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NCBIO members and legislators talked about the growth of the State's life science industry at NCBIO's Annual Legislative Breakfast on March 26. House Majority Leader, Rep. Hugh Holliman (D-Davidson), called the industry a bright star for the State in his greetings to the group. Senator Katie Dorsett (D-Guilford), Chair of the Senate Co-Chair of the Select Committee on Energy, Science and Technology, praised the industry's growth in the State's Triad area.
Senator Katie Dorsett and Rep. Hugh Holliman
More than 80 lawmakers and NCBIO members turned out for the event that was co-sponsored by Kryosphere and Yonkers Industries. NCBIO President Sam Taylor outlined NCBIO's 2009 legislative agenda, including the following proposals.
Founders Credit (SB 751, HB763) - A capital gains tax exclusion for start-up company founders and investors receiving stock after January 1, 2010. Companies registered as Qualified Business Ventures with the North Carolina Secretary of State would qualify for the exclusion.
Life Science Development Corporation (SB 580, S922) - A new $70 million loan fund to help finance construction of new first-product facilities for life science companies, including new biomanufacturing technologies, personalized medicine, laboratory testing and clinical research entities. Loans would be capped at $20 million.
SBIR Matching Grants (SB 608) - Continue funding for the One North Carolina Small Business Program, which matches federal SBIR grant with up to $100,000 State funds. The program has been funded on a non-recurring basis since 2005. NCBIO is seeking $5 million in recurring funding for the program.
Funding for NC Biotechnology Center (SB 532, HB 371) - Continue and strengthen funding for the NC Biotechnology Center, which serves as the hub for attracting and growing life science companies in the State.
Taylor also reported the results of NCBIO's 2008 annual listing of life science capital investments, licensing deals, grants and capital facilities funding. The report lists announcements totaling more than $1.1 billion.
 Governor Beverly Perdue's proposed 2009-11 State Budget (SB 1093) includes provisions that would establish a new tax exclusion for capital gains on stock acquired by founders and investors in qualifying North Carolina start-up companies. Referred to by Perdue as a "Founder's Credit," the provision would also apply to qualified grantee venture funds.
"We are pleased that the Governor included this credit in her budget proposal," stated NCBIO President Sam Taylor. "This item is a top priority for NCBIO and many emerging life science companies in the State. We discussed this with Governor Perdue in our meeting with her following the election."
The Governor's budget also includes $2 million in non-recurring funding for the Small Business Innovation Research matching grant program. NCBIO'2 2009 legislative agenda calls for creating a recurring $5 million dollar appropriation for the program.
In her State-of-the-State address to the General Assembly on March 9th, Governor Perdue noted the importance of the life science industry as she discussed current economic conditions. "We have broadened our traditional agriculture economy and become a Mecca for biotech, pharmaceuticals, and life sciences by uniquely bringing together government, higher education and private business," said Perdue. "This allows ideas to springboard from the lab to the market place. Just look around. There's Quintiles, Merck, Bayer, Biogen, PPD and more."
 The North Carolina State Senate has adopted its proposed version of the 2009-11 State Budget. The legislation includes a $2 million non-recurring appropriation to continue the One North Carolina Small Business Fund, as well as a $3 million one-time allocation for the North Carolina Biofuels Center. The bill does not provide any new money for the North Carolina Biotechnology Center, but would impose the same 2% cut that legislators have asked most agencies and state-funded non-profits to absorb.
NCBIO has pressed legislators to provide $5 million in recurring funding for the One North Carolina Small Business Fund and $4 million in additional recurring appropriations for the North Carolina Biotechnology Center. "Given the very significant revenue shortfall facing legislators this year, we are grateful for the modest appropriations approved by the Senate," said Sam Taylor, President of NCBIO. "There is still a long we to go in this year's budget process, and we will continue to press for increased funding for the North Carolina Biotechnology Center."
"With most other states cutting back on life science funding, North Carolina has a chance this year to once again differentiate itself as deeply committed to growing its life science economy," Taylor continued. "We hope that our legislators will find a way to take advantage of this important opportunity."
 Legislation has been introduced in the 2009 General Assembly to allow North Carolina to take advantage of new industrial revenue bond (IRB) opportunities included in the American Recovery & Reinvestment Act (ARRA). Section 1301 of the ARRA modifies the Internal Revenue Code to authorize tax exempt industrial revenue bonds to be used for financing facilities "used in the creation or production of intangible property." Bond attorneys at NCBIO member law firms report the new language would likely encompass corporate research and development facilities. Historically, R&D projects have not been eligible for IRB financing. The change applies only to bonds issued before January 1, 2011.
State Senator Dan Clodfelter (D-Mecklenberg) has introduced SB 754 (Statutory Changes for ARRTA Funds), which would conform North Carolina's industrial revenue bond statutes to the new federal law. NCBIO will be supporting enactment of SB754.
