The Walter Reed Army Institute of Research (WRAIR) has sought out and been open to partnerships with other U.S. and international medical research agencies, academia, industry, and allied governments. Today, the agreements defining these collaborations are varied and depend on the partner and have names like cooperative research and development agreements (CRADAs), interagency agreements (IAAs), memoranda of agreement (MOAs), and education partnership agreements (EPAs).
“In most of WRAIR’s work, we have partners. For example, for therapeutics after brain injury or new antimalarials, our researchers develop teams with industry and academia,” said Debra Yourick, Ph.D., director of Science Education and Strategic Communications. “So it’s really about collaboration in research and development [R&D] for a final product that then becomes available for our service members.”
“In most of WRAIR’s work, we have partners. For example, for therapeutics after brain injury or new antimalarials, our researchers develop teams with industry and academia.”
CRADAs were created by the Federal Technology Transfer Act of 1986, making it easier for scientists in federal labs to work with private industry, universities, and state and local governments. Its goals include speeding technology commercialization, optimizing resources, and protecting the rights of both private companies and their government partners when intellectual property is created.
The federal lab may provide personnel, facilities, equipment, and other resources to support specific R&D efforts consistent with the lab’s mission. The outside partner provides an appropriate amount of the funding for conducting the research at the government laboratory. Both parties may file patents as appropriate and, when a private company has patents and retained patent rights, the government gets a license to the patents.
“Our two goals are to advance research and, second, especially OCONUS [outside the continental United States], to improve the medical capacity of the host nation,” according to Col. Steven Braverman, WRAIR’s commander.
WRAIR’s partnerships and collaborations stem from advancing military medical research to meet specific Army requirements. Those involving military labs are especially well connected.
“The Army, Navy, and the Department of Defense [DoD] recognize that there are important military medical research gaps that guide the work of the medical research laboratories like WRAIR; we also work closely with the Naval Medical Research Center,” said Yourick. “Many of our programs are moving toward being neither just Army nor Navy. Military Infectious Diseases Research Program [MIDRP] is joint, and within MIDRP we now have a joint Military Malaria Research Program [MMRP].”
“We also do military operational medicine and casualty care through other groups. We’re moving toward a joint military health care system. It’s all evolving very rapidly,” said D. Renee Davis, the new director of WRAIR’s Business Management Office.
“We also do military operational medicine and casualty care through other groups. We’re moving toward a joint military health care system. It’s all evolving very rapidly.”
The collaborations negotiated by WRAIR’s Office of Research Technology Applications (ORTA) are true partnerships, with principal investigators (PIs) on both sides, government and nongovernment.
“We create agreements where each partner does its piece, as defined from the beginning. Although, because it’s research and you can have both breakthroughs and setbacks, new partners coming aboard, etc., we frequently have to renegotiate modifications. It’s always bilateral,” Davis said.
“‘Whom’ is not as important as the type. We partner with other government entities, academia, nonprofit, and for-profit – anyone with a mission set that can further our core research mission. They do not have to be U.S. – we have a substantial number of international agreements.”
Malaria and Other Infectious Disease Collaborations
The oldest and most intensive research WRAIR conducts – focused on malaria – also has the most partnerships, of all kinds and at all levels.
“The current Phase III efforts, the big efficacy study for a malaria vaccine, is being conducted largely by GSK [GlaxoSmithKline] and with the largest amount of funding, I think to the tune of about $200 million, from the [Bill & Melinda] Gates Foundation,” said Col. Robert Paris, MMRP director. “Our malaria research program here is not directly involved with that, although we are indirectly involved with doing some assays from the study.
“However, our own lab in Kenya is a participating site for testing this malaria vaccine, in and around Kisumu. Our investigators there delivered the most recent data on that study in South Africa at the MIM [Multilateral Initiative on Malaria] conference. Those studies are the culmination of 20 years or more of effort here at WRAIR.”
All programs depend on collaboration, from dengue vaccine and therapeutics research to a vaccine for diarrheal diseases. Any new therapeutic or preventive vaccine requires industry involvement before it can be marketed. WRAIR’s studies, via DoD funding and through its mission to find military relevant products, often take away early financial risk in product development by identifying promising leads that can then be collaboratively researched and finally approved for the benefit of the health of service members and others at risk.