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 Legislative negotiators have agreed on a budget conference report that would appropriate an additional $4 million in non-recurring support for the North Carolina Biotechnology Center in the 2008-09 fiscal year. The new monies will be used to expand the Center's loan programs for pre-venture start-up companies and to jump-start fundraising for an expansion of the Center's facilities. The appropriation brings total funding for the center in 2008-09 to $19.4 million.
"Additional funding for the Biotechnology Center was at the top of our legislative agenda for this year," said NCBIO President Sam Taylor. "We are delighted that our legislators have once again chosen to invest heavily in our state's life science future.
Of the new funds, $1.5 million are earmarked for the Center's loan programs and $2.5 million for the building expansion project. Additional funds for the new facilities are expected to come from the federal government and private sources.
The budget agreement must receive final legislative approval in floor votes by both chambers and be signed by Governor Mike Easley before it will take effect.
Legislative budget negotiators have agreed on a variety of measures increasing North Carolina 's commitment to biotechnology and life sciences. In addition to $4 million in 2008-09 supplemental appropriations for the North Carolina Biotechnology Center (see related article), the budget agreement includes:
The budget agreement also sets aside $35 million in capital funds to complete planning, begin site development, and pre-purchase materials for a Biomedical Research Imaging Center at the University of North Carolina at Chapel Hill. In addition to imaging research facilities, the Assembly approved money for wet labs and drug research space not included in the original project scope. The proposed 343,000 square foot building is expected to ultimately cost $260 million.
Tax provisions in the budget agreement reauthorize North Carolina's Research and Development Tax Credit through 2013 and increase the annual statewide cap on North Carolina's Qualified Business Venture Tax Credit from $7.0 to $7.5 million beginning with investments made in 2008. NCBIO lobbied legislators throughout the session in support of the two measures.
Budget changes proposed by House and Senate negotiators fail to fully fund continuation of Governor Mike Easley's One North Carolina Small Business Fund, which provides state matching grants for North Carolina companies winning federal SBIR or STTR awards. The budget agreement includes only $3.5 million in non-recurring funding for the program, compared to $5 million of one-year funding in 2007. NCBIO worked with the North Carolina Department of Commerce and other innovation-based industry associations to fight cuts in the program.
"We are disappointed that the Assembly did not fully fund this important grant program," said NCBIO President Sam Taylor. "These monies provide very important to very early-stage companies that conducting proof-of-concept experiments and other research necessary to demonstrate the feasibility of new technologies."
"These funds were fully utilized by applicant companies in 2007," said Taylor. The budget agreement amounts to 30% cut to the One North Carolina Small Business Fund. Shortchanging this program hurts our state's pipeline of developing innovation-based companies by reducing support for companies that, if successful, will go on to raise tens, if not hundreds, of millions in private equity to bring proven innovations to market."
The North Carolina Biotechnology Center has unveiled a unique fellowship program to help postdoctoral scientists from the state's research universities transition into industry R&D careers. The NCBC Industrial Fellowship Program will retain home-grown research talent by providing work experience in North Carolina 's life-science companies. It is designed to fill a gap for scientists in need of industry experience as well as for companies in need of scientific expertise.
"We know of nowhere else in the world where there is a defined pathway for life scientists seeking to transition from academia to industry," said Rob Lindberg, Ph.D., R.A.C., director of the Biotechnology Center's Business Acceleration and Technology Out-licensing Network (BATON) program.
"Not surprisingly, many freshly minted Ph.D. scientists and postdoctoral fellows are considering futures in industry," said Lindberg. "But unlike degree programs in fields such as engineering, law or business, graduate and post-graduate scientific training programs do not typically provide exposure to the world outside of academia as a formal component of the training."
To facilitate the connection between scientist and company, the Biotechnology Center will provide two years of salary and benefits for five NCBC Industrial Fellowship recipients per year. Eligible sponsors are North Carolina biotechnology companies that are engaged in discovery or contract research. The company must provide a senior scientist to mentor the fellow. Fellows are Ph.D. scientists who are hired by the sponsor company as full-time employees. Additionally, NCBC fellows will have access to programs in business, intellectual property, regulatory affairs and other areas to complement their training.
