Day Two

• Managing access requests for populations typically excluded from trials or standard programmes (e.g. pregnancy)
• Translating incomplete or indirect evidence into defensible access decisions without creating research like risk
• Balancing ethical pressure to act against safety uncertainty and lower monitoring intensity in access programmes
• Establishing internal guardrails for exception based access that stand up to scrutiny

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

Two real-world case studies showing how teams successfully onboard and remediate access programmes post-acquisition or organisational change – without compromising patient continuity.

• 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

• 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