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NCBIO This Month

· Lawmakers Work on Budget Compromise· NC’s Medical Device Environment and Opportunities· “Working with Millennials” Topic of BMF Meeting· NC Life Science Industry In Top Tier of States· Growth of Industry, Investments and Other Topics #BIO2016· Forum on Zika Virus· NCBIO Members Receive Life Science Awards

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· At the National Level· Member News· Member Benefits· Calendar

Lawmakers Work on Budget Compromise

NC House and Senate budget conferees are trying to work out differences in House andSenate budget proposals. Both plans include full funding for the NC BiotechnologyCenter and a $1.5M expansion for the SBIR matching grant program. Legislators hopeto have a spending plan in place by June 30th prior to the new fiscal year that beginsJuly 1.

A key part of legislators’ discussion is tax policy. The State House wants to repeal theState’s existing 1%/$80 privilege tax on manufacturing and R&D equipment. The StateSenate disagrees, and wants instead to adopt market-based sourcing (MBS) languagethat is opposed by House. MBS affects what sales multistate corporations must count incalculating the portion of their income that is taxable in North Carolina. Legislatorscould comprise by adopting current or revised versions of either bill, or adjourn withoutacting on the two packages.

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NC’s Medical Device Environment and Opportunities

June 2016UPDATEServing the NC LifeSciences Industry

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Medical Device Panel - Noel Harvey, Hugh Crenshaw, Ed Chekan, Debra Grodt,Roberto Manson and Andrew DiMeo

Opportunities for collaboration and strengthening the medical device cluster in NorthCarolina were discussed at the May 26th NCBIO Life Science Luncheon and Forum.More than 70 individuals from across the state attended the event.

Moderated by Noel Harvey, Senior Vice President, Research and Development, BD, apanel of five industry and academic leaders discussed challenges and resourcesavailable for medical device companies and combination products.

Hugh Crenshaw, CEO of Physcient, Inc., outlined the growth of his emerging companyand its efforts in redesigning the surgical tray. He noted most of the company’spartners were located in RTP. He called for “more collaboration with companies anduniversities” with access for companies to university libraries, animal labs, cadaver labsand physicians.

Dr. Ed Chekan, Medical Director for Teleflex in Morrisville stated that five years fromnow, “North Carolina could have a significantly more robust medical device sector if…

Enabling medical device companies have most support functionsavailable on contract basisEstablished medical device companies expand their footprint, and partnerwith local universities and medical schoolsAn easy way for industry to collaborate with academic institutions in newproduct development is established.

Debra Grodt, Director of Regulatory Affairs, Novella Clinical, outlined the total productlife cycle of the Med Device Development Continuum. She stated that developing amedical device hub will require, “infrastructure, accessibility, affordability, workforceand desire.” She discussed the merging of technology, drugs and devices and thedevelopment of more sophisticated delivery systems.

Dr. Roberto Manson, Associate Medical Director of the Surgical Education and ActivitiesLab and Assistant Director of Surgery at Duke University Medical Center, reviewed theresources available at Duke and the variety of medical device companies the medicalcenter has assisted. He discussed ways Duke might assist medical device companies.

Andrew DiMeo, Associate Professor of Practice at the UNC & NC State BiomedicalEngineering Program discussed the work under way at the two universities. He outlinedthe ecosystem for medical devices combining academia, health care and industry. Hepreviewed the idea of a “Medical Innovators Garage” that is a collaboration of theecosystem providing “low overhead, maker space, asset assessment, IP Safe Haven,student internships and training.”

Forum participants held roundtable discussions following the presentations and cameup with a number of suggestions for improving opportunities for the medical devicecompanies. Noel Harvey agreed to lead a group of volunteers in some initial meetingsto review ideas and decide next steps. For more information, contact Brenda Summers– bsummers@ncbioscience.net.

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Sponsors - Jason Wood (Wyrick Robbins), Robin Grandl (TransEnterix),and Matt Keffer (PwC)

Thanks to PwC, TransEnterix and Wyrick Robbins Yates & Ponton LLP for sponsoring thisevent.

