Triangle CERSI NAMeRS Program

The New Approach Methodologies for Regulatory Science (NAMeRS): A Roadmap Accelerator Program is one of several Triangle CERSI initiatives focused on advancing New Approach Methodologies (NAMs) to support collaborative, human-relevant regulatory science aligned with evolving FDA priorities.

May 27, 2026

Triangle CERSI & Burroughs Wellcome Fund NAMeRS Summit 2026

June 29, 2026 | Research Triangle Park, NC + Virtual Participation

The centerpiece of the program is the 2026 NAMeRS Summit, A NAMolution: How the Next Generation of Scientists Is Leading the Next Generation of Science, a one-day hybrid event convening leaders from FDA, NIH, academia, industry, and nonprofit organizations to explore how NAMs are moving from innovation toward implementation in regulatory science.

Registration is now closed.  

The Summit featured:

• A keynote presentation from Dr. Nicole Kleinstreuer, NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives
• Presentations from recipients of the NAMeRS Accelerator awards
• Internationally recognized experts discussing case studies in NAM translation
• A panel featuring a multi-sector collaboration on a liver platform moving through FDA’s ISTAND qualification pathway
• Conversations surrounding societal and biological considerations in NAMs
• Perspectives on forthcoming funding priorities and opportunities in NAM science

Summit AGENDA

Speaker BIOGRAPHIES

NAMeRS Awardee SUMMARY

Watch RECORDING

The program is designed to engage and inspire the next generation of scientists — including trainees, early-career investigators, and emerging leaders — alongside regulators, industry professionals, and established researchers working at the forefront of biomedical innovation and regulatory science.

April 2, 2026

Triangle CERSI Announces 2026 NAMeRS Awardees

Triangle CERSI is pleased to announce the inaugural FY26 NAMeRS awardees advancing human-relevant regulatory science through innovative, translational NAM platforms. Read more.

Launched in alignment with FDA’s 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies, the NAMeRS Program provides seed funding and collaborative support to accelerate the development, validation, and regulatory translation of New Approach Methodologies (NAMs), including organ-on-chip systems, computational models, advanced human tissue systems, artificial intelligence approaches, and other predictive, human-relevant technologies.

The program supports short-term, cross-sector projects designed to generate preliminary data, strengthen regulatory framing, establish strategic collaborations, and position teams for competitive follow-on funding opportunities. Participating investigators span the four Triangle CERSI universities: UNC-Chapel Hill, Duke University, North Carolina Central University, and North Carolina State University.

Project titles, investigators and affiliations are as follows:

• Assessing Anxiety and Anxiolytic Efficacy in Early Development Using Zebrafish Embryos as NAMs
  • Deepak Kumar, PhD, and Zainab Afzal, PhD
  • North Carolina Central University
• In Silico Models of Cardiovascular Disease as an Alternative to Animal and Human Imaging Trials
  • Ehsan Samei, PhD; Paul Segars, PhD; Alejandro Frangi, PhD; Nick Felice, MS, Melissa Daubert, MD
  • Duke University and University of Manchester
• Human Tonsil NAMs to Reduce Animal Testing in Preclinical Vaccine Safety
  • Brook Heaton, PhD; Herman Staats, PhD; Henry Yang, PhD
  • Duke University
• From Prediction to Regeneration: Cutting-Edge AI NAM Platform Targets Neuroimmune Responses for Next-Gen Peripheral Neuropathy Therapies
  • Neill Li, MD; Danyal Raza, MS; Amit Mohite, BS
  • Duke University
• 3D iPSC-Hepatocyte NAMs as Predictive Tools for AAV Gene Therapy
  • Zhenwei Song, PhD; Chengwen Li, MD, PhD; Liujiang Song, MD, PhD; Marjory Moreau, PhD; Paul B. Watkins, MD, PhD
  • UNC-Chapel Hill, Ohio State University, ESQLabs
• Establishment and Validation of Tumor-On-A-Chip Platform for Chemo-Immunotherapeutic Interventions in the Tumor Microenvironment
  • Alexander V. Kabanov, PhD; Sarah Shelton, PhD; Adriana Beltran, PhD; Hallie Hutsell; Alyssa Holden
  • UNC-Chapel Hill and NC State University

November 17, 2025

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

PROGRAM ANNOUNCEMENT

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 early 2026

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.