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 As 2007 draws to a close, NCBIO members can look back on a year packed with important milestones for the North Carolina life science industry. Equity investments, licensing deals, grants and facilities financing announcements by North Carolina life science companies continued at a billion-dollar-per-year pace; state legislators ramped up investments in life science development programs; and the State began to turn its attention to broad new areas of opportunity including biofuels and advanced medical technologies.
Life science funding announcements in 2007, including equity, grants, licenses and facilities, totaled $1.1 billion as of December 15th. Publicly announced equity investments totaled $567 million during the period, investments in facilities totaled $205 million, grants totaled $204 million and licensing deals totaled $101 million. Click here for a summary of all announcements.
North Carolina's life science sector also enjoyed continued funding from state leaders. The 2007 General Assembly appropriated nearly $120 million in recurring and non-recurring funding for life science research, industry support and economic development activities in the 2007-09 biennial budget. The Assembly also set the stage for construction of nearly $300 million in new university facilities directly related to life science research and education. Finally, legislators continued and expanded a variety of important tax credits or other reductions that will benefit life science companies, including extension of the Qualified Business Venture Tax Credit, an increase in the state's R&D tax credit and a new sales tax rebate for certain medical testing supplies. Click here for a complete summary of 2007 legislative action affecting the life science industry.
Projects funded in previous legislative sessions also began to reach maturity in 2007. North Carolina State University's GOLDEN LEAF Biomanufacturing Training and Education Center (BTEC), originally launched with $35 million in construction grants from North Carolina Golden LEAF Foundation, opened its doors with a formal dedication in September of this year. A sister facility, the Biomanufacturing Research Institute and Training Enterprise (BRITE), a drug discovery and process development teaching center, will open at North Carolina Central University in 2008. Both programs will be supported by strong community college programs (BioNetwork) also launched with Golden LEAF funding. Annual operating appropriations for the three programs now total approximately $21 million per year.
Also in 2007, the State launched a new North Carolina Biofuels Center to lead efforts to expand the state's production and use of biologically-derived fuels such as ethanol and biodiesel. With $5 million in start-up funding, the Center will follow-up on a biofuels strategic plan developed by the North Carolina Biotechnology Center with support from institutional partners including NCBIO. In addition, the Biotechnology Center completed a year-long study of North Carolina's advanced medical technologies industry and pledged $100,000 to support planning for future strategic initiatives to support the growth of the state's medical technologies industry. NCBIO provided technical support for the study and will be working with the Center in 2008 to plan and launch the new North Carolina Advanced Medical Technologies Center that the study recommended (See following article).
NCBIO itself also made important changes in 2007. In October, the Organization hired Sam Taylor as its first full-time president. Although Taylor had worked for NCBIO in part-time capacities since 1994, the full time position sets the stage for a broader and more robust program of activities for the Organization in 2008. NCBIO also launched new networking and education programs for its emerging company members and continued similar programs already underway within its Biotech Manufacturers Forum.
In all of its work in 2007, NCBIO enjoyed strong support and assistance from its members – without which the year's successes would not have been possible. The NCBIOstaff, Sam Taylor, Hal Price, Brenda Summers and Jennifer Fong, wish all of you Happy Holidays and a prosperous New Year. We look forward to working with you again in 2008.
 The North Carolina Biotechnology Center has awarded NCBIO a $100,000 Phase I Centers of Innovation Grant to develop plans for a new North Carolina Advanced Medical Technologies Center. NCBIO partnered with universities and regional economic development entities across the state to submit the grant application. The group will work together in 2008 to craft an organizational structure and business plan for the new Center. The plan will focus on growing North Carolina's advanced medical technologies sector by supporting commercialization of new products and recruitment and expansion of advanced medical technologies companies.
NCBIO's partners in the project include the Charlotte Research Institute, the Duke University Department of Biomedical Engineering, the East Carolina Brody School of Medicine, the Joint School of Biomedical Engineering at North Carolina State University and the University of North Carolina at Chapel Hill, the Joint School of Nanoscience and Nanoengineering at the University of North Carolina at Greensboro and A&T State University, and the Wake Forest University Institute for Regenerative Medicine. Also participating in the planning process will be the technology transfer offices of the partnering academic institutions, and the representatives of the state's regional economic development partnerships in Charlotte, the Piedmont Triad, the Research Triangle and Eastern North Carolina.
