Momentum is increasing for New Approach Methodologies (NAMs) as alternatives to traditional animal testing. On December 2, the FDA released a draft guidance that identifies certain product types where six-month non-human primate toxicity studies may be reduced or eliminated. This follows an earlier proposed agency template for NAMs introduced in April.
The Validation and Qualification Network, which includes partners from regulatory agencies such as the FDA and European Commission, along with pharmaceutical companies like Sanofi, Novo Nordisk, GSK, and Charles River Laboratories, held a meeting in July to discuss progress on these methods. Additionally, Reuters reported in September that artificial intelligence-driven drug discovery is gaining traction as the FDA encourages efforts to decrease reliance on animal testing.
In the latest episode of Denatured, Jennifer C. Smith-Parker interviews Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health, and Patrick Smith, Senior Vice President of Translational Science at Certara. The discussion focuses on recent regulatory developments and what lies ahead for NAMs.
"Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations."
