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Clinical Trial Events
DIA Europe

Talk Regulatory Strategy & EU Pharmaceutical Policy track

S0902 - Need is in the eye of the beholder: Unmet Medical Need from different perspectives and how to find common solutions

Tue, Mar 18, 2025 · 1:30–2:40 PM CET Montreal Room, Congress Center Basel

About this session

The concept of unmet medical need (UMN) plays an important role in investment and priority-setting decisions by a range of stakeholders, including regulators, HTA bodies, payers, academics and the pharmaceutical industry. Identifying a particular condition or disease area as an UMN is intended to signal its health policy significance, stimulate research activities and incentivise the development of innovative treatments, diagnoses or health technologies in these areas. As the European Commission proposed to define the concept of UMN in the current legislative pharma review, the concept is broadly discussed with divergent views.

This session will bring together key players in pharmaceutical innovation - developers, regulatory authorities and patients - to discuss Europe’s ambition for a definition of unmet medical need, what is needed, what are the challenges and how this might influence regulatory decision-making.

Programme:
- 1. AI capturing Patient Experience Data: how can it support UMN? — Julian Isla
- 5. Panel Discussion — Julian Isla, Niklas Hedberg, Francesca Cerreta, Isabelle Huys, Rick Vreman, Lucia D'Apote
- 2. Balancing innovation with stimulation of research in underserved areas — Isabelle Huys
- 3. An industry perspective — Lucia D'Apote
- 4. A regulatory perspective — Francesca Cerreta

Speakers