NCBIO president, Sam Taylor said, "We are very grateful to the North Carolina Biotechnology Center for this opportunity to collaborate with academia and government in planning for North Carolina's advanced medical technologies future," Taylor added, "NCBIO is also extremely pleased to have this opportunity to work collaboratively in this project with so many of North Carolina's top universities and economic development agencies."
Creation of a statewide advanced medical technologies center was recommended in a strategic study published by the Biotechnology Center with support from NCBIO earlier this year. The study concluded that North Carolina is home to a nascent but strong medical device industry and recommended that the State seek to capitalize on the economic potential of the sector by supporting the convergence of classical device industry with complimentary technologies such as biotechnology, information technology, regenerative medicine and nanotechnology.
Taylor stated, "NCBIO believes that the proposed Center will allow North Carolina to leverage its existing strengths in biotechnology, nanotechnology, information technology and regenerative medicine to propel it to a national leadership position in the advanced medical technologies industry." Taylor continued, "With these assets, there is no reason that North Carolina should not achieve the same international prominence in medical technologies that it has attained in biotechnology."
NCBIO expects to retain a Project Coordinator for the planning process and hold its first meeting of project partners in January.
 Winston Salem will again play host to North Carolina's statewide biotechnology conference in 2008. The Council for Entrepreneurial Development's 17th annual Biotech Conference will be in Winston-Salem, on May 19-20. The annual event, which is supported by NCBIO, draws a variety of top-notch industry executives, including the region's most innovative biotech entrepreneurs, major pharmaceutical companies, life science research leaders, policy makers and nationally prominent investors.
Sponsorships for the event are still available. In addition, NCBIO members can receive a special discount for registrations for the conference. Click here to find out about BIOTECH 2008 and to register for the event. E-mail ncbioadmin@ncbioscience.org for the registration discount code. For specific questions about Biotech 2008, contact Jessica Hegele .
 Mission Health & Hospitals has made a $50,000 grant that will enable Bent Creek Institute to equip the nation's first germplasm, or genetic repository, for medicinal plants. Based in Asheville, Bent Creek Institute is part of The North Carolina Arboretum. The grant will be used to purchase equipment for plant propagation, seed storage and processing, and plant tissue culture incubation. Bent Creek Institute is a new, cutting-edge research organization whose mission is to discover medicinal treatments for disease based on plants and other organisms such as fungi that are native to Western North Carolina, the most biodiverse region in North America.
Cheryl McMurry, executive director of Bent Creek Institute, explains, "Germplasm is a term used to describe the DNA of an organism. This germplasm repository contains core collections of medicinal plant germplasm representing the diversity of species found in the Southern Appalachians. This scientific resource will enable Bent Creek Institute to use biotechnology tools to delve into the complex chemical properties of these plants so their secrets are finally understood. The plants will not be genetically altered -- maintaining the natural integrity of our products will be an important competitive advantage for our region."
Other donors funding the germplasm project include Buncombe County, which has contributed $150,000, and the North Carolina Biotechnology Center, which has contributed $100,000.
There's still time for your company to participate in the life science internship fair scheduled for January 25th. NCBIO and other members of the Biomanufacturing and Pharmaceutical Training Consortium will be hosting this event Friday, January 25th, 2008, from 1:30 to 4:30 p.m. at the Golden LEAF BTEC facility at North Carolina State University. Students from North Carolina State University, North Carolina Central University and North Carolina community colleges will be meeting with companies. Students attending the fair will have the opportunity to talk with company representatives as well as get tips on interview techniques, learn more about North Carolina's life science industry, have their resumes reviewed, and take a tour of the BTEC facility. If your company is interested in participating, please contact Brenda Summers.
 Transportation of dangerous goods and infectious materials has become increasingly regulated. Just in 2006, the FAA investigated 2,345 hazardous material enforcement cases collecting $4.94 million. The February seminar will help participants understand risks and liabilities involved in the worldwide transport of time- and temperature-sensitive life sciences shipments.
