Realizing The Promise Of New Approach Methodologies (NAMs)

By Bob Moyer, Battelle Research Leader

The landscape of toxicology and drug development is shifting from a reliance on traditional animal models toward New Approach Methodologies (NAMs). These advanced tools—including microphysiological systems, organ-on-chip platforms, and computational simulations—offer a more human-relevant framework for evaluating safety and efficacy. By leveraging human cells and data-driven modeling, organizations can identify potential liabilities and de-risk candidates much earlier in the development cycle.

The current challenge has evolved from proving the technology works to determining how to apply it effectively within regulatory and funding frameworks. Success requires a "fit-for-purpose" strategy: selecting the right combination of methods for a specific biological question and translating complex data into actionable evidence. Embracing these methodologies can lead to faster decision-making, reduced costs, and closer alignment with modern ethical standards.