 NCBIO This Month
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NCBIO’s 16th Annual Meeting included a half-day program focusing on North Carolina’s rapidly growing vaccine cluster. According to a report presented by North Carolina Biotechnology Center Vice President, Maria Rapoza, North Carolina has 30 companies that are involved in vaccine research and development, clinical research, and manufacturing. Four of the world's five leading vaccine manufacturers call North Carolina home. Research institutions in the State received $111 million in vaccine-related grants from NIH in 2009. Rapoza reported that global vaccine market sales exceeded $22.1 billion in 2009 and could be as high as $35 billion in five years.
Dr. Brad Walters andDr. Philip Dormitzerat the Conference
“North Carolina is a great place to be,” Dr. Philip Dormitzer, Head of Viral Advanced Programs Global Program Team of Novartis Vaccines told NCBIO members and guests at the meeting. Dormitzer outlined some of the steps taken by Novartis in developing the H1N1 vaccine and discussed strategies for “cell-derived vaccines strains [that offer] potential for shorter lead time and better strain match.” He explained that in four months last year, Novartis had been able to develop three licensed vaccines, the fastest development in history.
Dr. Brad Walters, Chief Medical Officer for RTI International, described the global health impacts of vaccines and emphasized that future vaccine development and use depend on a “science-literate population, demonstrated vaccine quality and safety, and a commitment to research to develop future generations of production. We need to be vigilant at all times,” said Walters.
Dr. Jennifer Kuhns, Senior Scientist, Parenteral Technologies at BD Technologies discussed the development and advantages of micro-needle delivery of vaccines, including studies showing improved immune response to influenza vaccine in humans.
Panelists from universities and emerging companies outlined innovative research under way in North Carolina. Dr. Steven Mizel of Wake Forest University School of Medicine also outlined steps that should be taken to facilitate accelerated vaccine development in the State, including access to preclinical development and regulatory expertise; pilot-scale cGMP facilities for production of vaccines; better opportunities for testing vaccines in non-human primates; and infrastructure for inter-institutional education, collaboration, interaction, and dissemination of information.
Dr. Bob Johnston, of the non-profit vaccine development company Global Vaccines and Dr. Kathy Smith, Senior Scientist at Arbovax, reiterated Mizel’s comments. Smith complimented the State on its vaccine support programs, including strong worker training. Dr. Richard Frothingham, FACP, Director, Regional Biocontainment Laboratory (RBL) at Duke Human Vaccine Institute, outlined the role of the Duke Lab and other RBL facilities in the study of infectious diseases.
Representatives of Gold Sponsors - Ed Frantz, Bahnson Environmental Specialities; Terry Smith, Pfizer; Brad Peganoff, RTI International and Terry Costello, Yonkers Industries
"The 2010 NCBIO Annual Meeting was a tremendous success in bringing the NC life science community together for a common cause - a leader amongst states in vaccine development. As noted by Dr. Hunter-Cevera in her opening remarks, RTI International is actively seeking partnerships and collaborations on such," commented Brad Peganoff of RTI International, Vice President Government & Corporate Relations.
Terry Costello, President and Chief Operating Officer at Yonkers Industries noted that, “Merck, Novartis, and Pfizer all provide a solid foundation for continued vaccine industry growth here in the RTP area as well as North Carolina in general. But, we must continue as a state to provide incentives and infrastructure for these and other successful global partners to locate, grow, and maintain their vaccines business here, and that is what is most important right now.”
More than 200 people registered for the Annual Meeting. The North Carolina Biotechnology Center co-hosted the event with NCBIO. NCBIO thanks Gold-level sponsors Bahnson Environmental Specialties, Novartis, Pfizer, RTI International, and Yonkers Industries; Silver-level sponsors CRB, K&L Gates and Smith Anderson; and Bronze sponsors BD Technologies, O’Brien/Atkins and Premier Research.
 “North Carolina’s existing vaccine cluster can be super-charged through targeted investments in development of vaccine assets and improved incentives for capital-intensive manufacturing facilities,” NCBIO President, Sam Taylor told participants attending the NCBIO program on North Carolina’s Vaccine Cluster. He noted that North Carolina needs to take action because it faces competition for the industry from other states and nations.
