Explore the Agenda
8:00 am Registration & Morning Coffee
8:50 am Chair’s Opening Remarks
Designing Region-Ready Expanded Access Programs in a Shifting Regulatory Landscape
9:00 am Building Managed Access Programs That Align with Development, Launch & Evidence Strategy – where to start? (US & Europe)
- 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
9:30 am Roundtable – Middle East: Expanding Access in High-Demand, Rapidly Evolving Regulatory Environments
- Supporting access where regulatory frameworks are still evolving
- Operating without local affiliates or established infrastructure
- Managing political sensitivity, sanctions, and cross-border care realities
10:00 am Session Reserved for Early Access Care
10:30 am Morning Break & Speed Networking
Join our speed networking session, tailored for Expanded Access experts like yourself, to connect with fellow industry peers to facilitate a rapid yet meaningful exchange of insights and expertise. Elevate your networking experience during this session designed for impactful connecting within the space.
Post Trial Access: Planning Early, Transitioning Smoothly, & Executing Ethically for Sustainable Patient Access
11:30 am Designing Post-Trial Access Strategies Before the First Patient Enrolls
- 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
12:00 pm Transitioning Patients Without Breaking Programs, Budgets, or Trust
- 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
12:30 pm Session Reserved for myTomorrows
1:00 pm Lunch & Networking
Sustaining Expanded Access for Rare, Pediatric, and High-Cost Therapies
2:00 pm Planning for Long-Duration & Lifelong Treatment Access
- Forecasting demand and cost for chronic, ultra-rare, and lifelong therapies
- Budgeting for extended treatment durations beyond typical oncology models
- Aligning ethical responsibility with long-term program sustainability
- Preparing for patient and physician expectations when benefit continues
2:30 pm Pediatric Gene Therapy Access: Communicating with Families, Managing Expectations & Supporting Early Expanded Access Requests
- Educating patients and families about the risks and benefits of gene therapy and the expanded access process
- Communicating transparently when programs are early and pediatric data is limited
- Working compliantly with patient advocacy groups, who are monitoring clinical trials and other potential pathways to treatment
- Managing sensitive conversations around eligibility, timelines, and uncertainty in lifelimiting pediatric conditions
3:00 pm Afternoon Break & Networking
3:45 pm Fireside Chat: Delivering Expanded Access for High-Complexity and One-Time Therapies
- How do companies practically operationalize Expanded Access Programs for cell and gene therapies?
- What factors most often determine feasibility when manufacturing constraints, logistics, and cost are extreme?
- How do organizations assess when expanded access is realistic – and when it risks creating false hope for patients and providers?
- How can regulatory incentives and long-term development strategy be thoughtfully integrated into Expanded Access decision-making?
Managing Labeling, Forecasting, and Distribution Under Time Pressure
4:15 pm Maintaining Access When Supply Pathways Break Down
- Forecasting demand for EAPs when patient numbers, geographies, and treatment duration are unknown
- Coordinating with distributors and hospitals in regions with limited EAP infrastructure
- Mitigating access delays in APAC and LMICs caused by importation, customs, and administrative hurdles