By Jeffrey M. Soares, USAMMDADecember 12, 2018
USAMMDA works with military, federal civilian and contract professionals to develop and deliver quality medical products.
Since its establishment more than 30 years ago, the U.S. Army Medical Materiel Development Activity (USAMMDA) has been partnering with industry to create effective medical product solutions to support our warfighters in the field and at home. Over the years, USAMMDA's multiple project management offices have overseen the development of numerous medical products and devices, which include the antimalarial drug tafenoquine, an adenovirus vaccine, freeze-dried plasma, the Chemical Patient Protective Wrap, the Environmental Sentinel Biomonitor and the Laboratory Assay for Traumatic Brain Injury. In so doing, the organization has used a number of approaches to secure the right type of partnership for a given product, such as various types of contracting methods, cooperative research and development agreements (CRADAs) and "open campus" models.
As a subordinate command of the U.S. Army Medical Research and Materiel Command at Fort Detrick, Maryland, the USAMMDA team is a partnership of military, federal civilian and contract professionals working together in support of the organization's mission to develop and deliver quality medical capabilities to protect, treat and sustain the health of our nation's service members. However, given the nature of medical product development in the world of Army acquisition, USAMMDA does not have the manufacturing capability to carry a product all the way through the life cycle pipeline on its own. Therefore, the command uses its expertise in project management and reaches out to commercial partners to create the best product to satisfy a given military requirement.
In addition to creating products for troops on the battlefield, USAMMDA works to find solutions to treat wounded warfighters returning from battle. While the scars of traumatic brain injury and post-traumatic stress disorder may not be readily visible, the damage of catastrophic wounds can clearly be seen, and the command has multiple teams that look to discover treatment options for these types of physical and emotional injuries.
PARTNERING FOR SUCCESS
While USAMMDA does its part in the development of critical medical products moving through the acquisition pipeline, it relies heavily on commercial partners in industry to complete this important task. Kathleen Berst, USAMMDA's deputy for acquisition, explained that the command seeks opportunities to partner with companies currently holding a technology that has a civilian market and is militarily relevant but not necessarily military-specific.
"Everything we do is driven by a requirement," she said. "However, our requirement is probably not the only driver of our industry partner's development effort. So the question we ask ourselves is, 'How do we integrate our requirement with the industry partner's strategy to deliver a commercially viable product that is sustainable and meets the military's need?' "
Berst pointed out the similarities between DOD's business model and that of typical companies throughout the industry. "We both look at the same factors: How much will this cost? What is the need for this? What is the market? How long will it take to develop? What's the programmatic risk? The bottom line is that it's an investment decision," she said.
Berst explained that, working within a relatively small budget, the Army must remain diligent in its investment decisions, so it considers partners with the greatest chances for success. DOD cannot create a militarily- unique product that leaves the government as the only customer, as this would create the difficult scenario of having to solely sustain the product indefinitely.
Dr. Lawrence Lightner, project manager of USAMMDA's Pharmaceutical Systems Project Management Office (PSPMO), which oversees the development of items including tafenoquine, the adenovirus vaccine and freeze-dried plasma, provided insight regardingunderscored the critical role of contracting in the partnering process. He explained that a government contract provides a flexible mechanism for using DOD funds to assist industry partners in a variety of areas. The CRADA is a very important tool as well.
"The CRADA essentially affords the DOD a 'seat at the table' in contributing to decisions made by the industry partner," said Lightner. "Under a CRADA, the industry partner may provide funding to DOD for specific activities, while DOD can provide other material items to the industry partner for the product development process."
The CRADA played an important part in the recent U.S. Food and Drug Administration (FDA) approval of tafenoquine, which was realized after 40 years of research and development involving numerous partners. Malaria remains the top infectious disease threat to U.S. service members deployed overseas, and DOD has been committed to discovering an effective solution for the prevention and treatment of this life-threatening illness among its troops, as well as civilian populations worldwide.
Tafenoquine was first discovered in 1978 within the Experimental Therapeutics Branch at the Walter Reed Army Institute of Research. In 1988, the drug was transitioned to USAMMDA's PSPMO for management and oversight of the product development effort, and it has remained under the PSPMO's guidance ever since. While many organizations have been involved in the studying of the drug, production of tafenoquine as a weekly prophylaxis was secured through the establishment of a CRADA between USAMMDA and its industry partner, 60� Pharmaceuticals LLC, which will manufacture the drug for DOD.
The result of this type of partnership is usually a win-win scenario: The industry partner ends up with a commercially profitable product that DOD can purchase, generally at a reduced cost, for use throughout its military forces. As DOD cannot solely sustain a militarily unique product for the sake of its warfighters, industry partnerships such as this are vital to maintain military readiness and to provide medical product support. Although some exceptions exist for products that are a DOD operational priority but have no civilian market, these cases are rare.
