Black Mesa announces funding from the Advanced Research Projects Agency for Health (ARPA-H) to develop a Good AI Practice (GAIP) framework for drug development.
BOSTON, MA, UNITED STATES, January 20, 2026 /EINPresswire.com/ — Black Mesa announces that it has been awarded funding from the Advanced Research Projects Agency for Health (ARPA-H) to develop a Good AI Practice (GAIP) framework for drug discovery and development. This project, under ARPA-H’s CATALYST program (Computational ADME-Tox and Physiology Analysis for Safer Therapeutics), will develop and publish a framework and associated technical methods that helps organizations use artificial intelligence (AI) in a manner that upholds rigorous data integrity under 21 CFR regulations. The GAIP framework is modeled after existing Good Practice standards (like Good Laboratory Practice and Good Manufacturing Practice ) and is designed to protect the safety and efficacy of drugs by preventing the data integrity risks posed by uncontrolled AI use.
The ARPA-H CATALYST is led by ARPA-H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D: ”CATALYST’s data and computational tools will make shorter development timelines, less expensive therapies, and better patient safety a reality. We are excited to work with our partners at the FDA, NIH, and across government, academia, and industry to make this vision a reality.”. Black Mesa’s GAIP project directly supports the goals of ARPA-H’s CATALYST program, which seeks to revolutionize preclinical drug testing through advanced computational models. Black Mesa’s GAIP framework will complement these efforts by creating the methods that enable AI models, datasets, and infrastructure used in such predictions to be of high quality, traceable, and meet strong regulatory requirements.
“We are excited to support the ARPA-H CATALYST program on this forward-looking effort. It builds on prior work we have done with HHS where we defended billions of dollars of infrastructure critical to the American medicine cabinet.” said Charles Fracchia, CEO of Black Mesa. “The GAIP framework will help researchers and regulators alike ensure that AI technologies are used responsibly and that their results are trustable by the public.”
About Black Mesa
Black Mesa is a Boston technology company developing tools to increase quality, efficiency, and process integrity in critical manufacturing sectors with strong assurance and regulatory needs. Black Mesa is now deploying VERISCAN, a patent pending product that bridges the gap between traditional paper and electronic batch records. VERISCAN leverages strong proven cryptography, machine learning, and data analytics to streamline quality review – without requiring customers to switch to a fully digital system. VERISCAN improves batch cycle times, facilitates process improvement, enables historical data digitization, and brings many of the benefits of electronic batch records to the paper world at a fraction of the time and cost.
Charles Fracchia
Black Mesa
contactus@blackmesa.com
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