Explore the Agenda
8:15 am Check-In & Morning Coffee
8:50 am Chair’s Opening Remarks
Designing Ethical, Defensible, & Actionable Data Strategies in Expanded Access
9:00 am Turning EAP Data into Action: Applying Insights to Regulatory & Access Strategy
- Differentiating how EAP data complements clinical trial outcomes
- Understanding how EAP data is being used to support regulatory dialogue and submissions
- Integrating real-world insights into broader evidence-generation and access planning
- Demonstrating how RWD collected through EAPs is used to inform pricing, reimbursement decisions, and negotiations with health authorities, backed by realworld case studies
9:30 am Roundtable: What Data Can We Ethically & Safely Collect in Expanded Access?
- Clarifying what constitutes acceptable insight generation versus study-like data collection
- Reducing internal risk aversion by aligning on intent, transparency, and patient benefit
- Defining ethical, regulatory, and reputational guardrails for EAP data collection
10:00 am Session Reserved for MedaSystems
10:30 am Morning Break & Networking
Building Sustainable Access: Provider, Patient, and System-Level Solutions
11:15 am Redefining Expanded Access in ALS: Lessons from a Government- Funded National Program
- Balancing compassionate access with scientific rigor in a federally funded ALS Expanded Access Program
- Advancing health equity by prioritizing access for underserved and remote ALS patient populations
- Generating real-world evidence from expanded access data to support regulatory and development decisions
11:45 am Empowering Oncology Health Care Providers to Improve Expanded Access Enrollment
- New insights into knowledge gaps among U.S. oncology health care providers related to Expanded Access Programs
- Key patient enrollment and operational barriers encountered by providers and care teams
- Interactive discussion on how industry can better support oncology health care providers through education, tools, and process improvements
- Practical strategies to help providers more efficiently connect eligible patients to Expanded Access treatment options
12:30 pm Patient-Led Models for Scaling Access Across High and Low-Income Countries
- Reaching underserved populations when traditional access mechanisms fail
- Managing chronic treatment access for thousands of patients across diverse health systems
- Coordinating pharma, clinicians, and patient organizations to reduce friction and delay
- Embedding access strategy early to support long-term equity and sustainability
1:00 pm Lunch & Networking
2:00 pm Session Reserved for Inceptua
Launching Expanded Access with Limited Teams, Budget & Infrastructure
2:30 pm Building Credible EAPs as a Team of One
- Establishing fit-for-purpose policies and documentation without large pharma systems
- Educating internal stakeholders on how EAPs differ from clinical trials
- Balancing strategic planning with day-to-day operational execution
- Building internal confidence and decision-making credibility without a dedicated team
3:00 pm Roundtable: Securing Buy-In, Funding, & Guardrails in Risk-Averse Organizations
- Navigating leadership concerns around regulatory, reputational, and approval risk
- Making the business and ethical case for EAP investment pre-approval
- Designing guardrails that protect programs without stalling access
Avoiding Patient Disruption as Expanded Access Ends & Commercial Begins
3:30 pm FDA approval: Now What?
- Defining strategies for EAP patients that are now ready to be transferred to commercial products