North Carolina elected Democratic Lt. Governor Beverly Perdue to succeed Mike Easley as Governor last week. Before being elected Lt. Governor in 2000, Perdue held various key roles in the state legislature, including chairing the Senate Appropriations Committee.

Perdue has promised to be a strong supporter of biotechnology. In remarks at UNC-Charlotte's annual life science forum in October, Perdue told academic and industry leaders that she wants to keep North Carolina at the forefront of the world's biotechnology industry. "I want to tell New England and the Terminator [California Governor Arnold Schwarzenegger] that North Carolina is coming," Perdue said. "I want to be number one."

Perdue said she would boost start-up funding through the One North Carolina Fund, part of which is used to provide start-up funding to fledgling companies. Perdue also indicated that she would support agricultural biotechnology, including work to use plants in biomanufacturing.

"Biotechnology is an economic mainstay," Perdue said. "We have more than 450 companies and employ about 55,000 people. We are getting something right here."

In the state legislature, preliminary results indicate that Democrats will continue to control 68 of the chamber's 120 seats. Unofficial results from State Senate races indicate that Democrats lost one seat, to reduce their majority to 30 of the chamber's 50 seats.

Among new faces on the state's nine-member Council of State will be Democratic State Senator Janet Cowell, selected by voters to replace Richard Moore as State Treasurer, and Democratic State Senator Walter Dalton, who was elected Lt. Governor. Cowell has been an advocate of tax policies favorable to innovation-based start-up companies. In 2007, she sponsored legislation that would have established a reduction in tax rates on capital gains from investments in companies eligible for North Carolina's Qualified Business Venture Tax Credit.

Academia, science, industry and government leaders gathered in Kannapolis, October 20th for the dedication of the David H. Murdock Core Laboratory Building, the UNC Nutrition Research Building and the North Carolina State University Fruit and Vegetable Science Institute Building at the North Carolina Research Campus. 

The UNC Nutrition Research Building will house programs from NCA&T State University, North Carolina Central University, UNC Chapel Hill and UNC Greensboro.  North Carolina State University, Appalachian State University, and Dole Food Company will occupy the NCSU Fruit and Vegetable Science Institute Building. UNC Charlotte will have tenure track faculty members located in both facilities, and will also have a presence in the 311,000 square foot David H. Murdock Core Laboratory Building.

"This campus fulfills my lifelong dream of being able to change the world's thoughts on nutrition and find ways to cure many of the dreadful diseases that have affected all of us and our families. It excites me to think of the groundbreaking research that will occur as a result of having these world class universities and companies here working together all in one place," said David Murdock.

The David H. Murdock Research Institute, located within the David H. Murdock Core Laboratory, will house state-of-the art scientific equipment for genomics, proteomics, metabolomics, animal and plant imaging, microscopy, and structural chemistry.  In preparation for the opening of the campus, the DHMRI made initial equipment purchases for the various core laboratories, including a Bruker Biospin 950 MHz Nuclear Magnetic Resonance (NMR) imager.   In addition, Mr. Murdock himself has invested $35 million in a longitudinal population-based research initiative led by Duke University to examine the behavioral and genetic differences that may be related to the development of disease. Duke University also has announced that it will open a business incubator called the Biomarker Factory on the Research Campus in the same facility that will house the Murdock Study.

In a surprise announcement at the dedication ceremonies, officials of PepsiCo announced that the company will establish a presence at the new campus.

Merck has dedicated its Durham, North Carolina, vaccine manufacturing operations. At dedication ceremonies in October, Merck announced that it is naming the facility in memory of Maurice R. Hilleman, Ph.D, a Merck microbiologist who developed vaccines for measles, mumps, rubella and other diseases for which vaccines are now routinely recommended for children in the United States.

North Carolina Governor Mike Easley

Governor Mike Easley; Congressman David Price; Durham officials; Merck Chairman, President and CEO Richard Clark; Plant Manager John Wagner; and other Merck leaders were present for the dedication.

Construction of the Durham facility began in 2004. The company has announced plans for two expansions of the facility. The initial project created 150 to 200 jobs, with subsequent phases creating more.

