Establishing Qualification Processes for Point-of-Need Pharmaceutical Products

Recent technological advances, fueled by machine-learning models, synthetic chemistry, and manufacturing hardware enabled the rapid synthesis and manufacturing of drug products critical for protecting warfighter health in forward operating bases. These technologies have advanced to the point of being able to manufacture not just one, but multiple high quality drug products at point-of-need through software and limited hardware reconfiguration. Despite this progress, there is insufficient data for regulatory agencies to formulate an appropriate regulatory approval framework for this emerging technology.

To compound this problem, the lack of a rapid regulatory approval pathway has limited the availability of private capital required to commercialize this technology and generate valuable data to inform the development of a new regulatory approval framework. Without data, it is impossible to develop a regulatory framework that can attract private capital and bring this technology to the market.

DARPA’s new Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) program seeks to demonstrate a real-time digital regulatory approval framework for multiple finished drug products produced on a single reprogrammable hardware platform. The program aims to support up to four pilot agile pharmaceutical manufacturing sites that will generate the data required to inform the creation of a future regulatory framework.

“Rolling drug shortages are costing U.S. hospital system over $550 million annually,” said Dr. Vishnu Sundaresan, DARPA’s program manager for EQUIP-A-Pharma. “DARPA is initiating this effort in collaboration with the Department of Health and Human Services Administration for Strategic Preparedness and Response with a goal to help bridge the Valley of Death for advances made in DARPA’s Battlefield Medicine, Make-It, and Accelerated Molecular Discovery programs. Our aim is to provide the data necessary to help in the development of a regulatory framework for agile pharmaceutical manufacturing.”

If the 24-month program is successful, EQUIP-A-Pharma will demonstrate the feasibility to qualify small-batch drug products in real-time (seconds to minutes vs. months-long) and provide the data needed to develop a needed regulatory framework.

EQUIP-A-Pharma performers will engage with additional U.S. government and defense stakeholders as well as appropriate regulatory authorities, including the Food and Drug Administration’s Emerging Technology Program office to evaluate suitability for rapid qualification of drug products manufactured at point of need. Teams will be required to collaborate with ethical, legal, and societal implications experts and ensure the research addresses any related concerns.

The EQUIP-A-Pharma program solicitation is now available on SAM.gov.