Conference Program Home
My Program
All Times EDT
Legend:
CC = Walter E. Washington Convention Center M = Marriott Marquis Washington, DC
* = applied session ! = JSM meeting theme
Activity Details
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
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
498 * !
Thu, 8/11/2022,
8:30 AM -
10:20 AM
CC-150A
Making Data and Statistics Impactful Through Inclusivity, Powerful Collaboration, and Effective Innovation — Invited Papers
Stats. Partnerships Among Academe Indust. & Govt. Committee , Committee on Statistics and Disability, Justice Equity Diversity and Inclusion Outreach Group
Organizer(s): Ying Ding, University of Pittsburgh; Anja Zgodic, University of South Carolina
Chair(s): Erin Chapman, Amazon AWS Cryptography
8:35 AM
Urban Analytics: The Value of University/Government Partnerships and the Important Role of Statisticians
Katherine B. Ensor, Rice University
9:00 AM
Applying Universal Design to a Department
Presentation
Brianna Blaser, University of Washington
9:25 AM
Delphi's COVIDcast Project: Lessons from Building a Digital Ecosystem for Tracking and Forecasting the Pandemic
Ryan Tibshirani, Carnegie Mellon University
9:50 AM
FDA’s Complex Innovative Trial Design Program
John Scott, FDA / CBER
10:15 AM
Floor Discussion