USING THE OPEN CAMPUS MODEL
While USAMMDA maintains traditional commercial partnerships to produce the majority of its medical products and devices, it is engaged in a unique open campus project as well. The open campus concept brings together government, industry and academia in an effort to maximize both resources and output. Since 2016, representatives from USAMMDA have helped to guide the establishment of the Advanced Regenerative Manufacturing Institute (ARMI) in Manchester, New Hampshire.
In 2016, ARMI was awarded the BioFabUSA project, which is a DOD-sponsored initiative in the Manufacturing USA network, and the first to address biomanufacturing. The BioFabUSA program looks to bridge the gap between early scientific research and later-stage product development by advancing critical technologies to enable large-scale biological manufacturing efforts--in this case, tissue regeneration.
"ARMI is a public-private partnership serving as one of Manufacturing USA's 14 manufacturing innovation institutes," explained Air Force Lt. Col. Melinda Eaton, USAMMDA's director of strategic acquisition planning and program management. "My role in this effort is to serve as the government program manager, to help ensure that we are effectively utilizing the $80 million of federal funding provided by DOD to establish this partnership."
DOD's interest in tissue regeneration grew from the challenges of restoring service members to form, function and appearance following catastrophic combat injuries. As conventional approaches may sometimes fall short of full restoration, USAMMDA's Combat Trauma and Acute Rehabilitation Project Management Office has overseen numerous research projects focused on developing novel solutions to address this need. Currently, the most successful projects in its portfolio are efforts in the field of vascularized composite allotransplantation, which involves hand and face transplants, and the ongoing development of a skin substitute to treat burn wounds.
BioFabUSA is focused on tissue engineering, at manufacturing readiness levels between 4 (validated in a laboratory environment) and 7 (demonstrated in prototype in an operational setting), said Eaton. The group hopes to research immature technologies to see if these can be scaled up, or scaled out, to ensure a consistent quality of tissue manufacturing.
"We have more than 100 members within the various industries and academia and private partners that have joined the institute, and these will add over $200 million in private commitments," she said. "BioFabUSA is currently working with these partners to set up a tissue foundry so they can create test facilities where the partners can come in and learn how to scale up some of their own products.
"Our goal," continued Eaton explained, "is to ensure that these public-private partnerships are sustainable, so that after the government funding ends, the institute can continue on its own as a sustainable entity. In the end, we want to make sure we have those manufacturing partnerships in place with these industry partners."
Eaton values the open campus concept, as it allows USAMMDA to reach out to more partners than it could on its own. She believes it is helping the organization connect with researchers in academia as well as its usual partners in the commercial industry.
"We have a lot of partners in industry and academia that want to support the DOD, but they just don't know how--and we're able to provide them with our unmet needs and capabilities so they can provide support to the DOD," she said.
"At the same time, we're providing them with our expertise, and they are able to work with our science and technology partners, and tap into some of our military populations for clinical trials, if they would like to study the effects on our unique population," she said. "For example, we know we have unique wounds from the battlefield that they may not see in the civilian sector, and this could be very helpful to their own research."
It would be hard to diminish the value of industry partnerships or the open campus concept, especially in light of the recent success of tafenoquine as the first FDA-approved malaria drug in nearly two decades. The idea of collaboration is infused throughout the important work of USAMMDA and the collective mission of all involved.
Army Col. Ryan Bailey, USAMMDA commander, has been immersed in military medical product development since assuming command of the organization in 2017. He recognizes the true value of industry partnerships for success in these unique endeavors.
"These types of partnerships are not about multiple teams racing towards a finish line, hoping to jump ahead of each other in the final stretch," he said. "The concept is more like a relay race, where talented individuals work closely together to reach the goal, doing everything possible to ensure the team does not 'drop the baton' along the way."
Although the BioFabUSA project may have a great deal to prove going forwardin the future, the potential is immense and the prospects are exciting. In working with an extensive list of partners, it is likely that many good things will come from such synergistic relationships. For this important effort, restoring wounded service members and civilians to form, function and appearance remains paramount--and the possibilities through effective partnerships remain endless.
JEFFREY M. SOARES is a senior technical writer and communications specialist with General Dynamics Information Technology, providing contract support as chief writer for the Public Affairs Office and Office of the Commander at USAMMDA. He holds an M.A. in English language and literature from the University of Maryland, College Park, and a B.S. in education with a concentration in English from the University of Scranton.
This article is published in the January- March 2019 issue of Army AL&T magazine.