FORT DETRICK, Md. –
The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) Rapid Opioid Countermeasure System (ROCS) product team was selected to receive the 2022 MHSRS award for Outstanding Program Management (Team). This award recognizes outstanding medical product program management, highlighting team accomplishments that further mature medical research and development or commercial efforts. The ROCS team, a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), was recognized for addressing and minimizing the ROCS program’s developmental risks, managing cost, schedule, and performance, and adhering to all applicable regulatory requirements. The ROCS team’s end goal is to field and deliver a product to the warfighter that will fill a military medical capability gap.
The ROCS product team received the award for closing the capability gap for military personnel and chemical incident first responders who may encounter highly-potent opioids. This was accomplished on February 28, 2022, when the U.S. Food and Drug Administration (FDA) approved a 10 mg naloxone autoinjector
(NAI), manufactured and sponsored by kaléo, Inc. The NAI was developed for the JPEO-CBRND and funded by the Chemical and Biological Defense Program. Of note, the ROCS program is the first and only Department of Defense (DoD) medical program to deliver a service-wide capability using the middle tier of acquisition (MTA) pathway. Furthermore, the team developed this capability during the pandemic in a short, 30-month timeframe from contract to FDA approval in February 2022.
The ROCS team began by conducting market surveillance, identifying candidates and reliable platforms that could be repurposed into a 10 mg NAI. With the flexibility of the MTA and other transactional agreements, they proposed an acquisition strategy to leverage commercial drug-device products and production lines with a track record for meeting relatively new, strict regulatory metrics. The ROCS team leveraged a commercial FDA-approved 2 mg NAI from kaléo to accelerate the development of the 10 mg NAI. Partnering with kaléo enabled the program to reduce the 10 mg NAI development costs and accelerate timelines. The ROCS team worked with kaléo to deliver the product under budget and five months ahead of contract schedule, despite challenges presented by the COVID-19 global pandemic.
Tasked with delivering a life-saving pharmaceutical to combat opioid exposures, the ROCS team not only delivered a therapeutic, but also a prophylaxis. This lifesaving capability limits the risk of military personnel and first responders becoming non-ambulatory due to opioid exposure. Using innovative strategies and partnering with kaléo, the team accomplished their goals ahead of schedule and under budget, satisfying both demanding DoD acquisition criteria and FDA regulatory processes. By delivering the fast-acting opioid therapeutic naloxone and promoting research that could lead to better opioid therapeutics, the ROCS team’s efforts have increased warfighter readiness, supported Defense Support to Civil Authorities (DSCA), and reduced operational risk to potent opioid threat exposure.
“Synthetic opioids, such as fentanyl and carfentanil, pose a substantial threat to our service members, particularly to units involved in DSCA,” said Col. Matthew G. Clark, Joint Project Manager for the JPM CBRN Medical. “Immediate access to a point-of-injury countermeasure, such as the 10 mg naloxone autoinjector, is a major step forward to protect and maintain the readiness of the Joint Force wherever the threat may be encountered worldwide.”
About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. To learn more about the JPM CBRN Medical, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. The JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. The JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about the JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow the JPEO-CBRND on social media at @JPEOCBRND.