• NCBIO Connections Newsletter : October 2015

    Lawmakers Return April 25th


    Adjustments to the 2016-17 State budget will be the top priority for lawmakers when they return April 25th for the General Assembly “short session.” Funding for the North Carolina Biotechnology Center is included in the recurring State budget and should continue at the current level. Appropriations for the State’s SBIR/STTR matching grant program will be up for review again.

    Lawmakers will be looking at other issues including clarifications to the state’s new sales tax on repair, maintenance and installation services. The tax has created confusion among many taxpayers and the Assembly will likely act to address concerns about the tax before adjourning in July. NCBIO is be closely monitoring the session for changes in the State’s State’s existing 1%/$80 privilege tax on manufacturing and R&D equipment. (Both issues were reviewed in the March newsletter.)

    Sam Taylor and Laura Gunter of NCBIO will be working with lawmakers to protect the interests of North Carolina’s life science industry.

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    NCBIO Legislative Reception – May 3rd


    NCBIO invites you to the annual NCBIO Legislative Reception at the NC History Museum from 5:30 pm – 7:30 pm, May 3rd. More than 130 people have already registered for the event. NCBIO Members have received email invitations to the event. If you have not, contact bsummers@ncbioscience.net. More than 200 legislators and company representatives attended the 2015 event.

    Thanks to our sponsors for this event, Astellas, Amgen, Bayer Healthcare, Biogen, Johnson and Johnson, Lilly, Novozymes and Quintiles.

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    Medical Device Forum May 26th


    The NCBIO Life Science Luncheon and Forum brings together industry leaders to discuss university/industry collaborations, product development issues, and the changing clinical and regulatory landscape. The event is May 26th, 11 am – 2 pm at the NC Biotechnology Center.

    Panelists will highlight some needs and issues in each category. Following the presentations, break out groups over lunch will brainstorm on some actionable items that can expand the community across the state. Groups will report out and help determine next steps.

    Moderator for the event is Peyton Anderson, CEO, Affinergy.


    • Dr. Roberto Manson, Assistant Professor of Surgery, Duke University School of Medicine
    • Glenn Warren, Director of Market Development, TransEnterix
    • Other panelists are being confirmed

    Thanks to TransEnterix and Wyrick Robbins Yates & Ponton LLP for sponsoring this event. Others interested in supporting this forum, contact Laura Gunter.

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    Hold September 29th for NCBIO Annual Meeting


    Three life science leaders will be speaking at the NCBIO Annual Meeting. Steve Ubl, the new President and CEO of PhRMA; Joel Marcus, Chairman, CEO and Founder of Alexandria Real Estate Equities; and Joe Gilliam, Managing Director, Healthcare Investment Banking, JP Morgan, are speakers for the event.

    More information about the meeting will be in upcoming newsletters. NCBIO members will be receiving advisories so you can sign up for the event, that will be held at the NC Biotechnology Center from 8am – 1 pm, with a networking lunch 1-2 pm.

    To be a sponsor, contact Laura Gunter.

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    Novo Nordisk Breaks Ground on New Facility


    Novo Nordisk
    broke ground on its new $1.8 billion diabetes medicine production facility in Clayton. More than 100 community members, employees and policy makers attended a ceremonial event alongside Lars Rebien Sørensen, President and CEO officer of Novo Nordisk, and Pat McCrory, Governor of North Carolina.

    The facility will produce active pharmaceutical ingredients (API) for a range of Novo Nordisk's current and future GLP-1 and insulin medicines. Once fully operational in 2020, the Clayton facility will ensure production capacity for diabetes medicines in the U.S. for the decade ahead.

    Once complete, the new facility will measure 833,000 square feet and have a footprint of 417,639 square feet – the equivalent to approximately seven football fields. Read more.

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    Lean Six Sigma Discussed at BMF Meeting


    Glenn Scott, Doug Smith and Ryan Zigler

    Implementing Six Sigma and Lean strategies takes planning panelists told Biotech Manufacturers Forum (BMF) members at the March Meeting. Doug Smith of Pfizer outlined the work of the Sanford facility noting the importance of continuing to focus on culture, engagement and leadership during the ongoing process. He added, “The biggest challenge for all lean deployments or improvement initiatives is managing the mind set and behaviors around the change.”

