May 2024 Update

Serving the NC Life Sciences Industry

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The NC General Assembly gavelled in for the official start of the 2024 short session with both chambers meeting on Wednesday, April 24, for mostly ceremonial purposes. The majority of legislative work started this week with May 2 being the deadline for filing bills in both houses. 

 

The General Assembly returns this week to hold committee meetings and floor votes. It is anticipated that the budget technical corrections bill will be introduced as well. This bill is intended to address items in the past year's budget that are minor, though more substantive issues sometimes emerge.

Gov. Roy Cooper released his proposed budget on April 24. Since both chambers have a veto-proof majority, the Governor’s budget is more of a suggestion to the General Assembly this year.

Cooper’s plan calls for an 8.5% teacher raise and a $1,500 retention bonus for state employees. It also includes a proposed moratorium on additional funding for the state’s Opportunity Scholarship program, setting up a confrontation with GOP legislative leaders who have signaled for a significant expansion of the program in 2024.

North Carolina’s government should collect higher revenues during this fiscal year and next than what is projected in the current two-year state budget, according to a new forecast released Wednesday.

 

Economists for the General Assembly and Gov. Roy Cooper’s state budget office now predict collections will exceed revenue budgeted for the year ending June 30 by $413 million, or a 1.2% increase. And state coffers will bring in $1 billion more in the fiscal year starting July 1 than what was anticipated, or a 3% increase.

 

The budget law enacted by the Republican-controlled General Assembly had planned for a slight decline in revenue from this fiscal year to the next, in part due to tax cuts.

 

Ahead of releasing his budget, Cooper is calling for an 8.5% pay raise and retention bonuses for teachers. Legislators have also said they want pay raises for teachers and state employees along with expanded scholarships for private school tuition. Cooper opposes private-school scholarships.

 

A legislative staff economist’s email to lawmakers attributes the upgrade to stronger than anticipated individual income tax collections and modestly higher sales tax collections. The memo cites low unemployment, wage growth, additional consumer spending and rising prices.

 

NCLifeSci will be working on additional funding for the One NC Small Business Program, the NC Biotechnology Center request, support for a community college program called Propel NC that will focus on important sector jobs (like the life sciences) and reauthorizing the NC Rare Disease Advisory Council. We will also monitor environmental and infrastructure issues that may come up.

More at Associated Press and News & Observer

If there are any topics or issues that are affecting your business

or you want to know more about, please contact Laura Gunter.

A federal court on April 29 rejected Bristol Myers Squibb's and Janssen Pharmaceuticals' challenges to the Biden administration's Medicare drug price negotiation program.

 

The judge of the U.S. District Court in New Jersey agreed with earlier decisions by federal judges in Ohio and Delaware finding that participation in Medicare is voluntary and does not compel the companies to sell their drugs to the government.

 

Judge Zahid Quraishi said that the negotiation program doesn't regulate the pharmaceuticals market and is instead a result of Congress acting as a "proprietor of its own assets as opposed to regulating how a market is going to operate."

 

The companies could appeal the decision to the 3rd Circuit.

Rep. Deborah Ross (D-NC) at the 2024 BIO Agriculture & Environment Summit in Washington, D.C.

BIO’s inaugural Agriculture & Environment Summit brought together regulators and bipartisan policymakers who emphasized the promise of innovation to address key challenges such as climate change. Several speakers underscored the necessity of rules-based trade to foster American biotech innovation and leadership, stressing the importance of intellectual property protection and science-based trade policies and agreements.

 

Rep. Deborah Ross (D-NC) highlighted the need to invest in biotech, particularly climate-smart technology.

 

“In North Carolina, our communities and farmers are too familiar with the devastating impacts of climate change,” she said. “Agriculture and environmental biotechnology can help us produce climate-resistant crops that are better able to survive extreme weather and help our food security. Investment and innovation in these technologies is essential.”

 

Biotechnology regulators are working together to keep pace with scientific innovations in agricultural and environmental biotechnology and emphasize the importance of stakeholders engaging with regulatory agencies early and often. More at BIO

The FDA announced a new rule that regulates laboratory-developed tests as medical devices. This means these tests will be subject to stricter requirements rolled out over the next four years.

