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NCBIO This Month

· Lawmakers Focus on Tax and Budget Issues· NCBIO Legislative Reception April 5th· RSVP for NCBIO Life Science Forum on Medical Devices – Navigating the FDA· Hold October 5th for NCBIO Annual Meeting· Steps for Crisis Management and Business Continuity Planning· NCBIO Members Participate in Johnson & Johnson Innovation Event· Students and Companies Connect at BRITE Career Fair· Clinical Trial Supply Southeast Conference 2017· Ag Biotech Entrepreneurial Showcase – May 10-11· Precision Medicine World Conference, Duke May 24-25

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

Lawmakers Focus on Tax and Budget Issues

May 2017UPDATEServing the NC LifeSciences Industry

http://ncbioscience.net

919-281-8960

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As the 2017 legislative session nears its mid-point, NCBIO’s lobbying team is focusingon key objectives that will be addressed in the second half of the session. TheOrganization’s funding priorities include the North Carolina Biotechnology Center,appropriations for the NCBioImpact worker training program, and continued funding forSBIR matching grants. NCBIO is also seeking sale tax relief for small R&D companies.

NCBioImpact funding requests include a $1.5M appropriation to bring funding for BTEC-- the State’s biomanufacturing training program at North Carolina State University --back to pre-recession levels. NCBIO is also asking for money to repair or replacemalfunctioning equipment at the Biomanufacturing Research Institute and TrainingEnterprise (BRITE) at North Carolina Central University. The Organization also wants tosee funding for the North Carolina Biotechnology Center stay at the current level of$13.6M, and funding for State SBIR matching grants continued at $3.5M annually.

In the area of tax policy, NCBIO is seeking a sales tax refund for companies thatpurchase and use R&D supplies in North Carolina. Companies currently pay between6.5% and 7.25% on these products.

NCBIO is also working with its clinical research members to win enactment of market-base sourcing legislation – a tax change that would reduce the amount of income thatmulti-state corporations are required to assign to North Carolina for corporate incometax purposes.

If approved, NCBIO’s appropriations and tax refund requests will appear in draftbudgets scheduled to be unveiled by the State House and Senate in May. Please contactSam Taylor if you are interested in finding out more about these matters.

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NCBIO Legislative Reception April 5th

Legislators and NCBIO members talked about the future of the life science industry inNorth Carolina at the 2017 Annual Legislative Reception on April 5th. “We were pleasedwith the attendance and glad that three of the Co-Chairs of the Legislative Life ScienceCaucus and other Caucus members were at the event,” said NCBIO President SamTaylor. “NCBIO members had a chance to share information about their companies andthe impact on the state’s economy.”

Thanks to AbbVie, Amgen, Astellas, Bayer, Biogen, Johnson & Johnson, Lilly,Novozymes, PhRMA, and Syngenta for helping make this event possible.

(“The North Carolina Museum of History did not sponsor or endorse this event.”)

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RSVP for NCBIO Life Science Forum on Medical Devices –Navigating the FDA

Seats are filling up fast for the NCBIO Medical Device Luncheon and Forum May 16th atthe North Carolina Biotechnology Center from 11:30 am to 1:30 pm. The session will

Lilly

Pfizer

We Work For Health

NCBIO Supporting Members

Cook Medical

Merck

be led by Daniel Schultz, M.D., F.A.C.S., Principal, Medical Devices & CombinationProducts, Greenleaf Health and former Director of the Center for Devices andRadiological Health, Food and Drug Administration. Speakers joining the discussioninclude:

Patrick Daly, President and Chief Executive Officer, Cohera MedicalRich West, Chief Executive Officer and Founder, BaebiesTim Willis, Chief Executive Officer and Founder, MED1 Ventures

Thanks to PwC, Technosoft Innovations, and Wyrick Robbins for sponsoring the Forum.If you are interested in sponsoring the event, contact Laura Gunter. For moreinformation on the Forum program or to register, contact Amber Niebauer.

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Hold October 5th for NCBIO Annual Meeting

Network with NCBIO members at the Annual Meeting on October 5th. Hear from JeffGeorge, Former Chief Executive Officer, Sandoz and Alcon, Novartis Group, andMorten Nielsen, Senior Vice President, Diabetes API US, Novo Nordisk.

There will also be panel discussions – one on an update regarding federal issuesincluding health care reform, medical device repeal, PDUFA and MDUFA, and a secondon mergers and acquisitions in health care. You will be receiving additional informationin NCBIO advisories.

