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 Support for $6.75 million in increased funding for the North Carolina Biotechnology Center will top NCBIO's 2008 legislative agenda. Other priorities will include renewal of North Carolina's research and development tax credit and expansion of the Qualified Business Venture Tax Credit.
NCBIO will join the Biotechnology Center in requesting funding for several new and expanded programs.
- Up to $3 million in expanded funding for the Center's loan programs for pre-venture start-up companies
- $2.5 million to restore the Center's Historically Minority University Infrastructure Grant Program, which is designed to build capacity in the life sciences at these campuses
- $800,000 in additional funding for the Center's Faculty Recruitment Grant Program, which funds part of faculty start-up packages and builds foundational biotechnology research capacity at North Carolina universities
- $450,000 for expansion of the Center's biotechnology education grants, workshops and K-12 teach support programs.
In addition, NCBIO will support a request from the Center for $3 million to expand its program, support and staff spaces. The funding will be used to match contributions from other sources for a facilities expansion that will support initiatives in biotechnology leadership, entrepreneurship, K-12 education, workforce training, international recruitment and university research.
NCBIO will join with other technology sector trade associations to support renewal of North Carolina's research and development tax credit. The credit, which allows companies to recover between 1.25% and 3.25% of the cost of qualifying research activities conducted in North Carolina. The credit also includes a 25% recovering on sponsored research conducted at North Carolina 's public universities. The credit is currently scheduled to expire December 31, 2008.
NCBIO will also ask legislators to increase the statewide cap on North Carolina's qualified business venture tax credit from $7 million to $10 million annually. The credit allows individual investors to recover up to 25% of qualifying investments in innovation-based start-up companies.
The 2008 legislative session is set to convene Tuesday, May 13, 2008 for it's regular "short session," during which legislators focus on updating the second year of the state's 2007-2009 budget plan.
 Reform of the Small Business Research Innovation (SBIR) program is one of the issues life science leaders will discuss with the North Carolina Congressional delegation during the BIO Fly-In April 15-16. BIO is recommending that the SBIR reauthorization bill reinstate eligibility for small biotechnology companies that receive a majority of funding from multiple venture capital companies.
BIO is also supporting reform of the patent system and opposes provisions that would weaken the ability of the patent holder to enforce his or her patent, or would otherwise undermine the predictability and thus value of patent. Other issues for discussion with the delegation are funding for FDA and NIH, Biofuels, Follow-On Biologics legislation, and increased federal involvement in comparative effectiveness research.
The annual event in Washington, DC takes place every spring and hundreds of biotech industry executives participate. The event allows biotechnology industry managers to meet with the members of the 110th Congress and to advocate the BIO legislative agenda. BIO will schedule and coordinate all meetings with North Carolina 's congressional delegation. NCBIO President Sam Taylor will be among those from North Carolina talking with NC Congressional members. Click here for more information about the Fly-In or to register.
 Statistics compiled by the North Carolina Biotechnology Center indicate that the state has 460 life science companies employing more than 56,000 people. Bioscience employment numbers from the NC Employment Security Commission, which includes a broad range of companies such as medical equipment indicates there are more than 1,500 firms in the state.
The growth of the life science industry in the Triangle was featured in a real estate article in The Wall Street Journal, March 26. The new headquarters for Quintiles Transnational Corp., PharmaNet Development Group, and PRA International were mentioned in the article, which focused on whether the Triangle Real Estate Market was beginning to slow down. The article noted that the amount of new office space in 2008 would be down slightly from 2007, but concluded that the region's prominence as a biotech hub isn't expected to diminish over the long term.
A study is under way by the Research Triangle Partnership on biotech and pharmaceutical real estate in the 13-county region it covers. That report is expected to be released at the end of May.
 "Biotechnology Wants a Lead Role" is the focus of a roundtable discussion hosted by the NC Biotechnology Center and published in Business North Carolina magazine. Five industry leaders participated: NCBIO President Sam Taylor, NC Biotechnology Center President and CEO Norris Tolson, Aurora Funds Partner Chris Kroeger, Tranzyme Pharama CEO Vipin Garga, and Aqualutions CEO Sarah Yocum.
