Cell· 2026Q1· Review
New approach methodologies for drug discovery
- 25citations
- Q1SCImago
- 2026year
Short summary
New Approach Methodologies (NAMs) like stem cell, organoid, and in silico models now cover the entire drug discovery pipeline, from disease modeling to efficacy testing, offering a human-centered alternative to traditional animal-based methods.
AI-generated from the title and abstract; the full text is not read.
Key points
- NAMs, including stem cell, organoid, and in silico models, are increasingly used across all stages of drug discovery.
- These human-centered methods offer an alternative to traditional, high-failure-rate animal-based approaches.
- Progress includes identifying therapeutic candidates and developing advanced models and technologies.
- Key biological, technical, and regulatory bottlenecks must be addressed for robust translational adoption of NAMs.
AI-generated from the title and abstract; the full text is not read.
Abstract
Traditional animal-based drug discovery has high failure rates, prompting the search for and adoption of human-centered new approach methodologies (NAMs). Rapid advances in stem cell-, organoid-, and in silico-based NAMs, supported by evolving frameworks from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), now span the entire drug-discovery continuum, from disease modeling and drug design to efficacy testing. Our review highlights recent progress across these domains, including the identification of therapeutic candidates, the development of cutting-edge models and technologies, and the potential of NAMs themselves as treatments in preclinical and clinical contexts, while examining the key biological, technical, and regulatory bottlenecks that need to be addressed to enable robust translational adoption. We conclude by discussing the translational and societal considerations essential to the responsible adoption of NAMs and outlining future human-centric pipelines poised to redefine the landscape of drug discovery.
The authors' abstract, as published at the source. Cell, 2026 · DOI ↗
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