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BioSpaceAuthor: BioSpace
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New Approach Methodologies: Redefining Animal Testing Alternatives
Thursday, 4 December, 2025
Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced. The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing.In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsPatrick Smith, Senior Vice President, Translational Science, CertaraStacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
