Webcast | Virtual
Event Title
FDA Grand Rounds – Statistical Considerations for Drug Development in Rare Disease
January 15, 2026
- Date:
- January 15, 2026
- Time:
- 12:00 p.m. - 1:00 p.m. ET
Webcast Recording
Speaker
Emily Morris, PhD
Mathematical Statistician
Office of Biostatistics
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
About the Speaker
Dr. Emily Morris is a mathematical statistician in the Division of Biometrics IV in the Office of Biostatistics at the FDA’s Center for Drug Evaluation and Research. She provides statistical support for the Division of Rare Diseases and Medical Genetics, which reviews drugs and biologics intended to treat inborn errors of metabolism. Prior to joining the FDA, Dr. Morris received her PhD in Biostatistics from the University of Michigan.
About the Presentation
The first portion of this talk will focus on introducing some of the key challenges of designing a phase 3 trial in a rare disease setting and the ways statistics may be used to inform design decisions, and the second portion of the talk will focus on the ways adaptive design may be used to address the lack of information often faced at the design phase.