8th Expanded Access Progammes World Congress 2025 Europe
Comprehensive Analysis on Executing Expanded Access Programmes
Copthorne Tara Hotel London Kensington, London, United Kingdom
Day 1 - Wednesday 19th March 2025
OVERVIEW OF EUROPEAN REGULATORY LANDSCAPE
- Understanding the challenges in planning and implementing a global EAP
- Country specific framework and requirements to access investigational drugs
- Scientific elements and regulatory tools available to address the challenges and explore the flexibility within the current regulatory systems
- Significant degree of administrative effort required to initiate the programme for a timely access
- How far are we from establishing a harmonised guidelines across Europe
Panelist:
- Overview of the access journey in the UK
- Investigation of the benefits and challenges of Brexit for early and expanded access
- How early access can benefit patients
- Gaps in the UK against other countries
- Where VPAS 2024 dropped the ball
Where access could go in future
- Patients are well informed and capable of understanding where in the world treatments are available through expanded access
- Not every regulatory framework is favourable and this can lead to inequality and a frustrated patient community
STRATEGIES AND CURRENT TRENDS
- Defining key milestones and timelines effectively
- Selecting the appropriate stakeholders for involvement
- How to effectively manage communication and leadership when multiple companies are involved
- Integrating an EAP with the therapy clinical and commercialization plan
– Internal stakeholders
– Alignment on objectives
– Optimal timings for planning and initaition
Working with external stakeholders
– Stakeholder mapping
– Engaging with patient and advocacy groups early in development for well informed decision
– Considerations in planning EAP’s with patient in mind
Practical guide to initiation
The link to Market Access
- The Landscape
- A UK perspective
- The Good, The Bad & The Ugly
- What does this mean for patients and their future
- Next Step
MULTI-STAKEHOLDER APPROACH & COLLABORATION
- Defining guiding principles
- Determining the key stakeholders
- Considerations for a decision-making framework
- Why do we need early access programs
- What value do they bring and to who
- What are the opportunities and challenges
- Who should you engage with and when
- The market access perspective – when and how expanded access is helpful
- Expanded access in the context of the overall access strategy
- Going beyond the large countries to a global strategy
- Being inclusive to HIV+ patients
- When the patient disagrees – Dealing with online petition
- The right to a second-opinion following a rejection
- The importance of patient advocacy in providing a much-needed information on EAP’s available for patients
- Collaborating with one another to enable a much richer understanding of patient needs
- Patient groups importance in working with health authorities to advance policies that accelerates patient access to investigational medicines
- Creating a state-of the art payer engagement strategies to address challenges in pricing and reimbursement
