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 North Carolina's General Assembly returned to session May 13. Legislators will be looking at several issues important to North Carolina's life science community, including additional funding for the North Carolina Biotechnology Center, renewal of North Carolina's R&D Tax Credit, and a proposal to increase the statewide cap on claims for the Qualified Business Venture Tax Credit from $7 million to $10 million by 2010. The Session, which will likely run for only a few months, will focus mainly on updating the second year of the State's biennial budget plan, adopted in 2007.
Unlike many states, North Carolina is expected to enjoy a small revenue surplus when the current fiscal year ends on June 30, 2008; but the 2008-09 revenue picture will not be as rosy as when lawmakers held their last session, in 2007. Estimates by the State Budget Office indicate that 2007-08 revenues will exceed projections by about $150 million by year end. Legislators addressed a surplus of more than $1 billion in 2007.
Governor Mike Easley submitted budget recommendations earlier this month that include a $1.5 million in additional funding for North Carolina Biotechnology Center small business loans and other economic development programs. NCBIO is seeking a broader increase for the Center, totaling approximately $6.25 million and including funding for expanding the Center's education and workforce programs, reinstatement of the Center's grant program for historically minority universities. Governor Easley also recommended $2.5 million in non-recurring appropriations to support expansion of the Biotechnology Center's RTP headquarters facility. The Center expects to match the proposed state appropriation with funds from federal and private sources.
Governor Easley's budget recommendations also included an extension of North Carolina's Research and Development Tax Credit. The credit is currently scheduled to expire December 31, 2008. NCBIO is working with a coalition of technology-industry groups to win enactment of legislation extending the credit. The General Assembly's Revenue Laws Study Commission, which meets to address tax issues between legislative sessions, has also recommended reauthorization of the credit.
Easley's budget package also includes funding for a one-year extension of the State's novel SBIR matching grant program. Administered by the North Carolina Department of Commerce, the program provides state matching grants of up to $100,000 for North Carolina companies winning federal Phase I SBIR awards. The Governor has also recommended an additional $2 million for North Carolina State University to expand its bioengineering program. NCBIO will support these requests.
The Governor's budget also calls for substantial increases in teacher pay and funding for state mental health programs. To fund these and other program expansions, Easley is recommending at total of $165 million in tax increases on alcohol and cigarettes.
 NCBIO and its Medical Device Forum have retained RTI International* to support the Organization's work in developing plans for a new North Carolina Advanced Medical Technologies Center. RTI will work closely with Senior Project Executive, Greg Davis, in developing a business plan and organizational structure for the proposed Center. RTI's work is being funded with monies from a $100,000 Centers of Innovation grant awarded to NCBIO by the North Carolina Biotechnology Center.
"We are very excited to have RTI's extensive resources working in support our advanced medical technologies planning project," said Sam Taylor, President of NCBIO. "RTI brings considerable experience, insight and vision to this project. "We feel that by combining RTI's strategic strengths with Greg Davis's strong experience in the medical technology industry, we are on course to develop an effective and workable plan for supporting North Carolina 's growing advanced medical technologies sector."
NCBIO is collaborating with academic, economic development and business partners throughout North Carolina in development of plans for the new Center. For more on the partnership, see the April edition of NCBIO's Connections newsletter.
RTI's efforts in connection with the project will be led by Scott Mladsi, Senior Manager, Technical and Market Analysis. Mr. Mladsi brings more than 13 years of industry experience to the project. RTI's team includes both scientists and engineers responsible for analysis of the commercial potential and market opportunities of new technologies along with economic development professionals with experience in regional planning. RTI's project experience has included work in medical device technology management and technology-based economic development for organizations across the U.S. and internationally.
NCBIO expects to complete work on the AMTC planning project in late 2008. The proposed business plan and organizational structure will form the core of an application to NCBC's Centers of Innovation Program for a larger grant to fund start-up and initial operations of the proposed Center.
* RTI International is a trade name for Research Triangle Institute
 NCBIO President Sam Taylor and representatives of several of North Carolina 's largest life science companies and institutions traveled to Washington in April to participate the Biotechnology Industry's annual Congressional Fly-In. The North Carolina Fly-In group held meetings in the offices of nearly all of North Carolina's members of Congress.
