What's in a NAM?

Area of Science:

• Biomedical Research
• Toxicology
• Regulatory Science

Background:

• The scientific community is increasingly moving away from animal experimentation.
• New Approach Methodologies (NAMs) are emerging as key alternatives, supported by policy changes like the FDA Modernization Act 2.0.
• The term NAMs lacks a clear definition, causing confusion and potential misuse.

Purpose of the Study:

• To propose a unified definition for New Approach Methodologies (NAMs).
• To distinguish NAMs from traditional animal models and the 3Rs framework (Replacement, Reduction, Refinement).
• To highlight the broad applicability of NAMs beyond regulatory science.

Main Methods:

• Defining NAMs as species-specific, non-animal methodologies.
• Emphasizing the prioritization of the target species within NAMs.
• Leveraging advanced technologies such as organoids, organ-on-chip, AI, and machine learning.

Main Results:

• A proposed definition: NAMs are species-specific methodologies that do not involve living animals.
• NAMs eliminate the need for interspecies extrapolation, especially when the target species is human.
• NAMs provide novel biological insights and enhance species-relevant data accuracy compared to animal models.

Conclusions:

• NAMs represent a fundamental shift from animal models, offering more human-relevant and accurate data.
• Widespread adoption requires continued innovation, validation, policy support, and interdisciplinary collaboration.
• NAMs foster more sustainable, humane, and scientifically robust biomedical research.