A team that came together at the University of Florida early in the 21st century with the goal of revolutionizing testing for traumatic brain injuries is seeing its work pay off.
In February, the U.S. Food and Drug Administration approved a blood test that the team initially developed – an approach that will help doctors determine the need for a CT scan in patients with mild traumatic brain injury and help prevent unnecessary radiation exposure to patients.
UF was essential to reaching this milestone, said Ronald Hayes, who together with Nancy Denslow and Kevin Wang, founded the company developing the test, Banyan Biomarkers.
“As I worked with other institutions during our research, I realized how blessed we were to be working at UF,” he said. “UF has been very nurturing. Ideas like ours often wither on the vine.”
The synergy at UF had several components, including:
• UF’s support of researchers’ in commercializing their inventions
• The university’s diversity of researchers and its ability to attract new ones
• The connection of UF to congressional leaders who helped attract federal dollars for research on traumatic brain injuries
The key player who helped the team commercialize its work was David Day, whom Hayes met soon after coming to UF to head the Traumatic Brain Injury Center at UF’s McKnight Brain Institute.
Day headed the Office of Technology Licensing (now UF Innovate | Tech Licensing) until he retired last year.
He transformed UF’s approach to helping researchers commercialize their work, resulting in the university becoming a national leader in the field, Hayes said. “David put us on the map in tech transfer,” he said.
With the help of the Office of Technology Licensing, Hayes started Banyan in 2002 – housing it in UF Innovate | Sid Martin Biotech in Alachua, a business incubator that helps start-up companies in their early stages.
Hayes also hired Jackson Streeter, who had experience in commercializing medical technology, as the company’s CEO.
“It’s been really important that UF has stayed with us through research milestones, business planning and financing,” Streeter said.
UF’s research environment was essential to Banyan’s emergence, Hayes said.
Nancy Denslow, one of the two other Banyan founders, already was on campus when Hayes started his research on biomarkers.
She was serving as director of the Interdisciplinary Center for Biotechnology Research and was known for her expertise in proteomics – the study of proteomes, the protein set coded by the genome
of an organism.
The third company founder was Kevin Wang, who had been working in pharmaceutical companies on the concept of using biomarkers to monitor diseases and develop therapies.
Banyan’s test detects two biomarkers that cross the blood-brain barrier after a head trauma.
UF’s culture of supporting researchers in commercializing their work is outstanding, Wang said.
When Hayes and his team were proving that two biomarkers could circulate in the blood and be associated with traumatic brain injury, the impact of concussions and more severe brain injuries from war and sports grabbed national attention.
“Banyan Biomarkers was in the right place at the right time,” Streeter said.
The headlines focused on memory loss, depression, suicide, and Alzheimer’s disease among National Football League players who had had experienced brain trauma.
In the wars in Iraq and Afghanistan, the Department of Defense found that as many as 400,000 soldiers had suffered traumatic brain injury in bombings.
“The signature injury of the wars in Afghanistan and Iraq was traumatic brain injury,” Streeter said.
At this time, David Flagg, a former Gainesville mayor and Florida state representative, was director of government relations for Shands HealthCare.
Flagg reached out the late U.S. Rep. C.W. “Bill” Young of Florida, then chair of the House Defense Appropriations Committee, about Banyan’s research.
Young requested the Department of Defense commit $3 million to Banyan over two years.
Flagg also gained the support of other members of the Florida congressional delegation.
“I reached out to this bipartisan group, and they enthusiastically accepted the timeliness of Banyan technology,” Flagg said.
Since the initial $3 million appropriation, the DOD has allocated $24 million for additional research and $64 million for the clinical trials that resulted in FDA approval of Banyan’s blood test.
The NFL and General Electric also have provided money for research that included studies of student-athletes.
Banyan is moving forward in partnership with two medical technology companies – Abbott Laboratories Inc. and bioMérieux of France – to incorporate its blood test onto diagnostic platform devices already in hospitals and emergency rooms throughout the world.
Streeter, now Banyan’s chief medical officer, is optimistic that the FDA approval will result in the blood test going to market in coming years.
“We’ve landed on the beach, just as the Allies landed on the beach in Normandy, and we’ll take it from there,” he said.
Photography by Michelle Friedline