Send your employees who handle these materials to the QuickSTAT seminar on life science transportation regulatory issues on Tuesday, February 5, 2008. The event will be at the Hamner Conference Center at the North Carolina Biotechnology Center. NCBIO members receive a discount. Click here for more information.
Microchip Technology (NASDAQ: MCHP) has selected Invisar, Inc. to be one of only five (5) Medical Design Partner Specialists worldwide. Invisar was selected for its expertise in electronics, electromechanical and regulated components to develop medical devices and medical electronics. This partnership between Invisar, Inc. and Microchip will help facilitate new product development.
W. Thomas Amick, Chairman and CEO of Aldagen Inc., a biotechnology company advancing a pipeline of clinical-stage regenerative therapies, made a presentation at the 19 th Annual Piper Jaffray Health Care Conference November 27-29 in New York, NY. During the presentation, Mr. Amick provided an overview of the company including recent clinical and strategic developments.
Argos Therapeutics has granted Therakos, Inc., a Johnson & Johnson company, an exclusive license for the research and development of novel treatments based on regulatory T cell technology developed by Argos. Terms of the agreement were not disclosed. John Bonfiglio, Ph.D., president and CEO at Argos Therapeutics said, "The licensing agreement with Therakos will enable accelerated development of an asset outside our primary focus, while providing Argos with non-dilutive financial resources. This transaction further demonstrates our ability to leverage Argos' leading immunotherapy science both through our own programs as well as through collaborations with select corporate partners. Argos continues to advance its proprietary portfolio of immunotherapies for indications such as cancer, infectious diseases, autoimmune disorders and transplantation." Argos Therapeutics officials made presentations of two abstracts related to its personalized dendritic cell-based immunotherapy programs at the 22nd Annual Meeting of the International Society for the Biological Treatment of Cancer (iSBTc), held November 2-4 in Boston.
The Board of Directors of Biogen Idec Inc. (NASDAQ: BIIB) has announced that, after completing a review of strategic alternatives to maximize shareholder value, Biogen Idec will continue on its present course as an independent company. The Board emphasized that Biogen Idec's business strategy is working and generating strong operating and financial performance. The Board noted that it is confident that continued execution of the Company's business plan will result in attractive value for stockholders. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis.
Fred Hutchison of the Hutchison Law Group PLLC has been selected as one of the 25 most influential people in the Southeast technology community by TechJournal South magazine.
Hutchison was the founding President of the Council for Entrepreneurial Development, the largest entrepreneurial support organization in the country. Additionally, he was the recipient of the Order of the Long Leaf Pine in 2006, the highest civilian honor given by the state of North Carolina. TechJournal South stated on Hutchison's selection, "Fred Hutchison is one of the single most influential attorneys in the Southeast technology arena."
Julie R. Brown has been elected to the board of directors of Targacept, Inc. (NASDAQ: TRGT ), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM). Since 2003, Ms. Brown has served as Advisor to the CEO of Amylin Pharmaceuticals, Inc., a biopharmaceutical company focused in metabolic medicine, including diabetes and obesity. From 2000 to 2003, as Amylin's Executive Vice President, she helped build the company's commercial organization. Prior to joining Amylin, Ms. Brown was Executive Vice President of Dura Pharmaceuticals, Inc., a specialty respiratory pharmaceutical company, where she was responsible for business development, product acquisitions and corporate strategy. Previously, Ms. Brown spent over 25 years with Eli Lilly and Company in roles of increasing responsibility. She holds a degree in microbiology from Louisiana Tech University.
Targacept has initiated a Phase I clinical trial of its product candidate TC-6499. The initiation of the trial triggers a $6.0 million milestone payment to Targacept under the terms of its alliance agreement with GlaxoSmithKline. TC-6499 is a novel small molecule that Targacept plans to develop initially as a treatment for neuropathic pain. In preclinical studies, TC-6499 demonstrated analgesic activity in multiple models of neuropathic pain. TC-6499 was discovered using Targacept's proprietary drug design technology known as Pentad (TM). The Phase I study is designed to evaluate the safety, tolerability and pharmacokinetics of TC-6499. The trial is a double-blind, placebo-controlled study with escalating single doses of TC-6499 administered orally to healthy volunteers.
