 NCBIO This Month
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Carson Burrington, Treasurer Cowell, Dr. Michael Luther, & Amy Fix
North Carolina State Treasurer Janet Cowell will soon announce further plans for a new economically targeted investment fund for North Carolina. Cowell told a meeting of NCBIO’s Emerging Companies Forum members on March 3rd that selection of a fund administrator and further operational details for the new North Carolina Innovation Fund will be announced within “a few weeks.” Cowell said the Fund will include $230 million from the alternative assets allocation of state pension funds administered by the Treasurer’s Office. She said monies from the fund will be deployed over a period of three to five years either in other funds, or as co-invest in individual businesses. The Fund’s maximum individual investment will be $25 million.
Cowell said that the Innovation Fund will be similar to economically targeted funds already launched 29 other states, and that her office has spent considerable time investigating best-practices among these existing programs. Her office has also discussed plans for the fund with key stakeholders such as state employees, the North Carolina Department of Commerce, the North Carolina Biotechnology Center and other interested groups. NCBIO met with Cowell’s staff regarding the concept in 2009. Cowell said feedback regarding the proposal has been overwhelmingly positive.
Cowell said that in addition to fund management, the administrator for the proposed fund would be required to field a local representative to conduct outreach to North Carolina innovation economy stakeholders. Cowell also said her office is considering ways that a portion of the new Fund might be used to support one or more targeted business accelerators – possibly including and accelerator focused on life science technologies. She said such accelerators might offer not only funding to client start-ups, but also consultative and other value-add services.
NCBIO thanks Treasurer Cowell and event sponsors North Carolina Research Campus, Womble Carlyle and Lab Support for their participation and support. NCBIO will be holding its annual Legislative Breakfast May 26th, 7:30 am, at the NC Legislative Building. RSVP Jennifer Fong by May 24th if you want to attend the event.
 North Carolina’s life science community attracted an estimated $903 million in grants, licensing payments, and equity funding and capital investments in 2009. The estimate is based on media reports tabulated by NCBIO. The 2009 total does not include a $950 million initial public offering by Talecris Biotherapeutics.
Although the $903 million invested in 2009 represents a decline of approximately 23% from 2008’s total of $1.18 billion, most of the decline was attributable to reduced capital investment, and in-flows of equity funding and licensing payments actually increased. The survey showed that, excluding the Talecris IPO, North Carolina companies attracted $428 million in equity investments in 2009, an increase of 32% over 2008’s total of $323 million. Similarly, licensing payments to North Carolina life science companies rose to $268 million, compared to $51 million in 2008, an increase of 425%. Grants to North Carolina life science entities decreased in 2008 to $190 million, a decline of approximately 15% from $224 million in 2008.
“Given the spectacular decline in overall economic activity in 2009, North Carolina’s life science community turned in a very strong performance,” said Sam Taylor, President of NCBIO. “Our growing strength in licensing and equity revenues reflects the continuing maturation of North Carolina’s life science industry cluster.
The North Carolina Biotechnology Center reports that employment by companies in its North Carolina life science database grew 1% in 2009, bringing total employment by database companies to 57,000.
“At a time when the rest of our economy is shrinking, the life science industry is actually adding jobs,” said NCBIO President Sam Taylor. “These numbers prove the merits of our State’s long-term investment in biotechnology and the life sciences as a strategy for promoting economic growth.
The Biotechnology Center’s company database includes research and development companies, production and manufacturing companies, and clinical research and testing organizations. In December 2009, the database included 530 companies with a total of 57,053 employees. At the same time in 2008, the database included 523 companies with 56,495 workers.
Governor Beverly Perdue kicked off the CED Biotech 2010 by saying that leaders would be hard pressed to find another state more committed to biotech than North Carolina. She noted that the State’s life science industry accounts for more than 180,000 jobs and $45.8 billion in economic activity. In video remarks from Washington, D.C. at the opening of the two-day conference, Governor Perdue called for a spirit of collaboration and innovation in charting the course for the future for the life science industry and for the State.
The conference brought together the largest concentration of venture capitalists to ever meet in North Carolina. In additon to the investors participating in the Hoffman-La Roche Venture Day, the North Carolina Biotechnology Center brought together 42 emerging companies to meet with representatives of the big names in the pharma industry to discuss overlapping interests in their development pipelines.
 Larry Stern, Chairman and CEO of Talecris Biotherapeutics, in discussing financing innovation, stated, “This industry has to change. Returns have to be commensurate with risks.” Stern noted the importance of a collaborative effort to address the efficiency at the FDA. He stressed that investors are looking for companies that have a good management team and sustainability with a next generation of products.
