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March 28, 2017

In Gainesville, Biopharma Finds a Place in the Sun

Florida Region Has a Top-Tier Incubator, Recognized Schools, and Growing Companies

In Gainesville, Biopharma Finds a Place in the Sun

Applied Genetic Technologies is conducting clinical trials of adeno-associated virus-based gene therapies for rare diseases.

  • From temperatures ranging from the 60s to the 90s, to natural attractions like the Butterfly Rainforest at the Florida Museum of Natural History, Florida’s Gainesville region is best known for sun and fun.

    Yet, the region is also home to a Biotech incubator ranked among the world’s best, and one of the nation’s top medical schools, both part of the University of Florida (UF). Another area academic institution, Santa Fe College, trains entry-level lab technicians through its biotechnology laboratory technology program, which helped the school win the 2015 Aspen Prize for Community College Excellence. Students from Santa Fe and UF staff biopharma companies in and around Gainesville, where an historic railroad bridge was transformed into the Double Helix Bridge, a pedestrian overpass resembling DNA.

    “Florida is a pretty nice place to work. We're not on the coast, but it's an easy drive to either the Gulf Coast or the Atlantic Coast from where we are,” said Gary A. Ascani, vice president of business development with Nanotherapeutics, a development- and manufacturing-focused biopharma based in Alachua, FL, a two-hour drive from Orlando.

    In December, Nanotherapeutics celebrated the completion of a 183,000-square-foot BSL-3 single-use, multiproduct, multipurpose facility in Alachua. Work has already begun in the process development labs, with manufacturing qualified to begin there by early April. The facility’s four suites can be used upstream or downstream as needed; two are now upstream, two downstream.

    “We envisioned, as did the DoD, that this facility could actually double in capacity,” Ascani said. “We expect that by the end of 2017 or beginning of 2018, we'll be getting close to a point where we'll have to start planning the build-out in the facility here,” Ascani said.

  • Doing Great Things

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    Nanotherapeutics recently completed construction of a 183,000-square-foot BSL-3 single-use, multiproduct, multipurpose facility in Alachua.

    Helping bring that facility to Alachua was the Gainesville Area Chamber of Commerce and its economic development arm, the Council for Economic Outreach. They worked with officials from the state of Florida, Alachua County, and the City of Alachua to craft an up-to-$1.05 million tax-rebate package for the company in return for creating up to 150 new jobs. The state agreed to pay 80% of that rebate, with the county and city each shouldering 10%.

    “Nanotherapeutics was one of the perfect examples of a high-wage job developer in one of the industry sectors that we're targeting, and it's a home-grown company just doing great things,” said Staci-Ann Bertrand, the Chamber’s director of industry development.

    Nanotherapeutics built the Medical Countermeasures Advanced Development and Manufacturing Facility after leading a consortium of companies in winning a 10-year, just-over $400 million DoD contract. In addition to DoD work, the facility allows expansion into commercial markets. To date, seven companies, all undisclosed, are at various stages of contractual work—including a flu vaccine developer expected to start within weeks.

     “A significant portion of the facility is likely going to be used for manufacturing work with commercial companies that have monoclonal antibody products, vaccines, or other biological products,” Ascani said. “There really is a need for BSL-3 space, and certainly single-use and flexible manufacturing space.”

    Ascani said the new facility reflects a change in direction for Nanotherapeutics: “We are essentially doing a pivot from being a product-centric company to a service provider, being one of a few contract development and manufacturing organizations that actually has BSL-1 through BSL-3 capabilities.”

    Privately held Nanotherapeutics has about 188 employees, of which 125 are based in Alachua. Another 45 work in a BSL-3 commercial-scale manufacturing facility in Bohumil, Czech Republic, that the company acquired from Baxter International. Ten are based at the company’s government contracting office in Frederick, MD; and eight in Berkeley, CA, where the company has secured from XOMA a technology to produce monoclonal antibodies against botulism toxins.

