“The perfect storm.”
That is how three University of Florida researchers describe their collaboration that resulted in Banyan Biomarkers.
The company made the news in February when the U.S. Food and Drug Administration approved Banyan BTITM (Brain Trauma Indicator), a blood test to aid in the evaluation of patients with suspected traumatic brain injury (TBI). Based on the level of specific biomarkers present in the blood shortly after trauma to the head, doctors now have a quick and objective way to identify patients with head trauma who could safely forego the need for a CT scan, thereby avoiding unnecessary radiation to the brain and reduce costs of care.
“No idea originates in a moment,” said Dr. Ron Hayes, the lead researcher and one of the founders of Banyan Biomarkers. “Collectively, ideas become a kind of stew.”
“The idea that led to Banyan Biomarkers started with a simple collaboration between a biochemist and an expert in traumatic brain injury, me. Add an expert in proteomics – and you have the perfect storm of collaborative relationships.”
This perfect storm of collaborative relationships built a company that can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury. The goal is to bring this test to the sideline of an athletic field or in a medical facility near a battlefield or near an accident on the highway. It can make the difference between life and death.
The long, hard struggle, the day-to-day challenges of a startup company that led to this moment, this story of success is a convergence of not one but rather a number of perfect storms. A perfect storm of collaboration. A perfect storm of circumstances. A perfect storm of support.
And the end result is what one participant called a good story about “a good company with good people committed to saving lives.”
Perfect storm of collaboration
Hayes, along with UF researchers Dr. Kevin Wang, the “biochemist,” and Dr. Nancy Denslow, the “expert in proteomics,” are the “perfect storm” of collaborators who founded Banyan Biomarkers.
The trio met at UF Innovate | Tech Licensing recently to discuss their company’s success and reminisce about the company’s progression from an idea to an FDA-approved product with the potential to make the world better. Hayes, originally recruited by the University of Florida’s McKnight Brain Institute to start a center for traumatic brain injury, has more than 35 years of experience studying brain injury.
(Nancy Denslow, Kevin Wang, and Ron Hayes are UF research collaborators who formed Banyan Biomarkers.)
Back in 2001, the National Institutes of Health (NIH) asked Hayes about proteomics.
“Proteomics is a field interested in providing a comprehensive view of proteins in an organism – both in specific time and conditions and over specific time and conditions,” Hayes explained. “At the time, it was a relatively new field never applied to brain injury.”
Proteomics is the study of proteomes, the entire protein set coded by the genome of an organism or cell type. Proteins are vital parts of living organisms that aid enzyme catalysis, defense, transport, support, motion, regulation, or storage.
“When you use the proteomic method, you find hundreds of proteins,” Wang said. “It’s impossible to narrow the field except by using ‘smart proteomics’ – finding candidate proteins and then pulling on the backgrounds and knowledge and expertise of the inventors to find the ones relevant to brain injury.”
“I reached out to other researchers, Nancy Denslow and Kevin Wang,” who both had experience in proteomics, explained Hayes, “and, ultimately, we came up with blood-based biomarkers for brain injury.”
Wang came to the McKnight Brain Institute in 2002 after working in pharmaceutical companies, where he got introduced to the concept of using biomarkers in disease-monitoring and in therapeutic development. His work in neuroproteomics, biomarkers research and industrial experience has proven invaluable to the Banyan team.
Denslow has a joint faculty appointment through the College of Veterinary Medicine and the College of Medicine at UF. But when Hayes reached out to her in 2001, she was serving as director of the Interdisciplinary Center for Biotechnology Research and was known for her expertise in proteomics.
“Identifying biomarkers is easy,” said Hayes. “It’s finding the clinical value of the role of the biomarkers in injury and disease that’s extremely difficult. And that was the unique strength of the inventors.”
Biomarkers are measurable substances that indicate the presence or severity of disease. The brain-specific biomarkers Banyan uses are the proteins Ubiquitin C-terminal Hyrdolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP). Immediately following an injury to the head, these proteins are released from the brain and circulate in the blood.
Banyan’s simple blood test of these two specific protein biomarkers provides objective quantifiable information to physicians, to eliminate unnecessary CT scans, guide patient care, and increase efficiency in the emergency department.
Perfect storm of circumstances
UF Innovate | Tech Licensing works with university staff and students to protect their intellectual property and help them get their ideas out of the lab into the marketplace where the ideas can do some good. Sometimes getting those ideas into the marketplace takes inventors who believe so much in their invention that they’ll become entrepreneurs and create a startup to make it happen.
Hayes, Wang and Denslow are those inventors. Though they had no experience in starting a business, they did what it took to get the company going.
“Banyan is a perfect illustration of how UF works,” Denslow said.
“UF was very supportive,” agreed Wang. “We were all faculty – and yet they enabled us to do this.”
The team took space at UF Innovate | Sid Martin Biotech in Alachua and benefitted from the incubator space as well as the leadership of Patti Breedlove, then-director of Sid Martin.
“Your passion has to be nurtured by your naiveté if you’re starting a company,” Hayes observed. “We faced great skepticism on this journey. The first time Kevin and I went to the NIH, they had absolutely no interest. People at that time simply didn’t believe biomarkers in the blood could indicate brain injury.