Stern was on a panel that discussed funding models in biotechnology. Moderator of the panel, Stephen Sands of Lazard’s Health Care Group, noted that although volatility in US equity markets has declined in recent months, there remain few signs of near-term IPO opportunities, primarily because biotech companies continue to have a hard time convincing investors that they will produce an acceptable return on investment. A survey by his firm found that among four recent biotech IPOs, two are trading above the IPO price and two are below.
Winners of One North Carolina Small Business Program SBIR and STTR matching grants were honored at a reception. Randall Marcuson, former CEO of Embrex, Inc. was presented the CED Leadership in Biotechnology Award by Dr. Charles Hamner, Chairman of the Hamner Institutes for Health Sciences and past NC Biotechnology Center President. NCBIO and the NC Biotechnology Center were co-hosts for the 19th annual CED conference.
PhRMA President and CEO Billy Tauzin said he doubted that a bi-partisan health care reform bill would pass Congress this year. He stated the last year has been a challenging for the industry because of concerns about government leadership at the federal level. He noted that the nation currently has a “sick care system” in place rather than a “health care system.”
Billy Tauzin and Sam Taylor
Tauzin said the 12-year data exclusivity for follow-on-biologics remains a top priority for the pharmaceutical and biotechnology industries. He commended Governor Perdue and Senators Richard Burr and Kay Hagan for their support of data exclusivity provisions in health reform legislation.
In a panel on the impact of health care reforms on biotech Dr. Kevin Schulman of Duke University noted that many healthy people are dropping insurance thereby raising the costs of those that remain in the system. He also stated that in the absence of incremental health care reforms, the nation could face catastrophic and unpredictable economic dislocations.
Dr. Anthony Sun of Aisling Captial said health reformers need to emphasize improvements in the quality of care and stated that adding excise taxes to medical devices and other health care innovations would have a negative impact on investments in these products.
In a separate panel discussion, CEOs of successful life science companies shared their tips for leadership in changing times. Participants gave a standing ovation to outgoing Inspire CEO Christy Shaffer in recognition of her 12 years of contributions to the industry. Shaffer moderated the panel.
Don deBethizy of Targacept advised conference participants to keep everyone focused on long-term strategies and to maintain trust among employees. Neal Fowler of Liquidia Technologies noted the importance of leaders surrounding themselves with smartest people they can find and of keeping of positive attitude because staff and board will react to that.
Other conference sessions focused on personalized medicine, opportunities and challenges in global health and licensing best practices for emerging companies.
 The Biotechnology Industry Organization will host its annual Congressional Fly-In in Washington, DC, on April 13-14, 2010. The event, which takes place every spring, brings hundreds of biotech industry executives to Capitol Hill to meet with members of Congress. BIO’s agenda for 2010 will include health reform, patent reform, and other matters of importance to the industry. Registration for BIO's 2010 Legislative Day Fly-in is now open. To register, click here. Also please contact NCBIO President Sam Taylor if you plan to attend.
Seventy sponsors from North Carolina’s life science community will be represented in the State’s Pavilion at BIO 2010. There will be a cross section of the industry including CROs, biologics and pharmaceutical companies, educational institutions, and support companies such as utility companies, law firms, and engineering firms. Six of North Carolina’s regional economic development partnerships will also participate in the Pavilion.
The North Carolina Commerce Department, the North Carolina Biotechnology Center, and NCBIO are assisting with the Pavilion. Visitors will enjoy an opportunity to test their golfing skills on an in-Pavilion putting green sponsored by Pinehurst Resort. The Resort has also donated 1,000 golf balls and a Donald Ross gift package for Pavilion visitors.
The 2010 BIO International Convention will also feature a new networking hub dubbed BIOPark. The new program will focus on fostering networking and collaboration among academics, licensing professionals, incubator services, and early-stage companies. The BIOPark is designed to facilitate key conversations about technology transfer and will include displays of innovative products and services and a presentation theater.
“We recognize the critical need for bringing together the tech transfer community for networking and discussions focused on licensing, collaborations and academic partnerships,” said Jim Greenwood, President and CEO of BIO, the producer of the BIO International Convention.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Biolex Therapeutics, Inc. has announced that interim results from two Phase 2b clinical trials of its lead product candidate Locteron® for the treatment of chronic hepatitis C have been accepted for oral and poster presentations at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) to be held in Vienna, Austria in April 2010. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care. The objectives of the two Phase 2b trials are to demonstrate viral kinetics and response that is at least equivalent to the PEG-Intron® control while also achieving at least a 50% reduction in flu-like adverse events.
Capstrat has announced that Andrew Meehan and Anna Marshall Gauss have joined the firm’s public affairs team, adding new media and grassroots coalition-building muscle to the firm’s team of experts on issues management, lobbying, media advocacy and opinion leader outreach. Prior to joining Capstrat, Meehan was the Manager of Government Affairs for the North Carolina Association of Electric Cooperatives. He has extensive experience mobilizing grassroots networks, creating message campaigns and lobbying before the N.C. General Assembly. Gauss was associate account executive at Ketchum PR in Washington, DC.