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“Working with Millennials” Topic of BMF Meeting

Millennials (those born between 1980-2000) are making up a larger part of the lifescience workforce as baby boomers retire. Panelists at the June Biotech ManufacturersForum talked about recruiting and engaging Millennials into the industry.

Millennials Panel - Brandi Nicole Johnson, David Smith, Tom Jede and Dan Moskey

Brandi Nicole Johnson with the Center for Creative Leadership (CCL) told participantsthat 50% of the American workforce will be Millennials by 2020. She stated Millennialswant many of the same things in the workplace as that of workers of other generations.Brandi highlighted some of the recommendations in the book, What Millennials Wantfrom Work, for those who manage Millennials. Some of those recommendations were:

Minimize repetitive work.Engage Millennials to improve processes.Make use of their willingness to work long hours.Encourage employees’ desire to contribute.

Click for more information on the study.

David Smith of Biogen says Millennials want to know the mark your company is makingon the world, and he suggested the websites and social media should be used to recruitpotential employees and tell stories about their company.

Tom Jede and Dan Moskey of Seqirus discussed steps their organization has taken toengage Millennials at the Holly Springs site. Millennials make up 33% of theiremployees. The company holds regular forums to get insight and opinions fromworkers, assists with career frameworks for career paths, and provides opportunitiesfor community engagement.

For more information about the event, contact Brenda Summers or John Wagner.

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NC Life Science Industry In Top Tier of States

“North Carolina’s bioscience industry is large, growing, and highly specialized with adiverse set of niche strengths. The state industry employed more than 70,000 in 2014while operating 3,179 business establishments.” That finding and more are noted in astudy, The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life2016, released at the BIO International Convention.

The section on North Carolina state, “The concentration of employment in thebioscience industry is 46 percent greater across North Carolina’s economy relative tothe national average—its location quotient is 1.46. The state has an employmentspecialization in three of the five major subsectors—drugs and pharmaceuticals;research, testing, and medical labs; and agricultural feedstock and chemicals.Statewide, the bioscience industry had 6.6 percent job growth from 2012 to 2014, withthree subsectors contributing gains including especially large gains in research, testing,and medical labs. North Carolina is among the top tier across all states in key measuresof bioscience R&D and innovation including in academic R&D, NIH research funding,and venture capital investments. State research universities’ bioscience-relatedacademic R&D spending exceeded $2 billion in 2014. Click to get the NC report.

The report “shows increased employment within the U.S. bioscience industry for thelast four consecutive years. The report also shows impressive bioscience industrystrength and resilience, with employment growth of nearly 10 percent since 2001.Among technology sectors the bioscience industry has been a leading performer overthis period. The report finds U.S. bioscience firms employ 1.66 million people, a figurethat includes nearly 147,000 high-paying jobs created since 2001. The average annualwage for a U.S. bioscience worker reached $94,543 in 2014.” Read more.

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Growth of Industry, Investments and Other Topics#BIO2016

NCBIO’s Laura Gunter talks with Commerce Secretary John Skvarla at the NC Pavilion.

“Last year, our industry broke a number of important records. We attracted a recordamount of venture capital investment, and we saw record follow-on offerings in publicmarkets,” BIO President and CEO Jim Greenwood stated in his keynote address at the2016 Convention. “The FDA approved the most, new therapies in 18 years, the mostbiologics ever, and the most rare-disease drugs in history.” Read more.

The strategic venture arms of major biopharma companies like AbbVie, Amgen,Johnson & Johnson and Pfizer offer unique value propositions to early-stage companiesand have the flexibility to shape unique deal structures for advancing thesepartnerships beyond traditional corporate venture capital models. Speakers at a 2016BIO International Convention panel titled “Strategic Venture Investing by LargePharma: Is ‘Smart Money’ Right for Your Company?” provided their about how theseventure arms fuel innovation in the industry. Read more.

The redesigned North Carolina Pavilion, 1,000-sq.-ft. on the trade show floor, hosted bythe NC Biotechnology Center, represented the breadth of the state’s life sciencecapabilities. At the start of BIO 2016, the Center published an update on the growth ofinternational life science companies in the state. Commerce Secretary John Skvarla andEconomic Development Partnership of NC CEO Chris Chung visited the pavilion and lifescience companies during a trip to the convention. The Pavilion also hosted a barbecuefor NC life science companies and guests on June 7th.

