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Wednesday, June 22 • 9:00am - 10:00am
#307: Improve the Speed and Cost of Clinical Trials With Bayesian Approaches: Unpacked for Non-Statisticians

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-22-606-L04-P ; CME 1.00; RN 1.00

This session for non-statisticians will demystify Bayesian statistics, introduce a framework for thinking about how and when Bayesian statistical approaches may be used in drug development, and present case studies demonstrating successful use and impact on clinical trial design.

Learning Objectives

Compare the fundamental difference between Bayesian and frequentist statistical thinking and how Bayesian statistical approaches are valuable in drug development; Discuss how to capitalize on opportunities within their companies and organizations for expanded application of Bayesian approaches and create strategies to overcome barriers to broader application.


Stephen Ruberg, PhD, MS


Jiawen Zhu, PhD

Robert Hemmings, MSc

Telba Irony, PhD, MS, MSc

John Scott, PhD, MA

avatar for Stephen Ruberg

Stephen Ruberg

Adjunct Professor of Statistics, Purdue University; President, Analytix Thinking, United States
Steve Ruberg has spent over 40 years in the pharmaceutical industry in many leadership and technical roles. He is a Fellow of the American Statistical Association and an elected Fellow of the International Statistics Institute. He retired from Lilly as a Distinguished Research Fellow... Read More →
avatar for Robert Hemmings

Robert Hemmings

Partner, Consilium Salmonson and Hemmings , United Kingdom
Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of... Read More →
avatar for Telba Irony

Telba Irony

Senior Scientific Director, Quantitative Sciences, Janssen R&D, United States
Telba is Senior Scientific Director in Quantitative Sciences at Janssen R&D. She comes from FDA where she pioneered the use of Bayesian statistics and wrote several guidance documents. She received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative... Read More →
avatar for Jiawen Zhu

Jiawen Zhu

Senior Principal Statistical Scientist, Genentech, a Member of the Roche Group, United States
Jiawen Zhu is a Senior Principal Statistical Scientist in Data Science, Product Development, Roche/Genentech. Jiawen has broad experience across statistical method research, CDx development, early and late oncology molecule development. She has been a key contributor to numerous strategic... Read More →
avatar for John Scott

John Scott

Director, Division of Biostatistics, OBPV, CBER, FDA, United States
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored... Read More →

Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  12: Value-Access, Forum |   11: Statistics, Forum
  • Level Basic
  • Level Basic
  • Credit Type ACPE, CME, RN
  • Tags Forum