Thanks to Bioventus and Cook Medical for signing up as Platinum sponsors andNovozymes as a Bronze sponsor for the event. Contact Laura Gunter if you areinterested in sponsoring the annual meeting. For more information on the program orto register, contact Amber Niebauer.

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Steps for Crisis Management and Business ContinuityPlanning

Lynn Bottone, Pfizer Site leader, welcomes participants

Adam Kerop, CFS, Director, Pfizer's Business Resilience, Fire & Life Safety/LossPrevention says companies need to have a Crisis Management plan in place to handleevents like Hurricane Matthew last fall, company emergencies or for incidents at nearbyfacilities that may impact your site.

Kerop was the keynote speaker at the third Safety Summit hosted at Pfizer. He sayscompanies need “an integrated response.” Advice for companies included:

Doing a vulnerability/risk assessment;Developing an emergency preparedness plan, then an emergency

response plan;Preparing an overall Crisis Management Plan that goes beyond theemergency response; andDeveloping a Business Continuity Plan is also critical so companies knowissues to address once the crisis is over.

John Boone of Duke Energy talked with participants about power outages and ways toprepare for events and protect assets. Participants also attended workshops and joinedin scenario planning for a crisis.

Pfizer and Duke Energy sponsored the summit. NCBIO's Biotech Manufacturers Forumwas a supporter of this event.

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NCBIO Members Participate in Johnson & JohnsonInnovation Event

Johnson & Johnson speakers answer questions.

More than 200 individuals turned out April 12th to hear from Johnson & JohnsonInnovation (JJI) leaders. Participating representatives discussed the work of J&J in avariety of areas, its innovation hubs and ways companies can contact JJI officials.

Representatives from JJI included:

Dana Deardorff, Sr Director, New Ventures, Johnson & JohnsonInnovationStefanie Dhanda, Sr. Director, Consumer Scientific Innovation, Johnson& Johnson InnovationSamantha Lifson, Innovation Specialist, Johnson & Johnson Innovation,JLABSNicola La Monica, Sr Director, Infectious Disease and Vaccines ScientificInnovation, Johnson & Johnson InnovationBob Radinsky, VP, Oncology Scientific Innovation, Janssen R&D Eric Schaeffer, Sr Director, Neuroscience External Innovation, JanssenR&D

JJI leaders have indicated they may return to North Carolina for another event in thefall.

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Students and Companies Connect at BRITE Career Fair

NCBIO members Novo Nordisk, Pfizer and Quintiles IMS were among the companiesparticipating in the first BRITE CAREER EXPO at The Biomanufacturing ResearchInstitute and Technology Enterprise. North Carolina Central University has been rankedas one of the top HBCU’s in the country as a result of its signature programs, includingits degree in pharmaceutical sciences.

Students had a chance to find out more about life science companies and theopportunities for internships and careers at the Expo. If your company would like tolearn about students at BRITE, contact Natacha Janvier-Derilus, Cassandra Brown orWilliam Smith.

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Clinical Trial Supply Southeast Conference 2017

The third annual Clinical Trial Supply Southeast will be May 3-4 in Cary. The conferenceoffers industry peers in the Southeast area the opportunity to discuss and discoverpotential solutions to the biggest challenges with clinical supply processes.

Secure your place today by quoting reference MK-ACEL when registering. Email formore information.

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Ag Biotech Entrepreneurial Showcase – May 10-11

This is the fifth year that NCBiotech is convening ag biotech investment firms, globalagbiotech companies and other key industry stakeholders for information sharing,networking, and partnering at the Ag Biotech Entrepreneurial Showcase. The event is atthe Cotton Room in Durham. More on the event and to register.

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Precision Medicine World Conference

Many precision medicine initiatives at medical centers, foundations, and providers areaggregating vast amounts of medical data. Find out more at the first East Coast PMWC

2017 Duke conference on May 24-25. Coming from Silicon Valley, the 12th AnnualPrecision Medicine World Conference will focus on biomedical technologies that arespurring exciting capabilities and initiatives to enable the translation of precisionmedicine into improvements in health care.

What are the challenges of creating a universal approach to data sharing versus privateand/or proprietary approaches that are trying to differentiate themselves? How do weaccumulate and share data effectively while respecting patient rights? Speakers willcover these questions and more. Panelists include:

William (Bill) Dalton, M2GenRobert Califf, Duke UniversityRick Klausner, Grail

The PMWC event will have a number of sessions that will help overcome the challengesof adopting precision medicine. Find out more about speakers and topics.

