A Turning Point for Drug Development Models

The biopharmaceutical industry is at an inflexion point. For decades, animal models have served as the backbone of preclinical research, supporting target validation, efficacy assessment and safety evaluation. While these models have enabled countless therapeutic advances, their limitations in predicting human outcomes are increasingly well documented. Persistent late-stage attrition, unexpected toxicities and species-specific differences continue to highlight the translational gap between preclinical promise and clinical reality.

At the same time, a diverse set of human-relevant scientific tools has matured rapidly. Collectively referred to as New Approach Methodologies (NAMs), these approaches are reshaping how researchers think about safety and efficacy assessment. The term “New Approach Methodologies” was formally introduced in 2016 to describe a broad range of techniques, technologies and strategies designed to inform regulatory decision-making without relying on animal testing. While the acronym “NAMs” is sometimes informally used to mean “non-animal methods” or “new alternative methods,” its regulatory meaning is more specific. NAMs are fit-for-purpose approaches that generate data relevant to hazard identification, risk assessment or safety evaluation in a manner that can support regulatory review.