FDA purchases digiM I2S software for the assessment of product quality attributes

Reviewers and regulatory researchers to use AI image analytics for process-quality correlation

WOBURN, Mass., Jan. 24, 2024 /PRNewswire/ — The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully integrated image processing platform based on digiM’s proprietary cloud technology. I2S, short for Image to Simulation, is an end-to-end software combining data management, artificial intelligence image processing, structural analytics, and image-based simulation. FDA officers in the Division of Product Quality and Research (DPQR) will use the platform to assess the impact of material properties and process parameters on product quality attributes. The subscription will cover the period from September 2023-2024, including an optional four years extending to September 2028. The purchase includes support for a local installation of the cloud platform on the FDA DPQR’s in-house cluster.

digiM Director of Application Science, Joshua Lomeo, spoke about the licensing agreement. “We are excited to receive this opportunity from the FDA. In the universal movements around digitization, the use of real world imaging data and structural analysis is a key piece towards strengthening the connection between manufacturing science and product quality. Use of AI and cloud-based technologies also comes with great responsibility in maintaining data integrity and security, and we feel privileged that the FDA has entrusted us with this. I2S is built from the ground up with the best principles in data accessibility and tracking in mind, including audit capabilities for FDA 21 CFR Part 11 Compliance. The purchase of I2S reflects the agency’s continued efforts in exploring new technologies to better the assessment of drug products. We are honored to support their work reviewing life-changing therapeutics.”

Working directly with leading developers and regulatory agencies, digiM strives to enhance therapeutic development through novel characterization and predictive technologies. This partnership is a continuation of several critical research efforts conducted with the FDA, including internal research awards from the Office of Pharmaceutical Quality and grants from the Office of Generic Drugs for assessing Q3 structural equivalence. These works support digiM’s objectives in transforming drug development, including the democratization of novel analytics and developing a more integrated feedback loop between industry and regulatory bodies.

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