"Congress is facing an array of issues of critical importance to the life science industry this year," said Sam Taylor, President of NCBIO. "Important federal legislation under consideration this year includes patent reform, follow-on biologics, comparative effectiveness, SBIR grant eligibility, and funding for federal agencies such as the Food and Drug Administration and the National Institutes of Health. We feel very good about our discussions with the Delegation concerning these matters."
Taylor also joined representatives of the North Carolina Biotechnology Center in separate meetings to discuss federal funding for expansion of the Center's facilities an programs.
 Frederick Frank, vice chairman and director of Lehman Brothers Inc.; James Hunt, former Governor of North Carolina; John Maraganore, president and CEO of Alnylam Pharmaceuticals, Inc.; and Edward Saltzman, founder and president of Defined Health, will be the featured speakers at Biotech 2008.
This year's conference will be the 17th annual biotech event hosted by the Council for Entrepreneurial Development with support from the North Carolina Biotechnology Center and NCBIO. The conference will begin at 2:00 p.m., Monday, May 19 at the Benton Convention Center in Winston Salem and conclude the afternoon of Tuesday May 20.
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More than 200 scientists and other life science employees turned out for NCBIO's first annual Scientific Vendor Fair, held Tuesday, April 29 at the North Carolina Biotechnology Center. The program, which was co-hosted by VWR International, provided scientists from member companies and institutions opportunities to view and discuss the latest in scientific products for life science discovery and development. "We appreciate the support of VWR and the vendor community," stated NCBIO President Sam Taylor. "We hope to offer other events in the future to engage scientists working in our growing industry.
 The educational partnership built to meet the workforce needs of North Carolina's life sciences industry, formerly known as the North Carolina Biomanufacturing and Pharmaceutical Training Consortium (BPTC), is now NCBIOIMPACT. The new name was chosen to improve recognition and streamline access to the collaboration of multiple North Carolina entities that provide a unique statewide training effort.
The NCBIOIMPACT partnership has given North Carolina international recognition for its innovative training of employees for the specialized, high-paying jobs at the state's increasing array of biopharmaceutical manufacturers. NCBIOIMPACT combines education, industry and nonprofit organizations including the Golden LEAF Biomanufacturing Training & Education Center (BTEC) on North Carolina State University's Centennial Campus; the Biotechnology Research Institute and Technology Enterprise (BRITE), to be dedicated in June at N.C. Central University; the North Carolina Community College System BioNetwork; the North Carolina Biotechnology Center; and NCBIO.
Sam Taylor, president of NCBIO, stated, "NCBIOIMPACT is providing a constant flow of educated workers at all levels, which gives North Carolina a significant competitive advantage. This effort provides not only for entry-level employees, but also strengthens training programs for incumbent workers at companies already here."
Retiring Community College President Martin Lancaster's decade of leadership has been honored with a new award program for community college faculty – the Biotechnology Faculty of the Year Award. North Carolina Biotechnology Center President Norris Tolson and life sciences industry leaders unveiled the award at a reception honoring Lancaster for his role in shaping the state's world-class biotechnology workforce training programs.
The award will be given annually to a faculty member in the community colleges' BioNetwork, a statewide initiative that connects all community colleges providing specialized training for biotechnology and pharmaceutical jobs. The award winner will receive $500 to spend on teaching supplies or equipment.
Contributors to the scholarship fund, in addition to the Biotechnology Center, are NCBIO, the North Carolina Research Campus and Novo Nordisk Pharmaceutical Industries.
Hal Price, coordinator for NCBIO's Biotech Manufacturers Forum, stated, "North Carolina has enjoyed a significant competitive advantage because of our world-leading workforce training structure. It's been a key factor in achieving our status as the number three state in the nation in number of biotech companies. We can all thank Martin Lancaster for his leadership in making this possible."
 Syngenta, a global agribusiness company with a biotechnology research facility in Research Triangle Park, is the recipient of the third annual Industrial Biotechnology Leadership Award given by the North Carolina Biotechnology Center and the Biofuels Center of North Carolina. Representatives of the Biotechnology Center announced the selection during a breakfast meeting at the four-day World Congress on Industrial Biotechnology and Bioprocessing in Chicago. The selection committee cited Syngenta's commitment to innovative biotechnology research leading to enzymes useful in developing biofuels, its support of agriculture, education and community service, and its involvement in the World Congress.
