Beyond the Development of New Approach Methodologies (NAMs)
The discussion around New Approach Methodologies (NAMs) often focuses on scientific advances, validation, regulatory acceptance and emerging technologies. These are all important topics, but they are not the whole story. As the scientific community develops increasingly human relevant approaches, an important question emerges: What happens to the people, facilities, and accumulated knowledge that underpin current testing programmes?
This question is explored in a new NAM Journal article authored by Clive Roper and Professor Michael Coleman, titled From Vivarium to NAM-Centred Laboratory: A Practical Framework for Managing Infrastructure, Expertise and Organisational Transition. The authors argue that adopting NAMs should not be viewed simply as replacing one experimental model with another. It is a broader organisational transition involving infrastructure redevelopment, workforce planning, knowledge retention, investment, and long-term business sustainability. For decades, animal studies have informed regulatory decision making through the generation of toxicological endpoints, biomarker findings, and pathological data. This knowledge remains extremely valuable for developing future NAMs through clearly defined contexts of use and mechanistic understanding. The same applies to infrastructure. Whilst future laboratories may increasingly use organoids, microphysiological systems, and computational approaches, existing facilities, quality systems, and support functions can be adapted and repurposed rather than replaced.
Toxicologists, pathologists, bioanalytical scientists, immunologists, study directors, and technical staff possess expertise that will continue to be valued in the development, interpretation, and implementation of NAMs.
If we are serious about adopting human relevant methods, we need to consider more than scientific innovation. We must also be serious about preserving and repurpose the expertise that will support a successful transition.
Reference
Roper C and Coleman M (2026). From vivarium to NAM-centred laboratory: A practical framework for managing infrastructure, expertise and organisational transition. NAM Journal, 100129. https://doi.org/10.1016/j.namjnl.2026.100129
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