Short Courses

The 2022 workshop will offer 10 half-day short courses Tuesday, September 20. The short courses are ticketed events that can be added to your registration for an additional fee of $105 ($110 after August 16) each.

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

SC01: Nuts and Bolts of Defining Estimands and Constructing Estimatiors Based on ICH E9 Addendum (R1)
Yongming Qu, Eli Lilly and Company, and Ilya Lipkovich, Eli Lilly and Company

SC02: Leveraging External Data Through Bayesian Methods in Clinical Trials
Ying Yuan, MD Anderson Cancer Center, and James Travis, US Food and Drug Administration

SC03: Improving Precision and Power in Randomized Trials by Leveraging Baseline Variables
Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health; Kelly Van Lancker, Johns Hopkins Bloomberg School of Public Health; and Josh Betz, Johns Hopkins Bloomberg School of Public Health

SC04: Design Considerations and Statistical Methods for Vaccine Clinical Trials
Wenji Pu, GSK; Ivan Chan, AbbVie; Jonathan Hartzel, Merck & Co.; and Fabian Tibaldi, GSK

SC05: R for Clinical Study Reports and Submission
Yilong Zhang, Merck & Co.; Nan Xiao, Merck & Co.; and Keaven Anderson, Merck & Co.

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

SC06: Estimand Framework Implementation
Gregory Levin, US Food and Drug Administration; John Scott, US Food and Drug Administration; and Susan Mayo, US Food and Drug Administration

SC07: Use of External Data in Clinical Trials: Unleashing the Power of Information
Satrajit Roychoudhury, Pfizer, and Ram Tiwari, Bristol Myers Squibb

SC08: Leveraging Real-World Data in Medical Product Clinical Trials Design and Analysis
Chenguang Wang, Johns Hopkins University; Nelson Lu, US Food and Drug Administration; and Wei-chen Chen, US Food and Drug Administration

SC09: Estimating Treatment Effect in a Principal Stratum: Applications of Causal Inference to the Tripartite Estimand Approach (TEA) and Early Biomarker Response
Stephen Ruberg, Analytix Thinking, Purdue University, and Arman Sabbaghi, Purdue University

SC10: Cell and Gene Therapy: Concepts, Rationale, Statistical Issues, and Regulatory Considerations
Weidong Zhang, Jounce Therapeutics; Srinand Ponnathapura Nandakumar, Nurix Therapeutics; and Lynn Navale, Allogene Therapeutics

Key Dates

    Attend

  • August 16, 2022
    Early Conference Registration Closes
  • August 29, 2022
    Hotel Reservations Deadline
  • September 1, 2022
    Registration Cancellation Deadline
  • September 20, 2022 – September 22, 2022
    2022 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
  • Program Participants

  • July 7, 2022 – August 24, 2022
    Abstract Editing
  • August 19, 2022
    Short Course materials due from Instructors
  • August 31, 2022
    Best Poster Award Deadline