 NCBIO This Month
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 Sweeping changes in the composition of the North Carolina General Assembly are likely to result in significant changes in policy important to North Carolina’s life science industry. In the general election held November 2, 2010, Republicans, who have advocated for sharply reduced government spending and less aggressive government intervention into capital markets, captured majorities of both chambers of North Carolina’s legislature.
The State Senate, which was controlled by Democrats by a 30 to 20 majority in the last legislative session, will be comprised of at least 30 Republicans and no more than 20 Democrats when the Assembly convenes in 2011. The 30-seat majority is sufficient to override a gubernatorial veto. In the State House, where Democrats controlled by a majority of 68 to 52 in 2009-10, Republican’s captured at least 64 seats. A 65th seat, District 65 in Rockingham County, was won by an unaffiliated candidate who has indicated that he will caucus with the Republican majority. Four other seats were narrowly won by Republicans and may be subject to recount. Two seats narrowly won by Democrats may also be contested.
Republican leaders have already vowed not to increase taxes. Without such measures, legislators will likely need to make between $3.0 billion and $3.5 billion in spending cuts when crafting the State’s 2011-12 State Budget. Legislators cut approximately $3 billion in spending in 2009 and 2010, reducing the state’s General Fund budget from around $22 billion to approximately $19 billion in FY 2010-11. Most experts agree that additional cuts in 2011 will result in material reductions in state employment and potentially material reductions in state services.
North Carolina currently spends roughly $100 million a year in life science-related state programs, including $20 million for the North Carolina Biotechnology Center, more than $20 million for the North Carolina Research Campus at Kannapolis, $50 million for cancer research at the University of North Carolina at Chapel Hill, $10 million for regenerative medicine research at Wake Forest University and $5 million for the Biofuels Center of North Carolina. NCBIO’s top priority in 2011 will be minimizing reductions to these programs.
Republican leaders have also suggested that they may seek modest tax cuts in 2011. NCBIO will recommend that any such reductions be targeted to spur capital formation in North Carolina’s innovation economy.
NCBIO’s staff is working on details of a proposed 2011 legislative agenda that takes into account the change in legislative leadership and potential policy changes. The agenda will be reviewed by the Organization’s Board of Directors.
North Carolina's biotechnology sector grew at nearly twice the rate of the national bioscience industry between 2001 and 2008. Net job growth for the North Carolina cluster was 29 percent. These statistics and more are in the 2010 Evidence and Opportunity: Biotechnology Impacts in North Carolina, prepared by the Battelle Memorial Institute's Technology Partnership Practice for the North Carolina Biotechnology Center. The analysis is based on 2008 economic and employment data, the most recent available.
According to the report, the life science industry is a significant contributor to the State's economy. Life science activity:
- Brings $64.6 billion annually into the State's economy, $41.2 billion of that directly from biotechnology sector revenues.
- Provides $12.7 billion in employee compensation up from $9.6 billion in 2006.
- Generates 57,000 jobs at 530 biotechnology companies and 226,823 total jobs because of the industry's presence.
- Pays average salary of $74,829 – more than $35,000 above the State's private sector average.
- Contributes $1.9 billion in taxes each year to State and local government.
The Battelle Report, an update of the 2008 document Evidence and Opportunity, noted the success and strength of North Carolina's broad approach to technology-based economic development.
“This latest report supports what we have been telling State leaders about the growth and impact biotechnology is having in North Carolina,” stated NCBIO President Sam Taylor. “The life science sector is a job creation engine. We believe the growth will continue, but the rate of expansion will be dependent on continued partnership among government, industry and educational institutions.”
North Carolina companies will receive a total of slightly more than $36 million from Therapeutic Discovery Project grants in 2010 and 2011. A total of 103 North Carolina life science companies managing 166 R&D projects won grants. The program, jointly administered by the Internal Revenue Service and the federal Department of Health and Human Services, was enacted as part of the 2010 health reform legislation.
North Carolina ranked seventh in the nation in terms of total grants and credits received under the program. A total of $1 billion in grants and credits were awarded. Companies in California led the nation, drawing down $281 million. Massachusetts was second with $128 million in grants and credits.
“The building may be named for me but a lot people helped build the State’s biotechnology sector,” former Governor Jim Hunt told the more than 300 individuals who attended the dedication of the new addition to the NC Biotechnology Center. The new annex is named for Hunt, who was instrumental in the development of the Center in the 1980s, when it became the world’s first government-funded state biotechnology center. Hunt noted that biotechnology had helped change the State, which had been predominately rural and dependent upon agriculture, textiles and furniture, “into a leader in the world economy.”