“They had two prejudices: the scientific dogma that suggested the blood-brain barrier would prevent a measurement and the prejudice that they didn’t believe there was a need for such a test. Of course, now the clinicians would disagree.”
But in 2003, the NIH supported the team’s work financially. That funding supported biomarker research in human traumatic brain injury. The early basic science and clinical studies provided data for patent applications filed by UF and licensed to Banyan.
At the beginning of the 21st century, when Hayes and his team thought they were onto something special with their biomarkers for brain injury, traumatic brain injuries took center stage in both sports and war. Circumstances would add to “the perfect storm” of collaborator expertise.
“Banyan Biomarkers was in the right place at the right time,” according to former Banyan CEO Jackson Streeter.
Football and other sports showed that a number of retired players who had suffered repeated concussions and more severe brain trauma developed memory and cognitive issues, such as Alzheimer’s disease, depression, or chronic traumatic encephalopathy (CTE).
Autopsies done on some athletes who had committed suicide displayed evidence of CTE, raising public awareness of the long-term, potentially deadly, risk of repeated concussion and head trauma.
Traumatic brain injury also made headlines on the warfronts in Iraq and Afghanistan, where 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,” said Streeter, who currently serves as chief medical officer for Banyan.
Perfect storm of support
Those high numbers of brain injuries among soldiers made it easy to draw the attention of then-Congressman C.W. “Bill” Young, chair of the House Defense Appropriations Committee, to Banyan’s research.
“I was intrigued by the science and its potential for saving lives, plus the expanding market potential, and I readily agreed to help the company,” said former Gainesville Mayor David Flagg, who had been introduced to Hayes and his work with Banyan through a mutual friend. Flagg’s experience in Washington, D.C. would prove integral to navigating requests for federal government funding for Banyan.
As a state representative representing Alachua County and later as director of government relations for Shands HealthCare, Flagg had built relationships with the Florida Congressional delegation, including the late Rep. Young (R), Rep. Karen Thurman (D), Rep. Mike Bilirakis (R), Rep. Cliff Sterns (R), Sen. Bill Nelson (D), Sen. Bob Graham (D), and Sen. Connie Mack (R).
“I reached out to this bipartisan group, and the timeliness of Banyan technology was enthusiastically accepted by Congressional leaders,” Flagg said. “The rest of the Florida delegation came on board later. They saw Banyan’s technology as important, first of all to our military ‘warfighters,’ then for diagnosing TBI occurring in various sports as well as brain injury in the average population.”
Rep. Young requested the Department of Defense commit $3 million to Banyan over a period of 2 years.
“The DoD felt the impact of this issue because of the injuries soldiers were experiencing in the wars,” Wang explained, “and because the DoD is problem-solving oriented, they were more inclined to pursue objective solutions such as our biomarkers.”
The initial $3 million DoD appropriation was just the beginning. In 2006, it allocated $24 million to the stage of research. Following Banyan’s successful completion of that stage, the DoD allocated funding for $64 million for the FDA-sanctioned pivotal trial resulting in FDA approval of the blood test. The contract is still ongoing.
In addition, the National Football League and General Electric provided money to Banyan to do research with University of Florida and, eventually, additional NCAA athletes. The grant allowed UF physicians who work with the athletes to take baseline and post-injury tests to study their ability to help diagnose sports-related concussions.
In short, it was a perfect storm of circumstances that provided a perfect storm of support to a perfect storm of collaborators. The result was Banyan Biomarkers’ test that will change the landscape for diagnosing and treating brain injury.
David Day, then-director of UF Innovate | Tech Licensing, gives much credit to Hayes.
“Rare is the individual who has the vision and yet at the same time the professional humility to put together a solid scientific team, to bring in a government affairs pivotal player and then iterations of management leadership as the company grew and evolved,” Day said. “Ron is one of the few special individuals I have observed to pull off such a feat.”
Banyan Biomarkers’ simple test is the first objective blood test for traumatic brain injury. It measures levels of protein biomarkers specific to the brain and detectable shortly after an accident in which concussion or brain injury are suspected.
Physicians widely use CT scans to evaluate suspected traumatic brain injury, though the scans don’t provide clear and objective answers.
More than 90 percent of patients presenting to the emergency department with mild TBI or concussion have a negative CT scan. Despite these limitations, nearly all patients are sent for a CT, which results in increased costs to the healthcare system and unnecessary patient exposure to radiation.
Banyan’s blood test may rule out the need for CT scans in patients with suspected mild traumatic brain injury.
“It takes $200-300 million to get a biomarker approved by the FDA,” Hayes said.
The perfect storm of collaboration, circumstances and resulting support made it happen. Flagg credits Gary Ascani and Streeter, who both served as CEO at some point along Banyan’s journey, as well as current CEO Hank Nordoff and Amy Griffin, who has served as director of operations and been essential to Banyan’s progress.
“Working tirelessly together and always putting the company first, Team Banyan recently achieved a major goal – that of FDA approval,” Flagg said. “This distinction reflects that of a good company with good people committed to saving lives.
“The new Banyan test is named Banyan Brain Trauma Indicator. Watch for it.”