The Hamner Institutes for Health Sciences has announced that Chief Business Officer Rick Williams has been named to The Hamner’s Board of Directors. As chief business officer, Williams has piloted and launched The Hamner Bioscience Accelerator to generate additional opportunities for universities, The Hamner, and other research institutions as they seek to transfer technologies and spin out new companies. Williams has also played a leading role in creating The Hamner-China Biosciences Center, which has signed agreements with the Shanghai Center for Disease Control, China Medical City, and Newsummit Biopharma to create a Global Biosciences Gateway. The Gateway provides partners in China and Europe access to expertise and resources in North Carolina for advancing the development of bioscience technologies for the United States market. The partnership also allows companies in North Carolina to access new and growing markets in China.
Inspire Pharmaceuticals, Inc., has named Adrian Adams as President and Chief Executive Officer (CEO) of Inspire, and elected Mr. Adams to its Board of Directors. Mr. Adams most recently successfully led the growth and corporate development of two publicly traded companies. He brings strong skills in commercialization, business development and global partnerships, including experience in licensing and developing respiratory products, as well as an understanding of the evolving specialty pharmaceutical market. Mr. Adams served as President and CEO of Sepracor Inc. ("Sepracor") since 2007. Prior to joining Sepracor, Mr. Adams was President and Chief Executive Officer of Kos Pharmaceuticals, Inc. ("Kos") from 2002 until the acquisition of the company by Abbott Laboratories. In addition to Kos and Sepracor, included careers with ICI, SmithKline Beecham and Novartis.
Inspire Pharmaceuticals, Inc., also announced the election of George B. Abercrombie to its Board of Directors. Mr. Abercrombie will also serve as a member of the Audit Committee of the Board. Mr. Abercrombie most recently served as the President and CEO of Hoffmann-La Roche Inc. ("Roche") and Head of North American Pharmaceutical Operations.
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) located on North Carolina State University’s Centennial Campus and Kryosphere, Inc. have announced a collaboration to advance science, education, and training in cryobiology, cryopreservation, and sample management and their role in academic and industry research. In the first phase of the collaboration Kryosphere will provide BTEC and NCSU with biorepository services that meet cGMP (current Good Manufacturing Practice) standards and develop curricula designed to introduce students to this emerging field.
Novozymes is launching the first commercially viable enzymes for production of biofuel from agricultural waste. This breakthrough in enzyme technology will enable cellulosic biofuel to be a competitive alternative to gasoline. Novozymes’ new Cellic® CTec2 enzymes will allow the biofuel industry to produce cellulosic ethanol at a price below USD 2.00 per gallon at commercial-scale plants that are scheduled to be in operation in 2011. This cost is on par with gasoline and conventional ethanol at the current US market prices.
The North Carolina Science, Mathematics, and Technology Education Center (SMT Center) has selected Novozymes to receive the Business and Industry Award in Science, Mathematics, and Technology Education. This award recognizes a North Carolina business or industry whose support has strengthened science, mathematics, and technology preK-12 education programs in either formal or informal settings.
 Margaret Rosenfeld, a partner in Smith Anderson’s Corporate Law Practice, moderated a panel at an event hosted by the Research Triangle Chapter of the National Association of Corporate Directors (NACD) on February 18. The panel topic, “Finding the Right Directors at the Right Time,” focused on the critical role played by a nominating committee in Board composition and direction.
Talecris Biotherapeutics, Inc. was granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1- antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, especially emphysema, which typically emerges in the fourth decade of life. Currently, there are no approved, inhaled treatments available for the treatment of AAT deficiency.
Targacept, Inc., clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), has been awarded a grant of $304,000 from The Michael J. Fox Foundation for Parkinson's Research (MJFF). The grant is to fund a project entitled: “Development of an α6*-selective Neuronal Nicotinic Receptor (NNR) Imaging Agent as a Parkinson’s Disease Biomarker” and is the second awarded to Targacept by MJFF in the last six months.
TCG, LLC, Hughes Pittman & Gupton and Healthlinkeurope will run a workshops on "How to Enter the European Medtech Market on April 20 from 12:15-5:00 at the Sierra Hotel near the RDU airport. Medical products companies will learn how to get revenues from the huge EU market even before a US product launch. Four experts with launch experience will present in an informal half-day setting. Companies can learn more from the three participating firms or at the TCG website.
Concern about Proposed Changes in Gene Patents
 The Biotechnology Industry Organization (BIO) released a letter to Health and Human Services Secretary Kathleen Sebelius regarding the potentially harmful recommendations of the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) in its Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.
