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NCBIO Submits Report to Governor Perdue |
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 NCBIO has submitted a report of its November life sciences town meeting with then Governor-Elect Beverly Perdue. The report was forwarded to Perdue’s office days before she was sworn in as the State’s 73rd governor, promising to “focus on building our core strengths and building up new strengths.” Perdue has been a strong supporter of North Carolina’s life science industry since serving as a chairman of the General Assembly Senate Appropriations Committee in the 1990’s.
Perdue asked NCBIO for a record of the November town meeting proceedings, along with detailed information regarding some of the Organization’s 2009 legislative proposals. During the meeting, Perdue and representatives of more than twenty North Carolina life science organizations discussed matters including capital formation, technology transfer, education and workforce development, and company retention and expansion incentives. Click here for a copy of the full report.
The report also identifies issues that NCBIO will support during the 2009 General Assembly session, which convenes January 28th. Proposals include:
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Restore full funding to the SBIR/STTR Matching and Incentives Grant Program.
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Capital Gains Tax Exclusion for Founder’s Stock.
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Continue and Encourage life science facility expansions, updates and refits by providing incentives for these investments.
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Establish the Life Science Development Corporation to make loans to
target life science for buildings, equipment, or other tangible assets.
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Continue funding for worker training programs through NCBioImpact.
More details on the legislative initiatives will be included in the February Update.
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Bruce Kaylos – NCBIO BMF Consultant |
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 Members of the NCBIO Biotech Manufacturers’ Forum have selected Bruce Kaylos as the Forum’s new Program Manager. BMF provides a platform for biotech manufacturers in North Carolina to discuss and address major strategic issues of common interest, including best practices and work force training issues. Kaylos replaces Hal Price who has moved to Wilmington. Kaylos has over 35 years of experience in FDA regulated industry.
“We are pleased that Bruce is willing to assist the BMF and NCBIO with several key initiatives such as NCBioImpact, retention and expansion policies, infrastructure issues, and other concerns of the biomanufacturing industry in the State,” said Sam Taylor, NCBIO President.
In 2008, Kaylos retired from the Wyeth Biotech vaccine facility in Sanford where his 21-year career included various management roles including Director of Manufacturing, Site Managing Director and Government and Industrial Affairs. He also served as Wyeth’s liaison to state and local officials regarding matters related to the Sanford site and issues surrounding the biotechnology industry.
"I have enjoyed and valued working with many of the NCBIO BMF members on a number of projects while I was with Wyeth,” said Kaylos. “I welcome the opportunity to take on this role to strengthen the interaction of the state's biomanufacturing companies in areas of shared interest that are key to the continued and future success of the industry and its members."
For more information about BMF, contact Bruce at bkaylos@ncbioscience.org or call 919-281-8960.
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Biotech 2009 – Register Before January 16th and Save |
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 Biotech 2009 will be held February 16-17 at the Raleigh Convention Center. The event is hosted by the Council for Entrepreneurial Development and co-hosted by the NC Biotechnology Center and NCBIO. Featured speakers will include: Biogen Idec President and CEO James Mullen; UNC-CH Chancellor Holden Thorp; Quintiles Transnational Chairman and CEO Dennis Gillings; BIO President and CEO James Greenwood; Duke University Health System President and CEO Dr. Victor Dzau; and 2007 Nobel Prize winner and Excellence Professor at UNC-CH, Dr. Oliver Smithies.
To become a sponsor of this year’s event, call Stephanie Dorko-Austin at 919-549-7500 x126 or email sponsorship@cednc.org.
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BIO International Convention – May 18-21, 2009 |
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 NCBIO is working closely with the Biotechnology Industry Organization to maximize North Carolina participation in the 2009 BIO International Convention. The event will be held in Atlanta, Georgia, on May 18-21.
“North Carolina has a strong life science industry,” states NCBIO President Sam Taylor. “This will be an opportunity for us to demonstrate that the state is one of the top leaders in the nation in the concentration of biotech companies.”
Companies interested in being sponsors of the event can contact BIO or participate in the North Carolina Department of Commerce’s pavilion. For more information regarding pavilion sponsorship opportunities, contact Joe Conaty at the North Carolina Commerce Department.
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Two NC Companies Receive SEBIO Awards |
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Biolex and Serenex were among the award recipients at the SEBIO Tenth Anniversary Investor Forum in Palm Beach, Florida, in December. “The recipients of the awards have achieved outstanding success in 2008 and it’s a pleasure to honor them,” said SEBIO 2008 Awards Committee Chair Garheng Kong, of Intersouth Partners. “We have high hopes for them in the future and believe that these companies are an example of the numerous strong companies we have in the Southeast.”
Biolex, Inc. won the SE Deal of the Year: Venture Capital Transaction Award. Biolex was honored for its $60 million Series D financing in October. Leading the financing was Clarus Ventures with OrbiMed Advisors participating as a new investor. Existing investors participating in the financing included Intersouth Partners, Quaker BioVentures, Johnson & Johnson Development Corporation, Investor Growth Capital, Polaris Ventures, Mitsui & Company, The Dow Chemical Company, JP Morgan Securities and the North Carolina Economic Development Fund. Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX SystemSM to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The Company’s lead drug candidate is Locteron, a controlled-release interferon alfa designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products.
Serenex, Inc. won the SE Deal of the Year: Strategic Transaction for its strategic alliance with Pfizer, Inc. Pfizer acquired cancer treatment developer Serenex, a seven-year-old company that raised $81 million in equity over its life. Pfizer acquired the rights to Serenex’ lead compound, oral Hsp90 inhibitor SNX-5422, currently in Phase I trials for solid tumors and hematological malignancies. In addition, Pfizer also acquired Serenex’ drug discovery technology and its small molecule Hsp90 inhibitor compound library, including targets for cancer, inflammatory and neurodegenerative diseases.