Previous recipients of the Leadership Award include Novozymes, honored for its achievements in developing new enzyme technologies to reduce the cost of producing ethanol from cellulose. In 2007, DuPont won the award for its development of plastics made with renewable resources, such as corn, to replace petrochemicals traditionally used in the process. It was also noted for its development, with BP, of an alcohol compound fermented from sugar beets.
The U.S. Department of Energy has selected a Novozymes project to further develop enzymes for cellulosic ethanol production. Novozymes' Project DECREASE (Development of a Commercial-Ready Enzyme Application System for Ethanol) aims to improve performance of Novozymes' most advanced cellulase system, further decreasing the cost of cellulosic ethanol production. Novozymes has been working on enzyme development for cellulosic ethanol, where agricultural residues like straws and corn stover are converted into ethanol, since 2001 when the company received a previous Department of Energy-funded project. An article by Emmanuel Petiot of the Novozymes North American facility in Franklinton, appeared in the January- February issue of Chemistry Today. The article focused on "The Road to Cost-Competitive Cellulosic Ethanol."
As a result of the booming fuel ethanol market, Novozymes facility in Franklinton is expect to add 35 jobs in 2008 and at least another 10-15 jobs over the next few years. The company is investing over $26 million for production, labs and offices.
Argos Therapeutics closed on a $35.2 million tranched Series C financing in April. The financing was led by TVM Capital and included participation from new investors Mizuho Capital, Morningside Group and Japan Asia Investment Co. Existing Argos investors Lumira Capital, Forbion Capital Partners, CDP Capital, Intersouth Partners, Aurora Capital, and GeneChem also participated in the round, with several of these investors participating significantly above their pro rata share. Kirin Pharma Company, Ltd., which has an on-going worldwide collaboration with Argos, also participated. Proceeds from the Series C will be used to fund the achievement of Phase 2 efficacy results for the Company's Arcelis™ immunotherapy candidates in renal cell carcinoma and HIV. The financing will also support the further development of Argos' CD83 protein immunology program through an initial human clinical trial in transplantation.
"This significant financing illustrates the confidence in our technology and pipeline on the part of a world-class investor syndicate," said John Bonfiglio, Ph.D., President and CEO of Argos. "After demonstrating proof-of-principle and the superior potency of our Arcelis platform with these resources, we would be poised to enter pivotal trials with our dendritic cell-based immunotherapies."
GlaxoSmithKline (GSK) and POZEN Inc.have received FDA approval for Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet. Pozen has received a total of $20 million in milestone payments from GSK for the FDA approval of, and GSK's intent to commercialize, Treximet(TM) (sumatriptan and naproxen sodium). Dr. John R. Plachetka, chairman, president and chief executive officer of Pozen said, "We are extremely pleased that the FDA has approved Treximet and are very excited that GSK has already begun the process to commercialize the drug with expected availability in pharmacies by mid-May."
Hutchison Law Group PLLC, led all Southeast-based law firms in venture capital transactions in 2007, marking the 3rd consecutive year the firm has held this distinction. The number of venture capital transactions is reported annually by Dow Jones & Company and is published in conjunction with the March edition of its monthly journal, Private Equity Analyst. The report lists both private equity and venture capital transactions negotiated and closed in 2007. Based solely upon the venture capital transaction category, the firm stands 25th nationally and is 1st among all law firms based in the Southeast. "We're honored to once again rank so highly on this report," said Hutchison Law Group member John Fogg. "Many of the other firms listed in the report employ hundreds, if not thousands of attorneys. The fact that we continue to be listed among these large national and international firms once again validates our commitment to the Southeast venture community."
A British Member of Parliament, John Denham, was in the Research Triangle in April to meet with leaders at the North Carolina Biotechnology Center and local universities. Denham, a Member of Parliament and Secretary of State to the Department for Innovation, Universities and Skills was accompanied by several other representatives of the British delegation in meetings to explore North Carolina's development of the life science industry.
