RDDS 2024 — Rethinking Clinical Trials: What’s Doable? What’s Approvable?

Researchers are overcoming barriers posed by small populations using decentralized and basket trials, platform science, wearables, videos, natural history data and engaging diverse patients. But what does FDA guidance say? Are the regulatory constraints different? How can patient communities prepare by ensuring their data is well-structured?

Moderator:
Katherine Maynard
Partner, PWR

Panelists:
Jennifer Farmer
CEO, Friedreich’s Ataxia Research Alliance

Manoj Malhotra, M.D.
Chief Medical Officer, Ovid Therapeutics

Cynthia Rothblum-Oviatt, Ph.D.
External Engagement Lead for FDA’s Rare Diseases Team, U.S. Food & Drug Administration (FDA)