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 Expanded Access in 2026: New Guidance, Evolving Expectations, and What People Need to Know
- What has changed with the latest FDA Expanded Access guidance and what this means for sponsor decision‑making and risk‑benefit considerations?
- How evolving expectations around post‑trial access, use of real‑world data, and charging may reshape Expanded Access strategies
- Opportunities for sponsors, with key practical suggestions for program design, governance, and stakeholder engagement
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 When Access Creates Evidence: Real‑World Data from Expanded Access Programs
- Real‑world evidence generated through these programs that has informed regulatory decision‑making, contributing to EMA scientific advice discussions and, in specific cases, resulted in FDA labeling indications and marketing authorizations
- This session will focus on the types of approaches and real regulatory results
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 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 Panel 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 Data Driven Insights – Exploring Variations in Global Access
- Insights to regional variations in global access
- Comparison of access across therapeutic areas
- Exploring potential factors for variation and recommendations to reduce inequality to access
1:15 pm Lunch & Networking
2:15 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
Driving Efficiency & Compliance Across the EAP Supply Lifecycle
2:45 pm The Hidden Cost of Poor EAP Operations: What Regulators Actually Notice
- Expanded Access Programs may be non-pivotal but they are not non-consequential. Weak execution can blur the line between scientific uncertainty and operational failure, triggering regulatory friction, greater scrutiny, and more conservative decision-making
- Beyond endpoints, regulators assess governance of exposure, safety handling quality, traceability, eligibility discipline, product integrity, and consent rigor. Weak operational signals can erode confidence even before formal review discussions begin
- Well-executed EAPs preserve data interpretability, demonstrate organizational control, and build regulatory trust, preventing access programs from becoming liabilities and strengthening sponsor credibility during pivotal review and labelling discussions
3:15 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
3:45 pm Rapid Fire Solutions: Misconceptions about Chargeable Expanded Access Programs
This rapid-fire session cuts through common misconceptions around chargeable expanded access to focus on what’s possible and what actually works. Drawing on real-world experience, explore charging for investigational products, reference pricing, affordability, cost recovery, payer types, and other topics. Practical insight, grounded in real programs.
4:30 pm Network & Learn Break: Access Insights Session
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
5:00 pm Practical Considerations for Chargeable Expanded Access: Bridging Global Access Gaps While Driving Biopharma Sustainability
- Evaluate global access disparities, and how chargeable expanded access can advance global reach and patient access
- Navigate country-specific models and feasibility to tailor programs to local rules and economics
- Gain insights into practical application of chargeable expanded access in key markets including implementation challenges, protection of product valuation, and practical lessons learned
Post-Trial Access Made Practical: Navigating Operations, Compliance, & Global Complexity
5:30 pm Post-Trial Access in Practice: Navigating Unlicensed Pathways
- Why Post-Trial Access programs are rapidly increasing and what’s driving this global shift
- Common regulatory pathways and country-specific constraints sponsors often underestimate
- Complexities with a locally licensed drug for non-approved indications
- Managing timelines, cost drivers, and patient attrition expectations in PTA programs
- Scoping information required for accurate planning and quotations
6:00 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
6:30 pm Chair’s Closing Remarks
6:30 pm Operationalize: Expanded Access Programs Drinks Reception!
Join our dedicated drinks reception to further connect and network with like-minded experts!