NASEM Board Considers Scientific and Regulatory Context for NAM Use

By: Galen Cobb
Thursday, December 18, 2025
The Board on Animal Health Sciences, Conservation, and Research (BAHSCR) of the National Academies of Sciences, Engineering, and Medicine (NASEM) focused the first day of its fall meeting on the scientific, regulatory, and policy context shaping the federal government’s growing interest in New Approach Methodologies (NAMs). CAPT Brianna Skinner, DVM, MPH, Food and Drug Administration (FDA), and Monique Perron, DSc, Environmental Protection Agency (EPA), described how their agencies currently anticipate using NAMs in drug development, therapeutic review, and toxicological safety assessments.

While participants broadly agreed that NAMs will continue to play an expanding role in research and regulatory decision-making, speakers repeatedly emphasized that methodological choices should be driven by the goal of producing high-quality, reproducible, and translational science. Researchers highlighted the value of using NAMs alongside animal models, describing an integrated and iterative approach in which insights from different methodologies inform one another rather than operate in isolation.

Discussion also highlighted several challenges that complicate broader adoption of NAMs. Participants pointed to uneven access to technical expertise, cost and infrastructure limitations, and the concentration of many NAM technologies within private companies. Speakers noted that these barriers can limit feasibility across research contexts, including wildlife studies and work conducted in remote or resource-limited settings.

Panelists further addressed issues of standardization and validation, with several speakers cautioning that NAMs must be held to rigorous and transparent standards comparable to those long applied to animal models. At the same time, agency representatives acknowledged ongoing debate over how validation should be approached, particularly in cases where animal models themselves have demonstrated limitations in translatability. Participants also recognized the current scientific constraints of NAMs, including their inability to fully capture whole-organism effects relevant to many biomedical and veterinary research questions.

More information about the BAHSCR fall meeting, including the agenda and recording, is available on the NASEM event website.