Multidrug Resistance
Another major WRAIR effort in recent years has centered on research to identify organisms that have developed a resistance to multiple drugs typically used to combat such diseases.
“We work more and more on collaborations, because the problems are so complicated, one agency can’t do it all itself,” Col. Emil Lesho, director of the Multidrug-resistant Organism Repository and Surveillance Network (MRSN), explained. “Our closest relationship is with the Navy and Marine Corps; when they come across something, they give us a warning.
“We also work with the CDC [Centers for Disease Control and Prevention], Institut Pasteur, the VA [Department of Veterans Affairs]– including trying to get projects started at polytrauma centers – and the Baltimore Shock Trauma Center, which does complicated wound care. If a wounded warfighter can’t get care at Walter Reed, we send them up there.”
“We also work with the CDC [Centers for Disease Control and Prevention], Institut Pasteur, the VA [Department of Veterans Affairs]– including trying to get projects started at polytrauma centers – and the Baltimore Shock Trauma Center, which does complicated wound care. If a wounded warfighter can’t get care at Walter Reed, we send them up there.”
Military HIV Research Program (MHRP)
“CRADAs or other collaborations are determined based on the needs of the scientists in our program,” Col. Jerome Kim, principal deputy for MHRP, reported. “If one of our immunologists wants to collaborate with an immunologist at Harvard, they begin a discussion and, if there will be a transfer of materials or data, a material transfer agreement is signed.
Laboratory evaluation of the Rift Valley fever (RVF) virus assay. The validation process for VecTOR’s RVF virus assay was a joint effort among researchers from the Entomology Branch, WRAIR Virology Division, U.S. Army Medical Research Institute of Infectious Diseases, the Kenya Medical Research Institute, and the U.S. Army Medical Research Unit-Kenya. Photo courtesy of Capt. Elizabeth Wanja
“We can do agreements with more than one partner, although they’re difficult. We have clinical trial agreements with two different companies because negotiating a three-way CRADA was too difficult.”
A lot of discussion precedes a formal agreement, with preliminary discussions sometimes going on for two or three years. Additional agreements are made once a clinical trial starts or ends, including a data transfer agreement.
“As an organization, we put money into a cooperative agreement, which is midway between a contract and a grant. So I can do a clinical trial with the [Henry M.] Jackson Foundation [for the Advancement of Military Medicine], with much more ability to interact directly with the contractor should changes need to be made,” Kim said.
“We can do agreements with more than one partner, although they’re difficult. We have clinical trial agreements with two different companies because negotiating a three-way CRADA was too difficult.”
“Money goes directly from the Army to the Jackson Foundation, which can do contracts, material transfer agreements, etc. The senior military member typically decides who is involved on a team.”
HIV research and CRADAs are a significant part of WRAIR’s requirement to protect the force against infectious diseases.
“With HIV, you get a regional vaccine first, then a global vaccine. The CRADA also has key requirements for the number of doses. Seventy-five percent of the $100 million Congress allocated to NIH [National Institutes of Health] for HIV research was transferred to us under an interagency agreement. In another program, NIH has taken over funding the Army had been providing. We also receive grants, which define the studies to be done, from the Gates Foundation, although we don’t have a formal agreement with Gates,” Kim said.
Leishmaniasis as seen under a microscope at Walter Reed Army Institute of Research in Silver Spring, Md. The U.S. Army Medical Research and Materiel Command (USMRMC) marked a major advance against the disease cutaneous leishmaniasis when the U.S. Food and Drug Administration approved the marketing of a new diagnostic test developed by a partnership of WRAIR, the U.S. Army Medical Materiel Development Activity (USAMMDA), and the molecular diagnostics company Cepheid USA Inc. U.S. Army photo by Sgt. 1st Class Roddy Rieger
“So there are contracts, CRADAs, IAAs, voluntary associations. We work closely with NIH in our collaborative research – to set up committees to evaluate proposals, approve them scientifically or request further funding. Once those are done, we sit down with NIH and work out a way to move NIH money to fund those studies, wherever that work is to be done.”
WRAIR’s relationship with NIH on HIV research merges DoD capabilities with NIH funding, for the costly endeavor to develop the first ever HIV vaccine, for both the military and the world.
“Our partnership with NIH is the most obvious joint success in terms of agreements. It was set up at a time when DoD was going to transfer our program to NIH without transferring the personnel. Originally, NIH did not do much overseas research and they don’t develop products,” he explained.
“We are responsible to the U.S. ambassador, and the Army knows how to work with the State Department and foreign governments, while NIH works with them through others. The NIH focus on HIV was domestic, while the Army focus is overseas. We brought those two together, doing the research that needs to be translated into products.”
“We are responsible to the U.S. ambassador, and the Army knows how to work with the State Department and foreign governments, while NIH works with them through others. The NIH focus on HIV was domestic, while the Army focus is overseas. We brought those two together, doing the research that needs to be translated into products.”
NIH has agreed to fund several MHRP studies and Kim said some of that money may be coming from a $100 million research program President Barack Obama announced last year.
“Our program is funded out of the Pentagon, using one-year money. In general, Army money pays for all personnel; Jackson Foundation money funds Jackson researchers and so on,” he said. “There also is a clear line between government and contractor money; for example, government money can be used for salaries and travel that industry money cannot. NIH money comes to us at the end of the fiscal year. Army funds are used first, using current fiscal year funds for payroll.”