Health care reform, patent reform and follow-on biologics were just a few of the topics NCBIO members discussed with the State's Congressional delegation during the BIO Fly-In on April 1st. The Fly-In is hosted annually by the Biotechnology Industry Organization to educate members of Congress regarding policy issues of importance to the life science industry.
As part of this year's Fly-In, NCBIO members and staff met with the offices of thirteen of North Carolina's fifteen members of Congress. The delegation met personally with Senator Kay Hagan and Congressmen David Price, Brad Miller, Larry Kissell, Howard Coble and Bob Etheridge. Click for a summary of issues discussed at the Fly-In meetings.
In conjunction with the Fly-In, the North Carolina Biotechnology Center hosted on March 31st a briefing for delegation members and staff regarding the recently released North Carolina life sciences industry economic impact study prepared by Battelle Corporation. The briefing was attended by Congressmen Bob Etheridge and Walter Jones. The briefing also included short presentations from North Carolina Commerce Secretary Keith Crisco, NCBC President Norris Tolson, and NCBIO President Sam Taylor.
 The North Carolina Biotechnology Center has approved a landmark $2.5 million, four-year grant to help establish a new entity that will support the growth of North Carolina's medical device and related technologies sector. The Center of Innovation grant is the culmination of a two-year planning process that found North Carolina has a growing industry base, strong universities to drive technology development, and strength in a variety of domains that are expected to converge with classical device technologies.
Advanced Medical Technologies (AMT) include complex medical devices, medical instruments, and diagnostics. This four-year grant builds on a $100,000 planning grant awarded a year ago to a group of interested business, academic, government and non-profit leaders brought together by NCBIO and the Biotechnology Center to define the State's economic opportunities in this area.
The proposed center will not be a brick-and-mortar lab or production site, but will instead be an experienced team dedicated to promoting the growth of North Carolina's advanced medical technologies community. NCBIO led the development of a preliminary business plan for the new Center that includes activities such as outreach to innovators at North Carolina hospitals and research institutions; improving inventors' access to mentors, potential licensors and innovation service providers; working with economic development organizations to attract national attention to North Carolina's medical technologies assets; and developing new sources of funding for AMT commercialization activities.
NCBIO is currently working with its AMT project partners to recruit a founding president for the proposed AMT Center of Innovation. More information and instructions for applying for the CEO position can be found at NCBIO's website. Applications will be accepted through April 24.
 Steven Burke, the long-tenured senior vice president of the North Carolina Biotechnology Center, has left the Center to become president of the Biofuels Center of North Carolina. Burke has served since July 2007 as founding chairman of the board for the Biofuels Center and since August 2008 as its acting president.
Burke joined the newly established the North Carolina Biotechnology Center in 1985 as its fifth employee and has served since 1996 as senior vice president for corporate affairs.
"For twenty-four years at the North Carolina Biotechnology Center, Steven Burke has provided tremendous vision and steady leadership," said NCBC President Norris Tolson. "More than 180,000 North Carolinians have jobs because of the biotech industry that he helped develop. That's impressive, but we aren't resting. There's more work to be done, and biofuels is a large piece of it."
In another change, Biotechnology Center is asking staff members to take one day of unpaid leave per month as part of its effort to help North Carolina close a growing budget revenue gap. The policy affects all employees.
Tolson said, "The idea of a one-day-a-month furlough came from discussions with the staff, and the leadership agreed. Without eliminating a single job, we can conserve State resources and continue to conduct our programs that promote economic development during a time of shrinking budgets." Governor Beverly Perdue has directed State agencies and state-supported non-profits to decrease their budgets for the current fiscal year by 9 percent. The Center expects to save approximately $250,000 per year with this measure.
 Planning for a Center of Innovation for drug discovery is getting started with a $100,000 award from the North Carolina Biotechnology Center. The proposed Center, which will be a multi-institution public-private partnership coordinated by The Hamner Institutes for Health Sciences, will initially focus on oncology to maximize its impact. The proposed focus aligns with the North Carolina General Assembly's recent commitment to provide $50 million per year for a new University Cancer Research Fund.
"This Center of Innovation will accelerate the development of new, safer drugs as we link cutting-edge research in North Carolina academic institutions with the needs of biotech and pharmaceutical companies," said Rick Williams, chief business officer of The Hamner and a member of the planning team.
 CED will hold it's Venture 2009 partnering conference April 22-23 at the Pinehurst Resort. The annual event has been nationally recognized as the Southeast's premier venture financing event since 1984. Celebrating its 26th year, the program will showcase the region's best high-growth entrepreneurial companies in the life science and technology arenas. Since 2001, Venture presenters have raised more than $2 billion in venture capital.