Congressman David Price, Governor Beverly Perdue, Biotechnology Center Board Chairman Art Pappas, Former Governor Jim Hunt, Carolyn Hunt, Senator Kay Hagan, and former Glaxo Chairman Bob Ingram
Governor Beverly Perdue, Senator Kay Hagan, Biotechnology Center Board Chairman Art Pappas, former Glaxo Chairman Bob Ingram and Center President Norris Tolson outlined Hunt’s contributions to the industry and participated in the ribbon-cutting for the new facility.
Governor Perdue noted that she wanted to push North Carolina up from its number three ranking among states in biotechnology jobs and companies. Senator Hagan talked about North Carolina’s efforts in innovation and said that biotech leaders across the nation tell her they want to be in North Carolina. Mr. Pappas stated that a recent analysis by PriceWaterhouseCoopers found that 64 percent of venture investments goes into biotechnology and other life science companies. Mr. Ingram warned that state leaders should not be complacent because “there are a lot of competitors who want what we have.”
NCBIO President Sam Taylor speaks with former Governor Jim Hunt
The new 20,000-square-foot building will offer expanded program space to support Biotechnology Center initiatives in entrepreneurship, technology commercialization, business development, university research and workforce development.
Hundreds of medical technology professionals, students and suppliers will come together on November 30th at MedTech 10 to share their thoughts about the state of the industry and ways to move it forward. Interactive panels, breakout sessions and hands-on workshops are expected to encourage spirited discussions and the evolution of new product and policy concepts. The conference is hosted by ibiliti, North Carolina’s new non-profit educational and economic development entity for the medical technologies industry. All NCBIO members are invited to register, and to share insights about strategies for growing North Carolina’s medical technologies cluster.
The MedTech 10 Program will feature a variety of speakers and panels, including
- Rick Randall, CEO of Trans1, will discuss strategies for capitalizing medical technology start-up companies.
- Mark Henry, Founder and President of Grow Emerging Companies LLC, will discuss federal research and development funding for small MedTech firms, including an Introduction to Competing in the SBIR and STTR Programs.
- A state-of-the-industry report featuring E&Y’s recent annual review of the medical technologies sector, followed by commentary from veteran medical technology executives.
- Breakout sessions reviewing recent medical technology developments in diabetes, oncology and orthopedics.
- An interview of Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, and follow-up discussion with local medical technologies consultants and executives.
- A panel discussion featuring Don Bradley, Chief Medical Officer of Blue Cross Blue Shield of North Carolina, on the interplay of innovation, reimbursement, and patient quality of life in the commercialization of medical technologies.
Click here for more about the program agenda and schedule.
Register now to make sure you are part of this pivotal event. Seats are limited. For more information contact Ann Poorboy or call 919-782-1991.
North Carolina remains the state with the “Top Business Climate,” according to Site Selection magazine. It is the sixth year in a row and the ninth time in 10 years that the state has taken the top honor in the annual ranking by Site Selection. Meanwhile, Forbes magazine ranked North Carolina the third Best State for Business in America, an improvement from last year’s ranking of fifth. North Carolina got high rankings for its business climate and cost of doing business. The state ranked behind Utah and Virginia.
 North Carolina State University will use a new grant from the U.S. Department of Health and Human Services to train vaccine manufactures from across the globe to use best production practices to help prevent pandemic viral outbreaks. Fueled by a $861,453 grant from the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), NC State’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) will conduct the vaccine training program.
The trainees—who will come from countries with developing and emerging economies such as India, Indonesia and Brazil—represent agencies responsible for producing viral vaccines such as seasonal or H1N1 influenza. Thirty-six individuals are expected to receive the three-week training this fiscal year. The grant is renewable annually for five years.
In other BTEC news, NC State University is now offering the first cross-disciplinary graduate degree program in biopharmaceutical biomanufacturing in the country. BTEC is the program home for the two Professional Science Master’s degrees, a Master of Biomanufacturing (non-thesis) and a Master of Science in Biomanufacturing (thesis option).
