What Can You Expect?
Operationalize access from strategy to execution. Join the 2nd Operationalize: Expanded Access Programs Summit to master the end-to-end delivery of EAPs that are compliant, scalable, and built for impact. Gain practical frameworks, regulatory clarity, and operational strategies that enable you to launch, manage, and transition programs with confidence.
This leading forum unites 70+ access, medical affairs, clinical operations, and supply professionals driving the next generation of expanded access programs. Together, they’ll unpack how to streamline global operations, optimise RWD collection, manage complex supply chains, and deliver equitable access in low- and middle-income regions. Whether you’re designing your first EAP or scaling a global portfolio, walk away equipped to operationalise patient access with precision, compliance, and purpose.
What to Expect?
Designing Post-Trial Access Before the Patient Enrolls
Learn how early post-trial access planning can prevent ethical, regulatory, and operational challenges later in development. This session explores how sponsors can proactively design access pathways- balancing geography, disease context, and regulatory realities - while aligning clinical, medical, and access teams to ensure continuity of care beyond trial completion.
Planning for Long-Duration and Lifelong Treatment Access
As therapies increasingly deliver sustained or lifelong benefit, sponsors must rethink traditional access models. This session examines how to forecast demand, manage long-term costs, and balance ethical responsibility with program sustainability - while preparing for evolving patient and physician expectations when treatment benefit does not end.
Turning Expanded Access Data into Regulatory and Access Impact
Discover how real-world data generated through EAPs can meaningfully complement clinical trial evidence. This session highlights practical examples of how EAP data informs regulatory dialogue, supports submissions, and strengthens pricing, reimbursement, and health authority negotiations, transforming access programs into strategic evidence generators.
Building Credible Expanded Access Programs as a Team of One
Not every organization has large pharma infrastructure, but credibility is still essential. This session provides practical guidance for building compliant, defensible EAPs with limited resources, educating internal stakeholders, and balancing strategic planning with daily execution while establishing confidence in decision-making without a dedicated team.
Patient-Led Models for Scaling Access Across High- and Low-Income Countries
Explore innovative, patient-centered approaches to delivering access where traditional mechanisms fall short. This session examines how sponsors can coordinate with clinicians and patient organizations to manage chronic treatment access across diverse health systems, embedding equity, scalability, and sustainability into global access strategies from the outset.
Governing Expanded Access at Scale: Building Sustainable, Defensible Programs
As Expanded Access evolves from ad-hoc requests to global standing programs, governance becomes critical. This workshop focuses on building scalable, ethical, and compliant frameworks- covering ownership models, escalation pathways, automation, and cross-functional accountability - to ensure Expanded Access programs remain defensible as volume, geography, and scrutiny grow
Why Should You Attend As A Team
Create a shared, cross-functional EAP playbook
Expanded Access decisions rarely sit with one function. Bringing access, medical, clinical operations, regulatory, and supply together ensures your team leaves aligned on priorities, roles, and decision-making - not interpreting guidance in silos back at the office.
Pressure-test your internal approach against real-world peers
Teams can benchmark their current processes together against how other pharma and biotech organizations are handling post-trial access, long-duration programs, global requests, and data expectations - identifying gaps and opportunities in real time.
Accelerate decision-making once you’re back at work
When teams attend together, discussions don’t stop at “what did you learn?” Instead, you return with shared language, agreed principles, and practical next steps -reducing rework, misalignment, and internal debate.
Build cross-functional confidence for scaling Expanded Access
As EAPs become more visible, global, and scrutinized, teams need collective confidence - not just individual expertise. Attending together helps organizations move faster and more decisively while staying ethical, compliant, and patient-focused.
Explore the Full Event Guide
- Navigate global regulatory complexity as Expanded Access scales beyond the U.S.
- Design ethical, low-burden data strategies without delaying patient access
- Plan post-trial access early to protect continuity of care and control cost
- Build sustainable, defensible EAP governance as programs scale globally
- Align access, medical, clinical, and supply teams to deliver faster patient access
Attending Companies Include
Explore the Agenda
Uncover practical insights from leading access, operations, and medical affairs experts through real-world case studies, interactive discussions, and hands-on workshops designed to help you build, manage, and scale compliant, patient-focused Expanded Access Programs worldwide.
Partner With Us
Showcase how your solutions empower sponsors to operationalize access - from supply chain and digital workflow tools to regulatory consultancy and real-world data systems.
Join the Global EAP Community
Be part of the only west coast EAP focused meeting uniting 70+ access leaders across pharma, biotech, and service providers. Exchange practical experience, shape global best practices, and collaborate on solutions that advance equitable, ethical, and scalable access for patients in need.