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| Member News |
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Please have your organization's media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
The Hamner Institutes for Health Sciences has received a contract totaling $2.1 million from the U.S. Environmental Protection Agency to study vermiculite, a mineral resembling mica used in insulation, packing and other processes. Asbestos-contaminated vermiculite poses public health risks. The Hamner study will shed light on the vermiculite-asbestos contamination and provide data on the relative potency of inhaled contaminants related to these substances. “We are extremely pleased to work with the EPA on this important public health concern,” said Dr. William Greenlee, president and CEO at The Hamner Institutes for Health Sciences. “The research supported by this award will build on The Hamner’s reputation as a world-class nonprofit research institute dedicated to supporting governmental regulatory decisions on chemical health risks at environmentally-relevant exposure levels.”
Novartis has strengthened its vaccines pipeline through an exclusive agreement to license AlphaVax’s investigational Cytomegalovirus (CMV) vaccine program. This CMV agreement adds to Novartis’ promising early stage pipeline of novel vaccines, which focuses on significant unmet needs for the prevention of fatal diseases such as meningococcal infections and other hospital and community acquired infections. These include vaccines to prevent Helicobacter pylori infections, a major cause of gastritis that can lead to gastric cancer, and a Group B Streptococcus vaccine candidate with potential to protect against 85 percent of neonatal sepsis and meningitis.
“We are happy to gain access to a promising vaccine candidate for the prevention of cytomegalovirus infections, which are particularly problematic during pregnancy as they can cause permanent disability in newborns,” said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.
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| At the National Level |
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 BIO Applauds President-Elect’s
Science Advisor
Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), has commended President-Elect Obama’s appointment of Harvard University professor John Holdren as assistant to the President for Science and Technology and Director of the White House Office of Science and Technology Policy.
“We applaud President-Elect Obama’s visionary and ambitious plans to invest in one of our country’s core strengths – innovation,” said Greenwood. “President-elect Obama’s comments on the importance of scientific discovery and his appointment of Professor John Holdren indicate that the incoming Administration is truly committed to continuing America’s global leadership in technological innovation.
“Biotechnology is our nation’s most recent contribution to technological discovery,” Greenwood continued. “It stands at the center of our innovation economy, generating high-wage, high-skill, green jobs. Biotechnology research is the most promising science for developing cures and treatments for some of the world's most intractable diseases, such as cancer, Alzheimer's, Parkinson's, HIV/AIDS, and diabetes, and for addressing some of the most pressing agricultural and environmental challenges facing our society today, including the development of renewable sources of clean energy.”
Concern about Federal Report
The Biotechnology Industry Organization (BIO) issued a cautionary statement regarding a new Congressional Budget Office (CBO) analysis of estimated cost savings that may result from biosimilars (also known as follow-on biologics) and related changes in reimbursement rules for biologics.
“The CBO estimate is based on a troubling assumption that reimbursement rules for biologics would be changed in a way that would financially incentivize physicians to switch patients to a cheaper follow-on version of a product at the potential expense of patient safety and therapeutic efficacy,” the statement noted. “This change would penalize health care providers who dispense the innovative product over the lower-cost biosimilar since the reimbursement amount would not cover the full price of the pioneering product. The change would establish a perverse incentive to prescribe the lower-cost biosimilar regardless of efficacy or safety concerns. As we have said throughout this debate, we support a pathway to approve follow-on biologics but any such pathway must place ensuring patient safety – not potential cost savings – as the central concern.”
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| Calendar |
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Now through January 21, 2009. North Carolina Biotechnology Center 2009-2008 Mini-Grant Applications Accepted. All proposals must be submitted electronically using the Biotechnology Center’s online submission process. 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. For more information.
January 27, 2009. NCBIO Emerging Companies Forum. Hear from new State Treasurer Janet Cowell. The event is 8:30-9:30 a.m. at the NC Biotechnology Center. RSVP to jfong@ncbioscience.org by January 22nd.
February 16-17, 2009. CED’s 18th annual Biotech Conference unites the Southeast's life science community to celebrate one of the biotechnology industry’s most dynamic regions. This two-day conference includes world-class speakers, a variety of panels on industry topics and trends, and networking opportunities with life science leaders. For more information.
March 16, 2009. CED's Biotech Forum: Emerging Opportunities. CED's Biotech Forum, in partnership with the North Carolina Biotechnology Center, explores industry topics and trends, features expert speakers and provides high quality networking. Join biotech entrepreneurs, industry executives, research leaders, services providers and investors quarterly at the North Carolina Biotechnology Center, RTP, NC. For more information.
May 14, 2009. CED's Medtech 2009 Conference, Fuqua School of Business, Duke University, Durham, NC. For more information.
May 18-21, 2009. BIO International Convention, Atlanta, GA. For more information.
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Meet New State Treasurer
Janet Cowell
NCBIO Emerging Companies Forum January 27
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North Carolina’s new State Treasurer Janet Cowell will meet with NCBIO members on January 27th to discuss North Carolina's economic and financial outlook, with emphasis on capital formation opportunities for innovation-based start-up companies. As a state senator, Cowell twice introduced legislation to establish a capital gains tax exclusion for founder's stock in North Carolina innovation-based companies.
Join our sponsors McGuireWoods and Forma Life Science Marketing, as well as other life science leaders Tuesday, January 27th to hear from the new State Treasurer. The event will be held at the NC Biotechnology Center beginning at 8:30 a.m. A continental breakfast buffet will be provided. Please RSVP to jfong@ncbioscience.org by January 22nd.
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NCBIO This Month
