Day One

• 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

• Deciding when and where to initiate managed access across the US and Europe as assets approach planning for submission
• Structuring early access, individual patient, protocol-based, and post-trial access pathways within a single coherent strategy
• Aligning managed access programs with clinical development plans to avoid trial interference while meeting unmet needs
• Navigating labeling, launch sequencing, and regional differences when operationalizing programs pre-approval
• Embedding managed access into broader investigator-driven research and evidencegeneration capabilities

• Navigating regulatory and importation bottlenecks in Latin America, including the impact of government changes and evolving approval pathways (with a focus on Mexico, Argentina, and Brazil)
• Managing operational and supply‑chain challenges in rare disease Expanded Access Programs while balancing global standards with country‑specific realities
• Strengthening physician engagement to sustain program momentum and patient access in high‑complexity regions

• Supporting access where regulatory frameworks are still evolving
• Operating without local affiliates or established infrastructure
• Managing political sensitivity, sanctions, and cross-border care realities

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• Real-world evidence generated through EAPs that has informed regulatory decisionmaking, contributing to EMA scientific advice discussions and, in specific cases, resulted in FDA labeling indications and marketing authorizations
• This session will focus on the types of approaches and real regulatory results

• Embedding post-trial access planning into clinical trial design to avoid last-minute ethical and operational dilemmas
• Evaluating when post-trial access, long-term extensions, or hybrid approaches make the most sense by disease, geography, and duration
• Anticipating regulatory constraints that may prevent post-trial access in certain countries and adjusting trial footprints accordingly
• Aligning clinical development, medical affairs, and access teams early to support continuity of care

• Managing patient transitions as programs move from trial to post-trial access and into commercialization
• Navigating internal handoffs as responsibility shifts from clinical operations to medical affairs or access teams
• Balancing ethical obligations to patients with resource constraints and long-term sustainability