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The North Carolina Community College System’s BioForum is now a leading online training program free to anyone with a computer and Internet connection. Greg Smith, BioForum’s committee chair and curriculum coordinator for the BioNetwork Bioprocessing Center in Greenville, says that the online webinars are a main source of training for faculty and staff but now life science professionals and high school,
community college and university educators take advantage of the programs as well. Past webinars, which are archived for on-demand viewing, cover topics like fermentation, converting algae to biodiesel, regenerative medicine, micropropagation, plant grafting and organic grapes.
The North Carolina State University College of Management is offering a Technical Professionals Business Series, with classes beginning in January 2011. This certificate program was developed for engineers, scientists and designers with college degrees who desire a broader business perspective, who are changing organizational roles, or who lead or will be leading teams of technical professionals. The Technical Professionals Business Series is a certificate program that includes a portfolio of eight courses in three tracks: Foundation Track, Specialization Track and Leadership Track.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Affinergy announced that Terry Schlotterback has joined its Board of Directors. Schlotterback spent 20 years with Zimmer, most recently in two key leadership roles as President of Zimmer Trauma Division and President of Zimmer Spine Division. Previously, he served as Vice President at Zimmer in Sales, Product Development, and Global Marketing Services roles as well as leadership roles at Depuy and Mitek Surgical Products, divisions of Johnson and Johnson. Affinergy develops medical devices for use in orthopedics, sports medicine, and general surgery. "Terry has a unique combination of experiences across orthopedic markets as well as across functional areas such as product development, sales, and executive leadership," said Peyton Anderson, CEO of Affinergy. "He has already proven to be a tremendous advisor in terms of our product development and hiring plans for the Affinergy commercialization team. Terry's expertise and deep industry connections will be critical to our long-term growth plans. On a personal level, Terry is a thoughtful mentor with impeccable integrity who is deeply committed to improving patient outcomes."
Biolex Therapeutics announced positive results from two Phase 2b trials further demonstrating the strong anti-viral response and tolerability advantages of the 480 µg dose of Locteron® in the treatment of hepatitis C. In the Phase 2b trials, patients directly reported flu-like adverse events on a daily basis through an electronic patient-reported outcome (ePRO) system, and the results demonstrated a statistically significant reduction in the frequency and severity of flu-like adverse events and reduced use of concomitant (analgesic/antipyretic) medications for patients treated with Locteron compared to patients treated with the PEG-Intron® control. Locteron, controlled-release interferon alpha 2b, is designed to offer key advantages compared to currently marketed interferons as a core component of combination therapies for the treatment of hepatitis C. These advantages include reduced flu-like symptoms, reduced rates of depression, and a less frequent dosing regimen with half the number of injections. The "EMPOWER" Phase 2b ePRO results were presented in a late-breaker session at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The Board of Directors of Biolex Therapeutics, Inc. has announced the appointment of Kurt Graves as Executive Chairman of the Board. In this newly created position, Mr. Graves will provide strategic leadership to the Board and work closely with executive management as the Company advances its potential blockbuster Locteron.
The United States Food & Drug Administration (FDA) reviewed and approved the BioLink Life Sciences, Inc., plan to file a New Drug Application (NDA) in 2011 for FDA approval of PiLo™, a novel phosphate binder. The FDA will not require additional clinical trials. “PiLo™ is BioLink’s first new drug,” Company President Deanna Nelson said. “Obtaining FDA concurrence that our New Drug Application will provide sufficient data about its safety and efficacy to allow approval without additional clinical studies cuts millions of dollars and years off of our development plan. This decision promises to make the drug available to patients much sooner than we originally predicted.” BioLink developed PiLo™ from an odorless and tasteless calcium salt that is used as a dietary supplement. PiLo™ will replace calcium acetate, a phosphate binder that may cause acid reflux and vinegar breath. PiLo™ binds phosphate as effectively as calcium acetate and will not cause these irritating effects. Patents are pending.
Inspire Pharmaceuticals, Inc. presented data on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the 24th Annual North American Cystic Fibrosis Conference (NACFC) October 21-23, 2010 in Baltimore, Maryland. The presentations are based on clinical and nonclinical research conducted with denufosol. The data from TIGER-1, Inspire's first Phase 3 clinical trial with denufosol, a novel inhaled ion channel regulator, suggest that denufosol has potential to benefit adolescent patients and those on minimal concomitant therapies. Additionally, Inspire's research suggests that denufosol inhibits sodium absorption, stimulates chloride secretion and has the potential to target the small airways of the lungs where CF lung disease begins.