The Biotechnology Center is currently accepting applications from sponsoring companies. Details and applications for companies and fellowship candidates are available at www.ncbiotech.org/fellowship. The deadline for company applications is July 15, 2008.
 A new report sponsored by the Biotechnology Industry Organization shows that all sectors of North Carolina's life science economy grew between 2001 and 2006, with total employment reach 50,000 by the end of the period. The report, which was released at the BIO International Convention in June, also shows that life science companies in the state indirectly support an additional 178,000 jobs, bringing the industry's total economic impact in 2006 to more than 227,000.
Technology, Talent and Capital: State Bioscience Initiatives 2008, presents data on employment between 2001 and 2006 in four major segments of the bioscience sector, (i) drugs & pharmaceuticals; (ii) agricultural feedstocks and chemicals; (iii) medical devices and equipment; and (iv) research, testing and medical laboratories. It also examines a series of key performance metrics and describes individual state policies and programs designed to accelerate the growth of the biosciences.
The report's analysis of North Carolina's life science industry shows that drug and pharmaceutical companies make up the state's largest bioscience sector, employing nearly 19,500 people statewide in 2006, more than 6% of the nation's total. Annual wages among state drug and pharmaceutical companies averaged $81,085. Employment at North Carolina drug and pharmaceutical companies grew by 3.1% between 2001 and 2006.
Research, testing and medical laboratories employed 16,000 workers in North Carolina, earning an average wage of $69,174. Employment in the sector grew a whopping 56.9% between 2001 and 2006. Medical device and equipment companies employed nearly 9,200 workers statewide, up 14.0%, with average annual wages of $59,441. Agricultural life science companies employed 4600 North Carolinians at an average annual wage of $59,061; employment in the sector grew 3.0% during the period.
In other highlights from the report
- Academic bioscience research and development expenditures in North Carolina topped $1.3 billion in 2006, the 6th largest sum among the fifty states.
- North Carolina ranked 7th nationally in NIH funding in 2007, with $931 million in grants.
- Bioscience-related venture fund investments in North Carolina totaled $1.53 billion between 2001 and 2007.
- Bioscience-related patents issued to North Carolina entities totaled 2,340 from 2002 to 2007, ranking North Carolina 20th in the nation.
The report was prepared by Battelle Memorial Institute with assistance from NCBIO and the North Carolina Biotechnology Center.
An analysis completed by NCBIO earlier this month shows that North Carolina companies registered for the state's Qualified Business Venture Tax Credit raised more than $1.05 billion in venture capital and other equity between 2003 and 2007. Investments in QBV companies trended upward during most of the period, ending with an annual total of $286 million in 2007.
The QBV Credit gives angel investors a credit against personal income tax for up to 25% of investments in qualifying companies. Investors received a little over $30 million in credits between 2002 and 2007.
"This analysis shows the tremendous return on investment that North Carolina achieves through the QBV Tax Credit," said NCBIO President Sam Taylor. "By stimulating angel investment, the credit creates investment opportunities for venture funds and, ultimately, public equity markets. Furthermore, most monies invested in these companies also contribute to our local economy as they are used to pay for goods and services required by qualifying start-up companies."
NCBIO has regularly lobbied for extension and expansion of the QBV Tax Credit. Earlier this year, the Organization asked legislators to expand the current statewide cap on the credit from the current $7 million annually, to $10 million by 2010. Legislators instead elected to fund a modest $500,000 increase in the cap for investments made in or after 2008 – bringing the total cap on the credit to $7.5 million annually.
 Mingjuan Zhang, 18, a senior at the North Carolina School of Science and Mathematics in Durham is the winner of the 2008 Snofi-Aentis International BioGENEius Challenge. Ms. Zhang received the award at BIO 2008. Her project was titled "Characterization of a Synthetic Microbial Pathway for the Production of Bioplastics."
