Moving NAMs from Progress to Practice: Building the Foundation for Broader Adoption

Biotech Moving NAMs from Progress to Practice: Building the Foundation for Broader Adoption Sep 14, 2026 8:00am Biotech New Approach Methodologies (NAMs) have the potential to reshape preclinical research and toxicology. In a previous discussion, we explored three key barriers limiting broader adoption of in vitro NAMs: cell sourcing, standardization and regulatory acceptance. Those challenges remain real, but meaningful progress is underway.

The next stage of NAMs adoption will depend on addressing all three simultaneously.Building the Foundation for Broader AdoptionScientific innovation alone does not move new technologies into routine use. Widespread adoption requires a supporting framework of biological standards, reproducible methods and evidence that can withstand regulatory scrutiny. Developing that infrastructure is a collective effort that extends beyond any single organization.Strengthening Biological SystemsWhile both in vitro and in silico NAMs face implementation challenges, many of the most immediate obstacles center on biological models.

The quality of any NAM study ultimately depends on the biological system generating the data, making careful model selection and characterization essential.Several areas are particularly important:Selecting and characterizing cell sources. Primary human cells, iPSC-derived cells and immortalized cell lines each bring different strengths and limitations related to physiological relevance, consistency and maturity. Choosing the right cell source for a specific application, and documenting that choice appropriately, is critical to generating defensible results.Expanding donor diversity.

Many studies still rely on cells derived from a single donor, despite well-established differences in drug response across age, sex and genetic background. Models that better reflect patient diversity are likely to provide more representative insights. The growing availability of iPSC banks is helping make this possible.Understanding model maturity.

Some cell systems may be ready for regulated applications, while others continue to evolve. Recognizing those limitations and communicating them transparently is essential for building confidence in the resulting data.Establishing Shared StandardsEven well-designed studies have limited value if their results cannot be compared across laboratories and programs. Standardization does not require every organization to use identical methods.

It does, however, require enough consistency that data generated in different settings can contribute to a broader body of evidence.Achieving that goal will require several complementary efforts:Cross-laboratory evaluations and ring trials that assess whether comparable methods generate comparable results and identify areas where protocols should be aligned.Shared reference datasets that establish common expectations for variability and performance across different model systems.Practical definitions of "fit for purpose" that help researchers determine which methods are appropriate for screening applications versus higher-stakes safety evaluations.These efforts help transform individual studies into a foundation that the broader field can build upon.Creating Regulatory-Ready EvidenceRegulatory confidence is built through evidence accumulated over time. For NAMs data to support meaningful decisions, it must be generated within processes designed to meet those expectations from the outset.Key elements include:Documented quality controls, traceable methods and robust SOPs developed with regulatory use in mind.Benchmarking against human clinical outcomes, where those data are available, rather than relying solely on comparisons to traditional in vivo results. When differences emerge, they may indicate improved human relevance rather than shortcomings in the model itself.Transparent reporting of results and limitations, including unsuccessful outcomes.

Confidence in NAMs will depend on a complete understanding of both strengths and constraints.The systems surrounding a study, including documentation, traceability and quality practices, may be less visible than the science itself, but they are what make data credible when important decisions are being made.Turning Potential into PracticeThe barriers to NAMs adoption are significant, but they are not insurmountable. Success will depend on the sustained work of improving biological systems, strengthening standards and generating evidence that can support regulatory decision-making.At Battelle, we approach NAMs development from a platform-agnostic perspective, selecting cell sources and model systems based on scientific fit and intended use. Our teams bring together expertise in cell biology, analytical chemistry, engineering and quality systems to generate data within a regulatory-ready framework and support evidence development across the NAMs landscape.Organizations that begin building these capabilities today will be best positioned as the science, standards and regulatory environment continue to evolve together.

The editorial staff had no role in this post's creation. Biotech