 

The new rule includes a clause that exempts currently available tests from some of the new requirements, and the FDA says it will “generally not enforce” premarket review and quality systems requirements for currently marketed tests.

 

Industry groups and some lawmakers are critical of the FDA's action, arguing that the agency is overstepping its authority. They have called for legislation to address LDT regulation. On the other hand, some lawmakers who previously proposed legislation are urging for continued collaboration between FDA and Congress. The FDA's preference was for Congress to establish a new framework for regulating diagnostics, but legislative efforts failed. 

 

The rule has been criticized for potentially hindering the development of innovative and life-saving tests by placing a heavy burden on laboratories. The College of American Pathologists, for example, is urging the Biden administration to reconsider.

 

The future of the FDA's rule is uncertain given the upcoming election and potential for a lame-duck session of Congress.

 

Industry groups representing large labs are also opposed to the rule and are pushing for a different approach.

NCLifeSci President Laura Gunter and representatives of We Work for Health met with Rep. Deborah Ross in Raleigh on April 23 in anticipation of World Intellectual Property Day on April 26. 

 

Ross sits on the House Judiciary Subcommittee on Courts, Intellectual Property and the Internet and has been a champion for protecting IP. The group was able to thank her for her support and to have an open conversation about IP issues and industry priorities.  

NCLifeSci and 28 other CSBA organizations representing 28 states participated in the BIO Fly-in April 16 and 17, including 52 CSBA members and 50 representatives from small member companies.

 

CSBA representatives visited more than 130 Hill offices where they educated policymakers on the importance of the bioscience industry and the need to advance policies like the ORPHAN Cures Act and a bill to restore R&D expensing.

Neil Jones of Lindy Biosciences, XX, Patrick Jordan, Sen. Thom Tillis, XX, NC LIfe Sci President Laura Gunter

Patrick Jordan, Neil Jones, XX, Rep. Don Davis, Laura Gunter, XX

Laura Gunter, XX, Rep. XX, Patrick Jordan, XX, Neil Jones

The US Food and Drug Administration has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in medical devices. The agency says the dataset is meant to help streamline the medical device biocompatibility testing and review processes.
 
The dataset, called the Chemicals List for Analytical Performance, includes 100 example chemicals characterized by the Center for Devices and Radiological Health’s laboratories. It includes the physicochemical properties of the chemicals and is meant to help medical device sponsors determine whether the chemicals they use in their device development are biocompatible. More at Regulatory Focus

Nicole Bell of Galaxy Diagnostics with Steven Walther of Continuous

Precision Medicine and Marcel Frankel of Ten63 Therapeutics (voted in previously)

The NCLifeSci Board of Directors met Thursday, April 25, at the NC Biotechnology Center and voted unanimously to accept the following companies as new members of the organization:

• Continuous Precision Medicine    
• Eupry ApS​
• FiveStar Awards & Engraving​
• HIPP Design + Consulting, Inc.​
• IMMvention Therapeutix, Inc.
• Genmab​
• Galaxy Diagnostics​
• MyData-TRUST​
• Nelson Mullins Riley & Scarborough, LLP​
• New England Biolabs
• Nuream, Inc.​
• Praetego​
• SiNON Nano Sciences​

Melissa Li, Ph.D., NCI program director; Rob Lindberg, Ph.D., NCBiotech vice president, science & technology development; Monique Pond, Ph.D., NCI program director; Swamy Tripurani, NCI program director; and NCLifeSci Membership Director Natacha Janvier

NCBiotech and NCLifeSci hosted a seminar on Wednesday, April 17, on the National Cancer Institute’s Small Business Innovation Research and Small Business Technology Transfer programs.

 

Attendees heard from NCI SBIR/STTR program directors about funding opportunities for early-stage start-ups, academic spin-out companies, and entrepreneurs; tips for writing competitive SBIR/STTR grant proposals; and commercialization resources for applicants and awardees.

