On June 15, 2026, the National Institutes of Health (NIH) announced that moving forward, NICEATM will continue its important work as a division of the newly created NIH Office of Research Innovation, Validation, and Application (ORIVA). Soon, NICEATM content that you see on this webpage will be transitioned to the NIH ORIVA webpage. In the meantime, you can learn more about the new office and how it is structured.

https://ntp.niehs.nih.gov/go/ampd-wksp-2026

Workshop: Alternative Methodologies in Pharmaceutical Development

October 20, 2026 – 10:00 a.m.-5:00 p.m.
October 21, 2026 – 10:00 a.m.-12:00 noon
NIH Neuroscience Center Building, 6001 Executive Blvd, Rockville, MD

Links to registration and agenda will be placed here when available.

Hosted by the National Cancer Institute (NCI) and the National Institutes of Health Office of Research Innovation, Validation, and Application (ORIVA). 

While new approach methodologies (NAMs) have historically been advanced to support replacement, reduction, and refinement of animal use (3Rs) in safety and risk assessment, they are increasingly recognized for their potential to enhance the mechanistic understanding of human biology, disease pathogenesis, and therapeutic response. Despite these advances, there remains a critical need for broader validation, standardization, and integration of NAMs across both the drug development pipeline and fundamental biomedical research.

This workshop will address two major hurdles in achieving wider adoption of NAMs in drug development and biomedical research.

  • Awareness: Many stakeholders have not been fully exposed to the expanding range of NAM applications, including their utility in studying disease mechanisms and informing translational research. The workshop aims to highlight current NAM strategies that can be implemented across safety assessment, efficacy evaluation, and mechanistic studies.
  • Confidence: Definitions of confidence vary among stakeholders. For pharmaceutical developers and biomedical researchers, confidence encompasses the ability of NAMs to generate biologically relevant, reproducible, and translatable insights into human disease and therapeutic response.

This workshop will convene pharmaceutical developers, regulators, and biomedical researchers to discuss the current and future applications of NAMs across safety, efficacy, and disease modeling. The goal is to foster dialogue on strategies for the evaluation, integration, and submission of NAM-based evidence, ultimately advancing their use in both regulatory and research settings in a nonbinding, collaborative environment.

The workshop will be structured into sessions outlined below. Each session will be followed by a discussion period, with a final discussion planned to synthesize workshop learnings and establish next steps. While the workshop will be webcast, those interested in participating fully in the discussions are strongly encouraged to attend in person.

Tentative Sessions

Day 1

  • Session I: Current State of New Approach Methodologies (NAMs) in Drug Development
  • Session II: Regulatory and Scientific Barriers to NAM Adoption
  • Session III: Regulatory and Government Initiatives and Future Directions

Day 2 

  • Session IV: NAMs in Disease Biology and Biomedical Research