Jose Ricardo Perez
Vice President, Genitourinary Portfolio, Medical Affairs Exelixis, Inc.
Jose Ricardo Perez has a rich background in oncology and has been instrumental in the development of innovative cancer treatments at Exelixis. His extensive experience in the pharmaceutical industry, including roles at Novartis, has equipped him with a strategic perspective and vision that has led to significant discoveries and successful outcomes. Perez’s leadership at Exelixis has been marked by a commitment to patient care and a focus on delivering results and new medicines to treat and defeat cancer. His work has not only advanced the company but also contributed to the broader field of oncology by providing hope and new treatments for cancer patients.
Seminars
- Understanding how Expanded Access expectations have evolved following recent FDA guidance – and what this means for program design today
- Navigating the realities of implementing global EAPs across regions with differing regulatory frameworks and infrastructure
- Establishing clear ownership: which functions should lead, support, and govern Expanded Access programs as they scale
Expanded Access no longer sits at the margins of development. As companies launch EAPs earlier – often in parallel with trials, named patient sales, and post-trial access – misalignment is creating regulatory risk, internal friction, and patient confusion. This masterclass establishes a shared foundation for positioning Expanded Access correctly within the broader access ecosystem and designing first programs that are credible, compliant, and future-proof.
This workshop will gather experts to discuss:
- Clarify where Expanded Access sits within the broader access ecosystem – and where it does explain not fit
- Differentiate Expanded Access, compassionate use, right-to-try, named patient sales, and post-trial access to avoid regulatory and operational missteps
- Design a first EAP with clear intent, governance, and guardrails that withstand internal and external scrutiny
- Align medical, regulatory, clinical, supply, and patient-facing teams from day one
- Build a scalable foundation that prevents rework as programs expand