 

Following the program, attendees were able to meet in person and one on one with NCI directors to discuss cancer technology or any questions the participants had about NCI SBIR/STTR programs.  

Merck and North Carolina Agricultural and Technical State University announced April 19 the opening of the Merck Biotechnology Learning Center at Gateway Research Park in Greensboro, North Carolina.

 

The Merck Biotechnology Learning Center is a 4,025-square-foot facility that includes classroom space, a process laboratory and state-of-the-art biopharmaceutical manufacturing equipment. In the Learning Center, students and Merck trainees will experience hands-on learning and advanced discovery opportunities to enhance academic programming and training for biotechnology careers.

 

The opening was marked with a joint celebration that included senior leaders from both Merck and A&T, current and former A&T students, and local government officials, including North Carolina Commerce Secretary Machelle Sanders. Attendees participated in tours of the lab and classroom facilities to see firsthand the immersive learning opportunities.

 

“The Merck Biotechnology Learning Center will provide opportunities for N.C. A&T students to understand what a career in biotech looks like,” said Amanda Taylor, vice president and plant manager at the Merck Manufacturing Division site in Durham, North Carolina. “We have several wonderful N.C. A&T graduates working at our Durham site already, and there is so much growth in manufacturing across North Carolina. Through our collaboration with N.C. A&T, we’re developing new and innovative ways to build a pipeline of talent in the Triad and beyond.” More at NC A&T

(Left) NC A&T and Merck representatives field questions. (Right) NCLifeSci's Jenae Williams and Merck's Marlene Sanders, who is also an NCLifeSci board member.

Grifols, a global health care company and leading manufacturer of plasma-derived medicines, celebrated the 50th anniversary of its flagship site in Clayton, N.C.

 

Fifty years ago, the site opened as Cutter Laboratories and produced modest quantities of a single medicine, albumin, distributed domestically. Today, the Grifols Clayton campus manufactures more than 14 million vials of plasma medicines annually ? about 40% of the company’s total global output. The site's portfolio now also includes immunoglobulins, both intravenous and subcutaneous, as well as alpha-1 antitrypsin, specialty proteins and blood-clotting factors to treat patients all over the world.

 

Situated on 700 acres, having expanded tenfold since 1974, it is one of the world’s largest plasma fractionation sites. Its present plasma-processing capacity of 12 million liters annually is more than half of the company’s current global capability. More at Grifols

AskBio and Bayer AG announced that the FDA has granted Fast Track Designation for the AB-1002 program, an investigational one-time gene therapy designed to inhibit a protein linked to congestive heart failure. More >>

 

AskBio named Mansuo Shannon, Ph.D., the company’s chief scientific officer. Shannon succeeds Co-founder R. Jude Samulski, Ph.D., who served as CSO since the company was founded in 2001. More >>

 

Biocair published a case study that explores how its logistical support facilitated the progression of a drug development program from initial research, through clinical trial to FDA submission and approval. More >>

 

Biofidelity completed a financing round totalling $24 million bringing total funding raised since the company was founded in 2019 to $60 million. More >>

 

BIogen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for TOFIDENCE (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA. More >>

 

Cook Medical has been awarded an ECAT contract with the United States Department of Defense for implantable medical devices. The contract includes implantable vascular medical devices and associated interventional devices to treat patients with vascular disease. More >>

 

FUJIFILM Diosynth Biotechnologies announced an investment of $1.2 billion in its Large-Scale Cell Culture CDMO Business to further expand its planned end-to-end bio-manufacturing facility in Holly Springs, NC, bringing the total investment in the facility to over $3.2 billion. More >>

 

G1 Therapeutics and Pepper Bio announced a global licensing agreement for lerociclib, Pepper Bio’s potent and selective kinase inhibitor that has previously demonstrated impressive efficacy in clinical studies across various cancer types. More >>

 

Neurocrine Biosciences announced that the FDA has approved INGREZZA SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. More >>

 

Pfizer announced that the FDA has approved BEQVEZ (fidanacogene elaparvovec-dzkt) as a one-time treatment for adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy. More >>

NCLifeSci was pleased to attend SmaBio Labs' open house April 18 where the company displayed its expertise in drug discovery, product development and analytical services. More on LinkedIn

Click the video above to tune in to the April webinar where host Bernard Fallon, deputy vice president of industry programs at BIO, gives a brief overview of what you can look forward to at BIO 2024.