SEBIO Conference Held in Pinehurst
More than 400 people attended the Ninth Annual Southeastern BIO Investor Forum on November 7th-8th in Pinehurst, North Carolina. The Forum is the Southeast's premier life sciences venture capital conference.
SEBIO 2007 Investor Forum Co-Chair Garheng Kong of Intersouth Partners noted, "The 2007 Investor Forum was successful in connecting emerging life science companies with potential investors in a manner that provided meaningful networking opportunities." Cat Lineberry of Constella Group, the other Co-Chair along with Fred Hutchison of Hutchison Law Group, added "We anticipate a significant increase in deal flow over the next year as a result of the Forum."
The two day event explored research, market, and financing trends with nationally recognized leaders from the investment and bioscience industries. Participants included biotechnology executives, entrepreneurs, venture capitalists, investment bankers and other industry professionals.
The conference's opening keynote panel session, "What Emerging Companies Want to Know," featured business development leaders from the big pharma, big biotech and medical device industries, including Rick Anderson, Company Group Chairman, Johnson & Johnson and Worldwide Franchise Chairman, Cordis Corporation; Leslie Boyd, Vice President of Scientific Licensing, GlaxoSmithKline; Edward T. Mathers, Executive Vice President, Corporate Development and Venture, MedImmune; and Kenneth Lee, General Partner, Hatteras Venture Partners as the moderator. The panel provided insight into the culture and objectives for growth in larger companies, with an emphasis on the role of partnerships and other arrangements with emerging companies.
 Sarbanes-Oxley Hearing
At the House Small Business Committee hearing on Sarbanes-Oxley Section 404 in December, the Biotechnology Industry Organization (BIO) reiterated its support for additional revisions to Sarbanes-Oxley rules that would provide appropriate relief to smaller public companies from unnecessarily burdensome compliance costs. Jim Greenwood, president and CEO of BIO said, "Biotechnology researchers are creating innovative technologies that provide hope to patients worldwide. Most biotechnology companies, however, are small start-ups years away from having products on the market. So with no income, and no definition of a small business, these companies will bear outsized compliance costs – revenue that could otherwise go to developing life-saving therapies."
Specifically, BIO once again asked the Securities and Exchange Commission (SEC) to include an objective definition of small company in its guidance regarding implementation of Section 404. Such a definition was recommended by the SEC's Advisory Committee on Smaller Public Companies but was omitted from the final Auditing Standard Number 5 (AS-5) guidance issued this year. The Advisory Committee defined small companies as "companies with a market capitalization of approximately $700 million or less, with reported annual revenue of approximately $250 million or less." In order to comply with the congressional intent of the Sarbanes-Oxley Act of 2003, the Advisory Committee's proposed definition provided scaled audits for small businesses who are burdened with costly compliance under Section 404.
Bioenergy Summit
Rapid advances in biofuel research and development are being driven by concerns about the environment and the need for renewable fuels, according to top industry and government officials from China, Canada, the United States and Hawaii attending the second annual Pacific Rim Summit on Industrial Biotechnology and Bionergy. The conference was hosted by the Biotechnology Industry Organization (BIO), the American Chemical Society and the State of Hawaii.
"Building new business partnerships within the bioenergy industry, particularly along the Pacific Rim, was a primary objective of the Summit," said Brent Erickson, executive vice president of BIO's Industrial and Environmental Section. "As we heard from our plenary speakers, government policies that support development of the industry, which are being driven by concerns about the environment and future economic growth, have been vital in attracting the private investment needed to make this industry successful. Pacific Rim countries have been in the lead in implementing these policies. The Pacific Rim Summit showcased the latest biotech advances in feedstocks, production processes and novel biobased product."
