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 More than 300 people attended a public hearing hosted by the Department of Homeland Security in Granville County last month to collect input regarding a state proposal to locate the country's new National Bio- and Agro-Defense Facility (NBAF) in Butner. Supporters far out-numbered detractors of the project, and leading public officials, including Senator Richard Burr, Congressman David Price, local legislators, and UNC System President Erskine Bowles, spoke in favor of the facility. Most local leaders also spoke in support of the planned 520,000 square-foot laboratory. The project is supported by a consortium of North Carolina government, academic and business entities.
NCBIO President Sam Taylor told federal officials that "NBAF will be a critically important asset to our nation's economy and our well-being as a society and . . . Butner, North Carolina, is an ideal location for the facility." Taylor referenced North Carolina's new world-class life science education and training initiative, the Biomanufacturing and Pharmaceutical Training Consortium, as a leading asset in the region's bid to host the facility. He also cited the success of other, similar federal facilities in the area, including the Environmental Protection Agency and the National Institutes for the Environmental Health Sciences.
When built, the NBAF will conduct focused research on a wide range of pathogens that could threaten American food supplies. About 10 percent of the facility will be comprised of Biosafety Level 4 research laboratories. The Department of Homeland Security has narrowed its site search for the new laboratory to North Carolina, Texas, Georgia, Kansas, and Mississippi. The Department is now conducting an environmental impact assessment of the five sites. The Department is also evaluating a sixth site, an existing animal disease research facility at Plum Island, New York, as a no-action alternative.
Some local residents and a group of environmental activists from outside the area spoke against the facility, expressing safety concerns and arguing that local residents will not benefit from jobs and investment associated with the new laboratory. The facility is expected to create more than 1,000 construction jobs and a few hundred permanent positions. NCBIO believes that the laboratory would substantially strengthen research and commercialization of infectious disease technologies in North Carolina and will serve as a magnet to new life science companies and research activities.
Governor Mike Easley says the new Golden LEAF Biomanufacturing, Training and Education Center (BTEC) on the North Carolina State University (NCSU) Centennial Campus "will open the door of opportunity to thousands and hundreds of thousands of North Carolinians across this state to participate in the growing biotechnology industry."
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BTEC Main Entrance, Centennial Campus, Raleigh |
More than 300 state, education, foundation and industry leaders attended the dedication of the largest training facility of its kind in the nation. Through the partnerships between NCSU, North Carolina Central University (NCCU) and the North Carolina Community College System (NCCCS), BTEC's distance education and on-site programs will train as many as 2,000 students, prospective and current employees per year.
NCBIO and its Biotech Manufacturer's Forum (BMF) have worked with the educational institutions and the North Carolina Biotechnology Center to develop the workforce projects. Governor Easley noted that NCBIO BMF consultant Hal Price was "the glue that held all this together. He is the one who made all of us give speeches, [and] do what we said we were going to do."
The Golden LEAF Foundation, a non-profit foundation that invests in long-term economic development projects in the state, provided $70 million in startup funding for the consortium – its largest investment in a single enterprise. Valeria Lee, president of Golden LEAF stated, "BTEC gives students, incumbent workers and people interested in employment in biomanufacturing relevant, hands-on training in a pilot-scale manufacturing facility."
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Susan Seymour, Li An Yeh, Peter Kilpatrick |
Designed to create the most well-trained, industry-focused professional workforce in the world, BTEC begins its work this fall with seven courses and will increase to nearly a dozen in the spring. Every course but one has an associated advanced, hands-on laboratory in a current Good Manufacturing Practice (cGMP) environment using facilities and equipment that match those in place at the world's leading biomanufacturing companies.
In addition to university-level courses, the BTEC will support NCCCS's BioNetwork, which will offer biotechnology-related curricula at community colleges across the state. Currently, more than 20 community colleges statewide are growing the workforce for this sector, with support from six specialized centers offering expertise in different aspects of biotechnology. Since BioNetwork's inception, more than 4,700 students have received biotech training made possible either directly or indirectly by $17.9 million in BioNetwork funding. Collectively, these students have entered or re-entered the workforce earning wages estimated to be $13,246 per year higher than their previous employment.
