Talk Value & Access track
S1003 - EU HTAR and Surrogate Endpoints in Oncology: How Can We Ensure JCA Supports Faster Patient Access?
Wed, Mar 19, 2025 · 4:50–6:00 PM CET Montreal Room, Congress Center Basel
About this session
The session will address the acceptance of surrogate end points in oncology, and differences between regulatory guidance and methods for EU JCA. The panel of experts from HTA, regulatory, clinical and patient backgrounds will discuss some of the causes of different evidence requirements, what difference they expect the JCA process will make and what (if anything) is making them optimistic about closing evidence gaps and preventing delays to access for EU patients. We'll also be asking participants to think through what THEY would do if they were working on a promising therapy in development: focus on the fastest route to regulatory approval, or aim for HTA-required data even (if this took more time)?
Programme:
- 1. Setting the Scence — Adam Heathfield
- 2. Panel Discussion — Caroline Pothet, Anja Schiel, Rosa Giuliani, Valentina Strammiello
Speakers
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Head of advanced therapies and haemato-oncology · European Medicines Agency
Panelist
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Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA · Norwegian Medicines Agency (NoMA)
Panelist
