Organoid-AI platforms need integrated governance in drug discovery.

Journal: Drug discovery today
Published Date:

Abstract

Organoid-AI platforms are becoming decision systems in drug discovery, not just combined tools. They shape compound prioritisation, toxicity assessment, and programme progression. Yet governance often validates the biological model and the computational model separately, even when the evidential claim depends on their interaction. But separate validation can create false assurance: donor imbalance, batch effects, and culture drift can become algorithmic shortcuts, while confident model outputs can obscure weak biological transportability. This Feature proposes proportionate, platform-level governance built around a single context of use, linked provenance, transportability testing, and predefined fallback rules, scaled to decision stakes. The aim is not to slow adoption, but to make these platforms credible enough to act as preclinical gatekeepers.

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