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Day 1

6th Expanded Access Progammes World Congress 2024 Europe

Holiday Inn London - Bloomsbury, an IHG Hotel, London, United Kingdom

Day 1 - Thursday 11th April 2024


  • 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

Nora Pöntynen, Global Medical Affairs, Boehringer Ingelheim International GmbH
Robert Donnell, EVP, Medicines Access, Smartway Pharma

Dr.Dinesh Kumar, International Medical Director, Alnylam UK

  • 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

Gordon Lundie, Executive Director, Market Access and Pricing, Gilead Sciences

  • 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

Cameron Miller, Director of Policy & Strategy, The Brain Tumour Charity


  • Defining key milestones and timelines effectively
  • Selecting the appropriate stakeholders for involvement
  • How to effectively manage communication and leadership when multiple companies are involved

Ana Tediosi, Head of Expanded Access Strategy, WEP Clinical

  • 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

Robert Donnell, EVP, Medicines Access, Smartway Pharma, a leading provider of Early / Expanded Access Programs (EAP).

  • The Landscape
  • A UK perspective
  • The Good, The Bad & The Ugly
  • What does this mean for patients and their future
  • Next Step

Bob Stevens, Group CEO, MPS Society


  • Defining guiding principles
  • Determining the key stakeholders
  • Considerations for a decision-making framework

Jennifer Grigonis, Sr. Director Business Development, EAP, Bionical Emas

  • 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

Sheela Upadhyaya, Chair Elect, Rare Disease Special Interest Group, ISPOR

  • 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

Katja Berg, Innovative Value and Access Strategy, AstraZeneca

  • Being inclusive to HIV+ patients
  • When the patient disagrees – Dealing with online petition
  • The right to a second-opinion following a rejection

Menno A. Kiel, Global Medical Leader, Research Physician & Health Economist, Roche


  • 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

Katja Berg, Innovative Value and Access Strategy, AstraZeneca
Paul Blakeley, Sr Policy Advisor, Health and Life Sciences, Tony Blair Institute for Global Change 

Cameron Miller, Director of Policy & Strategy, The Brain Tumour Charity

Dr James Duboff, Strategic Partnerships Director, Genomics England

Robert Donnell, EVP, Medicines Access, Smartway Pharma

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