Pfizer Sanford has long played a vital role in the vaccine industry, and now has a new role as Pfizer’s late-stage clinical and commercial launch site for new vaccine candidates. Throughout the 23-year history of the Sanford facility, the site has successfully launched 4 vaccines. The transition also means that some of the current work will be transferred to other Pfizer sites, including the transfer of some of Prevnar and Prevnar 13 components.
The TransEnterix SPIDER® Surgical System, an innovative platform that allows a surgeon to operate through a patient’s belly button, has received regulatory approval to market in the European Union. On Oct. 12, Professor Helmut G. Weiss, a respected expert in minimally invasive surgical techniques, used the SPIDER system to remove the gallbladders of two patients, repair an inguinal hernia in a third patient, and perform a colorectal procedure in a fourth. The surgeries took place at Barmherzige Bruder Hospital in Salzburg, Austria. The inguinal hernia repair was the first procedure of its kind in the world to be performed with the SPIDER system.
TransEnterix received the “Life Sciences Company” award from the North Carolina Technology Association (NCTA). The s award was conferred Nov. 10 during the NCTA’s annual 21 Awards program. This particular award honors a company that has achieved a milestone of innovation or other measurable success within the past year. In TransEnterix’s case, NCTA recognized its successful launch of the SPIDER® Surgical System earlier this year.
Viamet Pharmaceuticals, Inc. and Dow AgroSciences, a wholly owned subsidiary of The Dow Chemical Company, have entered into a crop protection research, option, and license agreement to evaluate the potential use of MetallophileTM Technology to develop novel agricultural chemicals with new modes of action. Under terms of the agreement, Viamet will utilize its proprietary MetallophileTM Technology, and Dow AgroSciences will employ its proprietary compound screening and product development capabilities, to discover and develop product candidates against priority targets in the crop protection field. “Partnering with Dow AgroSciences on this program provides Viamet with the opportunity to expand the MetallophileTM Technology beyond our current market opportunities,” commented Robert Schotzinger, M.D., Ph.D., President and Chief Executive Officer of Viamet. “Dow AgroSciences is the perfect partner to help us solve a significant problem faced throughout the world, namely crop loss. Safety and efficacy are the cornerstone for all of our human therapeutic programs and will certainly be a primary focus as we work with Dow AgroSciences on this important endeavor.”
Wyrick Robbins has released its 2010 North Carolina Executive Compensation Survey. The survey focuses on company demographics, boards of directors, executive compensation practices, and four C-level positions from 51 private and 58 public NC companies. While most surveys only include cash compensation, this survey also includes information on equity compensation and other terms and conditions of employment. A new feature of the 2010 survey is data regarding compensation and equity provided to outside directors. “This year’s survey includes data from a variety of sectors including technology, life sciences, manufacturing, banking, healthcare, and real estate,” said Diane Tindall, leader of Wyrick Robbins’ Labor & Employment Practice Group. “We believe the survey provides North Carolina companies with a unique tool for assessing and setting compensation and other benefits and terms of employment for their top executive employees.”
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 New Survey Shows Therapeutic Discovery Project Aids Small Companies
Leading biotech innovators say the new Therapeutic Discovery Project (TDP) – which makes available a tax credit to companies with 250 employees or fewer – will have a positive impact on advancing life-saving therapies and cures for patients, and U.S. biotechnology competitiveness, while helping sustain and create jobs.
CEOs of eligible biotech companies also say the program increases the likelihood that they will keep their operations in the U.S. The new findings were released by the Biotechnology Industry Organization (BIO).
“This survey demonstrates that the Therapeutic Discovery Project, and programs like it, can accelerate our industry’s ability to develop new treatments for individuals living with cancer, Alzheimer’s, Multiple Sclerosis, and many other debilitating diseases while preserving and creating new high-wage, high value U.S. jobs,” said Jim Greenwood, president and CEO of BIO. “America is the world leader in biotech, and we hope Congress will consider extending and expanding this program to support American innovation and speed the development of life-saving cures.”
More than half of the CEOs surveyed report that they have been approached by other countries to move some or all of their operations – and the American jobs that go with them – to foreign competitors including China and India. However, the survey also shows that biotech executives expect the TDP to have a positive impact on their ability to keep their companies’ operations in the U.S. Of the 125 respondents, 67% say the opportunity to apply for the tax credit makes them more likely to keep their companies’ operations in the U.S.
November 30, 2010. ibiliti MedTech Conference, Washington Duke Inn, Durham, NC. For more information, contact Ann Poorboy at ibiliti.
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