Science· 2026Q1· Review
Reimagining human-centric drug development with new approach methodologies
- 29citations
- Q1SCImago
- 2026year
Short summary
New Approach Methodologies (NAMs), integrating human-derived cells, microphysiological systems, and AI, are reshaping drug development by offering a more human-centric alternative to traditional animal testing.
AI-generated from the title and abstract; the full text is not read.
Key points
- NAMs integrate human-derived cellular systems, microphysiological platforms, and AI.
- NAMs aim to bridge the gap between preclinical models and human biology in drug development.
- Regulatory reforms, such as FDA Modernization Act 3.0, are enabling the use of NAMs.
- The integration of NAMs promises more predictive, efficient, and ethical drug development.
AI-generated from the title and abstract; the full text is not read.
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 human-based science in a predictive, efficient, and ethically grounded infrastructure of human-centered drug development.
The authors' abstract, as published at the source. Science, 2026 · DOI ↗
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