NCBIO's recommendations for strengthening the industry include support for shared pilot-scale manufacturing capacity for producing quantities of new vaccines for use in preclinical development and clinical trial, as well as expanded access to non-human primate testing capability. Such facilities would allow for sharing of capital-intensive development facilities and shorter turn-around times for vaccine testing and development. Taylor also called for state-supported platforms for sharing of expertise and information, continued excellence in workforce education and training, and better incentives for capital-intensive manufacturing and modernization.
“NCBIO will be working with the program participants, the North Carolina Biotechnology Center and other groups in the coming year to develop and seek implementation of some of these recommendations,” Taylor stated. NCBIO members interested in working on these initiatives should contact Taylor at staylor@ncbioscience.org.
Nine individuals were elected to the NCBIO Board of Directors at the Annual Meeting October 6th. “We are pleased to have a diverse group of Board members representing life science companies and service sectors that work with the industry,” stated Sam Taylor, NCBIO President.
Those elected or re-elected include; Esther Alegria (Biogen Idec), Bjay Singh (BASF), Tim Gupton (Hughes Pittman & Gupton), Dennis Jones (Pfizer), Ken Lee (Hatteras Partners), Adam Monroe (Novozymes), Crawford Pounds (PriceWaterhouseCoopers), Russ Read (Forsyth Technical Community College), Bob Schotzinger (Viamet) and Will Lee (Cato Research).
Other current members of the Board are; Karen Albritton (CapStrat), Peyton Anderson (Affinergy), Lou Arp (Eisai), Dennis Burns (TCG), Chris Capel (Smith Anderson), Terry Costello (Yonkers Industries), Jeff Collins (Pappas Ventures), Ed Field (Aldagen), Charles Goldstein (BD Technologies), Matt Jennings, Mike Luther (David H. Murdock Research Institute), David Miller (GlaxoSmithKline), Alan Musso (Targacept), John Russell (K&L Gates), Tom Staab (Inspire Pharmaceuticals), Susan Thomason (Quintiles Transnational Corporation), Norris Tolson (NC Biotechnology Center), Jan Turek (Biolex Therapeutics), Eric Ward (CropSolution) and Mark Weedon (BWA Consulting).
Calling the new facility “a place where dreams come true," North Carolina Governor Beverly Perdue joined college leaders, research campus representatives and other elected officials to dedicate the new Rowan-Cabarrus Community College (RCCC) classroom and laboratory building at the North Carolina Research Campus (NCRC).
The 62,332-square-foot facility offers students state-of-the-art biology, microbiology, genetics, and chemistry labs; classrooms with a full array of technology; a high-tech distance learning classroom; and the opportunity to study and learn within easy walking distance of potential future employers. The building is designed to help students transition easily from college to careers or further study at a university," said Dr. Carol Spaulding, President of RCCC.
The RCCC classroom and laboratory building at the NCRC is the home of RCCC's associate degree program in biotechnology and the future base of planned associate degree programs in agricultural biotechnology and health information technology, plus multiple shorter-term certificate programs.
The Washington-based Manufacturing Institute (the Institute) and the National Center for the Biotechnology Workforce (NCBW) at Forsyth Technical Community College in Winston-Salem, have announced a formal alliance to jointly develop a highly-skilled and educated 21st century biotechnology and pharmaceutical production workforce. NCBW is a member of the North Carolina Community College’s BioNetwork.
The new collaboration includes a five-year commitment to support advancements in career and technical education, such as developing community college programs of study in biotechnology, pharmaceutical production, and medical device manufacturing aligned to industry standards. By jointly advocating for public and private investment in these workforce development initiatives and expanding outreach to students, parents, educators, and transitioning workers about valuable career opportunities, the partnership will build the talent pool and enhance the competitiveness of the U.S. biotechnology workforce and the industry as a whole.
 The national coalition, We Work for Health, has two new sites to keep the life science industry connected and informed about issues. Check out the Facebook site and the YouTube site.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
BD has announced plans to construct a new East Coast distribution center in Four Oaks, North Carolina. The $38 million investment project is expected to generate nearly 190 new jobs in Four Oaks and the surrounding communities by 2018. “Establishing our new distribution center in Four Oaks will enable BD to reduce cycle times and enhance the operational effectiveness of our entire supply chain,” said Stephen Sichak, Senior Vice President, Integrated Supply Chain. “Additional benefits include the skilled work force, transportation infrastructure and supportive government officials in this region.” The new 720,000-square foot facility, which will be constructed on 130 acres in the Four Oaks Business Park, will be expandable to more than 1.1 million square feet. It will service BD customers from Maine to Florida. Construction is expected to be completed in mid-2011, and the facility is expected to begin receiving product in late 2011.
