Explore the Agenda
8:00 am Check-In & Coffee
Track One
Track One: Opening Your First Early Access Program
9:00 am Workshop A: Expanded Access Programs 101 – Mastering the Fundamentals for Effective Patient Access
- Gaining a clear understanding of different types of pre-approval access programs and their purpose
- Mapping the global EAP landscape and navigating basic regulatory and ethical requirements
- Learning the key roles and responsibilities across clinical, regulatory, supply, and commercial functions
Track Two
Track Two: Advanced Challenges in Early Access Programs
9:00 am Workshop D: Timing & Risk Management in EAP Strategy
- Preparing EAP infrastructure early without certainty of trial readouts or approvals
- Balancing investment risk vs. readiness: how much to build before the data arrives
- Understanding the real timelines for opening EAPs across different geographies
- Creating flexible plans that allow quick go/no-go decisions aligned to pivotal data milestones
11:00 am Morning Break & Networking
11:45 am Workshop B: Strategic Enterprise Decision-Making, Challenges & Execution for Gene Therapy Expanded Access Programs
- Defining the Strategic Role of Expanded Access Across the Asset Lifecycle
- Structured Decision Framework to Determine Whether and When to Launch EAPs
- Considerations in Execution of Expanded Access Programs
- End to End Expanded Access Program execution processes
11:45 am Workshop E: Navigating Complex Ethical, Patient-Centric & Paid-for Challenges in EAPs
- Balancing fairness and feasibility when demand for access exceeds available supply
- Exploring ethical and operational challenges in paid-for EAP models, and understanding their implications for patient trust and regulatory compliance
- Design patient-centric governance approaches that balance transparency, feasibility, and sustainability in complex access scenarios
- Managing expectations and communication with patients, physicians, and advocacy groups when programs evolve, wind down, or require difficult trade-offs
1:45 pm Lunch Break & Networking
2:45 pm Workshop C: Managing EAPs End-to-End: Practical Tools to Deliver Timely & Compliant Access
- Mastering operational steps from program initiation through supply planning, labelling, and logistics
- Learning tactics for improving physician and site engagement to accelerating patient treatment
- Understanding how to anticipate and mitigating common operational and regulatory challenges
- Exploring strategies for program closure or transition to ensuring seamless patient access
2:45 pm Workshop F: Futureproofing EAPs for Sustainability & Scalability
- Build frameworks for scaling programs consistently across countries and patient populations while maintaining compliance
- Integrate EAPs into healthcare systems and leverage digital tools to enhance efficiency and monitoring
- Examine governance models that balance oversight, quality, and flexibility in evolving regulatory landscapes
- Learn approaches for optimizing vendor partnerships and internal resources for long-term program resilience
4:45 pm Afternoon Break
5:30 pm Workshop G: Designing Expanded Access That Works With – Not Against – Your Clinical Development & Commercial Readiness
- Enable teams to treat Expanded Access as a deliberate strategic choice—rather than a reactive obligation, while keeping patients, data integrity, and launch success in balance
- Explain how Expanded Access fits into the full product lifecycle from early-stage development through launch and post-commercialization
- Anticipate and manage cross-functional tensions, balancing perspectives from clinical, regulatory, medical, commercial, manufacturing, and ethics