Read more convention highlights.

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Forum on Zika Virus

RTI International hosted a roundtable discussion about North Carolina’s role in Zikaresearch, prevention, and response June 7th in the Research Triangle Park.Congressman David Price (D-NC) led a panel of government officials discussingresponse to the Zika Virus. Dr. Randall Williams of NC Health and Human Services(HHS) told forum HHS that NC has cut Zika virus diagnosis from 6 weeks to 6 days.

Dr. Ray Taylor of BioCryst Pharmaceuticals discussed potential treatments for the Zikavirus. Other participants discussed the need for more resources and strategies foraddressing the situation.

To help combat this critical public health issue, RTI is self-funding a number ofinitiatives in Latin America. These projects include studying how drones can be used forvector control activities of Zika-carrying mosquitos, examining potential aerosoltransmission of the virus, and understanding the long-term effects of the virus onbabies and their families.

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NCBIO Members Receive Life Science Awards

Rich West, Founder and CEO of Baebies, Inc., received theCEO of the Year Award fat the 2015 BDO Life SciencesAwards at a Triangle Business Journal Annual Event. Westhas more than 20 years life science experience. Baebies,Inc., is a company focused on newborn screening andpediatric testing, founded in 2014 by West and VamseePamula, following the successful development of digitalmicrofluidics technology, the development and launch ofmultiple products, and the eventual sale of AdvancedLiquid Logic to Illumina, Inc.

NCBIO President Sam Taylor presented the Life TimeAchievement Award Winner to Andrew Schwab, Presidentof the First Flight Venture Center. Schwab has been leaderof the technology incubator for the past five years.

Bayer was named Best Agricultural Biotechnology Companyand PPD Inc. – Best CRO.

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At the National Level

BIO Releases Largest Study Ever on Clinical Development Success Rates

The Biotechnology Innovation Organization (BIO) released the largest ever study ofclinical development success rates. The study, conducted in partnership with Amplionand Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phasetransitions, across 1,103 companies. Using clinical trial data from the past decade,“Clinical Development Success Rates 2006-2015” compares groups of diseases, drugmodalities and other attributes to generate the most comprehensive analysis, to date,of biopharmaceutical R&D success.

“This study provides a wealth of information about drug development success ratesacross a broad range of indications,” said Cartier Esham, PhD, BIO’s Executive VicePresident, Emerging Companies. “The results may be used to pinpoint disease areasand phases of development where the industry has been most successful in recentyears, as well as areas presenting challenges along the capital intensive-pathway ofdrug development.” Read about key findings.

US House Passes Innovation Bill

The Biotechnology Innovation Organization (BIO) applauded the US House ofRepresentatives for passing H.R. 4139, the Fostering Innovation Act. The bipartisanlegislation was introduced by Reps. Kyrsten Sinema (D-AZ) and Michael Fitzpatrick (R-PA).

The JOBS Act provides emerging growth companies (EGCs) with a five-year exemptionfrom Section 404(b) of Sarbanes-Oxley (SOX), which requires a costly externalattestation of a company’s internal financial controls. The Fostering Innovation Actwould extend the JOBS Act’s SOX 404(b) exemption for an additional five years forformer EGCs that maintain a public float below $700 million and average annualrevenues below $50 million. The additional five years of cost-savings would allowgrowing companies to focus their capital on groundbreaking R&D rather than one-size-fits-all regulatory burdens. Read more.

Senate Bill Would Streamline CMS's Process for Breakthrough Technologies

Scott Whitaker, President and CEO of the Advanced Medical Technology Association(AdvaMed), issued the following statement after introduction of legislation in the U.S.Senate, S. 2998, to expedite CMS decision-making for innovative medical technologies:

“The Ensuring Patient Access to Critical Breakthrough Products Act, will help bridge agap between FDA and CMS and improve patient access to breakthrough medicaltechnologies for serious illnesses.”

