Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs

• Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
• Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
• Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
• Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose

Speakers:

Karen Frascello

Senior Director, Medical Affairs, Early Access & Global Diagnostics

Alnylam Pharmaceuticals

Annmarie Galli

Head, Global Medical Affairs Research & Compassionate Use/ Managed Access Programs

GlaxoSmithKline

Romina Oxborough

Chief Executive Officer

Maprium

Dan Weeks

Head, Global Access Mechanisms

Biogen