Freda Cooner and Ed Luo, Workshop Co-Chairs

This year marks the 20th anniversary of the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, formerly known as the ASA Biopharmaceutical Section FDA/Industry Statistics Workshop. The workshop, sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association (FDASA), has grown steadily in popularity, attracting more than 800 participants in recent years.

The workshop will take place September 28–30 at the Marriott Wardman Park Hotel in Washington, DC. The theme is “Statistical Innovation: Better Decisions Through Better Methods.” Besides the 42 parallel invited sessions, this year’s program includes eight half-day short courses, two plenary sessions, 48 roundtable discussions, and 21 posters. Also, there will be a mixer on September 29. Housing and registration are open now.

The following short courses will be offered on September 28:

Introduction to Clinical Trial Optimization to Enable Better Decision Making
Instructor(s): Alex Dmitrienko, Quintiles

Bayesian Biopharmaceutical Applications Using SAS
Instructor(s): Fang Chen, SAS Institute; Guanghan Liu, Merck

An Overview of Methods to Assess Data Integrity in Clinical Trials
Instructor(s): Richard Zink, SAS Institute; Marc Buyse, IDDI; Paul Schuette, FDA

Statistical Methods and Software for Multivariate Meta-Analysis
Instructor(s): Haitao Chu, University of Minnesota; Yong Chen, University of Pennsylvania

Writing Clinical Trial Simulators
Instructor(s): Scott Berry and Anna McGlothin, Berry Consultants

Use of Biomarkers for Surrogacy and Personalized Treatment Selection
Instructor(s): Tianxi Cai, Harvard School of Public Health; Layla Parast, RAND Corporation

Structured Benefit-Risk Evaluation and Emergent Issues
Instructor(s): Weili He, Merck; Qi Jiang, Amgen; John Scott, FDA/CBER

Design and Statistical Analysis of Biosimilars
Instructor(s): Shein-Chung Chow, Duke University

View the full online program here!