Consensus Conference on Drug and Device Development Efforts for Traumatic Brain Injury

DOD Program Joins Universities, FDA, Companies, Philanthropies


Better designed clinical trials leading to the first successful treatments for traumatic brain injury (TBI) are the goals of UC San Francisco neurosurgeon Geoffrey T. Manley, MD, PhD, and a team of the nation’s experts on the TBI Endpoints Development (TED) Award. Launched in October 2014 with a $17 million, five-year award from the Department of Defense (DoD), the TED team recently hosted a consensus conference on February 2-3 on the campus of the National Institutes of Health in Bethesda, MD, with panels and expert working groups drawn from academic research, the medical device and pharmacologic industries, philanthropy, and Food and Drug Administration (FDA) regulators. The TED Initiative is at the forefront of the precision medicine approach to developing drugs and devices for effective diagnosis and treatment of brain injury.

Each year more than 2.5 million people in the U.S. seek medical care for traumatic brain injuries that arise when blows to the body or nearby explosions cause the brain to collide with the inside of the skull. According to the U.S. Centers for Disease Control and Prevention and an estimated 2 percent of the U.S. population now lives with TBI-caused disabilities, at an annual cost of about $77 billion. No TBI treatment has proved to be effective.

“TBI is really a multifaceted condition, not a single event,” said Manley, the principal investigator for the new award. “Over 30 clinical trials of potential TBI treatments have failed, and not a single drug has been approved. We will bring a precision medicine, Big Data approach to understanding the complexities of the condition, and its effects on individuals. Only this kind of deep knowledge will get us to the treatments we desperately need.” Manley and UCSF Vice Chancellor for Research and Executive Vice Dean of the School of Medicine Keith Yamamoto have long advocated for this approach, and were guests at the White House when President Obama announced the “Precision Medicine Initiative” on January 30, 2015.

TED’s unique public-private partnership of researchers are collecting a broad range of long-term data from existing studies and databases, and integrating these into a dataset that can be interrogated for TBI associations and causes in a way that has never before been possible.

“The conference kicks off what we hope will be ongoing and collaborative work with the FDA to come up with better methods for selecting patients for clinical trials, and better ways to measure patient outcomes to identify effective TBI treatments, using biomarkers from blood, new imaging equipment and software, and other tools,” Manley said.

To view the full conference agenda and presentation materials, click the links below.