    Ryan Zigler of Novozymes outlined the process that his company is just starting, first in the supply operations area. He stated key successes in the process so far included:

    • High level of commitment to strategy by VPs, Directors, and Managers
    • Gaining valuable problem solving experience
    • Improved team engagement in both understanding our current performance and involvement in problem solving
    • Improving communication across functions
    • Producing performance improvements

    Glenn Scott of Ernst & Young discussed how his firm has integrated lean, TPM and other strategies in an Integrated Work System to help companies achieve operational excellence. He talked about some of the key differentiators in the process so that “Results are achieved quickly with a focus on Run to Target (RTT).

    For more information about BMF, contact John Wagner.


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    Collaboration with NC State and Belgian Research Insitute


    NC State University and VIB, a life sciences research institute in Belgium, recently entered into a strategic collaboration agreement aimed at spurring growth in the plant biotech research sector in both Belgium and North Carolina.

    Both institutions are leading international players in plant biotech with strong interaction with local agrotech clusters – VIB with the Ghent Agro Cluster and NC State with the AgBio[sphere] in the Research Triangle. Read more.

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    At the National Level


    BIO, NCBIO and Other Groups Oppose Proposed Changes to Medicare Part B

    A proposed rule released on March 8 by the Centers for Medicare & Medicaid Services (CMS) would put patient access and care quality at risk for millions of Medicare patients through sweeping, aggressive changes to payment policy for drugs covered under Part B.

    Medicare Part B covers a subset of outpatient prescription drugs, used by patients with complex conditions who currently have few or no other treatment options. Maintaining access to medicines under Medicare Part B is crucial for vulnerable patients who suffer from serious illnesses such as cancer, cerebral palsy, and immune deficiency disease.

    NCBIO believes that CMS’s changes, which are published as a demonstration model by the Center for Medicare and Medicaid Innovation represent a significant over-reach of CMS’ authority and would reduce payment for many providers and, in later phases, rely on centralized government determinations of value.

    More than 300 organizations have joined together to oppose the proposal. The groups, including NCBIO, are writing the Congress asking that the rule be withdrawn.

    BIO Praises Advancement of Senate Biomedical Innovation Legislation

    Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood is pleased with Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative. “BIO was encouraged by the bipartisan mark-up today by the Senate HELP Committee of legislation as part of the Senate biomedical innovation initiative. In particular, BIO applauds the Committee’s passage of the Promise for Antibiotics and Therapeutics for Health Act, which would help address a critical barrier to the development of urgently needed novel antibiotics by creating a new approval pathway. We were also pleased that the Committee passed legislation to advance the President’s Precision Medicine Initiative.” Read more.

    Bipartisan Bill Will Improve Efficiency, Predictability at FDA

    Legislation introduced in the US Senate (S.2737) is designed to improve the effectiveness of operations at FDA. JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), stated, “FDA has made great strides in recent years to improve the efficiency, predictability and transparency of its medical technology review process. But we believe that more can be done so that FDA is operating at maximum effectiveness to ensure patients have timely access to medical innovations.” Read more.

    BIO 2016 Convention – June 6-9, San Francisco

    The BIO International Convention (BIO) attracts over 15,000 biotechnology and pharma leaders. Join with others from North Carolina at the NC Pavilion. The Early Bird rates for the event end April
    14th. Registration for BIO One-on-One Partnering System is now open.

    • The Convention offers many benefits including:
    • Ability to connect efficiently: Meet with 4,000+ attending companies and 1,800+ exhibiting companies 
    • Gain new perspectives from executive visionaries in the new Fireside Chats
    • Network with 2,500 CEOs and 15,000+ attendees from 69 countries
    • Explore solutions and meet service providers in one of the 7 product focus zones or specialty zones 

    Find out more about the agenda and registration.

    Negotiations Under Way on PDUFA Reauthorization

    President Obama’s administration and health leaders in Congress are working on the the reauthorization of the Prescription Drug User Fee (PDUFA), MDUFA and other similar user fee programs, which expire October 1, 2017 if new legislation is not adopted.

    At a We Work for Health event in RTP, life science leaders and patient advocates heard about some of the challenges for reauthorization proposals. Current plans are being negotiated by the outgoing administration and outgoing Congress, and will need review by the new administration and 2017 Congress.


    Mike Woody, Laura Perloff, Randolph Cloud and Ryan Long

    Two Washington observers discussed some of the issues with reauthorization. Mike Woody of the East End Group and Ryan Long of the BGR Group noted that the FDA met its PDUFA Goals of 96% of Novel Drug Approvals, with 45 Novel Drugs approved in 2015.