Petroleum-made plastic has two serious downsides: Its cost is rising with that of its key ingredient, and it does not biodegrade. Ms. Zhang is one of the researchers lighting the way toward a new era of bioplastics, made using plants or microbes. These new plastics are biodegradable, and may have other desirable material properties. Unfortunately, even with rising petroleum costs, bio plastics often remain uncompetitive. As Zhang's report notes, the bioplastic PHA—which can be produced in bacteria—costs almost $6/kg to produce, versus 20¢/kg for the petroleum-based plastic polypropylene.
As the BioGENEius Challenge first-place winner, Ms. Zhang will receive an award of $7,500. She was one of 16 finalists, representing six U.S. regions, Western Australia (for the first time this year) and Canada. The contestants presented their research to a panel of distinguished scientists, educators, and biotechnology leaders who chose first- through fourth-place winners. All competitors displayed their research at the BIO international Convention in San Diego.
Merck Announces Expansion
Merck & Co. Inc. plans to invest about $300 million to again expand its Durham vaccine manufacturing facility, creating an additional 150 to 180 jobs. The expansion will support the manufacture and global distribution of several of the international pharmaceutical company's key vaccines. "This expansion will further position the Durham facility to more effectively support Merck's growing global vaccine business," said plant manager John Wagner. "We appreciate the support we have received from state and local officials and the Durham community since we located here four years ago. We are proud to be a part of North Carolina's expanding biopharma sector."
In 2004 the company began construction of a $300 million, 235,000-square-foot facility in Treyburn Corporate Park in Durham that was completed this year. This facility is on schedule to become fully licensed to begin supplying vaccines to markets around the world in 2009.
In December 2006, Merck announced Phase II of the Durham facility: an expansion that includes a sterile processing facility, quality testing labs and high speed packaging line totaling approximately 110,000 square feet. Construction is currently underway and is scheduled to be completed in 2010.
The announcement in June of a Phase III expansion, which will include a new bulk vaccine manufacturing facility as well as expansions to the utility, warehouse and administrative infrastructures, is contingent upon approval of a grant by the Durham County Commission.
Assuming approval of that grant, construction is scheduled to begin in 2008 and be completed in 2011, bringing the projected total number of employees at the site to approximately 400.
Biogen Idec Funds Community College Scholarship Program
The North Carolina Community College System and Biogen Idec have created a scholarship program for students interested in obtaining a biotechnology-related associates degree. The program, funded with $25,000 from Biogen Idec, will help students with limited financial resources, but a commitment to the life sciences industry, pursue a two-year degree.
"North Carolina 's robust, industry-responsive community college system is one of the contributing factors that drew us to the state in the mid-90s," said Dr. Ester Alegri, Biogen Idec's vice president for manufacturing and general manager of the company's Research Triangle Park facility. "We – along with our industry peers – have experienced the benefits ever since. Whether it's providing scholarship funding or curriculum development assistance, Biogen Idec looks forward to continuing our partnership with out state's outstanding community colleges."
Eisai Wins FDA Priority Review
Eisai Corporation of North America has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for ONTAK®. The sBLA seeks to convert an accelerated approval indication into full approval. It is based on a placebo-controlled Phase III clinical trial to confirm the clinical effectiveness of ONTAK in certain patients with cutaneous T-cell lymphoma (CTCL).
ONTAK is indicated for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the IL-2 receptor. The safety and efficacy of ONTAK in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined. ONTAK was granted accelerated approval under Subpart E in February 1999. CTCL is a rare form of cancer in which T-cells, cells that the body uses to fight infections, become cancerous and affect the skin. CTCL can also spread to other organs in a small number of patients.
Hutchison Law Group Adds to Firm
Hutchison Law Group PLLC, has announce d that Bashir M.S. Ali, Ph.D. and Allyn B. Rhodes have joined the firm's intellectual property practice group. Bashir Ali focuses on patent law matters for clients primarily in the pharmaceutical and chemical industries, including preparing and prosecuting patent applications, and preparing opinions on validity, non-infringement and freedom-to-operate. Allyn Rhodes focuses on patent law matters for clients primarily in the pharmaceutical and chemical industries, including counseling clients on patent protection strategies, conducting due diligence investigations of patent portfolios and preparing and prosecuting patent applications.
