The case for switching from animal models to organoids in preclinical testing

Published: 3-Jun-2025

Mary Duseau, President of Molecular Devices, shares the FDA’s position on the value of human-relevant models in preclinical research and describes how organoids are evolving to become essential tools throughout the drug development process

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Hoping that researchers would replace them with technologies that more accurately reflect human biology, the US Food and Drug Administration (FDA) recently introduced a plan to phase out animal testing during the preclinical development of monoclonal antibodies and other drugs.1

A few weeks later, the National Institutes of Health (NIH) followed with the announcement of a new initiative to develop non-animal models for biomedical research.2

The FDA emphasised that the use of advanced technologies — such as organoids made from human cells and computational models that simulate biological processes — could accelerate drug development and improve safety while lowering research costs, potentially bringing down drug prices. 

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