Friday, October 24, 2025

12:15 PM - 1:00 PM

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Details

This session will examine current insights into the use of New Approach Methodologies (NAMs) to support First-In-Human (FIH) clinical trials. NAMs, including in silico modelling, in vitro human-based assays, organ-on-chip platforms, and advanced computational toxicology, are rapidly being integrated into the early phases of drug and medical device development. The discussion will cover the latest regulatory trends, recent validation successes, challenges with broader adoption, and future directions for NAMs, including their impact on the transition from preclinical research to human studies. Panellists representing diverse regulatory, industry, and academic perspectives will highlight real-world case studies, regulatory acceptance, and opportunities to reduce and, where possible, replace animal testing. The session will address practicalities around establishing confidence in NAMs, barriers to wider use for FIH trial support, and cross-sector collaborations accelerating change in risk assessment and safety science.

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Speaker