The DIA Artificial Intelligence Consortium, launched in 2025, is a neutral public-private partnership involving regulators like FDA, Health Canada, MHRA, PMDA, biopharma companies such as Gilead and Otsuka, academia, and tech providers.13
The consortium is developing a 7-step AI use case classification framework, risk-proportionate validation and monitoring approaches, and aligned regulatory terminology for AI applications from low-risk automation to decision-critical analyses.13
A webinar titled 'Operationalizing AI in Drug Development:
Inside DIA’s Global AI Consortium' is scheduled for March 17, 2026 (1–2pm EDT), virtually, to introduce the consortium and discuss use cases in regulatory, clinical, and manufacturing contexts with emphasis on human oversight and validation.16
DIA's efforts, including the AI Consortium, are helping regulators like FDA integrate AI into review processes for drugs, biologics, and devices, automating tasks and enhancing efficiency, with discussions at the DIA 2026 Global Annual Meeting in Philadelphia.35
Consortium working groups focus on validation frameworks ensuring reliability at technical and operational levels, mapping global regulator risk stratification, and aligning with Good Machine Learning Practice for proportional oversight.3
Sources:
1. https://www.biospace.com/events/register-operationalizing-ai-in-drug-development-inside-dias-global-ai-consortium
3. https://www.biospace.com/fda/how-dia-is-helping-regulators-turn-ai-principles-into-everyday-review-practice
6. https://www.califesciences.org/event/operationalizing-ai-in-drug-development/