Wednesday, September 30, 2026

15:15 - 16:00

AUDITORIUM MARGARITA SALAS

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Overview

Sponsor: CSL Behring, ClarkeModet.

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Details

Human-derived substances are at the forefront of a new wave of biomedical innovation, spanning cell therapies, microbiome-based interventions, and advanced medicinal products. As these technologies rapidly evolve, so too does the complexity of the regulatory landscape governing their development and clinical application within the European Union. This session will explore the scientific, clinical, and regulatory dimensions of substances of human origin (SoHO), with a focus on how emerging frameworks aim to balance patient safety, ethical considerations, and innovation. Experts will provide insights into the latest EU regulatory developments, including classification challenges, compliance pathways, and the implications of the evolving SoHO regulation. A featured perspective from industry will highlight real-world translation, showcasing how cutting-edge companies—such as those working in microbiome therapeutics—navigate regulatory uncertainty while advancing novel therapies toward the clinic. The discussion will emphasize practical strategies for stakeholders across biotech, healthcare, and policy to effectively bring human-derived innovations to market. Join us to unpack what truly constitutes “substance” in today’s biotech ecosystem—and how Europe is shaping its future.

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Speaker