Wednesday, October 21, 2026

4:30 PM - 5:15 PM

Discovery & Advanced Therapeutics Breakout Room

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Details

New Approach Methodologies (NAMs) are increasingly being used to strengthen translational confidence, reduce reliance on animal models and support safer progression into first-in-human trials. The next challenge is practical: how should NAM evidence be generated, presented, assessed and used by sponsors, Phase 1 sites, HRECs and regulators? Building on Bellberry and ASCEPT’s 2025 NAM Workshop 2 and double panel session at AusBiotech, this session will explore the practical application of Bellberry and ASCEPT guidance for the use of NAMs in first-in-human and early phase trials. The panel will bring together perspectives from a Phase 1 site, sponsor, technologist and the TGA to discuss what credible, consistent and useful NAM evidence looks like in practice.

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Speaker