“Currently, FDA has an established process to provide priority review to breakthroughtechnologies. We support reforms to that process in other pending legislation. However,there is no similar process at CMS to ensure patients have access to these devices anddiagnostics in a timely manner.” Read more.

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Member News

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

Argos Therapeutics Inc. announced that the independent data monitoring committee(IDMC) for the Company's pivotal Phase 3 ADAPT clinical trial of AGS-003 for thetreatment of metastatic renal cell carcinoma (mRCC) has recommended thecontinuation of the trial based on results of the IDMC's scheduled interim data review.Read more.

Baebies, Inc., a company focused on newborn screening and pediatric testing, unveileda prototype of the world’s first near birth newborn testing platform, FINDER™, at the2016 Pediatric Academic Societies (PAS) meeting held on April 30 – May 3 in Baltimore,

Maryland. Read more. Baebies has also unveiled a new website.

Mayne Pharma Group Limited has received FDA approval of its Abbreviated New DrugApplication (ANDA) for dofetilide capsules (125 mcg, 250mcg and 500 mcg) in theUnited States. Read more.

Seqirus announced that the US Food and Drug Administration (FDA) has approvedFLUCELVAX QUADRIVALENT™ (Influenza Vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two Bviruses recommended by the World Health Organization (WHO) and the FDA for thecurrent influenza season. Read more.

Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration(FDA) has granted Fast Track designation for VT-1129 for the treatment of cryptococcalmeningitis, a life-threatening fungal infection of the membranes covering the brain andspinal cord. VT-1129 is a highly selective inhibitor of fungal CYP51 that has cryptococcalmeningitis. “We are pleased that the FDA has granted Fast Track designation status toVT-1129 for the treatment of cryptococcal meningitis, as this provides the opportunityto deliver this potential life-saving treatment to patients in a more rapid timeframe,”commented Robert Schotzinger, M.D., Ph.D., CEO of Viamet. Read more.

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Member Benefits

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

The Biotechnology Innovation Organization (BIO) has announced a new partnershipwith Airgas, an Air Liquide company and one of the nation’s leading suppliers ofindustrial, medical, and specialty gases, and related products, to add cylinder gases,bulk gases, dry ice and related supplies to the BIO Business Solutions® offerings. As asupplier partner, Airgas is now part of BIO’s exclusive Business Solutions® programwhich is helping thousands of companies save on items they need to run a successfulbiotechnology enterprise. Read more.

NCBIO members now have access to a recorded webinar and/or white paper in thewebinar series "Must-Know Finance Conceptsfor Life Sciences Valuations” fromShareVault.

BIO has also extended its agreement with VWR to provide members with laboratorysupplies, equipment and chemicals through June 2023. VWR has updated its OrderStatus page with a new look and new functionality. You can now see more detailedinformation for your orders on vwr.com.

Complete, consistent, reliable, visibility to order statusEnhanced shipping confirmations including certificatesIncreased transparency with the latest estimated delivery date

Click here for more information about this new enhancement.

Calendar

Marine & Environmental Sciences

Monday Jun 27, 2016 - Wednesday Jun 29, 2016

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Biotechnology for the Classroom

Monday Jun 27, 2016 - Friday Jul 1, 2016

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Biotechnology for the Classroom

Monday Jul 11, 2016 - Friday Jul 15, 2016

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Assay Development and Validation in Biomolecules

Tuesday Jul 12, 2016 - Wednesday Jul 13, 2016

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GE Chromatography Column Packing

Tuesday Jul 12, 2016 - Thursday Jul 14, 2016

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Cell Culture Engineering

Tuesday Jul 12, 2016 - Thursday Jul 14, 2016

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Forensic Sciences

Tuesday Jul 19, 2016 - Thursday Jul 21, 2016

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Hands-On cGMP Biomanufacturing Operations

Tuesday Jul 19, 2016 - Friday Jul 22, 2016

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Biopharmaceutical Analysis

Tuesday Jul 26, 2016 - Wednesday Jul 27, 2016

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Fundamentals of Mammalian Cell Line Development

Tuesday Jul 26, 2016 - Thursday Jul 28, 2016

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