• NCBIO Connections Newsletter : October 2015

    Primary Elections


    North Carolinians will be choosing candidates for the general election in the state primary elections March 15th. In additional to the presidential candidates, voters will be deciding nominees for Governor, Council of State, legislative seats, and local offices.

    The ConnectNC Bond Issue on the ballot will provide funding for construction of life-science related buildings at North Carolina State University and East Carolina University. NCSU would receive $85 million toward funding a $154 million plant science complex that would also be integrated with NCSU's Biomanufacturing Training and Education Center (BTEC). East Carolina University would receive $90 million for a new life science and biotech building. The ECU facility would house the university's proposed Center of Excellence for Pharmaceutical Development and Manufacturing. The Center is expected to be a collaborative project of ECU, Pitt Community College and local life science companies.

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    Legislature to Return in April


    The North Carolina General Assembly will return to Raleigh April 25 for its biennial "short session." Although the main purpose of the session will be adjustments to the State's two-year budget, lawmakers will also be grappling with uncertainties and unexpected consequences of the Assembly's 2015 expansive tax reform legislation.

    For NCBIO members, one important issue will be the sales tax treatment of repair maintenance and installation ("RMI") services for fixtures such as HVAC and water handling systems. Legislation passed in 2015 subjects RMI services to sales tax if they are provided by a retailer; but services provided by companies specializing in in RMI for fixtures and other real property are excluded from the tax. The difference can mean thousands of dollars in tax liability for owners of manufacturing and research facilities. For more information contact Sam Taylor.

    Tax writers have indicated that they may also make changes to the State's existing 1%/$80 privilege tax on manufacturing and R&D equipment. One prominent legislator has suggested converting the current tax to an exemption for all capitalized equipment purchased by businesses, regardless of the equipment's use.

    Outside the tax arena, legislators may take up a variety of matters of potential importance to NCBIO members. These include funding for the North Carolina Biotechnology Center and appropriations for the State's SBIR/STTR matching grant program.

    As always, NCBIO will be monitoring legislative activity and working with lawmakers to protect the interests of North Carolina's life science industry.

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    Dr. Robert Califf Named FDA Commissioner


    Dr. Robert Califf was confirmed as the new FDA Commissioner by the US Senate in February. Last year Dr. Califf was named Deputy Commissioner for Medical Products and Tobacco for the Food and Drug Administration (FDA) and was nominated to become Commissioner when Dr. Margaret Hamburg left the agency.

    Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.

    NCBIO President Sam Taylor said, "We are pleased that Dr. Califf will be the FDA Commissioner. His work and research at Duke University along with his other experiences provide him with the knowledge and skills to lead the FDA."

    "BIO extends our congratulations to Dr. Califf on his confirmation as Commissioner of the FDA, a job that carries tremendous responsibility in protecting public health and advancing biotechnology innovation," stated Jim Greenwood, President and CEO of BIO.

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    NCBIO Life Science Forum Focuses on Social Media


    Michelle Alves, Christian Clymer, Richard Caira and Jay Dolan

    Life science companies can use social media in a variety of ways a group of panelists told NCBIO members at a Life Science Forum February 17th.

    Christian Clymer, Social and Digital Team Leader for PhRMA, encouraged participants "to focus on corporate news, philanthropy and public policy as safe areas to begin a social media presence." He gave examples of how companies have used executives and employees to be the face of the organization on social media.

    FDA and FTC compliance, Third Party platform rules, privacy and data security issues were just a few of the items covered by Richard J. Caira, Jr., a partner with Womble Carlyle. Caira outlined several issues companies should consider as part of reviewing the legal framework for using social media.

    Jay Dolan, Senior Social Media Strategist for Capstrat, talked about the importance of listening, of monitoring disease state conversations, competitor products, and life science and health conferences. He also noted the importance of using audience analysis to examine who is engaging with company Twitter, Facebook and other social media accounts.

    All of the speakers encouraged companies to develop a social media policy so employees are aware of procedures. Michelle Alves, Director of Communications and Channel Marketing for Merz North America was moderator of the panel discussion.

    Sponsors:  John Racine - World Courier, Meredith Friga - EY,
    and Jay Silver - Womble Carlyle

    Thanks to our sponsors for making this event possible for NCBIO members: EY, Womble Carlyle, and World Courier.

