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SWIFT ANTIDOTE


REAPING THE REWARDS


In recognition of their efforts and building upon previous recognition by the assistant secretary of the Army for acqui- sition, logistics and technology and the Edison Awards, the JPM CBRN Medical Rapid Opioid Countermeasure System (ROCS) product team received the 2022 Military Health System Research Symposium annual award for outstand- ing program management (team). Tis award recognized outstanding medical product program management, high- lighting team accomplishments in further maturing medical research and development or commercial efforts. Te team was recognized for addressing and minimizing the program’s developmental risks; managing cost, schedule and perfor- mance; and adhering to all applicable regulatory requirements.


Te award was presented to Saumil Shah, the assistant product manager for the Chemical Defense Pharmaceuticals prod- uct office, within the Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical, in Frederick, Maryland. Upon receiving the award, Shah commended the team, saying, “Using innovative strategies, the Rapid Opioid Countermeasure System program team accomplished its goals ahead of schedule and under budget, and satisfied demand- ing criteria in both the defense department acquisition and FDA regulatory processes.”


“Additionally, the program experienced zero cost overruns during the entire development effort. Tis could not have happened without an experienced and highly proficient matrixed team, combining functional expertise ranging from acquisition analysts, contracting specialists, financial experts, logisticians, regulatory specialists, legal counsel, technical subject matter experts and program managers.”


A WINNING TEAM


JPM CBRN Medical’s Rapid Opioid Countermeasure System (ROCS) product team receives the 2022 Military Health System Research Symposium award for Outstanding Program Management (Team) in September at Fort Detrick, Maryland. (Photo by Adam Lowe, JPEO-CBRND Public Affairs)


attracting nontraditional companies that might not ordinar- ily have the wherewithal to navigate the often difficult Federal Acquisition Regulations. Other-transaction authority agreements allow for discussion and collaborations with and between compa- nies during certain parts of the agreement process.


Trough source selection, the team selected Kaléo Inc. as the performer based on its prior success in development of the FDA- approved 2 mg naloxone autoinjector. Tis allowed the program team to accelerate the development of a 10 mg naloxone autoinjec- tor. During development, the FDA requested additional studies to demonstrate the safety and efficacy of the 10 mg dose. Kaléo was able to successfully complete the studies within the contract timeline because of its regulatory experience and expertise. Te


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program team worked with Kaléo to deliver the product under budget, five months ahead of contract schedule, despite numer- ous challenges presented by the COVID-19 global pandemic and additional FDA requirements.


(See related article in the Fall 2022 issue of Army AL&T, “Not-So- Secret Weapon,” Page 15.)


FAST TRACK When the FDA requested more detail on the efficacy of the drug, the program team and Kaléo used that opportunity to make the product even more valuable—using it for prevention, or prophy- laxis. Te prophylaxis indication would allow the use of the product when entering an area contaminated with high-potency


Army AL&T Magazine Winter 2023


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