Inspire One of Best Places to Work
The Scientist magazine has named Inspire Pharmaceuticals, Inc. as one of the "Best Places to Work" in 2008. Inspire ranked second overall in the annual survey conducted by the magazine. This is the third year the company has ranked in the top five. Inspire also recently received recognized by the American Heath Association as a Start! Fit-Friendly Company, and was named an honoree at Business Leader magazine and Rex Healthcare's "2008 Healthiest Companies" competition.
"Inspire is dedicated to fostering a positive work environment and exceptional corporate culture that enables our employees to achieve professional and personal success," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "Also, as a company in the healthcare industry, we are pleased to be recognized for our efforts to promote a healthier work place for our employees and their families."
Smith Anderson Receives National Recognition
Chambers USA: America's Leading Lawyers for Business has recognized Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. for the sixth consecutive year. The firm's Corporate/M&A practice received Chambers highest recognition, a Band 1 ranking, and is one of only two firms in North Carolina to receive this honor. In the Corporate/M&A category, Smith Anderson has more lawyers ranked in the Research Triangle area than any other North Carolina law firm. Of the top 8 ranked Corporate/M&A lawyers in the State, 3 are from Smith Anderson.
The following Smith Anderson lawyers received individual recognition: Corporate/M&A Christopher B. Capel, John L. Jernigan, Byron B. Kirkland and Gerald F. Roach. Labor & Employment Rosemary G. Kenyon and Kimberly J. Korando. Litigation (General Commercial) Mark A. Ash and Carl N. Patterson, Jr. Real Estate: C. Steven Mason and Lacy H. Reaves (Zoning/Land Use).
Talecris Completes Upgrade of Facility
Talecris Biotherapeutics, Inc., has reported that it is on track with the vertical integration of its plasma supply chain and that it has successfully completed a complex upgrade of its manufacturing facility located in Clayton, North Carolina, all intended to ensure increased supply of its plasma-based life-enhancing therapies to customers.
Lawrence D. Stern, Chairman and CEO of Talecris, said, "Growing our plasma supply chain and updating our manufacturing facilities are both key to providing the increased supply of the life-enhancing therapies that our customers rely upon. We have continued our significant investment in the vertical integration of our plasma supply chain and in the scheduled upgrades of our manufacturing facilities. I am pleased at the progress we have made in taking the steps we need to ultimately increase the supply of our products."
As part of the company's vertical integration of its plasma supply, Talecris has opened four new plasma collection centers throughout the United States in 2008, bringing the total to 53.
Targacept Joining Russell 3000
Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), that it is set to join the Russell 3000 (R) Index, according to a preliminary list of additions recently posted on www.russell.com. Targacept's addition to the broad market Russell 3000 Index remains in place for one year. "We are pleased to have our progress affirmed by inclusion in the Russell 3000 Index," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer. "We expect this broad-market index will increase Targacept's visibility to investors as we focus on advancing our pipeline of NNR Therapeutics."
Targacept also has announced the initiation of a Phase 2 clinical trial of AZD3480 (TC-1734) in adults with Attention Deficit/Hyperactivity Disorder, or ADHD. "In our previous clinical trials of AZD3480, the compound has demonstrated compelling attentional effects," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "We expect this well-designed pilot study to provide valuable insight that will facilitate future development planning."
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| photo by: NC Department of Commerce |
BIO International Convention Attracts 20,000
The 2008 BIO International Convention, produced by the Biotechnology Industry Organization (BIO), was attend by 20,108 industry leaders – a 36 percent increase from the last time the convention was held in San Diego, Calif. in 2001. Attendees hailed from 70 countries and 48 states, as well as 4,270 attendees and exhibitors from California.