A third element of the state's biotechnology education and training initiative, a Biomanufacturing Research Institute and Training Enterprise (BRITE), will dedicate a new 52,000 square-foot laboratory and teaching facility at North Carolina Central University in the spring of 2008. The building will support new undergraduate and graduate degree programs in pharmaceutical science. BRITE has recruited industry-experienced faculty to provide targeted preparation for student employment in pharmaceutical companies and to initiate research programs in drug discovery and new technology to support manufacturing. Currently, 57 bachelor's students and 27 master's students are committed to the program for fall 2007.
 North Carolina's life science business climate continues to support strong levels of business activity. News reports from October 2006 through September 2007 included announcements of more than $1 billion in equity investments, capital expenditures, grants, and other major funding events in the state. Equity investments during the period totaled $410 million; capital investments reached nearly $188 million; grant announcements totaled more than $267 million; and publicly announced licensing payments approximated $95 million during the period. Click here for a list of deals reported during the period.
"NCBIO has tracked publicly announced funding events in North Carolina for nearly two years now," said Sam Taylor, President of NCBIO. "Activity levels continue to increase, with announcements during the October to September period increasing slightly over the same period in 2006-07."
 Applications are now being accepted for the North Carolina Biotechnology Center 's 2007-2008 Mini-Grant Program. All proposals must be submitted electronically using the Biotechnology Center's online submission process. Proposals must be received by noon on January 23, 2008.
The Biotechnology Education Mini-Grant Program offers awards of up to $6,000 to assist in the development and implementation of activities, programs, and courses for biotechnology education and training at the K-12 level. Any North Carolina non-profit institution may apply.
Aldagen, Inc., a biotechnology company advancing a pipeline of clinical stage regenerative therapies, has raised an additional $9 million in its Series C financing, bringing the total round size to $23 million. The initial Series C closing was announced in December of 2006. New investors include Tullis-Dickerson and CNF Investments LLC. Existing investors Harbert Venture Partners, LLC and Intersouth Partners also participated in the additional financing.
POZEN, Inc. has started Phase III trials for PN 400, a fixed dose combination of the proton pump inhibitor (PPI) esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. An NDA is targeted for the first half of 2009, subject to the pace of enrollment in the pivotal trials. POZEN and AstraZeneca have amended their collaboration and license agreement for development of the drug. Under the terms of the amended agreement, AstraZeneca will pay POZEN up to $345 million in the aggregate, for the achievement of development, regulatory, and sales milestones.
Alan A. Musso, Vice President and Chief Financial Officer of Targacept, Inc. made a presentation at the "Newsmakers in the Biotech Industry" conference sponsored by BioCentury. The conference was held in September. Mr. Musso also spoke at the Bear Stearns 20th Annual Healthcare Conference.
NCBIO welcomes new members Applied Integrated Market Strategies, Device Partners International, Merck & Co. Inc., McGuire Woods Consulting, Sanofi Aventis, Whiting-Turner Contracting Company, and the Winston-Salem Chamber of Commerce.
To have your company news included in this section, please have your media relations contact add Brenda Summers, bsummers@ncbioscience.org to the distribution list.
 Small Business Investment Expansion Act Passes U.S. House
The United States House of Representatives has passed the Small Business Investment Expansion Act (H.R. 3567), which would restore SBIR eligibility to venture-backed start-up companies.
"H.R. 3567 allows small biotechnology and medical device companies to secure critical financial resources for their frontline research and innovation," said BIO President and CEO Jim Greenwood. "This legislation updates the current Small Business Administration (SBA) regulations to allow access for those small biotechnology companies who also rely on private-sector financing to conduct life-saving and life-enhancing research."
Outdated SBA regulations currently preclude small businesses, even those with only a handful of employees, from receiving assistance because they rely on venture capital to fund their research and development (R&D). H.R. 3567 corrects this inequity by allowing these small businesses to access SBA programs while also receiving necessary R&D investments from eligible venture capitals firms (VC).
H.R. 3567 also amends the Small Business Act to ensure that small business that receive VC dollars remain "independently owned and controlled," as long as the investing VC is not owned by a large company and meets other limitations. The legislation does not allow VCs to receive SBA dollars, instead it narrowly defines the type of VC investment that a small business can receive to remain eligible for SBA programs.