This year's Venture Conference will feature keynote remarks by Wells Fargo & Company President and CEO John G. Stumpf. Other speakers will include North Carolina State Treasurer Janet Cowell and University of North Carolina President Erskine Bowles.
Register before April 16th and save $100. Click for information, or contact Jessica Hegele at 919-549-7500 x103.
 Find out about proper classification, handling, packaging and documentation requirements for biohazard materials and get the latest FAA regulations on transportation on April 21st at the North Carolina Biotechnology Center. Hosted by NCBIO and QuickSTAT, the program will include training and certification on HAZMAT Transportation and Cold Chain Packaging. The program will run from 8:00 a.m. until 4:00 p.m. Please circulate this information to employees in your company who would be interested in packaging and transportation issues. Click to register.
 Sign up now for NCBIO's second annual VWR Scientific Vendor Fair, April 28th, at the Marriott Hotel in Research Triangle Park (4700 Guardian Drive). More than 77 suppliers will be on hand to demonstrate the latest products. Scientists, researchers and other life science employees are invited to attend any time between 10 am and 4 pm. GE Healthcare will hold seminars on Sensitivity, speed, and versatility: Quantitative Western blotting solutions at 1 pm and 3 pm. ZyGem will hold a seminar on DNA Extraction made easy, 1 Tube, 2 Steps, 3 DNA, at 10 am and 2 pm.
Lunch will be provided. Contact Leigh Kridle for more information and to reserve your admission to the event. Please circulate this information to other potentially interested persons.
 The Council for Entrepreneurial Development's second annual MedTech Conference is scheduled for May 14th at the Duke Fuqua School of Business. The conference will feature well-known leaders in the field including Dr. Gregg W. Stone, Director of Cardiovascular Research and Education, The Center for Interventional Vascular Therapies, Columbia University Medical Center and the Cardiovascular Research Foundation; William A. Hawkins, Chairman and Chief Executive Officer, Medtronic, Inc.; Rick Anderson Managing Director, PTV Sciences; and Dan Lemaitre Chief Executive Officer, CoreValve Inc. Click for information.
 Sir Elton John will be one of the speakers at the 2009 BIO International Convention at the Georgia World Congress Center, in Atlanta. May 18-21. John has been a strong advocate for AIDS research. Key sessions during the event will include the Burrill State-of-the-Industry Report; Ernst & Young's Biotechnology Report 2009; Weathering the Perfect Storm of Financial Distress and Political Pressure; and Global Biotechnology Innovation: Connecting the Laboratory, the Field and the Marketplace.
NCBIO members are eligible for an exclusive discount. When you register, simply enter the following promotional codes for the various options to save! NCF450 -- (Save $450) for Full Convention; NCS550 -- (Save $550) for Session Access; and NCE50 -- (Save $50) for Exhibit Hall Visitor. Please let others in your company know about these savings.
 SEBIO has launched Southeast BIOtech Connect, a regional interactive database to help attendees at BIO 2009 arrange contacts with life science companies in the Southeast. Southeast Biotech Connect includes more than 1,200 biotech companies and centers throughout Florida, Georgia, Alabama, North Carolina, South Carolina, Tennessee and Virginia. The database is designed to help BIO 2009 attendees schedule visits with regional companies and other life science-related entities during their time in the Southeast.BR>
Through collaboration with life science organizations in the Southeast, basic information (name, address, and website) on regional companies has been entered into the database. Company managers are asked to confirm and supplement their database entries. To access Southeast BIOtech Connect, click here. Enter your corporate email address to update your company's profile and/or choose to participate in the BIO 2009 site visit program. To opt out of the database, email sadams@sebio.org.
 For the 23rd year, the NC Biotechnology Center is hosting Workshops for Educators. North Carolina educators receive a daily stipend, room and board, technology or regular CEUs, and access to the Biotechnology Center's Free Supplies and Equipment Loan Programs. Five introductory workshops will be offered around the State for high school science teachers, and one workshop for middle school teachers. Special topics workshops will include one for CTE Agriscience teachers and two advanced workshops for high school teachers and college faculty who have previously completed an Introductory Complete information about the workshops can be found on the Biotechnology Center's Web site. Space is limited, so register now.
Please have your organization’s media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Affinergy, Inc., a Duke University spinout with a proprietary site-specific biological delivery system, announced that Dr. Bruce S. Lamb has joined the company as Senior Vice President for Research & Development. Dr. Lamb has 23 years of leadership experience in development of multiple surgical products. Most recently, Dr. Lamb served as Senior VP of Development and Regulatory Affairs at LifeCell, Inc. which was acquired in 2008 for $1.7 billion in cash.
