SOLUTION EVOLUTION
Technology landscape mapping is a method for determining which technologies may best address a given capability gap before the financial investments begin.
Pennsylvania-based Teleflex Inc., the manufacturer of a freeze- dried plasma (FDP) product called EZPlaz. Following the FDA’s emergency-use approval in 2018 of a similar product developed in France (referred to as “French FDP”), EZPlaz is under devel- opment to be the domestically produced version of French FDP, which Lightner said will ultimately be available for use wher- ever fresh, Frozen plasma is not available. Under a cooperative research and development agreement with USAMRDC, Teleflex contributes millions of dollars for manufacturing, licensure and commercialization of the product, while USAMMDA funds and manages the clinical trials required to support FDA licensure.
“We need our [industry partners] to share the cost of development because we don’t have the sufficient funding to simply contract with a company for the whole effort,” said Lightner. “So we need to have a commercial partnership to obtain licensure with the FDA, work with DOD on behalf of our unique population, and sustain the products post-licensure. Without that kind of partnering, we would probably be able to fund only a couple of development efforts instead of the 20 or so that we currently have in our portfolio.”
He added, “Tis maximizes our ability to move products out to the warfighter.”
DOD’s role in shepherding tafenoquine (tradename Arakoda) through this same acquisition process is, in many respects, a testa- ment to the idea that the entire acquisition framework is evolving. Approved by the FDA in 2018 for the prevention of malaria in adults 18 years and older, tafenoquine—which tested as more than 99 percent effective in clinical trials against all species of malaria and all stages of the parasite—was in the product pipe- line for nearly 30 years. Te lengthy nature of its gestation was
126 Army AL&T Magazine Winter 2020
RAMIN A. KHALILI is a writer with the USAMRDC Public Affairs Office. Before assuming his current role, he spent several years as the knowledge manager for the command’s Combat Casualty Care Research Program. During his previous decade-plus career 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.
largely the result of understandable difficulties with conducting clinical trials in malaria-endemic areas (as required by the FDA) and finding a reliable and suitable industry partner.
Large pharmaceutical companies are generally not interested in malaria prevention drugs because they don’t have a large commer- cial market: Malaria prevention via pharmaceutical intervention is not practical yet in endemic countries because of the cost, espe- cially for long-term use. Additionally, there is no large market for travelers who need the vaccine. DOD is the largest U.S. consumer of malaria prophylactics, so USAMRDC’s in-house program is critical in maintaining effective drugs to use in malaria prevention.
As a result, it was left to DOD to lead those development efforts. Following an extensive search of potential partners, 60o
Pharma-
ceuticals was selected to partner with USAMMDA in vaccine development. Te company is now boosting production of tafeno- quine to meet global needs. Te result will be the availability of the first new FDA-approved antimalarial drug in 18 years—one that is effective against all species and stages of malaria. Te worldwide impact, according to Lightner, will be significant.
“Tafenoquine taught us a number of lessons in both what to do and what not to do when developing products that we are apply- ing on a daily basis in our current efforts,” he said.
CONCLUSION In the end, perhaps the evolution of the USAMRDC acquisi- tion process—and DOD acquisition reforms in general—will create an even smoother process for Lightner and his team; a method even cleaner and more fluid than the ones before. How ironic, then—or just good timing—that all the lessons learned though decades of development, revision and modification have ultimately resulted in a more aerodynamic process where time and desire push each other forward in symbiotic fashion.
For more information, go to
https://mrdc.amedd.army.mil/ or
https://www.usammda.army.mil/.
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