THE STATE OF LIFE SCIENCE

By Dennis MeredithTHE STATE OF LIFE SCIENCENorth Carolina combines academic, industrial, government, and private resources to drive research, development, and manufacturing A half century ago, the world was only beginning to grasp the stunning implications of Watson's and Crick's double-helix DNA structure. Amidst those earliest glimmerings of the genetic revolution, North Carolina was already laying the foundation for its 21st-century success in biotechnology. In 1959, however, the evidence of North Carolina's ambitions consisted not of gleaming scientific laboratories, but only of 3,500 acres of dense pine forest. It was the daring plan of a cadre of academic, business, and government leaders to carve from that forest a vast Research Triangle Park (RTP) that would enlist the scientific talents of the area's universities, supported by government and private investment.Today, RTP sprawls over 7,000 acres in roughly the center of the state. It includes 19 million square feet of facilities and 119 research and development organizations. The park, as well as the tradition of collaboration that nurtured it, sparked a powerful driving force for the growth of the state's high-technology industry, and none so prominent as biotechnology.COURTESY OF RESEARCH TRIANGLE FOUNDATION OF NORTH CAROLINAThe evidence of biotechnology, however, now covers much of the state. Overall, North Carolina ranks third in the nation in biotechnology industry, with more than 358 bioscience companies either headquartered in the state or having operations there. These companies employ more than 48,000 people. Creating such an environment, though, requires teamwork on many levels.A STATE OF SUPPORTThe North Carolina state government contributed to biotechnology in many ways. In 1984, for example, the state founded the nonprofit North Carolina Biotechnology Center (NCBC), headquartered in RTP, which funds research and provides information and support services that strengthen the biotechnology capabilities of North Carolina's companies and universities. Since its founding, the NCBC has invested more than $187 million in state funds to develop biotechnology statewide. Biotech dreams: circa 1959, planning for Research Triangle Park."I think North Carolina is unique, in that we have had a very long-standing public-policy commitment to growing the biotech industry," comments Sam Taylor, president of the North Carolina Biosciences Organization (NCBIO), the biotechnology industry's trade group, which is also located in RTP. "In establishing the NCBC, the state's leaders went about it in a very thoughtful and systematic way," says Taylor. "They didn't ask for a whole lot of money to throw at the problem all at once. They built out a program from the ground up - based on good analysis and understanding of our assets and strengths - and over the course of 25 years laid the groundwork for the private sector to build out the commercial biotech research, development, and manufacturing capacity that we have here now."The history of NCBIO itself illustrates the explosive growth of the state's biotech industry. Formed with only six companies in 1994, the group blossomed to its current count, which is approaching 200. NCBIO establishes biotechnology collaborations with government and academia to "keep the industry pipeline flowing smoothly," as Taylor puts it.One portion of RTP, today.COURTESY OF STEVEN R. MCCAW, IMAGE ASSOCIATESENCOURAGING INDUSTRYNew companies, including biotechnology companies, can receive support services and guidance from the state's Council for Entrepreneurial Development (CED). This private, nonprofit organization fosters the entrepreneurial culture of the state by offering startup companies educational programs and mentoring, as well as aid in capital formation. North Carolina also houses numerous contract-research facilities, the most prominent of which is RTI international, historically the first tenant of the RTP. Some of RTI International's initiatives, including RTI Health Solutions, exemplify its emphasis on bioscience research. RTI Health Solutions conducts research in drug safety, epidemiology, health economics, and outcomes research. It also performs survey research for pharmaceutical and biotechnology companies. By far, the most important industrial foundation for any state's biotechnology industry comes from major pharmaceutical companies, and according to Taylor, North Carolina has been a major beneficiary of those companies. "Even as early as the early to mid-1980s, I would venture to say that eight out of 10 of the largest pharmaceutical companies in the world had a manufacturing presence in the state," says Taylor. "This gave us a manufacturing work force that is a good base for doing that kind of work here, and has also provided us with a labor pool of scientists and technicians - people steeped in pharmaceutical research who have then left those companies and started companies of their own."AN ENVIRONMENTAL ANGLEBesides private corporations, North Carolina attracted major federal research laboratories that contribute to its leadership in bioscience. In RTP, these laboratories include the National Institute of Environmental Health Sciences (NIEHS) and the Environmental Protection Agency (EPA), which sited its largest research facility there.The NIEHS was among RTP's earliest tenants, built on land donated in 1967. A laboratory of the National Institutes of Health, NIEHS studies the environmental influence on diseases, including birth and developmental defects, sterility, breast and testicular cancers, and Alzheimer and Parkinson diseases. The NIEHS also explores the risks of lead poisoning and agricultural pollution, as well as the interrelations among poverty, environmental pollution, and health. Says NIEHS director David Schwartz, "The NIEHS' location in RTP has allowed us to build productive working relationships with the area's outstanding universities and biomedical-research companies. There is strong appreciation, dedication, and support here for conducting innovative science that will yield tangible results, like improved patient care. This enriches the NIEHS research effort and adds to our collaborative research projects with sister NIH agencies in Bethesda, Maryland." Schwartz cites, for example, NIEHS' plans to open its first-ever outpatient clinical-research facility on its campus later this summer. The 11,500 square-foot facility will permit physician-scientists to conduct studies that involve on-site sample collection, pulmonary function assessment, and laboratory analysis."One of the overarching goals of establishing the new NIEHS clinical research facility is to integrate our science with the work of others in the area and at the NIH," says Schwartz. "Also, with so many esteemed universities and schools in the area, we can offer students meaningful work and training experiences right here at NIEHS in North Carolina." The EPA's RTP research facility