilly and Company
9:35 AM	Discussant: Alan Chiang, Lyell Immunopharma
9:55 AM	Floor Discussion

511 * !	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-207B
In Pursuit of Speed and Efficiency in New Drug Development: Statistical Designs at the Forefront of Pushing the Boundaries of Innovation — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, ENAR
Organizer(s): Junjing Lin, Takeda Pharmaceuticals
Chair(s): Margaret Gamalo , Pfizer Inc.
8:35 AM	Implications of Using Recurrent Episodes: Statistical Considerations in a Rare Disease Setting Hengrui Sun, FDA
8:55 AM	Incorporating External Information or Real-World Evidence into Adaptive Design with Sample Size Re-Estimation Ran Liao, Eli Lilly and Company; Junjing Lin, Takeda Pharmaceuticals; Margaret Gamalo , Pfizer Inc.
9:15 AM	Design and Analysis of Drop-The-Losers Studies Using Binary Endpoints in the Rare Disease Setting Ina Jazic, Vertex Pharmaceuticals; Xiaoyan Liu, Vertex Pharmaceuticals; Glen Laird, Vertex Pharmaceuticals
9:35 AM	A Bayesian Seamless Design for Phase 2 Early Signals of Efficacy and Dose-Ranging Studies with Historical/Virtual Placebo Controls Zhen Zhang, Pfizer Inc.; Vivek Pradhan, Pfizer Inc.; Yang Li, Pfizer Inc.
9:55 AM	Two-Stage Optimal Designs Based on Exact Variance for a Single-Arm Trial with Survival Endpoints Guogen Shan, University of Florida
10:15 AM	Floor Discussion

518	Thu, 8/11/2022, 8:30 AM - 10:20 AM	CC-204C
Estimand, Causal Inference, and Other Statistical Considerations in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Victoria P Johnson, GSK
8:35 AM	When Estimating Causal Effects, Start by Defining Causal Estimands—Not Estimators Marie-Abele Bind, Massachusetts General Hospital; Eric Macklin, Massachusetts General Hospital; Donald Rubin, Tsinghua University
8:50 AM	The Inherent Meaningfulness of a Novel Time Component Test (TCT): Combining Evidence Across Outcomes to Measure the Impact of Treatment on Progression Rate in Degenerative Diseases Nathaniel Hogan, Pentara; Jessie Johnson, Pentara; Newman Knowlton, Pentara; Sean Hennessey, Pentara Corporation; Suzanne Hendrix, Pentara; Samuel Dickson, Pentara
9:05 AM	Selection of Analysis Method for GOS-E in Future TBI Clinical Trials Using Retrospective Data Presentation Yu Wang, University of Kansas Medical Center; Byron Gajewski, University of Kansas Medical Center
9:20 AM	Use of Benefit-Risk, Safety, and Estimand Planning Tools to Optimize Drug Approvability and Labeling Susan Mayo, Food and Drug Administration, Center for Drug Evaluation
9:35 AM	A Bayesian Framework for Identifying Safety-Signal from Multiple Studies Adrijo Chakraborty, U.S.Food and Drug Administration; Ram Tiwari, Bristol Myers Squibb
9:50 AM	Bayesian Approach to Principal Stratum in a Clinical Setting Dominique McDaniel, Drexel University ; Ahmad Hakeem Abdul Wahab, Janssen Pharmaceuticals; Run Zhuang, Purdue University; Arman Sabbaghi, Purdue University
10:05 AM	Connecting P-Values and Posterior Probabilities Through Bayes Factor Bound: A Brief History and Its Application Xiting Yang, FDA; Greg Maislin, Biomedical Statistical Consulting; Dongfeng Qi, Boston Scientific

532 * !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-102A
Statistical Innovations Driven by the COVID-19 Pandemic — Invited Papers
Committee on Applied Statisticians, Section on Statistical Learning and Data Science, Biopharmaceutical Section
Organizer(s): Sameera Wijayawardana, Eli Lilly and Company
Chair(s): Sameera Wijayawardana, Eli Lilly and Company
10:35 AM	Statistical Innovations Driven by the COVID-19 Pandemic Juan Miguel Lavista Ferres, Microsoft
11:00 AM	Developing COVID-19 Treatments During the Pandemic: Unique Challenges, Opportunities for Innovation Lei Shen, Eli Lilly and Company
11:25 AM	Excess Mortality Associated with COVID-19: January 2020 Through September 2021, United States Lauren Rossen, National Center for Health Statistics, CDC
11:50 AM	Assessing Transmissibility and Associated Risk Modifiers of Emerging Infectious Diseases from Contact Tracing Data Yang Yang, University of Florida; Mingjin Liu, University of Florida; Neda Jalali, University of Florida
12:15 PM	Floor Discussion

536 * !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-201
Advanced Bayesian Methods for Modern Clinical Trials — Invited Papers
International Society for Bayesian Analysis (ISBA), Biopharmaceutical Section, Section on Bayesian Statistical Science
Organizer(s): Yuan Ji, The University of Chicago
Chair(s): Yanxun Xu, Johns Hopkins University
10:35 AM	Estimating the Design Operating Characteristics in Bayesian Adaptive Clinical Trials Presentation Shirin Golchi, McGill University
10:55 AM	On Bayesian Sequential Clinical Trial Designs Tianjian Zhou, Colorado State University; Yuan Ji, The University of Chicago
11:15 AM	The Use of External Control Data for Predictions and Futility Interim Analyses in Clinical Trials Lorenzo Trippa, DFCI
11:35 AM	Bayesian Nonparametric Common Atoms Regression for Generating Synthetic Controls in Clinical Trials Peter Mueller, The University of Texas at Austin; Noirrit Kiran Chandra, The University of Texas at Austin; Abhra Sarkar, The University of Texas at Austin
11:55 AM	Discussant: Yuan Ji, The University of Chicago
12:15 PM	Floor Discussion

