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MAJ Christopher Todd

Blast injuries form the basis for most of our casualties in the wars in Iraq and Afghanistan. While advances in body armor have exponentially improved levels of torso and head protection, extremities and exposed areas of the body remain largely vulnerable to the effects of improvised explosive devices and other battlefield explosives. As a result, injuries such as burns, soft tissue damage, compartment syndrome, and amputations are seen. Regenerative medicine shows exceptional promise in developing therapies to address these types of injuries.

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U.S. Army Surgeon General LTG Eric Schoomaker explains how researchers are growing a new ear for a badly burned Marine using stem cells from his own body. This is one area of advanced treatment being explored by AFIRM. (DOD photo by R.D. Ward.)

Regenerative medicine focuses on the treatment of tissue and organ injuries by using the body’s regenerative capability and cell integration with other biological materials to synthesize or “grow” tissues and organs to replace the damaged ones. Because of recent advances in regenerative medicine, AFIRM was formed in a collaborative effort among the U.S. Army Medical Research and Materiel Command (USAMRMC), the Office of Naval Research (ONR), the U.S. Air Force (USAF) Office of the Surgeon General, the National Institutes of Health (NIH), and the Department of Veterans Affairs (DVA).

AFIRM is a partnership that involves government, academia, and industry in achieving rapid advances in regenerative medicine to address combat injuries. AFIRM is not a “brick and mortar” institution, but rather a virtual organization of nongovernment research partners and the U.S. Army Institute for Surgical Research in San Antonio, TX, working in concert to achieve objectives in regenerative medicine. Eventually, the therapies developed and enhanced by AFIRM will also be translatable into viable treatments for the civilian population.

AFIRM’s Formation
A typical partnership between the government and outside entities normally forms around a contract. However, 10 United States Code 2358 authorizes DOD to conduct research and to enter relationships with external parties through grants and cooperative agreements, known collectively as assistance agreements. Unlike contracts, assistance agreements usually do not require the production of deliverables as a condition for receiving government funding.

Assistance agreements usually support defined research goals and objectives, but without guaranteed results. Moreover, DOD’s assistance agreements must be militarily relevant while supporting a public purpose. Each grant and cooperative agreement has different government involvement. Grants do not see much government involvement, while, as the name implies, cooperative agreements significantly involve the government in the research portion. Additionally, like contracts, assistance agreements are often awarded on a competitive basis. In lieu of a Request for Proposal, DOD will synopsize its research needs through Broad Agency Announcements or more specific Program Announcements (PAs).

AFIRM is a partnership that involves government, academia, and industry in achieving rapid advances in regenerative medicine to address combat injuries.

AFIRM was created on the award of cooperative agreements. COL Robert Vandre, USAMRMC’s Director of Combat Casualty Care Research, initially brought forward the AFIRM idea and sought funding partners with ONR, NIH, the USAF, and DVA. From this, USAMRMC approached its contracting arm, the U.S. Army Medical Research Acquisition Activity (USAMRAA), to solicit extra government interest in AFIRM. Like contracts, the authority to award assistance agreements is limited to those possessing a warrant. Gilbert Hovermale, a veteran of the acquisition workforce and one of USAMRAA’s warranted Grants Officers, issued a Request for Information (RFI) in January 2007 to determine the AFIRM interest level in academia and industry.

The RFI generated 28 responses from parties potentially interested in the AFIRM concept. These respondents, along with the sponsors, formed a community of interest in furthering the AFIRM concept by permitting idea sharing about regenerative research. As research began, USAMRAA issued a PA to further refine and target these research ideas. The PA elicited 14 proposals from parties potentially interested in the AFIRM. Eventually, the AFIRM’s direction was defined enough to issue the formal PA in August 2007.

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The Wake Forest Institute for Regenerative Medicine’s AFIRM research program has developed a way to grow living cartilage tissue on a synthetic ear-shaped implant (shown in the bottom image) in the laboratory. The microscopic view (shown in the top image) shows the interface between the implant (white) and the cartilage tissue (pink). (Photo courtesy of the Wake Forest Institute for Regenerative Medicine.)

The PA resulted in seven full proposal submissions for USAMRAA evaluation. To facilitate evaluation, two panels were established. The Peer Review Board, staffed by scientific experts in research, was responsible for proposal technical evaluation and for screening them for scientific merit to determine which proposal had the highest likelihood for rapid success. The Program Review Board, made up of sponsor representatives, was charged with making a funding recommendation to the Grants Officer.

The proposal evaluation process was accomplished in three phases, which were designed to select the proposal with the highest probability of generating advances in regenerative medicine that would quickly translate into viable treatments for wounded warfighters. The first phase was an initial screening of the proposal by the Grants Officer and the Peer Review Board Chair to determine the responsiveness to the PA’s terms and criteria. Five proposals were found to be generally responsive and went to the second evaluation phase.

The second phase was a full evaluation of written proposals by the Peer Review Board. As a result, two institutions were invited to the final phase of oral presentations in front of the Peer Review Board. After this final phase, the results and recommendations from the technical review were forwarded to the Program Review Board to make a final recommendation to the Grants Officer. During this programmatic review, the White House became aware of AFIRM and matched the original sponsor funding, bringing the federal funding available from $42.6 million to $85.2 million over a 5-year period.

Because of this increase in funding and the complementary nature of the two final proposals, the Program Review Board made an unconditional recommendation for two separate awards for the finalists. On Feb. 15, 2008, with the assistance of AFIRM Project Contract Specialist Susan Dellinger, the Grants Officer awarded Wake Forest University and Rutgers, the State University of New Jersey, for AFIRM research. These two universities will employ a multi-institutional base of academic and industry partners to accomplish the work under AFIRM. The recipients, along with respective nonfederal partner organizations, are also contributing funding to the AFIRM. The combined AFIRM budget is expected to exceed $250 million from all federal and nonfederal contributors.

The AFIRM process shows how DOD can partner with academia and industry quickly and successfully to achieve substantial improvements in military readiness.

AFIRM’s Future Capabilities
Because of AFIRM’s collaborative nature and the expected free flow of research information among participants, process managers will continually face various confidentiality and intellectual property rights during the agreements. Nonetheless, this symbiotic relationship will greatly enhance the speed in achieving research objectives. Accordingly, AFIRM is expected to make substantial gains in regenerative medicine within 1 to 2 years of its inception.

The AFIRM process shows how DOD can partner with academia and industry quickly and successfully to achieve substantial improvements in military readiness. Through participation from industry and academia, the sponsors’ exceptional foresight, and hard work from our acquisition professionals, AFIRM will soon be providing a foundation to greatly improve the medical care provided to our wounded service members.

MAJ CHRISTOPHER TODD is an Army Medical Department Military Acquisition Intern. He holds a B.S. in political science from Texas A&M University, an M.A. in management from Webster University, and an M.S. in logistics management from the Florida Institute of Technology.

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