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Day 1

6th Expanded Access Progammes World Congress 2024 Europe

Copthorne Tara Hotel London Kensington, London, United Kingdom

Day 1 - Thursday 11th April 2024

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:
Nora Pöntynen, Global Medical Affairs, Boehringer Ingelheim International GmbH
Yasmina Tazir, Sr Director Clinical Science, Clinical Policy, Chief Medical Office, AstraZeneca

  • Understanding the new MHRA’s IRP framework
  • How does it compare to other regulatory guidelines currently available
  • The significance of IRP for marketing authorization and patient access

Pedro Franco, Sr Director, Head, Europe Global Regulatory & Scientific Policy, Merck Healthcare

  • Key legislative changes to maximise the Scheme’s impact by accelerating availability of medicines for patients
  • Facilitating collection of real-world data which may support regulatory decision making
  • Implications to pharma industry and manufacturers supplying EAMS medicines
  • Benefits to patients and physician
  • 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

STRATEGIES AND CURRENT TRENDS

  • Understanding the disease area and impact on the patient and family
    When to engage with patient advocacy organisations and the value they can bring
    Best practices to ensure patients are partners in your clinical development process

Senior Representative, WEP Clinical

  • 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

  • Value of real-world data in EAP
  • The use of RW data for Market access and reimbursement
  • Regulatory considerations and country differences for collecting real-word data
  • Case studies

MULTI-STAKEHOLDER APPROACH & COLLABORATION

  • Internal stakeholder education and engagement
  • Setting global and local expectations
  • Cross functional consultations and considerations
  • Road map for development through implementation

Annie O’Keefe Martin, Global Medical Governance Lead for Managed Access Programs and Rare Humanitarian Programs, Sanofi

  • Understanding what EAP are for
  • Physicians responsibility in applying for EAP
  • Meeting criteria for EAP
  • Learning how patients will be transitioned to commercial supply

Lindsay Birrel, Co- CEO, Realise Advocacy, Chair of trustees, Medics 4 Rare Diseases

  • 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

  • Interaction between pharmaceutical companies and healthcare providers could foster the development of new medicines which will ultimately benefit patients.
  • Would this enhance technological innovation, fosters knowledge creation, aids disease control, and reduces polypharmacy issues?
  • Guidelines to help professionals navigate the opposing explanations of interactions with pharmaceutical companies

Dr.Dinesh Kumar, International Medical Director, Medical Review & Compliance, Alnylam UK Ltd

  • Importance of early access to medicine in deploying treatments to the patients who need it
  • Sustainable approaches to use pathways in low and middle income countries
  • Addressing logistical barriers to Access
  • Ethical issues and considerations
  • 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 

6:00 - 7:00 pm - Networking Drinks Reception

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