What's Standing In The Way Of Mainstream NAMs Adoption?

By Bob Moyer, Battelle Research Leader

New Approach Methodologies (NAMs) are widely viewed as a critical evolution in drug development and safety testing, offering the promise of faster timelines, reduced animal use, and more human-relevant data. Yet despite strong scientific momentum, NAMs have struggled to move from promising research tools into routine regulatory practice. The obstacles are less about scientific validity and more about infrastructure, consistency, and confidence.

Three interconnected barriers continue to slow adoption. First, cell sourcing remains a foundational challenge. Tradeoffs between primary cells, iPSC-derived cells, and immortalized lines complicate reproducibility, scalability, and physiological relevance—especially when donor diversity is limited. Second, the lack of shared standards across protocols, reagents, and acceptance criteria makes it difficult to compare results across studies or build a cumulative evidence base. Without reproducibility, credibility suffers. Finally, regulatory uncertainty creates a chicken-and-egg dynamic: companies hesitate to submit NAMs-based data without clear guidance, while regulators lack sufficient submissions to establish robust frameworks.

Recent regulatory and legislative signals suggest progress, but structural inertia remains. Breaking the cycle will require coordinated advances in sourcing, standardization, and regulatory engagement—simultaneously. For R&D leaders, the key question is not whether NAMs will play a role, but how prepared organizations are to use them with confidence when expectations shift.