USAMRDC's technology landscape-mapping workshops seek to find the right medicines and devices with input from an integrated stakeholder team.
If anybody knows how it all fits together, it's Dr. Lawrence Lightner. As a retired, 23-year veteran of the Army and current project manager at the U.S. Army Medical Materiel Development Activity (USAMMDA), Lightner knows almost everything under the sun about current initiatives, previous product efforts and, not least of all, the necessary U.S. Food and Drug Administration (FDA) process that occasionally accompanies the U.S. Army Medical Research and Development Command's (USAMRDC) acquisition process.
"We have learned how the process works and how to adapt to it," said Lightner, whose official title is project manager for warfighter protection and acute care.
And yet times are changing. While the organization-wide desire to both identify and develop solutions in warfighter care as fast as possible remains constant, the acquisition process for developing those technologies is now evolving, too, for the sake of increased efficiency. For Lightner and his team, a group that has ushered a wide variety of products through the acquisition process over the past two-plus decades, it's a sign that continued success is just around the corner.
TLM: EVOLUTION OF A SOLUTION
At USAMRDC headquarters at Fort Detrick, Maryland, Dr. Mark Dertzbaugh, acting deputy principal assistant for research and technology, marks up the whiteboard in his first-floor office like a football coach drawing up plays during practice, charting a potential product's timeline with both purpose and ease. For him, this is ground zero-the place where solutions are born.
"The idea is to develop a common vision among all key stakeholders," he said, "a vision where we on the science and technology [S&T] side can work in parallel in some places with our acquisition program managers [PMs] to help compress the timeline to product fielding."
That vision starts with a process called a technology landscape mapping (TLM) workshop, which is, in short, a method for determining which technologies may best address a given capability gap before the financial investments begin. This kind of effort starts with the targeting of a specific need, and then begins in earnest with a combination of brainstorming efforts, research reviews and briefs on both current and off-the-shelf products that may help fill that need. According to Dertzbaugh, TLMs accomplish this goal by pulling together key stakeholders, including requirements personnel, S&T staffers and PMs, to determine what the needs of the user are and which technology solutions best fit the bill.
Said Dertzbaugh, "Before we crack any test tubes, we do this paper exercise [TLM] to identify the best technology, and then determine how the S&T aligns with the acquisition program that will ultimately receive [those recommendations]. We're always trying to make sure we share a common vision of where we're going as an enterprise, in order to be as efficient as possible."
One of the key debates in that regard concerns maturity versus fit-or rather, which option increases overall lethality for the warfighter: a product that's further along in the developmental process (which feasibly could get to the warfighter faster), or a product that expressly fits the warfighter's specific needs (which may take longer to develop and, ultimately, field). Because of the potential for fluctuation on either end, the guiding document that comes out of the TLM must constantly (and necessarily) be revised.
"It's an evolving document," said Dertzbaugh. "There's always the chance there could be some disruptive technology which appears out there that we just don't know about yet."
The TLM concept is essentially a more structured approach to technology scouting, and is the process currently guiding the USAMRDC's investment in medical technologies needed to support the Army's modernization strategy. The ultimate desire, of course, is to develop products that save lives and improve Soldier lethality.
"We're trying to improve our shots on goal," said Dertzbaugh, using his best coach-speak, of this more forward-thinking approach. "It's all about securing and developing the best technology and trying to get it to the people who need it faster."
STATION TO STATION: THE NEXT STEP
From Dertzbaugh's office, the process moves to the next step: the second-floor office of Dawn Rosarius, USAMRDC principal assistant for acquisition.
"It's a collaboration from the beginning between S&T and program management, so we are more prepared when the solution is transitioned to us," said Rosarius of this next step. "We want to see the value when we take any product from the science and technology side of the house."
As such, and as part of the designated product pathway, Rosarius' team grabs the ball passed by Dertzbaugh's team and USAMRDC laboratories and then makes the requisite-and critical-decisions specific to that product's potential future.
"It depends on how advanced the product is," said Rosarius of how, exactly, her team chooses which products move forward and in what particular capacity. "Pharmaceuticals, such as those that Dr. Lightner oversees, have a lot of risk. Medical devices may as well; however, we want to transition those as early as possible to address issues such as sustainability, cyber and usability."
REALIZATION AND COMMERCIALIZATION
Back at the USAMMDA project management offices, in the veteran hands of Lightner and his team, the pieces processed through Dertzbaugh and Rosarius take on their final shapes before heading out the door.
"We're relatively unique within DOD as to how we develop products and what we need," said Lightner. "Our products are all commercialized, which means they're meant to be used not just on the battlefield by our warfighters, but during peacetime as well-as our target population is somewhat unique in the pharmaceutical industry. While most companies are targeting pediatric and geriatric populations, we need products for younger, 18- to 40-year-olds."
A good example of the latter is the vaccine used to prevent dengue, a mosquito-borne viral infection and a leading cause of hospital admissions in military units operating in the tropics. USAMMDA partners with a company that is keen to target the vaccine for use across a pediatric population. In exchange for DOD conducting part of the company's worldwide clinical trial at two DOD sites, the company has agreed to accelerate its license application for an adult indication as well. Additionally, the partnership gives USAMMDA a seat at the table at the company's product strategy meetings, which allows the organization to make informed decisions on the potential DOD use of the product. USAMMDA has several other similar partnerships in its portfolio.
According to Lightner, this type of grand commercialization requires robust backing from industry partners during the acquisition process, an effort that can be described more succinctly as an attempt to split the total cost of the licensing and production bills.
A prime example of this kind of partnership is USAMRDC's work with 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 development to be the domestically produced version of French FDP, which Lightner said will ultimately be available for use wherever 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, "This 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 testament 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 pipeline for nearly 30 years. The lengthy nature of its gestation was 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 commercial market: Malaria prevention via pharmaceutical intervention is not practical yet in endemic countries because of the cost, especially 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 Pharmaceuticals was selected to partner with USAMMDA in vaccine development. The company is now boosting production of tafenoquine to meet global needs. The 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. The 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 applying on a daily basis in our current efforts," he said.
CONCLUSION
In the end, perhaps the evolution of the USAMRDC acquisition 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/.
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.
This article is published in the Winter 2020 issue of Army AL&T magazine.
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