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U.S. Army Medical Materiel Development Activity

U.S. Army Partners with TRACK-TBI Network to Rapidly Advance TBI Drug Development

News release:

Point of Contact:
Carey Phillips
Public Affairs Specialist
U.S. Army Medical Materiel Development Activity
(301) 619-7056
E-mail: carey.a.phillips2.civ@mail.mil


FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity, a subordinate command of the U.S. Army Medical Research and Materiel Command, announced today the award of Defense Health Agency funds through the Medical Technology Enterprise Consortium to the University of California, San Francisco to conduct Phase 2 clinical trials on drugs for the treatment of traumatic brain injury. UCSF will serve as the lead partner for the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Network (TRACK-TBI NET).

From January 2007 through December 2017, there were 284,701 cases of TBI within the Department of Defense; injuries to the head have been prevalent in all past conflicts but are also common in Service Members in non-deployed settings, such as the training environment. As much as 47 percent of veterans with a TBI have symptoms such as sleep disturbances, headaches, depression and memory deficits that persist for years. The development of a drug to treat TBI could reduce secondary brain damage and improve the quality of life for our Service Members.

Despite years of research on the pathologies and symptoms caused by TBI, there are still no U.S. Food and Drug Administration-approved drugs for treating TBI. More than 30 drug trials for TBI have failed over the past few decades, and the reasons for these failures are complex. Recent publications regarding failures in TBI drug trials noted that there were risks in moving drugs forward into Phase 3 trials before understanding how the drugs really worked. They suggested that more work should be done during the early exploratory trials to understand how the drug works, the right dose and timing of the drug. It has even been suggested that the way clinical trials are conducted could improve by categorizing patients based on brain imaging and blood-based biomarkers, in order to tailor each drug trial.

The DOD has established an acquisition strategy to leverage partnerships to improve both the quantity and quality of drugs in the pipeline of development for the treatment of TBI. This important work by TRACK-TBI NET will fully characterize TBI candidate drugs in focused Phase 2 trials and help to understand their risks for Phase 3 trials. The ultimate goal is to partner with industry and stakeholder groups to advance TBI drugs into Phase 3 and obtain FDA approval to deliver this urgent need for the military.

"In essence, we need to find a better way for TBI drug development. For years, the TBI community, including the DOD, has funded partners to study TBI drugs separately, in silos. With this effort, we wanted to break down the silos by establishing a central network to standardize exploratory Phase 2 trials and study multiple drugs in one trial framework," said Dr. Krista Caudle, product manager at USAMMDA.

The DOD and TRACK-TBI NET will also work with the FDA to increase efficiency of TBI drug trials. The FDA's Center for Drug Evaluation and Research has recognized the need for alternative approaches to testing drugs and released a request for public comment.

"The TRACK-TBI NET team recently responded to the FDA's new program for Complex Innovative Designs Pilot, so we're excited to be at the forefront of this paradigm shift," said Caudle.

Increased efficiency of clinical trials has the potential to advance drugs to the next stage sooner and at a lower cost. In addition, this new acquisition strategy plans to capitalize on one of the advantages of the Medical Technology Enterprise Consortium Other Transaction Agreement mechanism, which has the potential to bring in funding from external partners to accelerate the testing of additional drugs.

"Ideally, our external partners will see the value and success in this new mechanism for TBI drug trials and will join the team. The more potential solutions we can study, the higher the probability of success in finding a way to prevent the progression of injuries in the brain and restore function for wounded Service Members," Caudle noted.

Public/private partnerships can leverage resources from stakeholders across the DOD, Government, academia, non-profits, advocacy groups and industry to tackle this complex gap in healthcare.

As the premier developer of world-class military medical capabilities, the USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.

Last Modified Date: 10/15/2018