"The 2008 BIO International Convention was a phenomenal success, bringing together thousands of leaders from industry, government, academia and other disciplines who are working to solve some of society's greatest challenges," said president and CEO of BIO Jim Greenwood. "I want to personally thank our many partners in San Diego, the region and throughout the industry who help make this event a success year after year."
More than 20,000 people attended the convention in San Diego . The North Carolina pavilion, with its new design this year, attracted a number of those attendees. Coordinated by the NC Department of Commerce, visitors could find out about research initiatives, companies, workforce training, and economic development activities under way in the state. Thirty-one sponsors had exhibits in the North Carolina pavilion.
Burrill Predicts Growing Impact of Personalized Medicine
G. Steven Burrill, author of Biotech 2008 - Life Sciences: A 20/20 Vision to 2020, the 22nd annual report on the biotechnology industry, told attendees at the 2008 BIO International Convention in June that personalized medicine will be a key driving factor in the life science industry's growth for the next decade.
Burrill predicted that by 2020 direct to consumer healthcare delivery institutions will become the place to go for medical treatment, with patients carrying their genome and health records on a smartcard. Burrill also forecast the availability of off-the-shelf organs, as well as implants and prostheses that mimic biological functions, restore critical functions to existing organs or tissues, or even augment those functions will begin to appear.
"Three years ago, we highlighted the fact that systems biology was beginning to move us to a more personalized medicine world that inevitably would lead us down the path to predictability and then on to prevention," said Burrill, CEO of Burrill & Company, a San Francisco based global leader in life sciences. "When we reach the year 2020, we will look back and note that 2007 was the year that personalized medicine started to play a role in every aspect of the healthcare continuum."
Biofuels Discussed at BIO
Attendees the 2008 BIO International Convention heard experts predict that increased crop yields will be able to satisfy both food and bioenergy needs. Richard Hamilton, president of Ceres, Inc., presented a case for biotechnology advances sustaining a long-term increase in crop yields on both marginal and primary cropland. Hamilton said that biotechnology-enhanced plants yield more per acre not just by "percentages but by multiples." Hamilton argued that if farmers the world over used conservation farming techniques and planted crops appropriate for the topography – for example switchgrass in locations with marginal topsoil and corn in locations with the best topsoil – the world would have a surplus of both food and fuel crops in just about every region.
Biofuels speakers at the BIO International Convention also noted that work to move laboratory-based early-stage products to commercial product ion will be the next major stage of biofuel development.
July 8-11, 2008. Let it Glow: Using GFP as a Basis for Understanding Protein Structure and Function, Campbell University . Buies Creek, NC. Green fluorescent protein (GFP) is used to explore protein expression because its glow makes visualizing the protein straightforward. For more information.
July 20-23, 2008. Cryo2008. Charlotte, NC. This four-day scientific conference will bring various science and academic officials to discuss everything from cryobiology to biopreservation. For more information.
July 22-24, 2008. BTEC - Fermentation Engineering. Raleigh, NC. This 3-day professional development course is suggested for those seeking a more advanced hands-on course on the engineering aspects of fermentation. For more information.
July 28-August 1, 2008. Introductory Biotechnology Workshop for Educators. Asheville, NC. Participants will learn basic scientific concepts and techniques in biotechnology, as well as how to teach these effectively according to the NC Standard Course of Study. For more information.
August 18-20, 2008. Duke Bioinformatics Workshop. Durham, NC. The finished sequence of the human genome represents an invaluable resource that will greatly accelerate scientific research. This workshop provides its participants with the expertise to efficiently explore this myriad of information. For more information.
September 9-10, 2008. BioPharm America 2008. Atlanta, GA. Based on the same winning formula used in EBD Group's distinguished European partnering conferences BIO-Europe and BIO-Europe Spring®, BioPharm America is expected to become the premier stand-alone biopharmaceutical partnering event in North America. For more information.
September 21-24, 2008. AdvaMed 2008, Washington, DC. 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. For more information.
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NCBIO This Month
