PROGRAM ANNOUNCEMENT

Triangle CERSI Presents: New Approach Methodologies for Regulatory Science (NAMeRS): A Roadmap Accelerator Program for FY26

Background
FDA’s 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies outlines a three-year plan to advance validated in vitro and in silico new approach methodologies (NAMs). The Triangle CERSI NAMeRS Program supports early collaborative projects that contribute to this roadmap and strengthen FDA-relevant regulatory science.

Program Overview
NAMeRS provides seed support for teams at Triangle CERSI institutions working with FDA and other CERSIs to generate preliminary data, build collaborations, and position projects for follow-on funding. Awardees will also participate in the 2026 NAMeRS Summit at the Burroughs Wellcome Fund to share progress and engage regulators, funders, and peers.

Full Program Announcement

Eligibility
Teams must include at least one PI from UNC-Chapel Hill, Duke, NCCU, or NC State. Multi-institution Triangle CERSI teams are encouraged; collaboration with other CERSIs (Johns Hopkins, U Maryland, Yale, Mayo Clinic, UC San Francisco, Stanford) is preferred; partnerships with FDA or industry are welcome but not required. NAMeRS funds can only be disbursed to CERSI institutions, with separate travel support available for non-CERSI collaborators.

Awardees to be announced shortly

Focus Areas
Projects may address aspects of FDA’s roadmap or broader NAM adoption (e.g., endpoint mapping, validation pathways, regulatory guidance, training, and performance metrics).

Expected Outcomes
Teams should generate early regulatory-science deliverables aligned with the roadmap and prepare for follow-on funding. Awardees will share progress and lessons learned at the 2026 NAMeRS Summit.

Funding Acknowledgement:

This Program is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award Center of Excellence in Regulatory Science and Innovation, U01FD007857. The contents are those of the author(s) and do not necessarily represent the official views, nor an endorsement by, FDA/HHS, or other U.S. Government.