Taylor talked about the state of the industry in North Carolina. "We've been around for 20 years, but the technologies that really have an application in health care are just beginning to open up. You're going to see this industry continue to grow steeply, not only in the number of jobs it creates but also in the amount of wealth it generates and the economic contribution it makes across the board."
Tolson said some of the state's focus must be on companies that are already here. "We spend a lot of money in this state to encourage complies to come here, but we need to invest money to help businesses that are here to grow. That's the thing that we here in the Biotechnology Center are interested in talking to our colleagues about in the General Assembly because we believe that the best growth – in most cases – is internal growth. Most new jobs in North Carolina come from businesses with less than 100 employees. We need to find ways to encourage small businesses to start here and to stay here." Click here to read the complete discussion.
A curriculum guide describing training available through the three education institutions involved in the Biomanufacturing and Pharmaceutical Training Consortium (BPTC) will soon be available online and in hard copy. Company representatives from NCBIO's Biotech Manufacturers Forum have been working with the institutions, NCBIO and the North Carolina Biotechnology Center to identify information that would help students, company trainers, incumbent and other interested individuals who seek life science training.
The guide is one of several projects the BPTC Industrial Curriculum Committee is working on to strengthen training activities in the state. The Committee also played a key role in a biosciences internship fair held at BTEC in February, and is helping the North Carolina Biotechnology Center with its participation in national worker training harmonization program.
The Forum is also in the planning stages of a project aimed at clearly identifying measurements needed to guide future strategy for the BPTC. Consortium members will be asked to participate in the development of the measurements that are of most importance.
BMF members are also working with officials at the BRITE facility at North Carolina Central University, which will become operational this summer. A dedication of the facility is tentatively scheduled for June.
If your company is interested in participating in the Industrial Curriculum meeting, please contact Hal Price.
 The Council for Entrepreneurial Development (CED) will hold its 25th annual Venture Conference, April 16-18, 2008 at the Washington Duke Inn on Duke University's Campus. CED's Venture conference is the Southeast's largest and most established event of its type, uniting more than 800 of the nation's top tier investors and the region's high growth companies. Venture promises to be a powerful event showcasing over 55 of the Southeast and Mid-Atlantic's most dynamic and promising business opportunities. In addition to 55+ presenting companies in various stages and industries, CED's Venture conference will also feature remarks from long-time Quintiles CEO, Dr. Dennis Gillings; NVCA President, Mark Heesen; and an LP panel on the State of Capital Markets. Register before April 9 and save up to $100.
NCBIO and VWR will host a scientific vendor fair at the NC Biotechnology Center, April 29. View the latest products from more than 40 suppliers such as Axygen, BD, Biofit, EMD, GE Health Care, Greiner BioOne, Mediatech, METTLER TOLEDO, Pall and Promega.
VWR specialists on chemicals, chromatography equipment, furniture, life science and safety will be on hand to discuss the needs of your company. Interested participants may come by the event any time between 11am and 1:30pm on April 29. Lunch will be provided. Register with Leigh Kridle.
Parking at the event is limited, and if several are coming from one company, please carpool.
 John Maraganore, Ph.D., President and CEO of Alnylam Pharmaceuticals, Inc. is one of the featured speakers for BIOTECH 2008. With more than 20 years of industry experience, Mr. Maraganore will share lessons from his senior management positions at Biogen Idec and Millennium Pharmaceuticals and discuss the future of RNAi drugs and their effect on the biotechnology industry.
Other keynote speakers include Edward C. Saltzman, President of Defined Health and former North Carolina Governor James B. Hunt, Jr. The event will feature discussions about the latest trends and hottest life science topics, including Financing a Life Science Company, The Impact of Globalization, The Paradigm Shift in FDA Approval, A Partnering Discussion with Pharmaceutical Executives, and Investment Bankers on the Future of Biotechnology.
BIOTECH 2008 will be held in Winston-Salem, May 19-20. The event is sponsored by CED and co-sponsored by the North Carolina Biotechnology Center and NCBIO.
NCBIO members are asked to inform educators in your community about this summer's 2008 Biotechnology Workshops for Educators, sponsored by the North Carolina Biotechnology Center. North Carolina educators receive a daily stipend, room and board, technology or regular CEUs, and access to the Biotechnology Center's Free Supplies and Equipment Loan Programs. Workshops are designed for high school teachers, but middle school teachers and college faculty may also attend.
