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Day 1

8th Expanded Access Progammes World Congress 2025 Europe

Comprehensive Analysis on Executing Expanded Access Programmes

Holiday Inn London - Bloomsbury, an IHG Hotel, 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
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