DARPA announces first of a kind project to allow real time drug approvals

One of the biggest things holding up the approval and commercialisation of new innovations – of any kind – is regulation and the regulators. So, as I’ve been discussing for a long time now a couple of countries have been trying to find new ways to speed up and automate both the regulatory approvals process and the “act” of regulation itself - such as enforcement, monitoring, and reporting.

Traditionally most of these efforts have been in the finance world, but now DARPA, the bleeding edge research arm of the US military is trying to develop new processes and new technologies that will let the US approve new healthcare drugs – which are now being developed incredibly quickly using Artificial Intelligence (AI)in real time. Yes, real time!

The capabilities of agile pharmaceutical manufacturing would be a game-changer for enabling point-of-need manufacturing to support distant operating bases, addressing the needs of the American public during public health emergencies, enabling a resilient pharmaceutical supply chain, and becoming the foundational tool for personalized medicine.

Recent technological advances, fuelled 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.

The DARPA 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 US hospital system over $550 million annually. 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.”

Dr. Vishnu Sundaresan, DARPA’s program manager for EQUIP-A-Pharma.

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.