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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

    Biogen CEO, George A. Scangos, is the new chairman of the PhRMA board. Joaquin Duato, worldwide chairman, pharmaceuticals, Johnson & Johnson is chairman-elect and Joseph Jimenez, CEO, Novartis AG assumes the role of board treasurer.

    Scangos formerly held the position of chairman-elect and succeeds Kenneth C. Frazier chairman and CEO of Merck & Co., Inc. as PhRMA board chairman. Read more. Read more.

    Biogen announced the appointment of Michel Vounatsos as executive vice president and chief commercial officer, effective April 18. Mr. Vounatsos will oversee the development and execution of Biogen’s global commercial strategy, with a focus on the continued growth of Biogen’s product portfolio and the development of the commercial infrastructure and approach to support the company’s key pipeline assets. Read more.

    Fujifilm Diosynth scientists made presentations at two different events in March. The first event, in Bethesda, MD, focused on the Analytical challenges of biotherapeutics. Dr. Greg Adams, Director of Analytical and Formulation Development, presented "Application of Analytical Techniques for Product Quality Driven Process Development and Routine cGMP Manufacturing." At BPI-West in Oakland, CA, a premier conference focusing on transition molecules form basic research into clinical products, Dr. Alison Young Principal Scientist in Cell Line Development, discussed “Are all Recombinant Proteins Equal? A Cell Line Development Perspective". Mr. Abel Hastings, Director of Process Sciences, presented “Establishing an Effective Quality Focus to Improve Biopharmaceutical Operation”.

    Christy Shaffer, a General Partner with Hatteras Venture Partners, received a Lifetime Achievement Award April 4th at the Triangle Business Journal Women in Business Awards. Dr. Shaffer was formerly President and CEO of Inspire. Read more.

    Quintiles has been recognized by the Ethisphere Institute, a global leader in defining and advancing the standards of ethical business practices, as a 2016 World’s Most Ethical Company®. “This award is a testament to the high standards our employees uphold every day,” said Dr. Dipti Amin, Quintiles’ Chief Compliance Officer. Read more.

    Pharmaceutical Product Development, LLC (PPD) is named the Best Contract Research Organization (CRO) at the 9th Vaccine Industry Excellence Awards at the World Vaccine Congress 2016. “We are honored to receive this award acknowledging PPD’s contributions in helping our customers bring life-changing vaccines to patients more quickly and with the highest standards of quality,” said Bill Sharbaugh, PPD’s chief operating officer. Read more.

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    Member Benefits


    BIO Business Solutions® offers NCBIO members special discounts. BIO Business Solutions gives you the purchasing power of the largest companies in the life science industry. 2,800+ companies saved over $135,000,000 in aggregate last year. Find out more.

    Discounts to MDMA Annual Meeting

    NCBIO also get discounts to partner events such as the MDMA Annual Meeting in Washington, DC, May 4-6. Members are eligible for a $100 discount. MDMA's Annual Meeting will cover key issues impacting the United States' leadership position in med tech innovation, and how we can all help shape the regulatory and legislative agendas. This year's meeting will provide the latest on regulatory, reimbursement, compliance and international trends, as well as share powerful stories of how med tech is improving patient care. Find out more about the event.

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     Validation Documentation

    Saturday Apr 16, 2016

    ... read more

    Aseptic Processing I

    Monday Apr 18, 2016 - Thursday Apr 21, 2016

    ... read more

    Medical Device Current Good Manufacturing Practices

    Monday Apr 18, 2016

    ... read more

    Risk Based Approaches to Validation

    Tuesday Apr 19, 2016 - Wednesday Apr 20, 2016

    ... read more

    Preparation and Purification of Biological Samples for HPLC Analysis

    Saturday Apr 23, 2016 - Saturday May 14, 2016

    ... read more

    Good Lab Practices: FDA and EPA Regulations

    Tuesday Apr 26, 2016 - Thursday Apr 28, 2016

    ... read more

    Cleanroom Gowning Certification

    Thursday Apr 28, 2016 - Friday Apr 29, 2016

    ... read more

    2016 NCBIO Legislative Reception

    Tuesday May 3, 2016

    ... read more

    Medical Device Manufacturers Association Annual Meeting

    Wednesday May 4, 2016 - Friday May 6, 2016

    ... read more

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