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Tuesday June 16, 2026 4:15pm - 5:15pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-596-L04-P; CME 1.00; RN 1.00

Learn how the Real-World Evidence (RWE) can be utilized in studies of rare outcomes and diseases. Speakers from industry, academia, and regulators share insights on external controls, causal inference, and evidence synthesis to inform regulatory submissions.

Learning Objectives

Identify when to use hybrid design and or external controls for rare outcomes and diseases using RWE sources; Design RWE-based studies and address confounding, missing data, and intercurrent events; Evaluate robustness of study results with sensitivity analyses.

Chair

Huan Wang, PHD

Speaker

Assessing the Validity of External Versus Randomized Controls in Pancreatic Cancer and Other Diseases
Ruthie Davi, PHD, MS

Real World Evidence for Post-Marketing Drug Safety Outcomes: FDA’s Sentinel System
Jennifer Lyons, PHD, MPH

Single Arm, External-Controlled Studies – Pitfalls and Pathways
Van Tran, PHD


Speakers
avatar for Ruthie Davi

Ruthie Davi

Senior Vice President, Medidata, a Dassault Systèmes Company, United States
Ruthie Davi is Senior Vice President, Statistics and Regulatory Science Innovation at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At... Read More →
avatar for Jennifer Lyons

Jennifer Lyons

Research Scientist, Harvard Pilgrim Health Care Institute, United States
Jennifer Lyons is a Research Scientist in the Therapeutics and Infectious Disease Epidemiology group at the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. She works on the FDA-sponsored Sentinel Initiative for drug safety surveillance... Read More →
avatar for Van Tran

Van Tran

Mathematical Statistician, OTS, CDER, FDA, United States
Van Tran, PhD, is a Senior Mathematical Statistician at the U.S. Food and Drug Administration, where she provides statistical review of clinical trials and real-world evidence to support regulatory decisions on drug safety and efficacy. Her interests include evaluation of rare and... Read More →
avatar for Huan Wang

Huan Wang

Mathematical Statistician, CDER, FDA, United States
Dr. Huan Wang joined the FDA in 2021, where he focuses on statistical reviews for drug approval applications in non-malignant hematologic diseases. Prior to this role, he earned his Ph.D. in Biostatistics from the George Washington University, where he conducted research on developing... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

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