EXPEDITED DELIVERY
Defense Pharmaceuticals team took the lead with development, creating an autoinjector solution as a rapid countermeasure to opioids. Te complex process to develop a new drug and get it approved by the U.S. Food and Drug Administration (FDA) can take upward of 20 years. When it comes to protecting warfight- ers, waiting decades for a solution is too long.
But where there’s a will, there’s a way, and the solution turned out to be closer than expected. In partnership with the Chem- ical and Biological Defense program, the assistant secretary of the Army for acquisition, logistics and technology approved JPEO-CBRND’s use of the middle-tier acquisition pathway as a regulatory strategy to quickly develop and field this critical medi- cal capability. Te middle-tier pathway enabled JPEO-CBRND to work on an expedited timeline.
Partnering with a U.S.-based drug development company, which already had an FDA-approved opioid overdose treatment on the commercial market, combined with DOD authorities granted by public law, meant that, from the very beginning of this race to fill a critical gap, JPEO-CBRND was already closer to the finish line than the starting blocks.
HIGH STAKES, FAST SOLUTION Te Rapid Opioid Countermeasure System (ROCS) naloxone autoinjector is a self-administered antidote (like an EpiPen) that protects service members against ultra-potent opioids. ROCS is the first-ever medical program approved to use the middle-tier pathway, enabling significant acceleration of the development timeline and making it possible to get ROCS into the hands of warfighters as soon as possible. Using the middle-tier path- way, and leveraging a previously approved naloxone autoinjector, allowed JPEO-CBRND’s Joint Project Manager for CBRN Medical (JPM CBRND Medical) to deliver ROCS four to eight times faster than the typical 10- to 20-year drug development timeline. (Read about all the ins and outs of the ROCS devel- opment process in the December 2022 Army AL&T article, “Swift Antidote.”)
One dose of ROCS contains 10 mg of naloxone—two and a half times the dose available in over-the-counter treatments—yet it is small and light enough to fit in a service member’s pocket and can be used without any formal medical training. Tis higher dosage reverses the effects of exposure but also allows the warfighter to remain on their feet and lucid enough to self-evacuate for
URGENT REQUEST
An urgent request in January 2021 set off the chain of events that led to the delivery of ROCS in 2022. (Photo by Yvonne Najera, Training Support Activity Europe)
38
Army AL&T Magazine
Fall 2023
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136
