MEDICAL PARTNERSHIP
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 part- ner 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 devel- opment 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? Te bottom line is that it’s an investment decision,” she said.
INTERNAL PARTNERSHIPS
When it comes to partnerships, those across the command are equally as important as the commercial ones established outside of the military for the advancement of critical products.
“USAMMDA has access to and the avail- ability of multiple contracts and sites to conduct the pivotal testing of vital Army medical products,” explained Lightner.
“For instance, with infectious diseases that are endemic in other countries of the world, we have command assets that include labs in Thailand and Kenya that have developed field sites to conduct clinical testing of products.
“Our DOD partners in these labs overseas are regionally focused and have access to populations that are directly affected by diseases we are trying to eliminate, so these locations remain extremely important with regard to product effec- tiveness testing,” he 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 indef- initely.
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, under- scored the critical role of contracting in the partnering process. He explained that a government contract provides a flexi- ble mechanism for using DOD funds to assist industry partners in a variety of areas. Te CRADA is a very important tool as well.
“Te CRADA essentially affords the DOD a seat at the table in contributing to deci- sions made by the industry partner,” said Lightner. “Under a CRADA, the indus- try partner may provide funding to
62 Army AL&T Magazine January-March 2019
DOD for specific activities, while DOD can provide other material items to the industry partner for the product devel- opment process.”
Te CRADA played an important part in the recent U.S. Food and Drug Admin- istration (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 civil- ian populations worldwide.
Tafenoquine was first discovered in 1978 within the Experimental Terapeutics Branch at the Walter Reed Army Insti- tute 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 studying 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 manu- facture the drug for DOD.
Te result of this type of partnership is usually a win-win scenario: Te indus- try 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 mili- tarily unique product for the sake of its warfighters, industry partnerships such as this are vital to maintain military read- iness and to provide medical product support. Although some exceptions exist
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