When Access Creates Evidence: Real‑World Data from Expanded Access Programs

• Real‑world evidence generated through these programs that has informed regulatory decision‑making, contributing to EMA scientific advice discussions and, in specific cases, resulted in FDA labeling indications and marketing authorizations
• This session will focus on the types of approaches and real regulatory results

Speakers:

Sarah Alummootil

Director Early Access Programs

Early Access Care

Anne B. Cropp

Chief Scientific Officer

Early Access Care