ACQUISITION AT SPEED
when entering early product develop- ment—by then it’s almost too late.”
KNOWLEDGE BAKED IN Because that process needs to be as stream- lined as possible, working with ORA is simple. For example, when an industry partner contracts with USAMRDC with the goal of developing a certain product, ORA joins the project management team almost immediately to begin providing advice and guidance on how to ultimately obtain FDA approval. Ten, project team members review the proposed testing efforts for the product (clinical trials, toxicity studies, etc.) and discuss the creation of a unique strategy to ensure the product being developed clears all regula- tory milestones as required by the FDA. In this way, ORA operates as the “transla- tors” of the regulatory world ensuring that both the FDA and the product developers are speaking the same language in their pursuit of a common goal: FDA approval.
Any product that receives an FDA approval is, of course, the ultimate goal for all involved. Zottig calls ORA the command’s “connective tissue” because the office works with so many people and programs within USAMRDC.
Tis enormous infrastructure allowed ORA to help facilitate portions of the command’s response to the coronavi- rus pandemic. During that time, while USAMRDC was helping secure personal protective equipment like face shields, face masks and specimen collection devices— products it helped physically create via on-site 3D printing technology—ORA teamed with the U.S. Army Medical Materiel Development Activity’s Additive Manufacturing Working Group to ensure said products were approved in a compli- ant manner. While such an effort would’ve taken years under normal circumstances, ORA was able to process the necessary
OVERDOSE AVERTED
ORA staff are working with private sector pharmaceutical companies to develop lifesaving treatments for warfighters, including a naloxone auto-injector—similar to the materiel pictured here—to reverse the effects of an opioid overdose on the battlefield. (Photo by Mark Herlihy, U.S. Air Force)
regulatory requirements for those new products in just weeks due, in large part, to their knowledge and familiarity of the FDA process.
CONCLUSION For Donovan and the team at ORA, this kind of work is what makes the end-result so rewarding. “What I really take pride in is being part of a team that knows exactly what to do to get something started, do it quickly, and, in essence, get the right product out at the right time for the right needs,” Donovan said. “I feel my pres- ence here and my contribution here is really needed, after all, what more could you hope for when you know your work is meaningful?”
For more information about USAMRDC, go to
https://mrdc.amedd.army.mil. For more information about ORA, go to
https://mrdc.amedd.army.mil/index. cfm/resources/researcher_resources/ regulated_activities_overview.
RAMIN KHALILI is a writer with
USAMRDC’s Public Affairs Office. Before assuming his current role, he spent five years as the knowledge manager for USAMRDC’s Combat Casualty Care Research Program. During his previous work as a broadcast journalist, he earned an Associated Press Award for his work in Phoenix, Arizona, before serving as chief NASA correspondent for CBS in Orlando, Florida. He holds a B.A. in communications from Penn State University. A frequent contributor to Army AL&T, his most recent article, “Te Magic Glove,” appeared in the Summer 2022 issue.
https://asc.ar my.mil
17
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 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148