Dr. Michael Allen Luther has been named President of the David H. Murdock Research Institute of the North Carolina Research Campus. Dr. Luther is a native of Albemarle, North Carolina. Prior to joining the DHMRI, he served as Vice President, Basic Research and Site Head of the Merck Frosst Centre for Therapeutic Research in Montreal. In this role, Dr. Luther was responsible for overseeing the development of novel therapeutics for respiratory, endocrine and metabolic disorders. Dr. Luther spent 15 years at GlaxoSmithKline in RTP and the UK where his last role was a Vice President in Discovery Research. He also worked at the predecessor companies, Glaxo and Glaxo Wellcome, in a number of roles of increasing responsibility including creating and leading a new business venture that in predictive medicine.
Tranzyme Pharma, a late stage biopharmaceutical company engaged in the discovery and development of first-in-class small molecule therapeutics, announced that the U.S. Patent and Trademark Office (USPTO) has issued three patents further enhancing Tranzyme's intellectual property portfolio for its current and future drug candidates. They are: US 7,476,653: Macrocyclic modulators of the ghrelin receptor; US 7,491,695: Methods of using macrocyclic modulators of the ghrelin receptor; and US 7,452,862: Conformationally-controlled biologically active macrocyclic small molecules as motilin antagonists or ghrelin agonists. Combined, the patents, with terms until at least 2024, provide strong and broad protection for the chemical structural class comprising Tranzyme's lead pharmaceutical development programs. Further, they provide Tranzyme with enhanced protection for the company's most advanced drug candidate, TZP-101. TZP-101 is an intravenous ghrelin agonist ready to enter Phase 3 studies for the management of postoperative ileus (POI).
ArtusLabs, Inc., the leader in scientifically-aware data management systems, and Viamet Pharmaceuticals, Inc., a human therapeutic company focused on "best-in-class" metalloenzyme inhibitors, have announced plans for collaborative development of Metallobase™, Viamet Pharmaceuticals' proprietary database of metalloenzymes and metalloenzyme inhibitors. "ArtusLabs was the perfect choice to help us develop this critical system for our internal discovery efforts. Their in-house technical expertise in chemistry-oriented solutions and drug discovery awareness were the skills that we were looking for in a data management partner," said Dr. Robert Schotzinger, President & CEO of Viamet Pharmaceuticals.
IMPACT, the biotechnology and life sciences magazine, has announced the hiring of Arden Armstrong as vice president of business development. Armstrong brings 31 years of experience in publishing, marketing and sales to the magazine. At the same time, the magazine is doubling circulation and moving from a bi-monthly to monthly publication schedule with the May edition.
 BIO Opposes Waxman BioSimilars Legislation
Biotechnology Industry Organization President and CEO Jim Greenwood voiced opposition to a proposal Introduced by Congressmen Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-GA) to establish a pathway for the approval of biosimilars. "The Biotechnology Industry Organization (BIO) continues to support strongly the development of a pathway for the review and approval of biosimilars. Unfortunately, the legislation introduced would take patients and our industry down the wrong path - a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer's," stated Greenwood. Greenwood noted that the legislation would impair the life science industry's ability to help meet President Obama's call for a cure to cancer ‘within our time' as well as efforts to realize the promise of stem cell research.
"This bill seeks to cut prices but instead cuts corners," said Greenwood. "The legislation does not strike the necessary balance for patients or the economy. Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars."
BIO Applauds President Obama's Action on Stem Cell Research
The Biotechnology Industry Organization has lauded President Barack Obama's Executive Order to allow the National Institutes of Health (NIH) to fund research using embryonic stem cells. The NIH was previously able to fund research only on a very limited number of stem cell lines. "We fully support and are enthusiastic about President Obama's decision to allow the NIH to fund embryonic stem cell research," said Jim Greenwood, president and CEO of BIO. "BIO believes that research on both adult and embryonic stem cells holds great promise to produce new therapies and possibly cures for the millions of patients in the U.S. and around the world suffering from cancer, diabetes, Alzheimer's, Parkinson's, spinal cord injuries and other life-threatening diseases and conditions."
Greenwood noted that embryonic stem cell research will also further the development of cell-based therapies by leading to greater scientific understanding of cell differentiation (the process by which cells become specialized to perform certain functions) and proliferation (the process by which cells expand or multiply for controlled use as a potential therapeutic).
April 21 NCBIO and QuickSTAT HAZMAT and Cold Chain Packaging Training and Certification Seminar, 8:00 am - 4:30 pm, North Carolina Biotechnology Center, RTP, NC. For more information.
April 22-23 CED's Venture 2009, Pinehurst Resort, Village of Pinehurst, NC. For more information.
April 28 Scientific Vendor Fair, 10:00 am - 4:00 pm, Marriott Hotel, 4700 Guardian Drive, Durham, NC. Hosted by NCBIO and VWR. Contact Leigh Kridle for more information.
May 14 CED's Medtech 2009, Fuqua School of Business, Duke University, Durham, NC. For more information.
May 18-21 BIO International Convention, Atlanta, GA. For more information.
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NCBIO This Month