  • Keeping Down Costs

    Also growing is Applied Genetic Technologies Corp. (AGTC), which is conducting clinical trials of adeno-associated virus-based gene therapies for rare diseases. AGTC’s pipeline includes six ophthalmology development programs: X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia caused by mutations in the CNGB3 and CNGA3 genes, wet age-related macular degeneration and blue cone monochromacy—as well as a program targeting alpha-1 antitrypsin deficiency; and proof-of-concept data in additional indications.

    The company’s priorities for 2017 include advancing patient enrollment in the ongoing Phase I/II clinical trials for its XLRS and achromatopsia candidates, and filing an IND for the XLRP candidate. Data from the dose-escalation phase of the XLRS trial is expected in mid-2017. AGTC is developing the XLRP and XLRS candidates through an up-to-$1 billion collaboration with Biogen launched in 2015.

    AGTC has 75 employees, of which 50 are based at its headquarters in Alachua. The rest are in Cambridge, MA, where the company bases employees working in business development, patient advocacy, legal, and pharmacology & toxicology.

    “The Cambridge area affords us direct access to peers and to partners, and to intellectual property at other universities, but maintaining a large footprint here in Florida keeps our overall cost structure down,” Washer said. “With the all-in-square-foot-cost in Cambridge at approximately $120 a square foot, and the all-in-square-foot-cost in Florida at approximately $35 a square foot, we have quite a motivation to maintain our presence here.”

    The Gainesville region’s strengths, Washer said, include its mix of life science businesses, four of which are publicly traded. In addition to AGTC, they include medical technology companies Exactech, AxoGen, and Royal Philips-owned Invivo.

    Both AGTC and Nanotherapeutics emerged and graduated from the Gainesville region’s Biotech incubator, the UF Sid Martin Biotechnology Institute. Established in 1990, Sid Martin opened its current facility within Alachua’s Progress Park five years later, and in 2013 won the “World’s Best University Biotechnology Incubator” ranking in a study by Sweden-based research group UBI.

    Over the past seven months, Sid Martin has welcomed 14 new companies filling some 90% of the former space of Pasteuria Bioscience, an agricultural biotech founded at the incubator in 2003 and acquired in 2012 by Swiss-based agribusiness Syngenta for up-to-$113 million.

  • Three Expectations

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    Established in 1990, Sid Martin opened its current facility within Alachua’s Progress Park five years later.

    Mark S. Long, director of the UF Sid Martin Biotechnology Institute, says the incubator has three expectations of its startups.

    “Number one is grow—take up more size than we could really give them. They really should be occupying more than 20–25% of the total building,” Long said. “Number two is become profitable—put a product out on the market and start making revenue. Number three—we sit down with them along with the mentors and advisors that we have on our advisory board, and set milestones for them, and they need to hit them.”

    Sid Martin’s 28,000 square feet of leasable space is home to 16 tenant companies, four “associate” companies that have graduated and still maintain an association; and 12 “affiliate” companies that use services of the Institute but do not occupy space.

    Small labs range between 450 and 500 square feet. Larger labs are 950 to 1,000 square feet and small offices, about 150 square feet. Rent is $28 per square foot for startups, $32 per square foot for established companies.

    Biopharma and other “human life sciences” constitute one of five industry sectors targeted for growth by the Gainesville Area Chamber and Council, through their Transforming Greater Gainesville Five-Year Economic Development Strategy, launched in 2015. The other sectors are agricultural life sciences, software IT, advanced logistics, and advanced materials. The Chamber and Council have committed to adding 3,500 new jobs and $250 million in investment from the industries.

    The region’s Biopharma workforce as of 2015 included 550 jobs classified by the U.S. Census Bureau as R&D services, and another 280 jobs at medical and diagnostics laboratories. Helping build the Biopharma workforce, Bertrand said, has been UF’s College of Medicine, which has graduated more than 5,000 physicians and climbed to 40th of 140 medical schools ranked by U.S. News & World Report.

    “The ultimate goal is that Gainesville be a global hub of talent, innovation and opportunity,” Bertrand said.

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