Biotech 2009, North Carolina's statewide conference for the life sciences industry, will be held in Raleigh, February 16-17, 2009. The conference, which celebrates one of the biotech industry's most dynamic regions, is sponsored by the Council for Entrepreneurial Development, NCBIO and the North Carolina Biotechnology Center. The two-day conference will focus on potential impact of the 2008 elections on state and federal policies affecting the life science industry.

Confirmed speakers for the event include the honorable James C. Greenwood, President and CEO of the Biotechnology Industry Organization; John J. Campbell, founder, Chairman and CEO of Campbell Alliance; Dennis Gillings, Chairman and CEO of Quintiles Transnational Corporation; James C. Mullen, President and CEO of Biogen Idec; Colin Goodard, CEO of OSI Pharmaceuticals, Inc.; and H. Stewart Parker, President and CEO of Targeted Genetics Corporation.

NCBIO, CED and BIO members are eligible for discounts on registration for Biotech 2009.

The Southeast will have a chance to showcase life science growth in the region at the BIO conference May 18-21, 2009 in Atlanta. NCBIO will host an information session, Thursday, November 20, 8:00-9:15 a.m. at the North Carolina Biotechnology Center. All NCBIO members are invited to attend. 

Hear from BIO staff members - Scott Whitaker, Chief Operating Officer, Robbi Lycett, VP, Conventions & Conferences and John Sloan, Managing Director, External Relations & Development. Representatives from the North Carolina Department of Commerce will also be present to discuss the North Carolina Pavilion at BIO 2009. Please RSVP to Jennifer Fong at or call (919) 281-8960 by November 17th, if you plan to attend.

Arthur M. Pappas, founder and managing partner of the Research Triangle Park venture capital firm Pappas Ventures, has been elected chairman of the North Carolina Biotechnology Center's Board of Directors.

"I'm honored to serve as chairman of this organization as it moves into its second quarter-century of serving North Carolinians in an increasingly competitive global biotechnology environment," said Pappas. "These tough economic times reinforce the importance of our mission to expand the role of biotechnology in creating high-paying jobs statewide to meet the challenges of the 21st century. Nowhere else in the world can you find our rich blend of assets for growing biotech, including our strong research capabilities, our workforce training infrastructure, our low cost of doing business and our outstanding quality of life."

Pappas succeeds Sue W. Cole, a principal of Granville Capital Inc. of Greensboro. Cole was board chair from 2006 to 2008 and continues to serve on the board's executive committee. In addition to electing Pappas chairman, the board elected Patricia Morton vice chair. John Atkins was re-elected Treasurer and Jack Cecil was re-elected Secretary of the Center. Morton is a partner with Franklin Street Partners, a private investment management firm in Chapel Hill. Atkins is president and CEO of O'Brien/Atkins Associates in Durham, and Cecil is president of Biltmore Farms in Asheville.

The North Carolina Biotechnology Center has launched a new program to help the state's bio-scientists and other fund-seekers improve their chances of writing successful grants and submitting them to the best possible funding sources.
 
Dubbed the "Gateway to Funding Resources," this addition to the Biotechnology Center's website is expected to help North Carolina organizations be more successful in attracting funding from the National Institutes of Health, the Department of Defense and other sources. The program is separate from, and complementary to, the Center's own program funding opportunities.

The site offer's a how-to guide for identifying grant sources. Users can quickly assess funding opportunities via free and fee-based grant database listings, databases containing awarded proposals, and various instructional sites containing tips and fundamentals for successful grant writing.

More than 2600 people toured the BioNetwork Mobile Laboratory – called the BioNetworkBus – at the North Carolina State Fair this year, compared to 200 people last year. "We are pleased with the response," said BioNetwork Director Matt Meyer. "I think this is another indictor of the growing interest in the life science industry in North Carolina.

BioNetworkBus is the nation's only mobile laboratory designed to offer biotechnology-related incumbent and potential new-hire worker training. The Mobile Laboratory is a component of the BioNetwork Capstone Center, which is based at the Biomanufacturing Training & Education Center on North Carolina State University's Centennial Campus.  While there are at least seven mobile laboratories around the country with a K-12 teacher and student focus, none have the focus of the BioNetworkBus, which offers worker training at company sites and local community colleges. The BioNetwork Mobile Laboratory offers accelerated laboratory-based biotechnology training to community college students in remote areas across the state and takes specialized equipment and experienced faculty straight to company sites for incumbent worker training.

