6th Expanded Access Progammes World Congress 2024 Europe
Day 1 - Thursday 11th April 2024
Robert Donnell, EVP, Medicines Access, Smartway Pharma
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 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
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
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
MULTI-STAKEHOLDER APPROACH & COLLABORATION
- 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