"We appreciate the overwhelming support of the 325 Members of Congress who voted for the legislation and want to especially thank the leadership displayed by Chairwoman Nydia Velazquez (D, NY-12), Ranking Member Steve Chabot (R, OH-1), and Representatives Jason Altmire (D, PA-4) and Sam Graves (R, MO-6) in shepherding this critical legislation through the House floor," Greenwood added.
PDUFA Package Will Provide Needed Resources to FDA
BIO President and CEO Jim Greenwood has praised the U.S. Senate for its passage of the Food and Drug Administration Amendments Act of 2007 (H.R. 3580) reauthorizing the Prescription Drug User Fee Act (PDUFA). "We are pleased that the House and Senate have voted to reauthorize PDUFA so this important legislation can finally be signed into law. The final package will help enhance and improve drug safety while providing the resources necessary for the Food and Drug Administration (FDA) to continue the efficient and comprehensive review of new drugs and biologics.
"This legislation provides the FDA with the enhanced capacity for drug evaluation with greater transparency and consistency and an active post-market surveillance system to better elucidate the benefits and risks of drugs and biologics. The legislation also takes steps to advance the Critical Path Initiative and provides important incentives for pediatric research."
Since its inception in 1992, PDUFA has provided FDA with the resources necessary to review more than 1,100 new medicines, and to reduce review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments.
Patent Reform Bill Passed by US House Needs Revisions
"BIO appreciates the continued efforts by the House to improve the Patent Reform Act of 2007, but unfortunately cannot support the legislation passed as it threatens continued biotechnological innovation," according to BIO President Jim Greenwood. "We welcome improvements to the U.S. patent system, particularly those that increase patent quality, increase public participation, and provide additional resources to the Patent and Trademark Office (PTO). However, the legislation that passed the House and the legislation currently pending in the Senate do far more harm than good to our nation's patent system," Greenwood continued.
"While we are disappointed that the legislation passed the House, we were heartened that it did so narrowly and that there was strong bipartisan opposition to the bill. This opposition demonstrates the serious concern of varied stakeholders -- across many industries, research institutions and other interests -- with the bill and the need for a more consensus-oriented approach to patent law reform."
"We look forward to working with the Senate to improve upon this legislation, particularly with respect to provisions relating to damages, inequitable conduct reform, post-grant review proceedings and PTO rulemaking authority."
October 10-11 CED's Tech 2007 Conference, Friday Center , Chapel Hill, NC. CED's 17th annual Tech Conference will explore ways to live, think, communicate, and do business. Tech 2007 will unite the best in disruptive thinkers and tech industry professionals to converse on clean tech, med tech, new tech, and more. The Tech 2007 Demo Room will showcase pioneering technologies from entrepreneurial companies, universities, corporations, and research institutions across the Southeast and Mid-Atlantic regions. More information.
October 17 MedTech Forum: Medical Device Opportunities in Asia and Japan. MCNC Building #1, Research Triangle Park . Greg Davis, an experienced medical device executive who lived and worked in Asia and Japan for five years, will share his thoughts and insights on conducting business in the region. Topics in his presentation include Intellectual Property, Firstin Human Testing & Clinical Trials, Regulatory Approvals, Reimbursement & Pricing, Manufacturing & Distribution, Physician Customers and Patients. $25 pre-registration, $30 on-site registration. For more information.
October 22, Biotech Forum, "Anatomy of a Deal – Viamet Pharmaceuticals," 5:30 p.m., NC Biotechnology Center. More Information.
November 5 Nanotechnology in Biology and Medicine. Hosted by the North Carolina Biotechnology Center, UNC-Charlotte, and the Carolinas Medical Center, the conference will feature experts with state-of-the-art presentations on nanotechnology as it relates to biology and medicine. Cannon Research Center Auditorium at Carolinas Medical Center, Charlotte, 8:30 a.m. to 7:00 p.m. More information.
November 6, SEBIO 2007 Venture Conference. Pinehurst. More information.
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NCBIO This Month
