What question did this study set out to answer?

The aim is to evaluate how new approach methodologies (NAMs) can improve drug development by better aligning preclinical models with human biology.

April 18, 2026

Reimagining human-centric drug development with new approach methodologies

Key Points

The aim is to evaluate how new approach methodologies (NAMs) can improve drug development by better aligning preclinical models with human biology.
Review of various biological and computational NAMs
Analysis of regulatory reforms like FDA Modernization Act 3.0
Discussion on ethical frameworks for NAM integration
Outline of strategies for incorporating NAMs into drug development processes.
NAMs show promise in bridging the gap between preclinical models and human biology.
Regulatory changes support the use of NAMs over traditional animal testing.
The integration of NAMs can lead to more predictive, efficient drug development.

Abstract

Despite unprecedented technological progress, most drug candidates continue to fail in clinical trials, reflecting a persistent gap between preclinical models and human biology. New approach methodologies (NAMs), by spanning human-derived cellular systems, microphysiological platforms, and artificial intelligence, offer a paradigm shift in human-centric drug development and biomedical research. Recent regulatory reforms, such as the US Food and Drug Administration (FDA) Modernization Act 3.0, have begun to position NAMs as a complement to or replacement for animal testing. This Review synthesizes emerging biological and computational NAMs and examines how their integration is reshaping drug development. We also discuss regulatory and ethical frameworks enabling this transition and outline a roadmap for embedding NAMs in a predictive, efficient, and ethically grounded infrastructure of human-centered drug development.

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