New Approach Methodologies (NAMs) are laboratory- or computer-based research approaches intended to model human biology and complement or in some cases replace traditional animal models. NAMs include organoids made from stem cells, computational models, and microphysiological systems, as well as non-mammalian models. NIH is establishing the Office of Research Innovation, Validation and Application (ORIVA), which will coordinate efforts to develop, validate and scale the use of NAMs across the agency’s biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for public health protection. ORIVA will expand funding and training in non-animal approaches and awareness of their value in translational success. New funding opportunities will include evaluation criteria that assess methods based on their suitability for the research question, context of use, translatability and human relevance. Infrastructure for non-animal approaches will also be expanded to make these methods more accessible to researchers.
While human cells made from stem cells in a dish provide a powerful tool to study disorders and to help develop new treatments, these human stem cell models have limitations in the context of aging research. Aging is a major risk factor for most degenerative diseases, and it is very difficult to model aging using human stem cells, because human cells run on human timeframes even in a petri dish. Thus, it is not possible using current technology to study aging in human cells in a meaningful fashion, even in long term cell culture experiments of one year. The lack of a robust cell system for studying age related disorders in a petri dish is a major impediment to progress in the field. While human cells have the limitations we described above, mouse cells derived from stem cells run on mouse developmental time. Thus, in principle we can study the aging process in an experiment in a petri dish in a reasonable timeframe with mouse cells.