Novartis Reimagines CMC with an AI-Native Data Platform

As therapeutic modalities and data-driven regulatory expectations intensify, traditional document-centric CMC models fall short. At Novartis, an interoperable, AI native data platform enabled a shift to a data asset-centric CMC operating model, connecting data and workflows across sites and modalities. This transformation enables process monitoring and predictive risk management, delivering measurable performance gains and cost-savings through elimination of trial supply delays, and substantial efficiency improvements.