Why Attend the 7th Operationalize Expanded Access Programs Summit?
The Definitive East Coast Meeting for the Expanded Access Community
The 7th Operationalize: Expanded Access Programs Summit brings the EAP community together to get into the realities behind program delivery. Across three focused days, hear directly from teams navigating difficult decisions around Post-Trial Access, real-world data, regulatory complexity, reimbursement, global expansion, patient continuity and program transitions, with candid insight into what worked, where challenges emerged and what they would approach differently next time.
Through first-hand case studies, practical workshops, live problem-solving and dedicated peer networking, benchmark your approach against programs being delivered today, find experience relevant to the challenges you are facing and uncover ideas you can apply to your own EAPs. Leave Boston with stronger industry benchmarks, practical lessons and relationships you can continue drawing on long after the Summit.
What You Can Expect:
Navigate the Added Complexity of Controlled-Substance EAPs
Learn from Definium Therapeutics’ experience establishing access for controlled substances, navigating additional approvals, governance and cross-functional requirements without allowing added complexity to unnecessarily delay patients.
Turn Post-Trial Access Commitments into a Repeatable Operating Model
Apply Alexion’s approach to build clearer PTA processes, ownership and cross-functional responsibilities, creating a framework that can flex across programs and countries without reinventing the model each time.
Run EAPs Alongside Clinical Development Without Compromising Either
Learn from Amylyx how Expanded Access approaches can adapt across disease areas, balancing trial recruitment, rapid patient access, safety monitoring, physician familiarity and decisions around when real-world data genuinely adds value.
Turn Regulatory Intelligence into Faster EAP Decisions
Take inspiration from Sanofi’s development of a practical regulatory intelligence dashboard, transforming fragmented country-level insight into accessible information that global teams can use to navigate EAP requirements more efficiently.
Turn EAP Real-World Data into Clinical, Regulatory & Business Value
Unpack BioMed Valley Discoveries’ five-year EAP supporting 200+ patients to understand how a small biotech generated real-world datasets supporting clinical strategy, regulatory filings and partnering.
Close the EAP Awareness Gap Through the Patient Voice
Hear first-hand from Myasthenia Gravis Patient Advocate Thomas Bartlett on what navigating serious disease reveals about EAP awareness, and where industry, physicians and advocacy groups can work differently to help patients understand available access routes.
Divide & Conquer: Tailored Learning for Every Stage
Whether you’re helping establish your organization’s first Expanded Access Program or already responsible for complex global delivery, the pre-conference workshop day gives you the space to go deeper. Choose between two focused tracks built around where you are today, develop the skills most relevant to your role and work through real operational challenges alongside peers facing them too.
Track 1: Building Your First Expanded Access Programs
Build the foundations to get your EAP right from the start.
Designed for professionals newer to Expanded Access or organizations building their capabilities, this track moves from understanding the access landscape to establishing the governance, ownership, processes and data strategy needed to run a credible program in practice.
Expert Speakers Include:
Track 2: Advanced Challenges in Expanded Access Programs
Address the realities of scaling, complexity, and global delivery
Built for experienced EAP professionals, this track tackles the difficult decisions that emerge as programs become more global and long-term obligations grow. Explore how to protect continuity when conditions change, provide access where commercial launch may never follow, and manage program closure and patient transition across different markets.
Expert Speakers Include:
Explore the Full Event Guide
- Explore the full three-day agenda and key EAP priorities
- Preview first-hand case studies from programs in practice
- Meet the speakers and organizations joining us in Boston
- Discover new networking experiences built around relevant peer connections
- Share with your team and plan your attendance together
Attending Companies Include
Explore the Agenda
Uncover the real EAP case studies, emerging priorities and practical approaches shaping Expanded Access in 2027.
Partner With Us
Put your solutions in front of EAP decision-makers actively seeking expertise to scale and strengthen global program delivery.
Join the EAP Community
Connect with 150+ EAP leaders to benchmark decisions, exchange first-hand experience and build relationships that extend beyond Boston.