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    Life Science Conference


    The latest developments and trends transforming the life science landscape in North Carolina and around the world were highlighted at the CED Life Science Conference, co-hosted by NCBIO and the NC Biotechnology Center.

    A number of NCBIO members made presentations or moderated panels at the conference. To find out more about those and for a recap of the conference click here.

    Congrats to NCBIO members, Innocrin, KeraNetics and Physcient, who presented at CED as Showcase Companies, and to those in the Innovation Room:Agile Sciences, BioKierImmunoReagents, MED1 Ventures, Renovion, and Trana Discovery.

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    2015 Innovators Report


    Fifty-two life science companies completed 58 deals, netting almost $584 million according to the 2015 Innovators Report released by CED in February. The report tracks technology-based entrepreneurial activity in North Carolina.

    The report for 2015 shows that 170 North Carolina entrepreneurial companies in the technology, life science, cleantech and advanced manufacturing and materials sectors collectively raised nearly $1.2 billion in funding through 191 equity investment deals. This includes venture capital, angel, corporate, growth equity and strategic investments. Read more

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    Hold the Date - NCBIO Legislative Reception - May 3rd


    Mark you calendar now for the annual NCBIO Legislative Reception at the NC History Museum from 5:30 pm - 7:30 pm, May 3rd. More than 200 legislators and company representatives turned out for the 2015 event.

    Thanks to our sponsors for this event, Astellas, Amgen, Bayer Healthcare, Biogen, Johnson and Johnson, Lilly, and Novozymes. If your company is interested in being a sponsor of the event, please contact Laura Gunter.

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    BRITE Enters International Partnership


    The Bio-Manufacturing Research Institute and Technology Enterprise at NCCU (BRITE), one of the NCBioImpact training partners, has entered into an International Drug Discovery Partnership. BRITE signed an agreement with the Andrew Young Foundation and PROMETRA International. The focus will include research on traditional African medicines and the drug discovery process. For more information contact BRITE Interim Director, Dr. Anita Jackson

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    NCBIO Welcomes New Members


    The NCBIO Board of Directors approved the following new members at the March meeting. They are:

    Inivata, an international clinical cancer genomics company, is employing the precision of circulating tumour DNA (ctDNA) analysis to improve personalized healthcare in oncology. Using a simple blood test, ctDNA analysis is a new tool for oncologists to detect cancer, stratify patients, and assess individual response to treatment.

    KeraNetics is the global leader in the development and manufacturing of purified keratin medical products. KeraNetics' lead product in development is KeraStat® for the management of partial-thickness wounds and burns caused by thermal and radiation insult.

    MED1 Ventures was founded to provide a unique investment opportunity in the growing medical device market that manages investor risk and shortens the time to exit. MED1 incubates and develops innovative ophthalmic and women's health products that meet our stringent criteria designed to achieve commercial success.

    Renovion is a pre-clinical stage pharmaceutical company with a therapy for chronic inflammatory airway diseases. The company goal is to be the first drug ever approved for patients that have received a bilateral lung transplant.

    Trana Discovery provides a proprietary drug discovery technology platform that enables its partners to discover new treatments of bacterial, viral, and fungal infectious diseases. Company assays screen compounds to identify potential drug candidates that work through a novel mechanism of action: inhibition of the target pathogen(s) ability to use an organism-specific transfer RNA (tRNA), essential for propagation.

    Wake Forest Innovations brings industry and Wake Forest Baptist Medical Center scientists and clinicians together to appreciate each other's needs and capabilities, determine common goals, devise practical strategies and coordinate efforts to accelerate the process of developing high-value health care products.

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    At the National Level


    US Senate Considers Life Science Proposals

    Senator Richard Burr is sponsoring legislation - Advancing Breakthrough Devices for Patients Act of 2015 ( S. 1077 ), which would create an accelerated, seamless pathway for FDA approval or clearance for products that represent an opportunity to achieve significant improvements in treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Senator Burr is also sponsoring the Medical Countermeasure Innovation Act of 2015 ( S. 2055 ). The bill will give the Biomedical Advanced Research and Development Authority (BARDA) clearer authority to use monies from the BioShield special reserve fund, pressure regulators to complete work on an animal rule for testing biomedical countermeasures, and directing the Food and Drug Administration (FDA) to give priority review to material threat countermeasures. NCBIO is working with national partners to support these proposals.

