Jose Ricardo Perez Interview

Would you be able to share a few sentences about why your session is so important for today’s EAP landscape, as well as what you will be discussing?

• Changes into the EAP situation in 2026 after the 2025 guidance from the FDA
• Defining the ideal moment to launch an EAP in the life cycle of a drug
• What data can we get from an EAP?
• Challenges to implement a Global EAP
• Which team should manage an EAP?

 

How has Expanded Access changed in the last 12–18 months - and what’s driving that shift?

• The recently issued FDA guidelines have changed the EAP in the last months. There are substantial changes in the regulatory framework

 

What are the biggest challenges being faced by expanded access teams today?

• Expanded Access teams today are under pressure to deliver faster, more transparent, and more consistent access decisions - while managing limited supply, regulatory complexity, internal misalignment, and growing external scrutiny.

 

What’s something the industry isn’t talking about enough?

• The cumulative human and organizational cost of Expanded Access decision-making. The real blind spot is the sustained emotional, ethical, and cultural load placed on Expanded Access teams—and how poorly organizations are designed to absorb it.

 

What will your session cover and what will it help teams overcome?

• How Expanded Access expectations have matured without fundamentally changing the legal framework
• Why teams can no longer rely on ad hoc processes once programs scale
• What it means to “operationalize” Expanded Access in practice

 

What are you most looking forward to at the summit? 

• I’m most looking forward to the candid, peer‑to‑peer conversations - sharing real lessons learned with teams who are navigating the same operational, ethical, and cross‑functional challenges of delivering Expanded Access in today’s environment.