Novartis and Genedata Win Bio-IT World 2026 Innovative Practice Award for Genedata Vico
Co-developed with Novartis, Genedata Vico — an AI‑native solution for accelerating and strengthening CMC processes — has been recognized as an outstanding technological innovation, advancing quality and pushing the boundaries of biopharmaceutical CMC.
This collaborative initiative reimagines traditional CMC operating models with an interoperable, GxP‑enabled, AI‑native data platform — turning fragmented information into trusted, reusable data.
The result:
faster regulatory readiness, earlier risk mitigation, deeper scientific insight, and the potential to save months of development time and millions of dollars per site.
Press Release
The Challenge
In biopharma, the pressure to demonstrate drug quality continues to rise as regulatory expectations and therapeutic modalities become increasingly complex. CMC-related issues persist as a leading cause of regulatory delays and non-approvals. Critical information is often scattered across siloed systems and trapped in incompatible document formats.
Our Award-Winning Solution
Developed in partnership with Novartis, Genedata Vico is a purpose‑built, interoperable, AI‑native CMC platform that goes beyond generic data platforms. GxP‑ready at its core, Vico seamlessly connects and democratizes data, analytics, and AI across CMC workflows—enabling a data‑assets‑centered operating model that boosts development success and accelerates time‑to‑IND submission.
Impact
As demonstrated by the award‑winning organization and early adopter of Genedata Vico, Novartis, in its presentation at the Bio‑IT Conference, the solution validates an AI‑native approach to addressing persistent CMC challenges.
By strengthening enterprise‑wide data management, governance, and data consumption, Genedata Vico transforms CMC processes at scale and deliver measurable business impact, according to customer estimates, including:
Preventing up to 80% of typical batch losses, translating into multi‑million‑dollar savings per manufacturing site
Avoiding up to 15 months per year of cumulative clinical trial supply delays driven by CMC‑related issues
Driving significant productivity gains, enabling scientists and engineers to focus on high‑value scientific and process‑optimization activities rather than data preparation and rework