Explore the Agenda
7:45 am Check In & Coffee
8:20 am Chair’s Opening Remarks
Strategic Access Planning: Managing Exit Strategies & Reimbursement from Start to Finish
8:30 am Panel Discussion: Planning & Executing Smooth Transitions from EAP to Commercial Supply
- Anticipating patient needs and country-specific timelines to maintain uninterrupted access during program closure or handover
- Aligning internal teams, local stakeholders, and advocacy groups to address operational, regulatory, and financial challenges
- Learning from real-world multi-country cases to optimize transition planning and avoid common pitfalls
9:00 am Bridging the Gap Between Regulatory Approval & Commercial Launch: Access Strategies
- What are the important characteristics of early access in Europe, including what makes it complicated and whether it could become easier
- What are the key practical perspectives of EU early access to be aware of, particularly after centralized Marketing Authorization
- What does EU early access look like in small biotech, and how can the transition of an early access program from biotech to pharma be supported
9:30 am Roundtable – When ‘Free’ Isn’t Free: The Hidden Tax & Title Traps in Global EAP Supply
- Introduce the key themes in running global Early Access Programs, with a specific focus on title transfer and tax (VAT) implications
- Present three real‑world scenarios and use roundtable breakouts to identify gaps, challenges, and potential solutions
- Share recommendations for each scenario, providing practical guidance to help organisations identify tax risks early, make compliant decisions, and proactively manage VAT and title‑transfer implications in the Early Access setting
10:00 am 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
Driving Cohesion Across Internal & External Partners for Effective EAPs
11:00 am Clarifying Regulatory & Operational Differences Between Cohort & Individual Patient Programs to Align Program Design with Target Populations
- Unpacking important distinctions between cohort and individual patient regulatory pathways and impact on program design
- Exploring cost and resource considerations, including the need for a CRO, which are required to execute cohort and individual patient programs
- Implementing the obligatory commitments of running a cohort program into the pre-existing company infrastructure
11:30 am The Role of Compassionate Use & Expanded Access Programs in Epidemics & Pandemics: A Look at COVID-19 & Ebola
- Examine how Compassionate Use and Expanded Access Programs operate in fast-moving outbreaks, using Ebola and COVID-19 to illustrate the clinical, regulatory, and ethical landscape
- Compare two approaches our team deployed in each outbreak, explaining when and why they were chosen, how they were implemented, and their impact on patient access
12:00 pm Lunch & Networking
1:00 pm The Rationalization of EAPs for Small Biotech
- Getting to Phase 3 – The story of WinSantTor
- When Innovation is not always a good thing
- Going from unfundable to a precommercial company in three months
- The difference of Right to Try and Compassionate Use
- Navigating the evolving Expanded Access Programs globally
- How Right to Try will disrupt Innovation for other biotechs
Advanced Modalities: Delivering Innovative Therapies Through Effective EAPs
1:30 pm Roundtable: Rare & Ultra-Rare Diseases: Designing Programs for Maximum Patient Impact
- How are organisations currently navigating corporate pressures while maintaining ethical and equitable access in rare and ultra-rare disease programs?
- What are the key challenges sponsors face when deciding between single-patient access and cohort programs in today’s regulatory environment?
- What practical program design or operational approaches have been most effective in ensuring meaningful patient access in rare and ultra-rare diseases?
2:00 pm Afternoon Break & Networking
2:45 pm Implementing Home Infusions in Early Access Programs
- Navigating unique challenges of providing infusion therapy in a home setting
- Addressing operational and regulatory hurdles, including pharmacy manuals, IRB approvals, and agency contracting
- Engaging physicians and patients while ensuring uptake, satisfaction, and preparing for commercial transition
3:15 pm Gene Therapies: Global Pathways to Bridge Innovation & Access
- Enabling early patient access to investigational gene therapies through global pre-approval pathways and compassionate use programs
- Supporting patient access to gene therapy treatment with managed and conditional post-approval models
- Strengthening safety, effectiveness, and global alignment by leveraging multi-stakeholder data and collaboration