Dover, Delaware – October 06, 2026 -- The Digital CMC Consortium has launched as a new industry collaboration aimed at the end-to-end digitalization of Chemistry, Manufacturing, and Controls (CMC) processes in drug development. Founding participants include Novartis, Thermo Fisher Scientific, Takeda, Rockwell Automation, Flagship's Pioneering Medicines, Stellix, ZS Associates, and QbDVision.
Consortium targets legacy PDF-based workflows that bottleneck drug development
The CMC phase of pharmaceutical development remains tethered to manual, document-based processes that treat PDF tables as the source of truth, despite rapid advances in drug discovery and clinical trial digitization elsewhere in the industry. The Consortium aims to convert static CMC knowledge into reusable, interoperable digital assets to improve speed, quality, and regulatory confidence.
Group moves from proof of concept to industry-scale adoption after first year
Structured as a 501(c)(6) not-for-profit, the Consortium is now prioritizing frictionless technology transfer between sponsors and contract development and manufacturing organizations (CDMOs). The broader roadmap extends to digital twins, knowledge management, automated content authoring, and artificial intelligence across the full CMC lifecycle.
Mike Stapleton, Consortium Chairman and Chief Business Officer at QbDVision, said the collaboration seeks to solve interoperability challenges and build the structured, contextualized data foundation required for AI applications in CMC. Achim Frauenschuh, Co-Chair and Associate Director of Science and Technology Drug Substance Development at Novartis, said the group aims to reduce duplicative efforts by providing structured data models, standardized templates, and implementation guidance.
Consortium positions itself as unified forum for regulatory engagement
The group plans to serve as a coordinated industry forum for technical engagement with health authorities, developing standards intended to work for both internal operations and regulatory submissions. Work on digital tech transfer and interoperable exchange of standardized technical data and artifacts is currently underway.