BIO Comments on Patent Office Report
BIO President Jim Greenwood stated, "As the Senate continues to debate legislation aimed at improving the U.S. patent system, it is clear that the current system continues to promote American ingenuity and innovation – as evidenced by the high number of new patent applications and issuances in 2007." Greenwood spoke in reference to the Performance and Accountability Report for Fiscal Year 2007 issued by the U.S. Patent and Trademark Office (PTO). Greenwood continued, "and, despite the record number of new applications, the PTO is reporting marked improvement in the quality of patents issued, demonstrating a more rigorous process of patent examination. We urge the Senate to consider these trends as it debates patent reform legislation. While there are ways to even further improve patent quality, such as through meaningful inequitable conduct reform and more objectivity and transparency in the patent examination process, these trends reported by the PTO undermine the calls for draconian "reforms" to the patent system. To the contrary, it is clear that the fundamentals of our current system are sound, and improving over time. These fundamentals should not be undermined in the guise of ‘reform'."
December 19, 2007. MedTech Forum: Emerging Trends in Med-Tech - The Acquirers' Perspective. In this first forum of a two-part series, hear Bryant Moore, Vice President of Biotechnology and Technology Scouting at Medtronic; Jon Meltzer, Licensing and Corporate Affairs at LabCorp; and Al Lauritano, Director of Business Development for BD Technologies, as they participate in a panel discussion moderated by Bob Pozner, Adjunct Professor at Duke University. This Forum will focus on the large company perspective of R&D and new technology sourcing, triage and development. For more information.
January 14, 2008. Biotech Forum. Alternative Sources of Funding. Hear about the latest sources of funding for biotech and life science companies. An interactive panel of industry professionals will give insight to alternative sources of funding beyond the traditional venture capital method. Speakers include Clyde Higgs, Vice President of Business Development, Castle & Cooke North Carolina LLC; Timothy Janke, Executive Fund Director, Inception Micro Angel Fund; Troy Knauss, PAN Two Fund Executive, Piedmont Angel Network; John Richert, Vice President of Business & Tech Development, North Carolina Biotech Center. For more information.
January 23, 2008. MedTech Forum: Emerging Trends in Med-Tech - The Entrepreneurs' and Venture Capitalists'' Perspective. More information will be posted when available.
January 25, 2008. Biomanufacturing and Pharmaceuticals Internship Fair. Free event for students interested in careers in biomanufacturing and pharmaceuticals. Event will be held from1:30 to 4:30 at the Golden LEAF Biomanufacturing Training and Education Center. Registration required. For more information.
February 5, 2008. NCBIO/QuickSTAT Life Sciences Transportation Seminar: Overcoming Challenges of Life Sciences Transportation…Shipping Safely, Securely, and in Compliance. This seminar will focus on the risks, liabilities, and your responsibilities involved in the worldwide transport of Dangerous Goods, time and temperature sensitive Diagnostic/Clinical Samples, and Infectious Materials. For more information.
February 18, 2008. Biotech Forum. Venture Funding. The Biotech Forum is sponsored by CED in cooperation with the North Carolina Biotechnology Center. This Forum provides a meeting place for executives, professionals and academicians actively involved in the biotechnology industry. A pre-forum session precedes each program and networking reception follows. For more information.
March 6, 2008. CED MedTech Conference. CED presents the first annual MedTech Conference on March 6, 2008, in Durham, NC. MedTech 2008 will focus on accelerating the growth of the medical device industry in the Southeast. At MedTech 2008, meet with leading investors, corporate partners and industry entrepreneurs to connect on the entire spectrum of the medical device space. For more information.
March 6-9, 2008. Institute of Biological Engineering 2008 Annual meeting. The meeting will facilitate active interactions between IBE's attendees and the extensive community of biological engineering innovators in North Carolina, and will promote the transfer of new technologies into commercial entities. For more information.
March 17, 2008. Biotech Forum: How to Build a World Class Company in RTP. For more information.
April 14, 2008. Biotech Forum. Innovative Business Models. For more information.
May 19-20, 2008. Biotech 2008: Fusing Science, Technology and Industry Leadership. Benton Convention Center, Winston-Salem, NC . The 17th annual Biotech conference is presented by CED in partnership with the North Carolina Biotechnology Center and NCBIO. The Biotech Conference unites the Southeast's life science communities. Fueled by pioneering research and development and a strong entrepreneurial spirit, come see for yourself why Biotech 2008 will be the biotechnology event of the year, celebrating what is widely considered one of the biotech industry's top three economies in the country. For more information.
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NCBIO This Month
