Day One

• Examining how Expanded Access is evolving from a reactive access mechanism to a strategic function embedded within launch planning, post-trial access and evidence generation
• Assessing the growing impact of post-trial access, global pricing pressures and reimbursement considerations on program design
• Understanding how geopolitical, regulatory and market dynamics are influencing access strategies across different regions
• Identifying the biggest opportunities, risks and priorities shaping Expanded Access over the next 12-24 months

• Managing programs in regions where unmet need is high, but access pathways remain underdeveloped
• Navigating relationship-driven healthcare systems and local stakeholder dynamics
• Building sustainable access models in countries where commercialization pathways may be uncertain
• Understanding the operational and cultural challenges unique to program delivery in these regions 

This fast-paced session delivers practical, on-the-ground solutions to common EAP challenges. Featuring a series of concise, ten minute spotlights from leading biopharma, each presentation highlights a single innovation or tactic that helped unlock access, streamline processes, or support patient continuity. Designed to fuel actionable discussion, this session goes beyond the theory – focusing on what’s actually working, and where we go next.

Step outside the main conference room to explore practical examples, initiatives and lessons from across the Expanded Access community. Browse the posters at your own pace, speak directly with contributors and use the break to:

• Discover approaches other organizations are using to solve real-world EAP challenges
• Explore practical examples, tools and initiatives that may not fit into a traditional conference presentation
• Ask questions directly to contributors and dig deeper into the thinking, challenges and lessons behind their work
• Connect with peers working on similar priorities and identify ideas you can take back to your own programs

• Navigating the differing regulatory and access pathways across Middle Eastern and North African markets
• Understanding how local healthcare structures, stakeholder relationships and market dynamics shape Expanded Access delivery
• Adapting global access strategies to meet country-specific requirements without creating an unsustainable operating model
• Identifying practical approaches to establishing access in markets where formal pathways or local infrastructure may be less developed

Operating somewhere new? Facing a market-specific hurdle? Looking for someone who has already been there?

Head to the region most relevant to your work:

• Europe: Discuss regulatory pathways, operational challenges and access strategies across European markets.
• Latin America: Explore regional access requirements, local partnerships and operational realities.
• Asia-Pacific: Share experiences navigating diverse healthcare systems, regulations and market access landscapes.
• Middle East & North Africa: Exchange insights on evolving access frameworks, healthcare infrastructure and implementation challenges.
• Emerging Access Markets: Learn from peers operating in regions where access pathways are still developing or rapidly changing.

Meet others working in those markets, exchange first-hand experiences and compare how different organizations are navigating local requirements and operational realities. This isn’t about discussing regulation in theory. It’s about finding the people in the room whose experience could help you navigate your next regional challenge.

Brand New Networking Session

• Translating Post-Trial Access strategy into a practical operational framework that can be applied consistently across programs
• Defining the processes, roles and cross-functional responsibilities needed to operationalize Post-Trial Access effectively
• Sharing practical examples and lessons learned from managing Post-Trial Access, including common hurdles and how they have been overcome
• Building a framework that supports consistent decision-making while allowing teams to respond to different program and country requirements

• Using the mibavademab EAP as a case study to explore global post-trial access planning and treatment continuity
• Navigating differing regulatory requirements and access pathways across multiple countries
• Balancing governance, real-world data collection and cross-functional decisionmaking when implementing post-trial access globally

• Understanding post-trial ethical responsibilities across drug development
• Frameworks for continued access to investigational medicines and devices
• Navigating unexpected, early discontinuations to ensure regulatory requirements and post-trial ethical obligations are met
• Key lessons learned from implementing frameworks, evaluation processes, and governance structures within a large organization

Compare what you’ve heard so far and uncover different approaches from across the community.

• Combining company sponsored compassionate use via spINDs with a five-year Expanded Access Protocol to demonstrate meaningful impact across 200+ patients
• Managing the operational and financial components of a large-scale Expanded Access Program from a small early-stage Biotech footprint: impact of design, partnering and proactive stakeholder engagement
• Creation of real-world data sets supporting clinical strategies and regulatory filings with a direct impact on business development and partnering efforts

• Exploring how retrospective AI analysis can be applied to data collected through Expanded Access Programs, identifying patterns and insights across existing program datasets
• Sharing a real-world biotech case study on the approach, including what the analysis revealed and the potential for AI to strengthen how EAP data is interpreted and used

• Assessing inherited access programs against internal standards without interrupting treatment
• Prioritising remediation activities while maintaining non-negotiable patient continuity
• Aligning governance, documentation, and vendors under a new operating model
• Managing internal risk and accountability during program integration