Corporate Communications Solutions of Charlotte has published its first edition of IMPACT, a new biotech and life sciences magazine. IMPACT is a statewide, business-to-business publication that is dedicated to enhancing the understanding of all facets of science including biotechnology, life sciences, medical devices and applied technologies.

The magazine is published in partnership with BioNetwork, the North Carolina Community College System's biotechnology industry training program, and the sponsorship support of Rowan-Cabarrus Community College and MARBIONC, a marine biotechnology program operated at UNC Wilmington.

Tim Williams, president of Corporate Communications Solutions, and Jennifer Woodford, editor, launched IMPACT in response to a need for information about biotechnology and life sciences as an industry. The magazine's major focus is the intersections of biotechnology and life sciences with other industries; the opportunities that flow from commercialization of technology, business development, education and workforce development; and the innovations the industry produces.

IMPACT will be distributed to business leaders, government officials, professionals, educators, the University of North Carolina system, the North Carolina Community College System and community leaders. The magazine is starting as bi-monthly, but will begin publishing monthly in 2009.

The Biofuels Center, now in its eighth month, has expanded its Board of Directors to include a total of 35 broadly representative members. The new board includes senior executives from agriculture, forestry, universities and community colleges, financial institutions, state government, the petrochemical industry, environmental organizations, non-profits, and the biofuels industry.

"The significance of any endeavor is first measured by the persons who come to it," said Biofuels Center Board Chairman W. Steven Burke. "The evidence of my board colleagues shows biofuels to be something very important indeed to North Carolina."

Former Lieutenant-Governor and President of Jordan Lumber and Supply, Bob Jordan, echoed this sentiment, speaking about the strategic nature of the mission of the Biofuels Center, saying: "I don't know of any endeavor that is more important to North Carolina right now, than biofuels".

Please have your organization's media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org

Biolex Therapeutics, Inc. has announced the closing of a $60 million Series D financing led by Clarus Ventures, a leading biotechnology investor, 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.

In addition, Biolex has entered into an agreement with OctoPlus N.V. to acquire OctoPlus' 50 percent share of commercial rights to the Locteron product candidate for hepatitis C. Under the agreement, Biolex will take full responsibility for development and commer-cialization of Locteron. OctoPlus will retain a royalty interest in the product candidate and provide manufacturing and process development services to Biolex. The agreement calls for an up-front fee of $11 million to OctoPlus and Biolex will pay up to $138 million in additional development and sales milestones based on the progression of the product candidate through development and commercialization. Prior to entering into this agreement Biolex and OctoPlus shared the commercial rights to Locteron under a collaboration entered into in 2005.

Biolex Therapeutics, Inc. has announced that Walker Long, M.D. has joined the Company as Chief Medical Officer and Vice President, Drug Development, and that Anne McKay has joined as Vice President, Regulatory Affairs. The Company also announced that it has promoted Bipin Dalmia, Ph.D., MBA, to Senior Vice President, Business Development and Intellectual Property.

Entegrion announced that it has been awarded a contract from the Department of the Navy for the development of an integrated dried blood plasma storage and administration prototype. The single integrated unit will have two chambers, one for dried plasma powder and one for saline, a reconstitution fluid. Because of the difficulties in storing blood and blood products for long periods of time, this prototype would allow for lengthy shelf life and ease of administration.

GlaxoSmithKline's North Carolina headquarters located in the Research Triangle Park will become the U.S. headquarters for the company. The company had been operating dual U.S. headquarters in Philadelphia and the Research Triangle Park.

Inspire Pharmaceuticals, Inc. has initiated a Phase 1 clinical trial with INS117548 Ophthalmic Solution for the treatment of glaucoma. The placebo-controlled, dose-escalating trial is designed to evaluate the safety, tolerability and intraocular pressure (IOP)-lowering effects of INS117548 in approximately 60 subjects with early stage glaucoma or ocular hypertension. INS117548 is a Rho kinase inhibitor designed to lower IOP in glaucoma patients by disrupting the actin cytoskeleton (cellular skeleton) of the trabecular meshwork, an ocular tissue responsible for most of the outflow of aqueous humor. Inspire also has a Latrunculin B compound, INS115644, related to this platform that is in Phase 1 clinical testing.

