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Clinical Trial Events
BIO-Europe 2026

Fireside chat Regulatory Strategy track

From NAMs (New Approach Methodologies) Innovation to Regulatory acceptance: Accelerating human-relevant modelling

Wed, Nov 11, 2026 · 9:00–9:45 AM CET Regulatory Strategy Stage, Koelnmesse

About this session

Examine how NAMs can help accelerate drug discovery, streamlining development timelines, and open new pathways for regulatory decision-making. Understand the current NAMs landscape and the role of NAMs in reshaping biomedical innovation.Explore the European funding opportunities for driving human-relevant modelling: from organ-on-chip platforms to AI-enabled digital twins.Steps for regulatory acceptance: understanding the principles of a well-defined context of use, the evidence required to demonstrate fitness for purpose and available routes for regulatory interaction, from early advice and…

Speakers

  • Marco Straccia

    Co-Founder & CEO · FRESCI

    Moderator

  • Philip Hewitt

    Global Head of Early Investigative Toxicology · Merck KGaA

    Speaker

  • Reyk Horland

    CEO · TissUse GmbH

    Speaker

  • Milena Mennecozzi

    Project office, Joint Research Centre · European Commission

    Speaker

  • Ole Olesen

    Directorate-General for Research & Innovation · European Commission

    Speaker

  • Joana Portela

    Translational Sciences Office · European Medicines Agency

    Speaker

  • Orsolya Symmons

    Programme Manager for Health & Biotechnology · European Innovation Council

    Speaker