ACQUISITION AT SPEED
WEAPON NOT-SO-SECRET
USAMRDC’s Of fice of Regulatory Affairs facilitates the development of future medical materiel by making sure that all of the i’s are dot ted and the t’s are crossed.
by Ramin A. Khalili
test new medical devices, drugs and biologics—all potential solutions for the modern Soldier. She and the rest of the ORA team are tasked with guiding those solutions from infancy to, ultimately, a mature, fully realized product for use in the battlefield. For that reason—and so many others—ORA has become an increasingly important player in the USAMRDC operation.
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As part of a collaboration with USAMRDC’s U.S. Army Medical Materiel Development Activity Force Health Protection division, Donovan is working with Kaléo, a Virginia-based pharmaceutical company contracted by DOD to develop a high-dose auto-injector for naloxone, which is an opioid agonist. Tat means that it stops or prevents the effects of opioid drugs. In a combat situation, powerful opioids could be aerosolized and deployed as a chemical weapon. A naloxone delivery system like Kaléo’s auto-injector could be used on the battlefield to help mitigate opioid exposure and save warfighter lives. Te product is already being used by special forces units and is positioned at various U.S. military installations across the globe for expedited distribution in case an imminent threat presents itself.
Donovan, who has been with ORA since 2009, is a former pediatric oncology nurse. She previously worked at high-profile universities such as Georgetown in Washington and Johns Hopkins in Maryland. However, there’s something her current role offers that, as she put it, those other places just can’t match. While Donovan said she can’t know the person who is receiving the drug, product or tool individually, as she used to in nursing, “I do feel like I am part of a bigger piece of the puzzle that’s saving someone’s life,” noting that Kaléo’s auto-injector was scheduled to be commercially available by July.
ou don’t need a crystal ball to get a peek at the future of warfighter medical solutions. Instead, just talk with Cyndi Donovan of the U.S. Army Medical Research and Development Command (USAMRDC) Office of Regulatory Affairs (ORA). Donovan is a clinical research associate in the office, and watches from the ground level as command industry partners develop and
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