Capstrat President Karen Albritton discussed “Reining in Online Influencers: The Emerging Role of Strangers in Healthcare Decisions” as part of Charlotte Social Media Club’s Educational Event series. The panel addressed how crowdsourcing medical information is changing the patient-doctor relationship, and ultimately, the business of healthcare. Capstrat’s Chief Creative Officer, Todd Coats, discussed the changing landscape for creative professionals at the Ad Club of the Triangle’s annual Creative Director’s Panel. Top creative leaders from local agencies talked about the current state of creative and how the traditional agency creative model is changing.
Forma Life Science Marketing joined forces with the BIG Council and NC BioConnect of the greater Charlotte area to present “Understanding Customer Behavior,” a lecture and interactive marketing workshop from Forma CEO and chief strategist, David Chapin. Chapin discussed what science has discovered about buying behavior in consultative selling. Topics included the six stages of buying behavior, type of support at each stage and effective ways to provide support though marketing and sales communications.
ibiliti introduces Expert-on-Call program. Whether it’s setting up a distribution network or preparing to raise venture capital, you face significant strategic challenges every day. And, regardless of how organized you are or how clear your vision is, you might not always have the bandwidth, expertise or capital to wrestle with each and every challenge. That’s where ibiliti’s Expert-on-Call Program comes in.
ibiliti’s Expert-on-Call Program matches industry veterans who are committed to North Carolina’s medtech community with up-and-coming companies that are looking for guidance they can use to move their businesses forward. When you enroll in the program you’ll be matched with an expert who can coach you on critical topics including: Raising money, Product development, Preclinical and clinical strategies, Distribution and sales, Manufacturing.
Inspire Pharmaceuticals presented data on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the European Respiratory Society (ERS) Annual Congress September 18 - 22, 2010 in Barcelona, Spain. The data from Inspire's first Phase 3 trial with denufosol (TIGER-1) suggest that denufosol, a novel inhaled ion channel regulator, has the potential to provide benefit in lung function for those patients on minimal pharmacotherapy.
Novo Nordisk has announced a $73 million expansion of its Clayton manufacturing facility to accommodate increased production capacity for the company's insulin delivery devices. The initial expansion will create 205 new jobs, including 85 in the Novo Nordisk Clayton facility, which currently produces a number of products, including the Levemir® FlexPen® (insulin detemir [rDNA origin] injection) and other products for the entire diabetes portfolio. Novo Nordisk currently has more than 420 employees in Clayton who oversee the full production process for six different diabetes treatment products, from formulation through packaging and distribution. The expansion will include the addition of two final assembly lines, two packing lines and building refurbishment. "The investment to expand our Clayton facility is another example of our commitment to improving diabetes treatment options in the U.S. by ensuring patients have access to the latest advances in treatment," said Jerzy Gruhn, president of Novo Nordisk Inc.
Novozymes was ranked number 17 on the list of the best medium-sized companies to work for in the US. Recognition is by the Great Place to Work Institute in the US. Novozymes North America President Adam Monroe says, “Novozymes is making significant changes to position ourselves for growth. Therefore, it’s critical for the company’s future to consistently attract the best people. We're proud to be on this list among so many strong businesses across the US. Increasingly, businesses are seen as places with a void of trust and ethics. We aim to show the world that Novozymes is a trust-based workplace that cares about all our stakeholders.
In the first U.S. News/Best Lawyers “Best Law Firm Ranking” Smith Anderson has received first-tier rankings” in 15 categories and is the only firm with a first tier ranking in “Mergers & Acquisitions Law” and “Securities/Capital Markets Law” in the Raleigh metropolitan area. The firm has the highest number of first tier rankings in the Raleigh metropolitan area. The ranked categories include: Construction Law, Corporate Law, Employment Benefits Law, General Commercial Litigation, Government Relations Practice, Health Care Law, Land Use & Zoning Law, Medical Malpractice Law – Defendants, Mergers & Acquisitions Law, Personal Injury Litigation – Defendants, Product Liability Litigation – Defendants, Securities/Capital Markets Law, Tax Law, Trusts & Estates Law, and Venture Capital Law.
 BIO Hails Court of Appeals Action
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on action by the U.S. Circuit Court of Appeals to stay the lower court’s injunction on federally funded embryonic stem cell research: “We are pleased that the Court of Appeals lifted the lower court’s injunction which, in effect, allows the federal government to continue funding research utilizing embryonic stem cells while the underlying litigation proceeds at the district court.”
