GAINESVILLE — With the belief that scientific research fuels high-tech industry, state legislators have invested $10 million in the University of Florida to create the Center of Excellence in Regenerative Health Biotechnology in Alachua County. Leaders believe the center will move Florida to the forefront of the global technology industry by addressing an international shortage of bioprocessing facilities. The center is expected to create high-tech jobs in the community and training opportunities at UF and Santa Fe Community College, while also spinning off companies that have the potential to produce hundreds of additional jobs in the Gainesville area.
The University of Florida Research Foundation will add $3.6 million to the effort to purchase a pair of buildings, formerly occupied by Regeneration Technologies Inc., to house the bioprocessing center near the Sid Martin Biotechnology Incubator in Progress Corporate Park. Once the buildings are acquired, the center could be operational in less than two years. The complex will give area companies — many of them offshoots of Health Science Center research — a place to process regenerative health biotechnology products. Gene therapy and adult stem cell therapies will be developed for chronic diseases such as congestive heart failure, diabetes and cancer.
“The idea is to transition research that’s done at the university and make it into a viable commercial program,” said Barry Byrne, Ph.D., M.D., of the UF Genetics Institute and director of UF’s Powell Gene Therapy Center. “We can do a small safety study at the university, but to really help people with a given disease requires a commercial partner or an industry sponsor. That’s mainly because the production costs and standards are far outside of what a university-scale project would involve. In addition, viable treatments require marketing, distribution and other things that we don’t do in a university setting.”
The Center of Excellence evolved from the Florida Technology Development Act, spearheaded by Gov. Jeb Bush and passed by the Florida Legislature in 2002. It set aside $30 million to fund up to five Centers of Excellence at Florida universities, according to Win Phillips, UF’s vice president for research and dean of the Graduate School. In the end, three university proposals, including UF’s, were selected out of 16 considered. The mission of the centers is to create an economy in Florida that is driven as much by technology as by tourism. And the surest way to achieve that goal is through enhanced research and technology-transfer activities at universities, Phillips said. “All of the nation’s great technology centers are tied directly to universities: Silicon Valley to Stanford and Cal-Berkeley, Boston’s Route 128 to MIT and Harvard, and North Carolina’s Research Triangle Park to N.C. State, UNC-Chapel Hill and Duke,” Phillips said.
One or two companies will be created in cooperation with UF to manage the center, according to Sheldon Schuster, Ph.D., director of UF’s Interdisciplinary Center for Biotechnology Research and a professor of biochemistry and molecular biology. With a stake in the companies that run the center, UF will receive some revenue for research but none of the actual hands-on management responsibilities. “Say a scientist produces something useful in the laboratory that has potential to be used clinically — you don’t expect that researcher to hire people to set up processing facilities and quality-control procedures. That takes special skills and experience,” said Schuster, who presented UF’s proposal to the legislature. “You want a company that can say, ‘We have the skill set, we have the experience, we know how to do it. You come to us with your product, and we will work with you to get it scaled up, and we also have the procedures so that the product can be made under Good Manufacturing Practices standards.’” Meeting GMP standards, which are regulated by the Food and Drug Administration, is a hurdle that many fledgling companies can’t overcome, Schuster said. Facilities must be able to produce materials of such quality that they can be used in clinical trials. Every agent, product, work area and procedure must stand up to rigorous certifications. Production personnel must be trained and certified, and those certifications are continually reviewed. “Researchers with the Adult Stem Cell Research Program are a great example of people who may be able to use the center. They are going to produce cells that can hopefully be used to regenerate nerves. They are great scientists, but they don’t have the experience to scale things up to large levels,” Schuster said. “What they would do is go to the management company, and say, ‘Here is what we need to do. We need this much product to treat this many patients, and we need to have the procedures so the FDA can come and inspect and check all of our paperwork.’” Working under such stringent standards produces unique training opportunities, Schuster said. Programs will be developed at Santa Fe Community College and UF to teach students about Good Manufacturing Practices and FDA regulations. “We wanted to emphasize work-force training. Santa Fe Community College has a biotechnology training program, and it is going to increase its program to include regulatory affairs,” Schuster said. “The management company is going to use a large number of people, and they have to be produced in the community. So here is a really nice interface — we plan to put a small laboratory in the facility for Santa Fe students to use. The students will be able to get internships, training, and maybe even walk down the hall and get jobs.”
Executives with an Atlanta-based consulting company hired more than a year ago by the Gainesville Area Chamber of Commerce see tremendous potential for economic growth in the biotechnology sector, largely because of UF and the Sid Martin Biotechnology Development Incubator, said J. Brent Christensen, president and chief executive officer of the chamber and the Gainesville Council for Economic Outreach. The Center of Excellence is the next step for the area to realize that potential, Christensen said. “Our worry has been that we would incubate these companies only to watch them pull up stakes to do a clinical trial,” Christensen said. “They would get to the point of becoming a legitimate company, and we would watch them go away. We want to be able to house these companies here in Alachua County and keep them. We want to enhance our economy rather than Boston’s or Raleigh’s.” Besides the economic benefits, Schuster said the center would benefit UF’s academic and research programs. “Most of these companies are spinoffs from science going on at the Health Science Center,” Schuster said. “Some of these will become giant hits, and that is going to provide revenue back to the scientists, the labs and the university.”
When state officials evaluated proposals, they looked for areas where new science could emerge. UF emphasized epigenetics, which deals with the understanding of gene expression, such as how identical DNA in the cells of an organism can create either a caterpillar or a butterfly, depending on how the genes are regulated and organized, according to Thomas Yang, Ph.D., a professor of biochemistry and molecular biology and program director of the Center for Mammalian Genetics. Epigenetics is critical to the stem cell biology and gene therapy work that will go on at the regenerative health center, said Yang, who is a member of the UF Genetics Institute. In fact, the university committed $6.7 million over the next five years to establish three new faculty research positions in epigenetics, in addition to two positions in bioprocess engineering.
The possibility that the Regenerative Health Center might fall short of the great expectations held for it isn’t a consideration, said Dennis Steindler, Ph.D., of UF’s McKnight Brain Institute and a member of the Adult Stem Cell Research Program. “The programs and technology already in existence are great,” Steindler said. “What was required was investment and support for bioprocessing facilities and trained personnel. The state really has to be congratulated. This will produce jobs, facilitate training of technical people to work in this new area of regenerative health, and the effort spans all of the university’s departments and institutes.”