Advancing New Approach Methodologies: Building Standards and Evidence to Boost Preclinical Adoption

New Approach Methodologies (NAMs) are being hailed as a way to transform preclinical research and toxicology, but their wider use has been hampered by three key barriers: sourcing appropriate cells, achieving methodological standardization, and gaining regulatory acceptance.

Recent efforts are focused on creating a framework of biological standards, reproducible protocols, and robust evidence that can survive regulatory review, signaling meaningful progress toward routine implementation.

The reliability of NAM data hinges on the biological model used, making the careful selection and thorough characterization of cell sources-whether primary human cells, iPSC-derived cells, or immortalized lines-essential for relevance and consistency.

Stakeholders agree that addressing cell sourcing, standards, and regulatory concerns together will be critical to move NAMs from the lab into everyday practice.