REGISTER to attend the Precision Medicine World Conference and visit the NCBIO boothat the event.

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At the National Level

NCBIO and Other Groups Express Concern about Potential Changes inMedicare Part B

The Medicare Payment Advisory Commission (MedPAC) is currently consideringrecommendations to change the way that Medicare pays for Part B medicines. Morethan 180 groups including NCBIO have joined together to express concerns aboutchanges under consideration.

The letter stated, “Currently, Medicare Part B offers beneficiaries broad access toinfused therapies, allowing patients and their doctors to decide which treatments arebest. The MedPAC proposals would come between patients and their doctors by limitinga physician’s ability to offer certain therapies. Of note, we are concerned that:

Some providers, particularly those in small or rural practices would beunable to provide certain medicines if reimbursements are reduced orblended through consolidated billing codes. The assumption that the ASPadd on encourages the use of more expensive products fails to take intoaccount the many factors that impact providers’ decisions such asindividual patient characteristics, and the complex needs of Medicarebeneficiaries. Patient safety could be harmed if proposals to blend coding andreimbursement for biologics or therapeutically similar treatments goforward because it will be more difficult to track and attribute adverseevents. Further, CMS should not be put in a position to determine ordecide what is “therapeutically similar.” That complicated and extremelyindividual decision should be left in the hands of providers and patients. Proposals to blend coding and reimbursement for Part B medicines orestablish arbitrary reimbursement caps through an inflation limit couldstifle innovation in the next generation of Part B treatments, includingbiosimilars, which are expected to generate savings for beneficiaries andthe Medicare program. Finally, the MedPAC proposal to create a new “Drug Value Program”leaves a number of critical questions unanswered, and as proposed couldharm patient access by imposing new restrictions on Part B therapies.”

Contact Sam Taylor, staylor@ncbioscience.net for more information.

NCBIO Members Talk with Congressional Delegation at BIO Fly-In

BIO held its annual Fly-In on Capitol Hill on April 4-5. The event kicked off with alegislative briefing, before spending Wednesday calling on the NC delegation officeswith NCBIO staffer Laura Gunter, representatives from two member companies,Novozymes and Bayer, and a neurologist from Hickory.

Nathan Cude, Kristen Sheerer, Mary Lewis (all of Novozymes) Laura Gunter, ScottKohne (Bayer), Robert Yapundich (Neurology Associates)

Issues discussed included support for timely passage of negotiated FDA user feeagreements (PDUFA IV and BsUFA II); tax incentives for investment in innovation; fullappropriations for NIH, BARDA and other discovery programs; opposition to changes inMedicare Parts B and D; support for the Renewable Fuel Standard (RFS); support forpredictable, risk-based regulatory system for agriculture and animal products; supportfor the “One-Health” approach that recognizes the interconnectedness of human,animal and environmental health; and a thank you for passing a national “GMO” fooddisclosure solution.

BIO Has New Grassroots Program – Sign Up

BIO ACTION is a new effort by BIO to help NCBIO members and other BIO membersspeak out on federal, state and local issues. This advocacy program will keep youinformed of emerging policy issues and threats to biotechnology innovation. BIOACTION will ask for your voice when needed to encourage lawmakers to enact policiesto further innovation and stop harmful policies from passing.

To learn about some of the issues BIO ACTION will be actively working on, please visitthe BIO ACTION advocacy portal or text “BIO” to 52886. You’ll also find the new BIOACTION online tool that makes it easy for you to contact your federal, state and localpublic officials.

PhRMA Has New GoBoldly™ Campaign

The GoBoldly™ campaign, titled Together, features the stories of researchersdeveloping cutting-edge breakthroughs alongside patients fighting for their lives withthe help of biopharmaceutical innovation.

Together shows the connection between the patients living with and fighting hepatitisC, type 1 and type 2 diabetes, multiple sclerosis, amyotrophic lateral sclerosis (ALS),depression, juvenile rheumatoid arthritis (JRA), HIV/AIDS, breast cancer and organtransplant rejection and the scientists working tirelessly to transform the way thosediseases are treated.

Find out more.

BIO 2017 June 19-22 in San Diego

The 2017 BIO International Convention is just weeks away. Join NCBIO and others fromNorth Carolina. You can expect to see industry leaders with a wide range ofperspectives from every facet of the biotechnology and pharmaceutical industries in140+ breakout sessions, 7 fireside chats, 5 super sessions, and inspiring keynotepresentations.

