AI Safety 2026: The New Pharma Standard - Regulated AI & Model Drift Monitoring AI Safety 2026: The New Pharma Standard - A comprehensive guide to regulated AI systems, model drift monitoring, and pharmaceutical compliance The pharmaceutical and medical device industries have officially moved past the "experimentation phase" of Artificial Intelligence. In boardrooms from Basel to Boston, the conversation has shifted from "Can AI help us?" to the more pressing question: "Is our AI safe, regulated, and ready for a clinical audit?" By end of 2025, the FDA had approved or cleared 1,016 medical devices using AI/ML technologies- nearly double the number from 2022. Yet regulatory scrutiny has intensified proportionally. The FDA and EMA jointly issued guiding principles in early 2026 establishing that AI governance in drug safety must be explainable, traceable, and inspection-ready - no different from any other GxP-regulated system. This deep dive...
Big pharma's pre-competitive collaboration Merck, Eli Lilly and Pfizer have provided funding to launch Enlight Biosciences, a for-profit venture that aims to advance breakthrough technologies for drug discovery and development. The lowdown: There has recently been increasing emphasis from industry on participating in non-profit collaborations to address issues in drug development that are considered to be pre-competitive. Now, Merck, Eli Lilly and Pfizer, together with the venture capital firm PureTech Ventures and several leading academic researchers, have founded Enlight Biosciences. This is a for-profit venture that will aim to tackle critical unmet industry needs with innovations from academia and start-up companies. Enlight Biosciences, based in Boston, USA, will direct up to US$39 million into technologies that strengthen the connection between preclinical research, clinical research and post-market use, such as techniques that could help predict human responses to exp...