University-industry ties speed worldwide transfer of new human health-care products

Taking the innovative ideas of university researchers and turning them into marketable products is no small fete, given the fact that few researchers have equally sound footing in science and business.

At the University of Florida, such “mind to market” transfers have been accelerating briskly during the past five years through effective industry connections. A lot of the action results from discoveries in the life sciences, many of which have originated in the Health Science Center colleges and in multidisciplinary brain, cancer and genetics programs.

Recent discoveries by faculty in studies related to adult stem cells, genetics and immunology have yielded ideas that suggest potential new ways to treat diabetes and brain tumors and to aid prevention of kidney stones and common tooth decay. In all these subject areas, the scientists are seeking industry help to further evaluate their concepts’ marketability and to develop health-care products that meet FDA quality standards.

One key factor in the recent flourish of laboratory to market transfers is UF’s Sid Martin Biotechnology Development Incubator, named for the former state legislator who sought state funds to build the facility in 1988 at Progress Corporate Park near Alachua. The park itself, initiated by UF and later sold to private investors, also is thriving as it nears its 20th anniversary.

“The incubator and research park together serve as a catalyst for new company development and as a magnet that attracts outside health-related industries to this area,” said Sheldon Schuster, Ph.D., now in his 13th year at the helm of UF’s Biotechnology Program.

Schuster said the incubator now is gaining “national recognition for its progressive growth. The National Business Incubation Association last year ranked our facility first among 79 business incubators nationwide in the amount of intellectual property licensed into its client companies, fourth in average equity investment and seventh in average employment growth.”

Incubator Manager Patti Breedlove cites the numbers that support the ratings. She said 26 companies — all connected to the university — have launched their operations in the incubator. These companies have raised $36 million in equity investment, garnered $10 million in federal research grants and created the equivalent of 554 full-time job years. A dozen companies are still in the incubator, and another dozen are growing outside the park within the local region.

Occupants of the incubator have access to autoclaves, office equipment, high-speed Internet connections, modern animal research facilities and other resources difficult to afford during business formation. Close connections to UF’s biotechnology faculty and neighbors in the business park enable the fledgling companies to consult experts in business planning and management, legal affairs, government regulations, licensing agreements and marketing.

“We collectively — our many productive faculty scientists and their technical support teams — have become big enough and powerful enough to attract several venture capital companies to the Gainesville area,” said Schuster, who also directs UF’s Interdisciplinary Center for Biotechnology Research and is a professor of molecular genetics and microbiology.

The owners of one newcomer, Inflexion Partners, have announced plans to provide financial help to local small businesses involved in biotechnology and life sciences.

“To further expand UF’s biotech research enterprise, we’re trying to remove obstacles to the success of the companies we’re helping to build,” Schuster said. “One of the biggest limitations is the lack of a Good Manufacturing Practice (GMP) facility for large-scale production of human health-care products that meet FDA standards. It’s costly to build and staff such facilities, and there is an incredible shortage of such places that do this work for small companies.

“The good news,” Schuster said, “is that a solution appears to be in the wings through an anticipated $10 million appropriation from the state of Florida’s Emerging Technology Commission.”

Building on the successes of the business incubator, the UF Research Foundation plans to buy and renovate two existing buildings at Progress Corporate Park to create a GMP bioprocessing facility, which will be staffed by experts in quality control and regulatory affairs. The proposed facility will feature labs designed specifically for cell culture, production of gene-transport molecules (vectors) for gene therapy, and a large microbial fermentation system. “It will be the first facility of its kind in the Southeast, and we plan to make it a resource for scientists from all Florida universities,” Schuster said. “Services will be provided through contract arrangements with the users.”

First users are likely to include Ixion Biotechnology Inc., a company established to develop medical products based on internationally acclaimed discoveries by UF pathology Professor Ammon Peck, Ph.D. Ixion’s 17-member team of chemists and technical experts urgently need the modern high-speed fermentation equipment to produce sufficient quantities of a new bacterial supplement designed to prevent kidney stones and related diseases.

We have proven through extensive studies in rats that when sufficient amounts of the naturally occurring bacterium known as Oxalobacter formagenes are ingested, the organism breaks down harmful amounts of oxalate (a byproduct of digestion) before kidney stones can be formed,” Peck said. “We developed a bacterial supplement and gained FDA approval to evaluate it in clinical trials, but we are blocked by the lack of ability to mass-produce the supplement under GMP standards. We need sophisticated fermentation equipment in which to grow large amounts of this anaerobic bacteria, which thrives only in an oxygen-free environment.”

Peck, whose research team recently changed their dietary supplement from liquid to pill form, said, “The new GMP bioprocessing facility will certainly help us to move forward.”

And that will open the door to fully assessing the product’s effectiveness in preventing recurrent kidney stone formation in adults and in treating children born with a genetic abnormality that causes a lethal buildup of oxalate in their kidneys and throughout their bodies. The stakes are high for this research development, since more than half a million Americans develop kidney stones each year.

Schuster, well known as a visionary program builder, now is leading efforts to create a UF Center of Excellence in Regenerative Health Biotechnology that will capitalize on “breakthrough technologies” in gene therapy, bone and soft tissue replacements, organ transplantation, genetically modified bacteria for preventing tooth decay and treating certain infectious diseases, new anti-cancer drugs and immunotherapy for brain tumors, as well as the development of both a diagnostic test and a first-of-its-kind medication for traumatic brain injuries.

At the same time, as one of the organizers of a biotechnology trade organization called BioFlorida, Schuster is making a public bid to position Florida as “the epicenter of regenerative health and biotechnology research and company development within five years.” Jani Sherrard, associate director of the UF Biotechnology Program, says the time is right for both.

“Universities are like diamonds in the rough; we’re tripping over powerfully beneficial ideas that need industry support to develop high-quality marketable products efficiently,” she said. “There is greater receptiveness today to the tremendous intellectual capital spawned by university scientists and better awareness of the utility and human value of university-industry partnerships.

“What’s driving this is the obvious potential for public good,” Sherrard said.