For beginners, or for those who simply wish to brush up on their biotech, there are five Introductory Biotechnology Workshops being offered at locations around the state. For those educators who have attended an Introductory Workshop or have equivalent experience, Biotechnology Workshops in Special Topics are offerred. This year , educators can learn how to: (1) use biotechnology in the preservation of biodiversity; (2) use model organisms in the classroom to teach about applications of genomic science, including stem cells and bioinformatics; or (3) use the unique properties of green fluorescent protein (GFP) to teach how to express a protein in bacteria, purify it, and analyze its structure and function. Complete information about the workshops may be found on the Biotechnology Center's Web site. Space is limited. Click here to register.
 Business North Carolina is working on the 8th issue of Innovation North Carolina. This publication looks at new research and development under way in the state's laboratories, schools and companies. Innovation will be published twice in 2008. The midyear issue will be inserted in Business North Carolina magazine's July issue. It provides underwriters with an opportunity to promote their research activities and achievements to almost 100,000 Business North Carolina readers statewide. The Fall 2008 issue will be distributed with the North Carolina Economic Development Guide. The NC EDG is distributed year-round in partnership with the North Carolina Department of Commerce. Deadline for July 2008 issue is April 18. For more information, contact Ben Kinney, bkinney@businessnc.com, 704-523-6987 ext. 236.
Affinergy, Inc., a Duke University spinout with a proprietary site-specific biological delivery system, has been awarded five SBIR grants. One of the awards is a Phase 2 SBIR program for $2,053,845. The Phase II grant is funded through the NIH by the National Institute of General Medical Sciences. The focus of the program is to advance development and optimization of Affinergy peptide linkers to accelerate a patient's natural healing processes. The other 4 grant awards are for Phase I programs that, in aggregate, exceed $1 million.
Affinergy also has appointed two Vice Presidents to its leadership team Dr. Carmella S. Moody has joined Affinergy as VP of Regulatory & Quality Assurance and Dr. Bud Nelson has been promoted to VP of Intellectual Property. Dr. Moody has more than 20 years experience in the life science industry, primarily in the regulatory and clinical areas. Dr. Nelson has over 13 years experience as an intellectual property attorney in the biotech and pharmaceutical industries, and 7 years experience as corporate legal counsel.
Argos Therapeutics has announced the presentation of positive safety and feasibility data from a Phase 1 clinical trial of AGS-004 in HIV-infected adults in combination with antiretroviral therapy (ART). AGS-004 is an adaptation of the Company's ArcelisTM technology, a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient's unique viral burden. Researchers also presented an abstract describing the Company's method of RNA production which improves antigen expression in dendritic cells. These data were presented at the Keystone Symposia Conference on HIV Vaccines, held March 27 - April 1 in Banff, Alberta. "We are encouraged by the favorable safety and tolerability profile of AGS-004 in this trial, as well as the application of our ArcelisTM technology to creating immunotherapies to treat viral disease," said John Bonfiglio, Ph.D., President and CEO of Argos.
Gov. Mike Easley announced that BD (Becton, Dickinson and Company) will build a new plant in Wilson County and expand three facilities in Durham County. BD will add 274 new jobs during the next five years (182 in Durham and 92 in Wilson) and invest $134.7 million. The projects were made possible in part by a Job Development Investment Grant. "BD's presence is another example of why North Carolina has been consistently ranked among the top three states in biotechnology and life sciences," Easley said. BD manufactures and sells medical devices and instrument systems. The company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. It is focused on improving drug therapy, enhancing the diagnosis of infectious diseases and advancing drug discovery.
Stan Eskridge, CEO and president of Entegrion, joined twenty-four distinguished professionals as Triangle Business Leader magazine's 2008 Impact Business Leaders of the Triangle. The Impact Business Leaders were chosen from more than 180 nominations, and are recognized for their notable achievements and contributions to the Triangle business community. The Triangle's top business leaders were recognized at the Triangle Hall of Fame Gala March 3rd .
"I am truly honored to be recognized as one of the Triangle's business leaders," says Eskridge who became Entegrion's CEO and president in 2006. "To even be considered for this list of renowned business professionals is an award in itself."
