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

Workshop: Alternative Methodologies in Pharmaceutical Development

October 20-21, 2026
NIH Neuroscience Center Building, 6001 Executive Blvd, Rockville, MD

Final agenda (revised October 16)

Video of the workshop will be posted on this page when it has been formatted to meet government accessibility requirements. Announcements will be sent out via ORIVA News and D-NICEATM News when it is 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 addressed 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 highlighted 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 convened pharmaceutical developers, regulators, and biomedical researchers to discuss the current and future applications of NAMs across safety, efficacy, and disease modeling. The goal was 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 was structured into sessions outlined below. Each session was followed by a discussion period, with a final discussion planned to synthesize workshop learnings and establish next steps. 

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