Unlike previous years, the North Carolina Biotechnology Center will not be mounting astate pavilion. Instead, the Center is hosting an evening reception on Tuesday, June 20to celebrate and showcase North Carolina’s long history in the life sciences and itsaccomplishments. Email Sarah Bernart at sarah_bernart@ncbiotech.org to get yourinvitation and more information.

Register to attend BIO and learn more about One-on-One Partnering™. You will beable to access the system, set up your profile, open your calendar, and start requesting

and accepting meetings before schedules get filled.

AdvaMed and MDMA Join Together for Annual MedTech Conference

The MedTech Conference will partner with the Medical Device Manufacturers Association(MDMA) to make AdvaMed's annual conference an even better event this fall. The eventwill be held September 25-27 in San Jose, CA.

Register by July 7 to get early bird pricing and save $600.

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Member News

To be included in Member News, send information about your organization to BrendaSummers bsummers@ncbioscience.net

BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the developmentand commercialization of treatments for rare diseases, announced plans to explore anew oral liquid formulation of BCX7353 for the treatment of acute attacks in patientswith hereditary angioedema (HAE). The Company has received initial regulatoryapprovals in Europe to initiate the ZENITH-1 exploratory clinical trial this summer. More

bioMérieux, a major player in the field of in vitro diagnostics, and the world leader inmicrobiology, announces that BacT/ALERT VIRTUO™, its fully automated blood culturesystem, has received 510(k) clearance from the U.S. Food and Drug Administration(FDA). This innovative blood culture microbial detection system is now commerciallyavailable in countries that recognize CE marking and in the United States.More. bioMérieux also opened a new production line at its Americas Headquarters inDurham. The new production line represents an approximately $60 million investmentby the company and will produce the global supply of bioMerieux’s BacT/ALERT® 3Dculture products, which play a crucial role in the rapid diagnosis of resistant infectionsand Sepsis. More.

Patrick Daly, CEO of Cohera Medical and Chairman of the AdvaMed Accel board,testified before the US House E&C Health Subcommittee on the MUDFA agreement.

The DCRI, Duke University’s MURDOCK Study, and Boehringer IngelheimPharmaceuticals Inc. announced today the launch of a new collaborative research effortto closely follow 850 people living with chronic obstructive pulmonary disease (COPD).The study will measure changes to participants’ health to better understand how COPDprogresses within a community and follow participants for five years. More

Gore & Associates launched a new pre-packed chromatography technology in Januaryto fundamentally improve mAb purification. Initially targeting drug discovery andresearch, the GORETM Protein Capture Device uses a unique ePTFE membranecomposite to enable faster processing to screen more candidates in less time. Theseinnovative membrane devices are available in 1.0mL and 3.5mL sizes and capture ≥30mg/ml at 20 seconds residence time. More

Heat Biologics, Inc., a leader in the development of Immunotherapies designed toactivate a patient’s immune system against cancer, announced that it presented newpreclinical data from its collaboration with OncoSec Medical Incorporated, focused onevaluating the combination of Heat’s immunotherapy platforms with intratumoralelectroporation (EP), at the AACR Annual Meeting. More

MedSurgPI LLC announced that Shabnam Vaezzadeh MD, MPA has recently joined ourorganization. MedSurgPi provides medical consulting for product development andmedical affairs in the biopharmaceutical industry. Shabnam has previously providedglobal medical affairs expertise for several Medical Device and Biologics companiesincluding Johnson and Johnson and Acelity. As a Vice President for medical affairs,Shabnam has overseen Medical Science Liaisons, Medical Information and Publications,Medical Education, Grants, Advisory Panels and Key Opinion Leader Management aswell as Safety and Pharmacovigilance. After graduating from the University of TehranMedical School she received an MPA from the University of San Francisco. Shabnam willbe bringing her expertise in Medical Affairs, Safety and related Strategic consultation toMedSurgPi and our clients.

