FDA Grand Rounds – Statistical Considerations for Drug Development in Rare Disease Thursday, January 15, 2026 12:00 - 1:00 p.m. ET Webcast CE Credit Offered

https://www.fda.gov/science-research/about-science-research-fda/fda-grand-rounds?utm_medium=email&utm_source=govdelivery Title: FDA Grand Rounds: Statistical Considerations for Drug Development in Rare Disease (CE credit offered) Date: Thursday, January 15, 2026 Time: 12:00 pm - 1:00 pm ET Via webcast About the Speaker: Emily Morris, PhD Mathematical Statistician Office of Biostatistics Center for Drug Evaluation and Research Dr. Emily Morris is a mathematical statistician in the Division of Biometrics IV in the Office of Biostatistics in 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 FDA, Dr. Morris received her PhD in Biostatistics from the University of Michigan. About the Presentation: The first portion of this presentation 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 will focus on the ways adaptive design may be used to address the lack of information often faced at the design phase.