Short Courses
The 2024 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop offered 10 half-day short courses Wednesday, September 25. The short courses are added to your registration for an additional fee.
Morning Short Courses
8:30 a.m. – 12:00 p.m.
SC01: Adaptive and Complex Innovative Designs Across Trial Phases for Accelerated Approval
David Robertson, MRC Biostatistics Unit, University of Cambridge; Ayon Mukherjee, Merck KGaA/EMD Serono ; Sofia S. Villar, MRC Biostatistics Unit, University of Cambridge; and Thomas Burnett, University of Bath
SC02: Striving for PROgress: Lessons in Trial Design, Analysis, and Reporting of Patient-Reported Outcome (PRO)–Based Endpoints in Cancer Clinical Trials
Flora Mulkey, FDA; Madeline Pe, EORTC; Satrajit Roychoudhury, Pfizer; Mallorie Fiero, FDA; Ting Yu Chen, FDA; Monica Morell, FDA; and Weimeng Wang, FDA
SC03: Statistical Considerations and Design Strategies for Dose Optimization
Ying Yuan, MD Anderson Cancer Center; Jonathon Vallejo, FDA
SC04: Unleashing the Power of Machine Learning and Deep Learning to Accelerate Clinical Development
Li Wang, AbbVie; Sheng Zhong, AbbVie; and Yunzhao Xing, AbbVie
SC05: A Deep Dive into Matching, Stratification, and Weighting for Leveraging Real-World Data in Clinical Trials: Methods, Applications, and Regulations
Bo Lu, The Ohio State University; Chenguang Wang, Regeneron Pharmaceuticals; Xuefeng Li, FDA; Chi Song, FDA; and Jennifer Kirk, FDA
Afternoon Short Courses
1:30 p.m. – 5:00 p.m.
SC06: A Practical Guide to Estimand Thinking
Stephen Ruberg, Analytix Thinking
SC07: Cell and Gene Therapy: Introduction and Overview of Important Regulatory, Statistical, and Operational Considerations
Patricia Anderson, ICON; Revathi Ananthakrishnan, Bristol-Myers Squibb; and Shihua Wen, Novartis
SC08: Practical Considerations for Transforming Real-World Data (RWD) into Real-World Evidence (RWE)
Rima Izem, Novartis Pharma AG; Hana Lee, FDA; Pallavi Mishra-Kalyani, FDA; and Lisa Hampson, Novartis
SC09: Bayesian Statistics and Bayesian Models for Practical Dose Finding and Dose Optimization Oncology Clinical Trials
Yuan Ji, The University of Chicago
SC10: Overall Survival Analysis Methods Correcting for Treatment Switching Effects in Oncology Trials: Theory and SAS/R Code
Jing Xu, Takeda; Bingxia Wang, Takeda; Qingxia Chen, Vanderbilt University Medical Center; and Meijing Wu, Sanofi
