Day Two

A family's journey from devastating prognosis to access to an investigational treatment for a rare condition.

The lived experience of early access, providing valuable insights into what families would like all stakeholders to understand about navigating treatment access during times of crisis.

Life beyond treatment, examining the long-term impact of access to innovative medicines and how the experience inspired the creation of a rare disease advocacy organisation dedicated to supporting others facing similar challenges

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.

This interactive break is your chance to connect with peers, explore real-world experiences, and exchange insights shaping today’s Expanded Access landscape. Use this time to discover innovative approaches, discuss operational and regulatory learnings, and engage with colleagues advancing ethical, patient-focused access pathways. For more information or to share your work, please email info@hansonwade.com

• Assessing inherited access programmes 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 programme integration

• Clarifying sponsor versus physician responsibilities to avoid delays caused by expectation misalignment
• Supporting sites through access processes without crossing promotional, regulatory, or ethical boundaries
• Managing variation in site readiness, experience, and responsiveness across programmes
• Preventing access interruptions caused by site level uncertainty around documentation, reporting, and obligations

• When silence becomes an access barrier: considering whether limited awareness of access routes can unintentionally favour well-connected centres, established KOL networks or more vocal patient communities
• Responsible visibility, not promotion: exploring how factual, balanced and appropriately governed information can support equitable awareness without creating inappropriate demand, expectation or pressure
• Supporting fair, physician-led access: reflecting on how non-promotional communication can help HCPs understand when an access route may be relevant, while preserving clinical independence, patient safety and programme sustainability

• Managing programme handovers without disrupting active patient supply
• Preparing affiliates and physicians for new systems, workflows, and points of contact
• Preserving responsiveness and accountability when execution becomes more layered
• Learning how peers maintained confidence and continuity during vendor transitions

• Establishing a shared vision and foundation for Managed Access, aligning on ethical principles and industry standards to reduce fragmentation and enable sustainable global pathways
• Delivering value for patients, industry and stakeholders by accelerating equitable access, improving operational efficiency, and enabling meaningful peer and regulatory exchange
• Driving system level impact beyond individual programs by shaping policy, fostering multi stakeholder collaboration, and strengthening global trust in Managed Access

• Addressing growing delays in patient access to innovative medicines and where current systems are failing
• Designing a funding model that enables access beyond donation-based programmes through shared ecosystem contribution
• Navigating legal, supply, and operational considerations to ensure access remains compliant and controlled
• Engaging stakeholders across pharma, patients, payers, and philanthropy to enable scalable access

• Defining post trial access obligations at the trial design stage rather than at close out
• Choosing between open label extension, post trial access, or early access before Phase III completion
• Aligning PTA planning with budget, supply availability, and country level feasibility upfront
• Preventing long term, unsustainable obligations by understanding and documenting what was committed to authorities

This session brings together two real-world case studies to explore how organisations have managed the transition from clinical trial systems into post-trial access.

• Managing the transition from trial supply to post trial access without disrupting patient treatment
• Resetting site expectations around ordering, reporting, and documentation outside trial frameworks
• Addressing practical blockers in complex regions where PTA setup is slower, less defined, or inconsistently interpreted
• Deciding when post trial access can accommodate limited data collection and when patients must remain in extension studies instead