Bob Rhatigan has been appointed as President and CEO of Merz North America, andPatrick Urban will serve as Chief Commercial Officer. Prior to joining Merz, Mr. Rhatiganspent 17 years at Allergan where he completed his tenure as Senior Vice President,General Manager and Chief Executive of SkinMedica®. More

NeuroTronik Limited and NeuroTronik, Inc. announced closing on a $23.1 million SeriesB Preferred Stock Financing, tranched in line with project plan milestones. The fundingwas led by Boston Scientific Group, plc. Other major investors include Hatteras VenturePartners, Synergy Life Science Partners, Lord Baltimore Investment Partners, MountainGroup Capital, and Sovereign’s Capital. The investor group also includes other financialand industry participants. More

Novan also has formed an Advisory Council comprised of opinion leaders with broadexpertise in dermatology. Novan has recruited these leading physicians with reputationsas clinical experts to provide medical advice and drug-development insight to seniorleadership team and board of directors. More

Pharmaceutical Product Development, LLC (PPD) announced the kickoff of its 2017educational campaign to raise awareness about the life-changing impact of clinicalresearch, featuring a team of PPD Heroes who share their personal stories to inspirehope. More PPD also announced that its existing owners, affiliates of Hellman &Friedman and affiliates of The Carlyle Group (Carlyle), have entered into definitiveagreements to recapitalize PPD and expand the company’s ownership to include twonew investors, a subsidiary of the Abu Dhabi Investment Authority (ADIA) and anaffiliate of GIC, Singapore’s sovereign wealth fund (GIC). GIC and ADIA are longtimeinvestors in Carlyle and Hellman & Friedman and now will be direct investors in PPD.More.

QuintilesIMS announced an alliance with Salesforce, the world’s #1 CRM company andIntelligent Customer Success Platform, to offer life sciences companies new capabilitiesto move treatments more efficiently and effectively, from molecule to market. More

Smith Anderson’s Of Counsel lawyer, Richard Stevens, was awarded the DistinguishedPublic Service Award at the NC Chamber’s 75th Annual Meeting in recognition for hissignificant contributions to North Carolina’s economy and life of the state. The NCChamber presents the Award for Distinguished Citizenship, along with the Award forDistinguished Public Service each year to two individuals who have dedicated theircareers to helping make North Carolina a better place to live, work and raise families.More. North Carolina Lawyers Weekly recently announced its 2017 list of the 25 LargestLaw Firms in North Carolina by number of attorneys. Smith Anderson ranked sixth onthe list with 133 attorneys. More

Tryton Medical, Inc., the leading developer of stents designed to treat coronarybifurcation lesions, today announced that the first U.S. commercial case using theTryton Side Branch Stent to treat a coronary bifurcation lesion involving a large sidebranch (appropriate for a ≥2.5mm stent) was completed at New York-PresbyterianHospital/Columbia University Medical Center in New York City. More

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Member Benefits

BIO Business Solutions® offers NCBIO members special discounts. Find out more aboutNCBIO discounts.

A new partner in the BIO Business Solutions® program is American LaboratoryTrading (ALT), an Agilent Technologies Channel Partner. The company is a customer-focused, full-service provider of premium refurbished lab equipment and assetmanagement services for the life sciences. With sales, service, and warehouse facilitieson both coasts, ALT stocks more than 12,000 instruments ranging from small benchtopaccessories to robust triple quad mass spectrometers -- all carefully refurbished anddelivered with a one year warranty.

Member Benefits include –

Equipment Purchase:

Free one-year equipment warranty 15% no-hassle discount on list price* 10% additional discount on sale items* 5% discount on all Agilent Certified Pre-owned products, up to amaximum of $1,500 2% store credit toward future equipment purchases from ALT *Agilentfactory-refurbished equipment excluded

Asset Management Services:

2% store credit for cash offers on equipment ALT purchases 10% bonus on standard consignment split 5% bonus on seller’s premium in auctions 20% discount on asset management services Free subscription to LabDesk asset management software (Lite version) 10% discount on all other subscriptions

Click here for more about your benefits.

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Calendar

Clinical Trial Supply Southeast Conference 2017

Wednesday May 3, 2017 - Thursday May 4, 2017

... read more

Ag Biotech Entrepreneurial Showcase 2017

Wednesday May 10, 2017 - Thursday May 11, 2017

... read more

NCBIO Medical Device Forum 2017

Tuesday May 16, 2017

... read more

Chromatography Column Packing: Foundation & Applications

Tuesday May 23, 2017 - Thursday May 25, 2017

... read more

Precision Medicine World Conference (PMWC)

Wednesday May 24, 2017 - Thursday May 25, 2017

... read more

Foundations of Bioseperations & Biopharmaceutical Formulation

Tuesday Jun 6, 2017 - Thursday Jun 8, 2017

... read more

Downstream Biopharmaceutical Processes:Fundamentals & Design

Tuesday Jun 13, 2017

... read more

Medix

Wednesday Jun 21, 2017 - Friday Jun 23, 2017

... read more

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