537 * !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-202A
Recent Developments in Causal Inference with Real World Evidence in Drug Development — Invited Papers
Biopharmaceutical Section, Biometrics Section, Society for Clinical Trials
Organizer(s): Margaret Gamalo , Pfizer Inc.
Chair(s): Birol Emir, Pfizer Inc
10:35 AM	Target Trials: Emulating RCTs Using Observational Longitudinal Data James M Robins, Harvard University
11:00 AM	Targeted Learning of Causal Effects with Continuous Time-to-Event Outcomes Mark Van der Laan, University of California Berkeley
11:25 AM	Regulatory Considerations on the Use of Machine Learning for Real-World Evidence Studies Hana Lee, FDA
11:50 AM	Discussant: Demissie Alemayehu, Pfizer Inc.
12:10 PM	Floor Discussion

541 * !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-202B
Bayesian Design in Clinical Trial and Some Challenging Issues — Topic Contributed Papers
Section on Bayesian Statistical Science, Biopharmaceutical Section, International Society for Bayesian Analysis (ISBA)
Organizer(s): Fei Wang, Boehringer Ingelheim
Chair(s): Guan Xing, Gilead
10:35 AM	Practical Steps for Dynamic Borrowing of Historical Control Data in Clinical Trials Farid Jamshidian, Gilead Sciences; Ron Xiaolong Yu, Gilead Sciences
10:55 AM	Exploring Approaches to Sample Size Determination Within a Bayesian Framework Jane Pan, University of California, Los Angeles
11:15 AM	Predicting Outcomes of Phase III Oncology Trials with Bayesian Mediation Modeling of Tumor Response Xun Jiang, Amgen; Jie Zhou, Novartis; Brian P Hobbs, The University of Texas; Peng N/A Wei, The University of Texas MD Anderson Cancer Center; Amy Xia, Amgen
11:35 AM	Bayesian Design in Clinical Trial and Some Challenging Issues Fei Wang, Boehringer Ingelheim
11:55 AM	Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development Jennifer Clark, FDA; BSWG Medical Outreach Subteam, DIA
12:15 PM	Floor Discussion

548 !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-151B
Innovative Methods in Precision Medicine — Topic Contributed Papers
Biometrics Section, Biopharmaceutical Section, Section on Medical Devices and Diagnostics
Organizer(s): David Gold, Amgen, Inc.
Chair(s): David Gold, Amgen, Inc.
10:35 AM	Adjusting for Misclassification in a Stratified Biomarker Clinical Trial Susan Halabi, Duke University School of Medicine
10:55 AM	Estimation Following Two-Stage Adaptive Enrichment Design Peter Kimani, Warwick Medical School
11:15 AM	Subgroup Identification in Clinical Trial Xin Huang, AbbVie Inc.
11:35 AM	Pharmacogenomics for Tailored Therapies in Labeling of FDA Oncology Drugs Danni Yu, Nektar Therapeutics
11:55 AM	Discussant: Kay Tatsuoka, Santen

552 * !	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-152B
State of the Science in Patient-Focused Drug Development with Statistics Leading Innovation: Where Have We Been, and Where Are We Going? — Topic Contributed Panel
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Joseph C. Cappelleri, Pfizer Inc; Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania
Chair(s): Flora Mulkey, FDA
10:35 AM	State of the Science in Patient-Focused Drug Development with Statistics Leading Innovation: Where Have We Been, and Where Are We Going?
Panelists:	Joseph C. Cappelleri, Pfizer Inc Mallorie Fiero, US Food and Drug Administration Shing M Lee, Columbia University Jessica Roydhouse, Menzies Institute for Medical Research, University of Tasmania
12:10 PM	Floor Discussion

555	Thu, 8/11/2022, 10:30 AM - 12:20 PM	CC-156
Novel Methods in Estimation Enhancement — Contributed Papers
Biopharmaceutical Section
Chair(s): Qing Yin, FDA
10:35 AM	A Closer Look at Stratification/Stratified Analyses in Randomized Clinical Trials Devan V. Mehrotra, Merck & Co., Inc.; Rachel Marceau West, Merck & Co., Inc.
10:50 AM	Validity of Tests for Time-to-Event Endpoints in Studies with Minimization Victoria P Johnson, GSK; Michael Gekhtman, University of Notre Dame; Olga Kuznetsova, Merck
11:05 AM	Exploring Heterogeneity in Nonlinear Trajectories with Linear Spline Functional Form in the Framework of Individual Measurement Occasions Jin Liu, Vertex Pharmaceuticals; Tu Xu, Vertex Pharmaceuticals; Yijie Zhou, Vertex Pharmaceuticals; Tianchen Xu, Columbia University
11:20 AM	Robustly Leveraging the Post-Randomization Information to Improve Precision in the Analyses of Randomized Clinical Trials Yu Du, Eli Lilly and Company; Bingkai Wang, University of Pennsylvania
11:35 AM	Using Targeted Maximum Likelihood Estimation to Estimate Treatment Effect with Longitudinal Continuous or Binary Data: A Systematic Evaluation of 28 Clinical Trials Lingjing Jiang, Johnson & Johnson
11:50 AM	Floor Discussion

JSM 2022 Conference Program

Activity Details

American Statistical Association