Day One

• Surfacing the most common “blockers” to access and challenging their validity
• Exploring who gets to define acceptable risk – and whether patients are meaningfully part of that decision
• Creating space for more honest, less risk-averse dialogue across stakeholders

• Examining fragmentation across European early access pathways and the resulting challenges for industry payers and HTA decision making
• Exploring a working theory for greater alignment of early access policies across Europe drawing parallels with emerging EU frameworks such as joint clinical assessment
• Evaluating potential impacts of greater alignment including operational feasibility legal considerations and competitive dynamics across similar therapies

This interactive session puts you at the centre of the discussion. Join a small group of peers and take part in a structured exchange to share what you are currently working on, where you’re facing challenges, and what you need to move forward.

• Introducing your current programme context, including key challenges around regulation, data, supply, or execution
• Sharing what you are trying to solve right now, from pathway selection to scaling, transitions, or governance
• Collaboratively identifying practical solutions, workarounds, and approaches you can take back and apply immediately

• Exploring ACADIA’s European early access journey: how different country pathways and programme types shaped execution, timelines, and operational complexity
• Sharing first-hand experience of managing multi-country programmes: where structured, centrally coordinated approaches increased cross-functional burden, resource demand, and delivery risk
• Demonstrating how pragmatic, country-level and ad-hoc access routes enabled faster patient access
• Lessons learned on aligning programme design with organisational readiness, resourcing, and anticipated regulatory uncertainty to ensure sustainable, successful delivery

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.

• Breaking down what has actually changed in France’s early access and post trial access pathways
• Clarifying misconceptions around what is no longer possible versus what remains feasible with the right authority engagement
• Navigating increased scrutiny, economic paybacks, and stronger justification of medical need under the new rules
• Managing the operational transition from early access or post trial supply into commercial and paid pathways in France

• Interpreting recent FDA expanded access guidance on broader eligibility, sponsor responsibility, and proactive access planning – and what this changes in practice
• Understanding how MFN pricing dynamics are extending time to launch and increasing reliance on early and managed access pathways
• Aligning expanded access planning with pricing driven launch uncertainty without creating open ended access commitments
• Evaluating whether existing access governance, resourcing, and supply models are fit for increased regulatory expectation and prolonged pre commercial access

• Leveraging alternative access routes and managed access pathways across CEE, MENA, and developing markets
• Collaborating with authorities to unlock patient access through flexible and locally adapted solutions
• Balancing patient need, government priorities, and long-term programme sustainability
• Practical lessons from delivering access across diverse healthcare systems and economic environments

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

• Designing data collection approaches that remain within the treatment context and do not interfere with clinical trials
• Identifying what data is truly valuable to collect within EAPs vs where alternative approaches are more appropriate
• Building low-burden, scalable data capture frameworks for physicians and patients
• Translating EAP data into tangible value (e.g. informing safety, dosing, HTA, or prelaunch decision making)

• Exploring where expanded access delivers the greatest value within rare disease development and patient access strategies
• Preparing operationally and regulatorily for expanded access programmes prior to launch
• Aligning expanded access with broader regulatory pathways and evidentiary expectations
• Understanding the role of expanded access beyond data generation focusing on patient need and access equity