    BIO Fly-In April 12-13

    The BIO Fly-In is scheduled for April 12-13 in Washington, DC. NCBIO members are encouraged to participate in visits with the NC Congressional delegation. BIO will arrange the visits and BIO staff or NCBIO staff will accompany members. To find out more, click here. Laura Gunter and John Wagner from NCBIO will be attending this event. Email them if you are attending, lgunter@ncbioscience.net or jwagner@ncbioscience.net.

    AdvaMed Fly-In

    MedTech Senate Caucus Chairs, Sen. Amy Klobuchar (D-MN) and
    Sen. Dan Coats (R-IN)

    Thanking members of Congress for the two-year suspension of the medical device tax was a key item on the agenda for the AdvaMed Fly-In March 1-2 in Washington, DC. NCBIO Communications Director and Program Manager Brenda Summers and representatives from other state organizations discussed regulatory innovation proposals with members of Congress and staff members. They also met with the Medtech Caucus Chairs who discussed bi-partisan efforts in Congress to improve opportunities for the industry.

    Whitaker New CEO of AdvaMed

    The Board of Directors of the Advanced Medical Technology Association (AdvaMed) announced today that Scott Whitaker will be its next president and chief executive officer effective April 4. Whitaker joins AdvaMed, having served most recently as chief operating officer of the Biotechnology Innovation Organization (BIO).

    "We are very pleased that Scott has agreed to lead AdvaMed at a time of unprecedented change in health care," said AdvaMed Board Chairman Vincent A. Forlenza, chairman, CEO and president of BD. "Medical technology companies are at the forefront of developing solutions that improve patient outcomes and enable the delivery of high-quality, cost-effective care. However, continued progress in these areas depends on ensuring a strong innovation ecosystem. Scott has a proven track record as an association leader, and we believe he has the vision to set the course for AdvaMed's future." Read more.

    BIO Applauds Senate GMO Labeling Bill

    BIO applauds the proposal of food labeling legislation that will give consumers fact-based information without the added costs and confusion of differing state laws. The bill, posted by the Senate Agriculture Chairman Pat Roberts (R-Kan.), would establish a national standard for the safety and labeling of foods made with genetically modified ingredients (GMOs) and develop an accompanying public education campaign.

    "We are grateful to Chairman Roberts for his leadership towards advancing a common-sense solution to the GMO food labeling issue that protects our nation's farmers, consumers, grocers and small businesses," said Brian Baenig, BIO's Executive Vice President of Food & Agriculture.

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    Member News


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

    Argos Therapeutics, Inc. announced that it has entered into a securities purchase agreement for the sale of up to $60 million of Argos common stock and warrants in a private placement financing. Argos expects that this financing will fund operations into the second quarter of 2017, when the Company expects to have final data from its pivotal phase 3 ADAPT trial of AGS-003 (the "ADAPT Study"). Read more.

    Results from a BioCryst Pharmaceuticals, Inc. preclinical study of its broad spectrum antiviral BCX4430 in immune-deficient mice infected with Zika virus was presented at a World Health Organization (WHO) meeting March 7-9 in Geneva, Switzerland. The primary goal of the study was to assess the effect of BCX4430 treatment on survival through Day 28 in immune-deficient mice infected with the Zika virus. Read more.

    Bioventus has entered into a multi-year agreement with IBSA (Institut Biochimique SA), a pharmaceutical company based in Switzerland, to secure the exclusive US distribution rights for GELSYN-3™, a three-injection, hyaluronic acid (HA) product for pain relief associated with osteoarthritis (OA) of the knee. Read more.

    Grifols has announced construction of a new plasma fractionation plant at the industrial complex at Clayton with a fractionation capacity of 6 million liters per year. The construction will begin the first quarter of 2017 and is scheduled to start production in early 2022. The company will also add a new purification plant for intravenous immunoglobulin (IVIG) at Clayton to process the fraction II+III from the new fractionation plant to obtain between 25 and 30 million grams/year of IVIG, under the Gamunex® brand. It is scheduled to come into operation in late 2021. Read more.

