Short Courses
The 2025 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop will offer 10 half-day short courses Wednesday, September 24. The short courses are ticketed events that can be added to your registration for an additional fee of $120 each ($125 each after August 12).
Morning Short Courses
8:30 a.m. – 12:00 p.m.
SC01: A Practical Guide to Estimand Implementation
Stephen Ruberg, Analytix Thinking
SC02: Bayesian Study Design and Analysis in Regulatory Science
Tianyu Bai; Ming-Hui Chen, University of Connecticut; Margaret Gamalo-Siebers, Pfizer; Heng Li, FDA; and James Travis, FDA
SC03: Targeted Learning for Randomized Controlled Trials and Hybrid Studies in the Era of Artificial Intelligence and Machine Learning
Susan Gruber; Hana Lee, FDA, and Mark Van Der Laan, University of California at Berkeley
SC04: AI-Generated R Code in Combination with Simulation Software for Clinical Trial Design: A Case Study Approach
J. Kyle Wathen, Cytel; Subhajit Sengupta, Cytel; and Boaz Adler, Cytel
SC05: Precision Medicine and Companion Diagnostics: Statistical and Design Considerations
Gina D’Angelo, AstraZeneca, and Kui Shen, Bayer
Afternoon Short Courses
1:30 p.m. – 5:00 p.m.
SC06: Improving Power and Precision in Randomized Trials Using Covariate Adjustment
Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health; Kelly Van Lancker, Ghent University; and Joshua Betz, Johns Hopkins Bloomberg School of Public Health
SC07: Graphical Multiple Comparison Procedures: Combining Flexibility with Optimality
Dong Xi, Gilead Sciences; Yao Chen, Novartis Pharmaceuticals; and Frank Bretz, Novartis Pharma AG
SC08: Quantitative Decision-Making for Staging up to Phase 3 Clinical Development
Yusuke Yamaguchi, Astellas Pharma Global Development; Cong Han; Annie Wang, Astellas Pharma; and Yongming Qu
SC09: Statistical Considerations and Design Strategies for Dose Optimization in Simple and Complex Settings
Ying Yuan, University of Texas MD Anderson Cancer Center
SC10: Statistical Design and Analysis of Hybrid Controlled Trials with Real-World External Controls
Mingyang Shan, Eli Lilly and Company; Shu Yang, North Carolina State University; and Xiaofei Wang; Duke University Medical Center