“BIO plans to file an amicus brief at the appropriate time to explain the harm that the lower court’s initial reading of the law would cause to the future ability of our member companies to innovate on behalf of patients. We also urge Congress to pass legislation as soon as possible explicitly authorizing the use of federal funds for this critical research.”
“Patients are waiting for new therapies, and possibly even cures, that could result from embryonic stem cell research. We need to ensure that researchers in labs across the country are able to explore all promising avenues of stem cell research without fear that federal funding could again be suddenly halted.”
BIO Announces Education Campaign
Biotechnology industry leaders have announced a major new program to improve the quality of U.S. life science education. The Biotechnology Institute’s new “Scientists in the Classroom” initiative is the life science industry’s response to President Obama’s “Educate to Innovate” campaign to improve the performance of America’s students in science, technology, engineering, and mathematics (STEM) education. The announcement came as life science industry executives participated in a White House event announcing the creation of the new broad education coalition called "Change the Equation" comprised of CEOs from across a broad spectrum of industries.
The “Scientists in the Classroom” initiative will train and deploy scientists from 40 companies in high-impact collaborations with teachers and students on laboratory projects in high schools. The program will be launched in communities this fall in 10 states, including California, Florida, Georgia, Kansas, Maryland, Massachusetts, Minnesota, New Jersey, New York, and Pennsylvania, reaching a run-rate of 1,000 life scientists assisting in schools. Ultimately, the initiative seeks to inspire 250,000 high school students in all fifty states in the next five years.
Biofuels Legislation
A newly introduced bill will authorize the Department of Defense (DOD) to continue its leading role in helping to commercialize next generation biofuels. The Biotechnology Industry Organization (BIO) thanked Sens. Max Baucus (D-Mont.) and Jon Tester (D-Mont.) for introducing the American Security and Freedom Fuels Act of 2010, which would authorize the DOD to engage in long-term contracts for aviation biofuels.
Brent Erickson, executive vice president of BIO’s Industrial & Environmental Section, stated, “Advanced biofuel producers and algae producers are already working with the Navy, the Air Force and others to provide biofuels and diesel oils for testing in aviation and other applications. But efforts to commercialize advanced biofuels have been hampered during the recent recession by lack of access to institutional funding. Expanding the military’s ability to engage in long-term contracts could provide the certainty for leading companies and potential investors needed to commit capital to large-scale biofuel production.”
Friday, Oct. 22, 2010. AgBiotech Industry Roundtable. The event will be at the North Carolina Biotechnology Center. The goal of the AgBiotech Industry Roundtable is to strengthen industry/university collaborations and to provide insight to university researchers and business representatives from agriculture/biotechnology companies on how to foster greater innovation and economic development impact. For more information.
Wednesday, Oct. 27, 2010. Forsyth Tech SciTech Lecture Series: “The Benefits of 25 Years of HIV Research on Laboratory Technology and Human Health” Dr. Mark Wainberg, McGill University, Past President of the International AIDS Society. Hear scientists, researchers and industry thought leaders explore how science and technology are combining to change our world. All lectures are free and open to the public and will be held on Forsyth Tech’s Main Campus in Ardmore Auditorium at 4 p.m. on the Forsyth Tech Main Campus at 2100 Silas Creek Parkway Winston-Salem NC. To reserve a seat at any event, contact Mona Cofer at 336.734.7205 or mcofer@forsythtech.edu.
Tuesday, Nov. 9, 2010. NCABR Biosafety and Biocontainment Workshop, 8 am – 5 pm, Charlotte Research Institution. For more information.
Monday, Nov. 15, 2010. Forsyth Tech SciTech Lecture Series: “Biofuels Across the Landscape: Vision, Challenge, and Change” Steven Burke, CEO, Biofuels Center of North Carolina Hear scientists, researchers and industry thought leaders explore how science and technology are combining to change our world. All lectures are free and open to the public and will be held on Forsyth Tech’s Main Campus in Ardmore Auditorium at 4 p.m. on the Forsyth Tech Main Campus at 2100 Silas Creek Parkway Winston-Salem NC.To reserve a seat at any event, contact Mona Cofer at 336.734.7205 or mcofer@forsythtech.edu.
November 30, 2010. ibiliti MedTech Conference, Washington Duke Inn, Durham, NC. For more information, contact Ann Poorboy at ibiliti.
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