Short Courses
The 2023 workshop offered 10 half-day short courses Wednesday, September 27. The short courses are ticketed events added to your registration for an additional fee.
Morning Short Courses
8:30 a.m. – 12:00 p.m.
SC01: Implementing the Estimand Framework in Global Drug Development: Application of Causal Inference Approaches
Instructor(s): Mouna Akacha, Novartis; Kelly Van Lancker, Johns Hopkins University; Tianmeng Lyu, Novartis; Kaspar Rufibach, Roche; and Jiarui Lu, Novartis
SC02: Practical Dose Finding and Dose Optimization Designs in Oncology Clinical Trials
Instructor(s): Yuan Ji, The University of Chicago
SC03: Design and Implementation of Master Protocols for Complex Diseases: What Have We Learned?
Instructor(s): Ben Saville, Berry Consultants; Anna McGlothlin, Berry Consultants; Lisa LaVange, The University of North Carolina at Chapel Hill; and Christina Saunders, Berry Consultants
SC04: Empirically Based Bayesian Parametric Modeling for Clinical Dose Response Design and Analysis.
Instructor(s): Satrajit Roychoudhury, Pfizer; Neal Thomas, Pfizer; and Anindita Banerjee, Pfizer
SC05: Absolute Risk Prediction
Instructor(s): Qin Li, FDA; Mitchell Gail, NCI ; and Ruth Pfeiffer, NCI
Afternoon Short Courses
1:30 p.m. – 5:00 p.m.
SC06: Design and Analysis of Randomized Clinical Trials Incorporating Real-World Data
Instructor(s): Jiawen Zhu, Genentech, Inc.; Herb Pang, Genentech, Inc.; Donna Rivera, FDA; Shu Yang, North Carolina State Unviersity; and Xiaifie Wang, Duke University Medical Center
SC07: Introduction to Bayesian Methods for Clinical Trial Design and Sample Size Determination
Instructor(s): Joe Ibrahim, The University of North Carolina
SC08: Toward Better Practice of Covariate Adjustment in Analyzing Randomized Clinical Trials
Instructor(s): Ting Ye, University of Washington; Jun Shao, University of Wisconsin; Yanyao Yi, Eli Lilly and Company; and Marlena Bannick, University of Washington
SC09: Recent Development in Drug-Diagnostic Co-Development and Companion Diagnostic Device Validation
Instructor(s): Changhong Son, FDA; Wei Wang, FDA; Jane Fridlyand, Genentech, Inc.; and Raj Nair, FDA
SC10: Statistical Translation of Extrapolation: Demonstrating Efficacy and Safety of Investigational Medicines in Pediatric Populations
Instructor(s): James Travis, FDA; Meg Gamalo, Pfizer; and Jingjin Ye, BeiGene
