From Small Data to Big Data, from
RCT to RWE, the Impact of Statistics

September 23–25, 2019
Washington Marriott Wardman Park

Short Courses

The 2019 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop will offer 10 half-day short courses Monday, September 23. The short courses are ticketed events that can be added to your registration for an additional fee of $105 ($110 after August 12) each.

Morning Short Courses
8:30 a.m. – 12:00 p.m.

SC1: Simulation Practices for Adaptive Clinical Trial Design in Drug and Device Development
Greg Cicconetti, AbbVie, and Inna Perevozskaya, GSK

SC2: Biomarker-Assisted Clinical Designs: Concepts, Rationale, and Case Studies
Sandeep M. Menon, Pfizer Inc., and Weidong Zhang, Pfizer Inc.

SC3: Designing and Integrating RCT/RWE in Safety Decision-Making
Emir Birol, Pfizer Inc.; Yong Ma, FDA/CDER; and Richard Zink, TARGET PharmaSolutions

SC4: Methods for Causal Inference from Randomized Trials with Loss to Follow-Up or Non-Adherence
Ellen Caniglia, NYU Langone School of Medicine; Eleanor Murray, Harvard T.H. Chan School of Public Health; and Lucia Petito, Harvard T.H. Chan School of Public Health

SC5: Statistical Analysis of Composite Endpoints in Clinical Trials
Lu Mao, University of Wisconsin-Madison

Afternoon Short Courses
1:30 p.m. – 5:00 p.m.

SC6: Smart Simulation with SAS and R
Mehmet Kocak, The University of Tennessee Health Science Center

SC7: New Adaptive Design Guidance
Gregory Levin, FDA, and John Scott, FDA

SC8: Flexible Sample Size Designs with Applications to Improve the Efficiency and Probability of Success of Industry-Sponsored Clinical Trials
Lu Cui, AbbVie, and Lanju Zhang, AbbVie

SC9: Real-World Data and Evidence: An Interdisciplinary Approach and Applications to Precision Medicine and Health Care
Richard Baumgartner, Merck Research Laboratories; Jie Chen, Merck Research Laboratories; and Tze Lai, Stanford University

SC10: Use of Historical Data in Clinical Trial: An Evidence Synthesis Approach
Satrajit Roychoudhury, Pfizer Inc., and Sebastian Weber, Novartis Pharma AG


Key Dates