Christopher Downey

Christopher Downey, PhD, is director of the Division of Pharmaceutical Manufacturing Assessment VI, OPMA, OPQ, and CDER at FDA.

Articles by Christopher Downey

Global health safety regulation Concept, Businesswoman reviewing and approving FDA standard documents for medical and food, Compliance, laboratory inspection, certification, and international approval | Image credit: © Ticha - © Ticha - stock.adobe.com

FDA, Sanofi, Gilead Weigh AI Readiness and Validation Risk at PDA/FDA Conference

ByFeliza Mirasol,Jack Prior,Liatte Closs,Bob Buhlmann,Christopher Downey

September 16th 2026

Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.

Christopher Downey

Articles by Christopher Downey

FDA, Sanofi, Gilead Weigh AI Readiness and Validation Risk at PDA/FDA Conference

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