Day Two

• Sharing a firsthand patient perspective on navigating serious disease and the importance of access to treatment options.
• Exploring the awareness gap surrounding Expanded Access Programs and why so few patients know these opportunities exist.
• Discussing how pharma, biotech, patient advocacy groups, and healthcare providers can work together to improve awareness, communication, and patient engagement around Expanded Access Programs

• Assessing the practical implications of MFN
• Understanding pricing and reimbursement risks
• Evaluating the impact on program planning and country selection
• Preparing teams for future access decisions

• Gathering insights from local regulatory leads to build a clearer picture of countryspecific Expanded Access requirements
• Translating regulatory intelligence into a practical dashboard that gives internal stakeholders more accessible, usable information. Using initial feedback to generate a sustainable insight gathering survey platform that feeds directly into a dashboard.
• Sharing lessons from the development journey, including determining what information to capture and how best to present it to support Expanded Access decision-making 

Step outside the main conference room to explore practical examples, initiatives and lessons from across the Expanded Access community.

• Applying lessons from running a large-scale global Expanded Access Program to building a new program from the ground up
• Understanding how EAP strategy and execution need to adapt depending on organizational size, resources and existing infrastructure
• Prioritizing the processes, governance and cross-functional alignment needed to establish a new EAP capability
• Overcoming the early hurdles and practical challenges encountered when moving from strategy to operational delivery

• Improving how risks, uncertainties and limitations are communicated to patients
• Defining physician responsibilities throughout the patient access journey
• Managing difficult conversations around program closure and treatment discontinuation
• Strengthening trust through better informed consent and stakeholder engagement

A difficult EAP decision. Different perspectives around the table. Put yourself in the middle of a real-world Expanded Access scenario and work through the decision alongside peers from across pharma and biotech.

• Debate how you would respond and discover where approaches differ across organizations
• Work through the competing patient, operational, regulatory and commercial considerations influencing the decision
• Hear from peers who have faced similar challenges and share what has worked in practice
• Build connections through the problems you have in common

Meet the people you’ll want to call when you face the same challenge back at work.

Make the most of your final networking break to exchange details with the peers you want to stay connected with beyond Boston.

• Balancing Expanded Access alongside active clinical development without disrupting the clinical trial pathway
• Comparing approaches across different disease areas, including when and how to introduce a formal EAP
• Deciding when real-world data collection adds value versus when rapid access and safety monitoring need to take priority
• Navigating different levels of physician and internal team familiarity with EAPs and avoiding programs being approached operationally like clinical trials 

• Understanding the additional regulatory requirements and approvals required when setting up Expanded Access Programs for controlled substances
• Building internal processes and governance models that support compliance while maintaining timely patient access
• Coordinating effectively across Medical, Regulatory, Clinical Operations, Supply Chain, and Quality teams
• Lessons learned from launching and operationalizing controlled substance access programs, including common challenges and practical solutions