Tranzyme Pharma has announced positive Phase IIb results for its first-in-class, highly potent and selective ghrelin agonist, TZP-101, for the management of postoperative ileus (POI). Results demonstrated that TZP-101 was both safe and highly effective in reducing the duration of ileus following surgery in patients undergoing open bowel resection. Over 200 patients were enrolled in an adaptive, multinational, double-blind, placebo-controlled Phase IIb clinical trial designed to assess the time to recovery of gastrointestinal (GI) function. Either TZP-101 or placebo was administered intravenously within the first hour after surgery, followed by once-daily dosing for up to seven days. The primary study endpoint was time to first bowel movement (BM), also known as "GI1". Given its pharmacoeconomic importance, a key secondary endpoint was the percentage of patients that achieved GI recovery within 72 hours of surgery.

BIO Congratulates President-Elect Obama

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood has congratulated President-Elect Barack Obama and expressed the industry's desire to work with the new Administration. "On behalf of the more than 1,200 members of the Biotechnology Industry Organization, I offer our congratulations to Senator Barack Obama on his election victory.  We also offer our congratulations to the newly elected and returning members of Congress, governors and other elected officials across the United States.

"From health care to energy to climate change to environmental sustainability, President-elect Obama will enter office facing a daunting array of complex challenges threatening the well-being of our nation and the environmental health of our planet.  Biotechnology is uniquely suited to help provide answers to these challenges. 

"To continue our nation's global leadership in innovation and continue to fulfill the promise of biotechnology, we will work with President-elect Obama and the new Congress to ensure that we have the proper public policies that promote and facilitate continued innovation. 

"We must maintain strong protections for intellectual property – the key to an innovation economy – while enhancing patent quality and the objectivity, predictability, and transparency of the patent system.  We must increase resources for the federal Food and Drug Administration to enable the agency to keep pace with rapidly evolving biomedical science and make sound regulatory decisions in a timely and efficient manner.  We must provide the tax and investment incentives that promote continued biotech innovation and help accelerate the commercialization of advanced biofuels technologies.  And we must ensure the National Institutes of Health have the funding needed to sustain the public-private collaboration that is transforming biomedical discoveries into innovative treatments for patients. 

"We look forward to working with President-elect Obama, the new Congress and public officials at all levels of government to achieve these goals and continue to build our nation's innovation economy.  Together, we can implement the public policies necessary to help heal, fuel, feed and clean our nation."

Revenue Recognition Principles Hurt Biotech, New Study Confirms

Current revenue recognition accounting principles continue to place unnecessary challenges on small and medium-sized biotechnology companies who enter into collaborative arrangements, according to an independent study released by the Biotechnology Industry Organization (BIO). The study, entitled "Revenue Recognition for Collaborative Arrangements in the Biotechnology Industry, was conducted by Glass, Lewis, & Co., LLC, a leading research and professional services firm. 

"This analysis affirms the need for the Securities and Exchange Commission (SEC) and the Financial Services Accounting Board (FASB) to clarify revenue recognition accounting principles," said Alan Eisenberg, Executive Vice President for Emerging Companies and Business Development at BIO. "Collaborative arrangements are key financing mechanisms for small and medium-sized biotechnology companies and clearer guidance from the SEC and FASB would allow more critical resources to be dedicated to new research for life saving medicines rather than accounting concerns."  

"Lack of clarity in collaboration revenue recognition principles extended our IPO timeline by months - and resulted in financial reports that are unclear to investors," said Paul Cleveland, Executive Vice President and Chief Financial Officer of Affymax, a company whose initial public offering was delayed while the company evaluated its revenue recognition for joint steering committees. "Clear and consistent revenue recognition principles would facilitate fundraising and enhance investor understanding of biotech companies' financial results, potentially accelerating drug development efforts." 

November 17, 2008. Biotech Forum: Strategic Financing in Biotechnology 5:30-8:00 p.m. NC Biotechnology Center. More Information

November 20, 2008. BIO 2009 Regional Briefing, 8:00 am – 9:15 am, North Carolina Biotechnology Center, Congressional Room.

November 20, 2008. NCBIO Board meeting, 9:20 am – 10:45 am, North Carolina Biotechnology Center, Board Room.

December 4-5, 2008. SEBIO Investor Forum, Palm Beach, FL. More Information.