Governing Expanded Access at Scale – Building Sustainable, Defensible Programs

As Expanded Access moves from ad-hoc requests to standing global programs, governance, sustainability, and scalability are becoming the defining challenges. This workshop is designed for leaders responsible for ensuring EAPs remain ethically sound, operationally viable, and defensible as volume, geography, and scrutiny increase.

This workshop will gather experts to discuss:

• Design governance models that support consistent decision-making across regions, therapies, and program types
• Establish clear ownership, escalation pathways, and cross-functional accountability as programs scale
• Building consistency and scalability through automated tracking and response systems
• Build assurance that Expanded Access remains ethical, compliant, and viable over the long term

Speakers:

Annie Drelles

Senior Director - Office of Medical Access, Global Oncology Medical Affairs

Daiichi Sankyo

Marlen Casabona-Rojas

Global Director, Medical Access Programs , Oncology Medical Affairs (Eap)

Daiichi Sankyo