is the agency's major center for air-pollution research and regulation. It explores the effects of chemical, biological, and radiation pollutants, as well as climate change, on human health and ecosystems. NIEHS campus at Research Triangle Park.COURTESY OF STEVEN R. MCCAW, IMAGE ASSOCIATESThe renowned forests in North Carolina also make it a natural spot to spawn an international center for applying biotechnology to forestry. Thus, in 2001 forestry leaders in the state established the nonprofit Institute of Forest Biotechnology to benefit forests worldwide by fostering application of biotechnology and new policies. For example, the institute has focused on using biotechnology to rescue threatened and endangered tree species and on studies to understand the possible ecological disturbances from use of genetically modified organisms.AN EDUCATIONAL FOUNDATIONThe state's educational institutions, from community colleges to research universities, also play a seminal role in North Carolina's success in biotechnology. For one thing, these institutions provide professional-level academic programs in biotechnology and related fields.Various state universities also train students specifically for careers in biotechnology. For example, NCSU offers an undergraduate minor in biotechnology, as well as a graduate certificate program in molecular biotechnology. These programs also focus on the future. The University of North Carolina (UNC) at Charlotte ran its 5th Annual Charlotte's Emerging Role in Biotechnology conference in October 2006. In discussing this conference, Catherine Hicks, the director of life science ventures at UNC's Charlotte Research Institute, says, "Within the next 25 years, biotechnology and related bioscience technologies are projected to generate up to $24 billion in annual product sales and employ as many as 125,000 people in North Carolina." Those numbers emphasize the value of North Carolina's biotech future. In addition, the state's universities also foster leading-edge research in the biosciences. Medical centers - including those at Duke University, East Carolina University, UNC Chapel Hill, and Wake Forest University - provide major sources of bioscience discoveries. For example, Duke's Institute for Genome Sciences and Policy makes up the largest research initiative in the university's history. It encompasses research and education in many genome-related areas: ethics and law, genomic medicine, and genome technology and its applications.North Carolina engineers also launch biotechnology-related research initiatives. For example, researchers at Duke's Center for Biologically Inspired Materials and Materials Systems aim to "reverse-engineer" biological systems to use nature's principles to design new tools and devices, such as nanoscale sensors and self-assembling structures.COMPLETING THE CIRCLEThe connections between academic, government, industrial, and private organizations forge North Carolina's focus on life sciences and biotechnology. NCBC plays a major role in sparking the universities' biotechnology research, emphasizes Charles Moreland, retired vice chancellor for research and graduate studies at NCSU. The state-funded NCBC, through its research and equipment grants and funding for faculty positions, influenced the institutions to emphasize biotechnology research and enabled the universities to attract major federal funding, he says. "The universities used base funding from NCBC to get started," says Moreland. "And once they had the faculty, the equipment, and the research grants, they then were able to establish programs which got funding from national agencies." EPA campus at Research Triangle Park COURTESY OF RESEARCH TRIANGLE FOUNDATION OF NORTH CAROLINA What's more, says Moreland, NCBC has sparked the universities' efforts to more actively seek to commercialize their discoveries. "The universities did not have what I would call a really aggressive intellectual property program," he says. "Their emphasis was to license their discoveries out to companies. But in the early '90s, the NCBC advocated a more aggressive approach to stimulating the economy by starting up their own companies. And now, the three major universities are in the top echelon of technology transfer and in terms of spinoff companies." Such startup companies depend on venture-capital funds in the state for crucial financial nourishment. And while, according to Taylor, venture capital was initially slow to come into North Carolina, "We've now been successful in growing some venture-capital companies and attracting others." He adds, "Now, I believe we have more venture capital here than any other state, except for Massachusetts and California." Such groups as A.M. Pappas & Associates, The Aurora Funds, and Intersouth Partners are among those actively investing in North Carolina biotechnology startups. The Arbor Group consulting firm offers startups development, planning, and management services. Intersouth Partners' Robert Bell has had a front-row seat during the evolution of the state's biotechnology-industry infrastructure over the last two decades. Starting as a professor of biochemistry at Duke, he went on to found his own company, Sphinx Pharmaceuticals, in 1988, which constituted Intersouth's first biotechnology investment. The company's startup success illustrates the crucial role venture capital has played in the state, says Bell. "Without Dennis Dougherty at Intersouth, Sphinx would never have gotten off the ground," says Bell. "Dennis helped translate the scientific discoveries into a business." Bell himself moved to Intersouth in 2001, after a stint at Glaxo Wellcome as vice president for research. Bell also recalls other roadblocks for startups in the state that have since disappeared. "When I started as an entrepreneur I wasn't aware of any service providers for startups," he says. "Then you had to solve all the problems yourself - whether it was getting space or getting a license for radioisotopes - up and down the line. Now when you go to the Council for Entrepreneurial Development-sponsored meetings, there will be 400 or 500 service providers there to help people get companies started." What's more, says Bell, Sphinx was not only pioneering new technology at the time, but also blazing a new trail in terms of university technology transfer. "When Sphinx was started there really wasn't a process for addressing conflict-of-interest issues within Duke," he recalls. In fact, says Bell, Sphinx was the first biotechnology company to be formed as a result of Duke discoveries, and it "started a process," he says. "I think it is now easier within the universities and through the technology transfer offices, to get companies out." All across the state, advances in biotechnology emerge from combinations of insight, energy, and economics. That collaboration makes North Carolina the state of science.

THE STATE OF LIFE SCIENCE

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