The Defense Advanced Research Projects Agency has launched a new program to demonstrate a digital regulatory approval framework for pharmaceutical products produced on a single reprogrammable manufacturing hardware.
DARPA said Wednesday the Establishing Qualification Processes for Agile Pharmaceutical Manufacturing, or EQUIP-A-Pharma, program will support up to four pilot agile pharmaceutical manufacturing sites to produce data necessary to inform the development of a real-time regulatory approval framework.
Vishnu Sundaresan, DARPA’s program manager for EQUIP-A-Pharma, said the initiative aims to bridge the “valley of death” for medical products developed under 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,” said Sundaresan.
DARPA has partnered with the Department of Health and Human Services Administration for Strategic Preparedness and Response to initiate the effort.
A draft solicitation for the program has been posted on SAM.gov and responses are due Feb. 20.