    ImmunoReagents announces LigaTrap™ purification resins and kits. LigaTrap™ technology utilizes novel, patented ligands, designed for antibody purification. Each kit includes 10 spin columns filled with LigaTrap™ resin and buffers needed to capture species-specific antibodies. "There is an ongoing need in the research, biopharmaceutical, diagnostic and life sciences communities for novel products related to antibody and protein purification," said ImmunoReagents CEO Dr. Ann Black. "Working with LigaTrap™ Technologies, ImmunoReagents is commercializing a series of innovative antibody and protein purification kits with substantial advantages over current technologies." Read more.

    TCG (Technology Commercialization Group, LLC), announced excellent growth throughout 2015. In 2015, the firm:

    • Completed eleven strategic transactions and financings;

    • Served ten companies in Interim Management roles as CEO or as senior Business Development Executives, including companies from Switzerland, Canada, the UK, Norway, Israel and the US;

    • Added a new TCG Partner, Mike Garrett who offers 20+ years of legal and business development experience in the UK, France, Germany and the US;

    • Enhanced financing advisory activity through our affiliation with Daybreak Capital Partners, a New York-based investment banking firm. Read more.

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    Member Benefits


    UniFirst New BIO Business
    Solutions Partner

    BIO Business Solutions®, BIO's cost-savings program, has announced a new partnership with UniFirst Corporation. The UniFirst program, available to members of BIO and NCBIO, offers a wide selection of uniforms, lab coats, and other clothing items, along with facility service products and microfiber cleaning supplies with savings of 30-50%. UniFirst rental programs outfit members' employees in the work clothing of choice, provide scheduled pickups and deliveries, and handle hygienic cleanings, garment repairs, and replacements. Similar rental programs are also in place for facility service products and microfiber cleaning supplies. Click for full program benefits.

    The UniFirst partnership will also extend to program offerings from UniClean, a wholly-owned division of UniFirst that has the depth and breadth to be a single-source provider for specialized cleanroom and controlled environment garment-related needs.

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    Thursday and Friday, March 17-18, 2016
    8:00 AM


    Project Execution Planning (PEP) for Qualification

    Location: BioNetwork Capstone Center

    Description: A Project Execution Plan (PEP) is much more than a chart showing timescales: it is a document describing how, when and by whom a specific target or set of targets is to be achieved. These targets will include the project's scope, timescales, costs, quality, and benefits.


    Website: http://conted.waketech.edu/schedule

    Sponsor Contact: sschober@ncbionetwork.org

    Monday - Thursday, March 21-24, 2016
    6:00 - 10:00 PM


    Elements of Current Good Manufacturing Practices

    Location: BioNetwork Capstone Center

    Description: Expand your knowledge in the application of current good manufacturing practices (cGMP) in the production of biopharmaceuticals.


    Website: http://conted.waketech.edu/schedule

    Sponsor Contact: sschober@ncbionetwork.org

    Saturdays, April 2 - 9, 2016
    8:00 AM - 5:00 PM


    Basic Laboratory Skills

    Location: BioNetwork Capstone Center

    Description: This course introduces the basics of work in a laboratory setting. Hands-on training includes the use of instruments and equipment such as pipettes, micropipettes, balances, pH meters, autoclaves, microscopes, and spectrophotometers. The course also covers lab safety, equipment operation, documentation, preparation of chemical solutions, and use of chromatography in sample preparation and analytical techniques..

    Sponsor: BioNetwork

    Website: http://conted.waketech.edu/schedule

    Sponsor Contact: sschober@ncbionetwork.org

    Monday, June 6, 2016 - June 9, 2016
    8:00 AM


    BIO International Convention

    Location: Moscone Center in San Francisco, CA

    Description: There's no better place to connect with biopharma's top people and most innovative technologies than at BIO 2016. The ideas shared go beyond professional development. You'll benefit from invaluable education sessions, network with 15,000 attendees, visit 1,800+ exhibitors and meet with thousands of companies through BIO One-on-One Partnering™.

    Sponsor: BIO

    Website: http://convention.bio.org

    Sponsor Contact: http://convention.bio.org/contact_us/

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