Don deBethizy, Ph.D., President and Chief Executive Officer, Targacept, Inc. was a presenter at the Deutsche Bank 33rd Annual Health Care Conference. Targacept is a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM).
 ADVAMED 2008 Scheduled for September
NCBIO members can receive a $200 discount for Advamed 2008. The event will be held in Washington, DC, September 21-24, 2008. Designed by industry, for industry, AdvaMed 2008 is the premier medical technology conference and exhibition for business leaders, policymakers, investors, news media, patient advocates, and industry stakeholders from around the world. This year's conference offers a variety of workshops and panel discussions on subjects such as Medicare reimbursement, compliance, intellectual property, global market opportunities, corporate finance, public policy, emerging company issues, 21st century health care and the value of medical technology. The NCBIO discount is available to one person per member medical technologies company. To qualify for this discount, please send your contact information, including name, title and company, to Jennifer Fong.
Summer 2008 Biotechnology Workshops for Educators
Remind teachers in your community about this summer's 2008 Biotechnology Workshops for Educators, sponsored by the North Carolina Biotechnology Center. Workshops are designed for high school teachers, but middle school teachers, community college instructors and college faculty may also attend.
Three workshops on Special Topics in Biotechnology will be held this year.
- Using Biotechnology to Preserve Biodiversity
- Let it Glow: Using GFP as a Basis for Understanding Protein Structure and Function
- Genomics and Bioinformatics: Teaching with Model Organisms
2008 BIO International Convention – June 17-20, San Diego
Global issues such as intellectual property protections, follow-on biologics/biosimilars, international networking for research and development of neglected diseases and sustainable agriculture in developing countries will all be primary focus areas of the 2008 BIO International Convention. Hosted by the Biotechnology Industry Organization (BIO), the 2008 BIO International Convention will have more than 2,200 exhibitors showcasing the latest in biotechnology and life science related products and services. North Carolina will again host a pavilion at the event.
"More than 20,000 business leaders, scientists, executives, investors and industry leaders who are the drivers behind new scientific innovation will be participating in the BIO Exhibition," said Robbi Lycett, vice president, Conventions and Conferences at BIO. "This year, we are excited to welcome more than 100 new companies to the Exhibition and look forward to continued, quality growth in the years to come."
 Follow-On Biologics Legislation
The US House of Representatives has approved legislation reauthorizing the Small Business Innovation Research (SBIR) program (368-43), with provisions that allow more biotechnology companies to compete for research funding.
BIO President and CEO Jim Greenwood applauded the action, stating that the act "will increase access to early-stage funding for treatments and cures of debilitating diseases. Congress has recognized the capital-intensive needs of emerging biotechnology companies, whose development of a single new therapy often costs hundreds of millions of dollars and takes more than a decade to reach patients."
"BIO and patient advocacy groups around the world are especially pleased that the House reinstated the eligibility of small biotechnology companies with majority venture capital investment to compete for SBIR funding," Greenwood stated. "Both venture capitalists and the government's SBIR program are needed to fund the most promising science. These two sources of funding should work in a complementary manner to bring new therapies and innovations to the marketplace, ultimately to benefit patients and consumers."
Greenwood added, "BIO is also delighted to express its strong support for the inclusion of language in the reauthorization of the SBIR program that identifies rare disease research as an area that is deserving of special attention. We appreciate the House's efforts to stimulate research in orphan diseases such as ALS and provide much needed resources to small businesses, which are so critical to advancing the fight for a treatment and cure for such crippling diseases."
May 19, 1 pm, NCBIO Annual Meeting, Benton Convention Center, Winston-Salem.
May 19-20 Biotech 2008: Fusing Science, Technology and Industry Leadership. Benton Convention Center, Winston-Salem, NC.
More information.
June 4, 2008. CED MedTech Forum. 5:30-8:00 PM "New Opportunities: Microsystems and Nanotechnology in Medical Devices, Diagnostic Equipment and Delivery of Therapeutics.
More information.
July 30, 2008. CED MedTech Forum 5:30-8:00 PM. "How to Achieve a Therapeutic Valuation for a MedTech Company.
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