BIO was joined on the letter by the Association of University Technology Managers (AUTM), Genetic Alliance, the Wisconsin Alumni Research Foundation (WARF), and more than 20 other stakeholders in urging Secretary Sebelius to reject the Committee’s recommendations and to ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved.
In the letter, the stakeholders stated, “We welcome efforts to improve patient access to genetic tests, and stand ready to work with you and other interested parties to do so. But we believe that the recommendations, if implemented, would unravel two sets of laws that are the foundation of life science innovation in this country – the patent system and the Bayh-Dole Act. This would do more harm to patients than good, by impairing the research, development and commercialization of the medicines and diagnostic tests of tomorrow.”
“By undermining the value of gene-based patents, these recommendations would chill future investment and innovation, and would undermine the investment-backed expectations of current patent owners and licensees,” stated BIO President and CEO Jim Greenwood. “The United States must preserve incentives for investment and innovation, particularly given the current state of the economy. It is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation.”
BIO Business Solutions Vendor Launches Auction Program
BioSurplus, Inc., a leading provider of equipment management services and pre-owned laboratory instruments to the life science industry, has announced the launch of a new auction service, BioSurplusBid™, which will offer live, webcast and timed online auctions. The company’s auction premier will be held March 24, 2010, and will be delivered live and via webcast. BioSurplus participates in the BioBusinessSolutions program co-hosted by BIO and NCBIO. BioBusinessSolutions offers group purchasing discounts to BIO and NCBIO members.
BioSurplus’ proprietary auction software is web based and allows online customers to bid in real time against onsite customers. Unlike traditional auction houses, BioSurplus is solely focused on scientific instruments and plans to offer money-back guarantees and turnkey shipping on many auction items.
“We currently offer our customers access to equipment through our website, www.BioSurplus.com, and two California showroom locations” notes Preston Plumb, President and Chief Executive Officer. “This new auction service increases the number of ways that our customers can buy equipment. It also enables us to optimally tailor solutions to our clients who need to sell equipment, including outright purchase, consignment and storage, auctions, and any combinations thereof.”
Go to www.BioSurplusBid.com to register and view auction catalogs and details.
March - July 2010
Golden Leaf BTEC Short Courses. NCSU Biomanufacturing Training and Education Center. The biomanufacturing industry grows and changes rapidly from year to year, creating significant educational demands on our workforce. BTEC is committed to providing updated, cutting-edge short courses to workers who are grounded in the industry but may not be positioned to take advantage of new industry developments. All NCBIO BMF Members receive 20% off all courses. Visit here for more information.
March 18, 2010
BLT Steak, 110 N. College Street, Charlotte, NC. McGuireWoods will host a Lunch Break program on clinical trials, including managing adverse reporting, good clinical practice, and how changes at FDA may impact clinical trials. To be included on the guest or for more information, e-mail anorris@mcguirewoods.com or call Amy Norris at (704) 343-2228.
March 24, 2010
BioSurplus Auction. Visit www.BioSurplusBid.com to register and view auction catalogs and details.
March 30, 2010
WFU Babcock Demon Incubator. Frameworks! Educational and Networking Series. 7:30am in the Auditorium, Piedmont Triad Community Research Center, 115 S. Chestnut St., Winston-Salem, NC. If you plan to attend, please email Betsy Kraft at bkraft@triad.rr.com.
April 6-8, 2010
Translational Regenerative Medicine Forum, Benton Convention Center, Winston-Salem, NC. This event advances the field of regenerative medicine and healthcare innovation through the sharing of scientific discoveries, best practices and business models. The meeting will also feature a venture forum showcasing international regenerative medicine companies and investors from corporate venture, venture philanthropy, private equity and venture capital firms. For more information, go here.
April 13, 2010
BioNetwork BioForum: Biotechnology for the Non-Scientist Webinar FREE, but registration is required. Register NOW!
April 20-22, 2010
CED's Venture Conference: Where Great Minds Meet Smart Money, Pinehurst Resort, Pinehurst, NC. For the past 25 years, CED’s Venture conference has created business opportunities for hundreds of entrepreneurs and investors across North Carolina and the Southeast. As the nation’s longest running financing event, CED’s Venture showcases the region’s most promising companies to an audience of top tier investors and entrepreneurial leaders. Go here for more information.
April 21, 2010
Duke Clinical Research Institute: Next Generation of Quality: Linking Clinical and Organizational Performance. Fuqua School of Business, One Towerview Drive, Durham, NC. For more information, click here.
April 27, 2010
VWR Scientific Vendor Show. Information forthcoming.
May 21-22, 2010
NCABR 2010 IACUC Conference. North Carolina Biotechnology Center, Research Triangle Park, NC. For more information.
May 26, 2010
NCBIO Legislative Breakfast. Information forthcoming.
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