Explore the Agenda
7:30 am Registration & Morning Coffee
8:20 am Chair’s Opening Remarks
Overcoming Regulatory Barriers to Deliver Timely Patient Access Worldwide
8:30 am Setting the Stage – Expanded Access in 2026: From Ethical Imperative to Strategic Necessity
- Discussing how EAPs have evolved since their inception, from ad hoc programs to strategic global tools
- Highlighting the key forces shaping the landscape today: regulatory variability operational challenges, supply pressures, and the not-so-subtle shift toward data collection for regulatory purposes
- How EAPs are redefining their role and impact as vehicles for generating Real World Data/Evidence in clinical development and commercialization
9:00 am Overcoming Access Barriers in Low & Middle-Income Countries: Operational Lessons from The Max Foundation Model
- Highlighting the operational aspects and unique features of the Max Foundation’s access model
- Contrasting The Max Foundation’s humanitarian model with traditional MAP and compassionate use frameworks
- Navigating the unique operational realities of low- and middle-income countries – from infrastructure and supply chain to patient engagement
- Addressing the holistic challenges of access: practical, political, and logistical considerations in scaling impact
9:30 am Operationalizing Expanded Access Programs in Challenging Regional Landscapes: Lessons from Central America & the Caribbean
- Discussing unique regulatory and operational challenges in Central American and Caribbean healthcare systems
- Outlining practical approaches for implementing EAPs in high-cost therapy areas, including oncology and rare disease
- Building trust with stakeholders and navigating government/public payer systems to enable patient access
- Lessons learned and opportunities to strengthen regional EAP frameworks going forward
10:00 am Session Reserved for Early Access Care
10:30 am Morning Break & Speed Networking
Join our speed networking session, tailored for Expanded Access experts like yourself, to connect with fellow industry peers to facilitate a rapid yet meaningful exchange of insights and expertise. Elevate your networking experience during this session designed for impactful connecting within the space.
11:30 am Fireside Discussion: Navigating Global Differences & Business Decisions in Expanded Access Programs
- Compare regulatory frameworks and access pathways across the US (FDA), Europe (EMA), and other national systems such as France’s ATU
- Explore how approaches to expanded access differ between large pharma and smaller biotech organizations.
- Examine how companies assess the business case and operational feasibility of launching programs in emerging regions, including the Middle East and Latin America
Maximizing Value from Expanded Access: Collecting, Managing & Applying Real-World Data (RWD)
12:00 pm Fireside Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs
- Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
- Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
- Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
- Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose
12:30 pm Reducing Burden & Increasing Efficiency When Collecting RWD
- Determining the minimum set of data points required to ensure an EAP collects only ‘fit-for-purpose’ data
- Designing efficient data capture models including data collected in routine clinical practices (EMR), retrospective chart reviews, companion studies run in parallel to EAPs, and integrated EAP protocols
- Overcoming practical barriers including physician time constraints, absence of site contracts, and limited infrastructure for consistent data entry
- Sharing case studies from companies that successfully streamlined RWD collection without compromising patient access or overwhelming sites
1:00 pm Lunch & Networking
2:00 pm Case Study: Using Real-World Data from a Compassionate Use Program to Support Regulatory Filing in an Ultra-Rare Disease
- Examining a practical case study of how RWD was collected and applied support a regulatory submission in an ultra-rare indication
- Highlighting lessons learned from challenges in data collection, validation, and integration across functions
- Exploring how insights from RWD informed patient access, program design, or engagement with stakeholders
- Providing actionable takeaways for translating RWD into strategies that enhance EAP efficiency and impact
Driving Efficiency & Compliance Across the EAP Supply Lifecycle
2:30 pm Leveraging AI to Enhance Operational Efficiency in Expanded Access Programs
- Addressing compliance considerations using AI to flag operational risks and red flags early in the process
- Leveraging data analytics to reshape programs around unmet medical needs, geographic distribution, and demographic insights to improve patient access
- Exploring AI applications for patient eligibility assessment, supply forecasting, and resource management
3:00 pm Session Reserved for myTomorrows
3:30 pm Afternoon Break & Networking
4:15 pm Managing Complex Clinical Supply Chain in Unpredictable EAP Scenarios
- Case study: Maintaining patient treatment in Israel during conflict
- Highlighting issues/regions without a defined EAP framework
- Coordinating supply with EAP vendors. Navigating label regulatory ambiguity when clinical trial programs wind down, assets transfer, or treatment continues beyond planned timelines to maintain patient access
- Discussing practical lessons from a pharmacist’s end-user perspective to streamline investigations drug service operations and patient delivery
Post-Trial Access Made Practical: Navigating Operations, Compliance, & Global Complexity
4:45 pm Operationalizing Post-Trial Access: From Trial Close to Seamless Delivery
- Aligning internal teams, vendors, and stakeholders to manage supply, labeling, and distribution efficiently
- Forecasting patient demand post-trial and planning logistics to avoid delays or stock-outs
- Implementing practical tracking, communication, and reporting mechanisms for multi-country programs
- Learning from real-world examples of successful PTA execution to reduce operational burden and maintain compliance