Kryosphere is opening the first independent biostorage facility in North Carolina in May. Led by the team of Doug Baker, Eric Hallman, and Neil Jones Kryosphere provides secure biostorage, cold-chain logistics, and clinical sample management to the academic, government, and commercial research and services community. Kryosphere's first facility provides secure storage for over 5 million samples at ultra-low temperatures. With backup systems, emergency response teams and 24/7 monitoring, Kryosphere provides confidence in the safety and integrity of irreplaceable research samples. Kryosphere's inventory control systems and 24 hour access means researchers can get their samples when they need them. "With the hundreds of thousands of samples in the RTP and Triad area Kryosphere meets a growing need for safe and reliable storage. Why take chances?" says A. Neil Jones, VP for Scientific Operations.
Metabolon, Inc., a leader in metabolomics-driven biomarker discovery and analysis, and the Harvard-Partners Center for Genetics and Genomics (HPCGG), a collaborative program dedicated to promoting genetics and genomics in research and clinical medicine, have signed an agreement to develop an improved diagnostic test for enabling a more accurate dosing of warfarin. Warfarin, a blood thinning agent prescribed extensively during the last 50 years, causes more than 700,000 adverse events per year due to improper dosing (JAMA 2006; 296).
In related news, Partners HealthCare investigators have received preferred access to Metabolon's global biochemical profiling platform. Metabolon currently provides these services to the top pharmaceutical and biotechnology companies as well as other agriculture, consumer product and bioprocessing organizations. "We are very excited about initiating a long-term relationship with the Partners HealthCare research teams," said Dr. John Ryals, president and CEO of Metabolon. "Our work on the warfarin diagnostic coupled with the broad access to our discovery platform now available to the Partners HealthCare investigators, will firmly establish Metabolon's impact on the development and delivery of diagnostics tocritical areas within patient care."
Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), has initiated a Phase 1 clinical trial of TC-5214. Targacept is developing TC-5214 as an augmentation therapy for major depressive disorder (MDD). A Phase 2 clinical proof of concept trial is planned for later in 2008. The Phase 1 trial, which is being conducted in the United States, is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TC-5214 in healthy volunteers. TC-5214 is the S(+) enantiomer of the racemate mecamylamine hydrochloride, a broad spectrum NNR antagonist. In preclinical studies, TC-5214 has exhibited a better overall safety and efficacy profile than mecamylamine.
Alan A. Musso, Vice President and Chief Financial Officer of Targacept, made a presentation at the Cowen and Company 28th Annual Health Care Conference in Boston, March 18.
To have your company included in Member News, send releases to Brenda Summers.
 Follow-On Biologics Legislation
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood had comments about recent legislation introduced by Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) that would develop a regulatory pathway for approving follow-on biologics. "BIO commends U.S. Representatives Anna Eshoo and Joe Barton for taking a strong, bipartisan step forward toward developing a pathway for the approval of follow-on biologics – products that seek to imitate pioneering biotechnology medicines. The bill includes essential elements to ensure that any such pathway follows two critical principles: namely, protecting patient safety and ensuring continued innovation. Importantly, the bill recognizes the need to protect patient safety by calling for a set of studies demonstrating the safety and efficacy of the follow-on product, including clinical and immunogenicity studies."
"The proposal also establishes a mechanism for the U.S. Food and Drug Administration (FDA) to advise whether it is feasible, based on current science, to make a determination that a follow-on product is interchangeable with the pioneering biotech therapy," stated Greenwood. "While this provision improves upon previous legislative proposals, we continue to believe that patients should not be given follow-on biologics unless expressly prescribed by a physician. The legislation further seeks to provide pioneering biotechnology companies with a level of non-patent data exclusivity to promote continued innovation, although it falls short of the base 14 years that has been demonstrated to be the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry. Non-patent exclusivity is necessary to maintain effective market protection to attract the hundreds of millions of dollars necessary to research and develop an innovative new biotech therapy or technology."
April 24, 8:30 am, NCBIO Board of Directors meeting. NCBIO, 100 Capitola Drive, Durham.
April 28, 4 pm, Biotech Forum: How Early is Too Early? NC Biotechnology Center. More Information.
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.
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| NCBIO Annual Meeting May 19 |
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NCBIO This Month
