The Defense Advanced Research Projects Agency (DARPA) has launched a new program aimed at demonstrating a framework for regulatory approval of pharmaceuticals produced on a reprogrammable manufacturing device. According to DARPA, the program, called Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma), will support up to four pilot pharmaceutical production centers that will gather the necessary data to develop a real-time regulatory approval procedure.
Vishnu Sundaresan, DARPA program manager for EQUIP-A-Pharma, said that the initiative aims to overcome the “valley of death” for medical products developed under the Battlefield Medicine, Make-It, and Accelerated Molecular Discovery programs conducted by DARPA. “Our goal is to provide the data needed to develop a framework for regulatory approval for flexible pharmaceutical manufacturing,” Sundaresan said.
DARPA has partnered with the Office of Strategy, Planning, and Response of the Department of Health and Human Services to launch this initiative. The project was announced in a request for proposals on the SAM.gov website, with responses accepted until February 20.
FAQ:
1. What is the goal of the Establishing Qualification Processes for Agile Pharmaceutical Manufacturing (EQUIP-A-Pharma) program?
Answer: The goal of the EQUIP-A-Pharma program is to demonstrate a framework for regulatory approval of pharmaceuticals produced on a reprogrammable manufacturing device.
2. How many pilot pharmaceutical production centers will the EQUIP-A-Pharma program support?
Answer: The EQUIP-A-Pharma program will support up to four pilot pharmaceutical production centers.
3. What data will be collected by the pharmaceutical production centers under the EQUIP-A-Pharma program?
Answer: The pharmaceutical production centers will collect the necessary data to develop a real-time regulatory approval procedure.
4. What is the “valley of death” for medical products?
Answer: The “valley of death” refers to the situation where medical products developed under DARPA programs fail to go through the approval process and do not reach patients.
5. What other DARPA programs are being overcome through the EQUIP-A-Pharma initiative?
Answer: The EQUIP-A-Pharma initiative aims to overcome the Battlefield Medicine, Make-It, and Accelerated Molecular Discovery programs conducted by DARPA.
Definition of key terms:
– DARPA: Defense Advanced Research Projects Agency
– EQUIP-A-Pharma: Establishing Qualification Processes for Agile Pharmaceutical Manufacturing
– “Valley of death”: Refers to the situation where medical products developed under DARPA programs fail to go through the approval process and do not reach patients.
Suggested related links:
1. DARPA homepage
2. GSA SAM.gov website
The source of the article is from the blog elektrischnederland.nl