 

In addition to this year's program highlights and experiences, he also covers the following:

• Who attends the BIO International Convention
• Schedule of events
• Professional development courses
• Influential speakers
• Sample of sessions
• Start-Up Stadium
• Company presentations

Join NCLifeSci members and legislators for an evening reception highlighting the state’s life sciences industry. You will have the opportunity to discuss workforce training, life sciences program funding, innovation and tax policy and other topics of interest with legislators and policy makers.

Thank you to our premier sponsors Amgen, Biogen, Lilly, Novo Nordisk and Pfizer.

Thank you to our event sponsors: Acadia, BIO, FUJIFILM Diosynth Biotechnologies, KBI Biopharma, Mallinckrodt, Merck, Novartis, PhRMA and Smith Anderson.

Join NCLifeSci members for lunch and a panel discussion focused on Navigating the VALID Act. This will be an education opportunity and platform for better understanding the Verifying Accurate, Leading-edge IVCT Development Act. Panelists will

• cover the oversight and quality of laboratory-derived tests and in vitro diagnostics,
• discuss current regulation and modernization of regulation,
• explore pros and cons of FDA rule making versus legislation and FDA oversight and
• explore how the passing of this bill can advance patient care and public health.

Panelists include

• Nicole Bell, chief business officer, Galaxy Diagnostics;
• Anna Abram, senior adviser, Akin Gump Strauss Hauer & Feld LLP; and
• Matthew Roberts (moderator), attorney, Maynard Nexsen.

Thank you to the Economic Development Partnership of North Carolina and Maynard Nexsen for sponsoring this forum. If you are interested in sponsoring the Medical Device Forum, contact Membership Director Natacha Janvier for more details.

Join NCLifeSci online for an engaging virtual panel discussion on neurodiversity. Attend this session and you will be able to

• define neurodiversity and discuss the business case for hiring neurodiverse talent,
• hear real life experiences from various perspectives, success stories and tips from a panel of experts, and
• get equipped with resources and tools to help build a more equitable and inclusive workforce.

Virtual
Thursday, June 13
12 - 1 p.m

In the dynamic landscape of improving patient outcomes, New Horizons refers to the advances in diagnostics, technology, therapeutics and ecosystems that are enabling future innovation in patient treatments. Don’t miss this opportunity to connect with the One Nucleus network to explore New Horizons for Bio Innovation held July 4 in Cambridge, United Kingdom.

ON Helix 2024 offers:

• High content mix of keynote talks, exciting companies to watch and panel discussions from key opinion leaders
• Networking with 250+ delegates on the day
• Option to arrange 1-2-1 meetings with delegates via the event app
• ON Helix Fringe events for informal in-person networking 
• Exhibition Area for invaluable support from our network
• Delegate rates from only £325 +VAT (approx. $440+VAT)
• Sponsorship opportunities from £1.5K + VAT (approx. $1890+VAT)

NCLifeSci receive a 10% discount off registration. Contact Amber Niebauer for a discount registration code.

The 2024 Annual Meeting will feature a keynote presentation and three panel sessions.

• Keynote by Edgardo Hernandez, executive vice president and president, manufacturing operations, Eli Lilly and Company.
• Federal Update / Patient Advocacy
  • Karin Hoelzer, senior director, policy and regulatory affairs, National Organization for Rare Disorders
    Melissa Horn, director of state legislative affairs, Arthritis Foundation
  • Michele Oshman, vice president, external affairs, Biotechnology Innovation Organization
  • ​Brian Smith, executive director, patient advocacy, Merck
• Best Practices and Lessons Learned from AI
  • Marinela Profi, global strategy advisory lead, SAS
  • ​Jay Silver, partner, Womble Bond Dickinson (moderator)
  • John Van Hoy, executive director, data science and advanced analytics, PPD
• Past, Present and Future
  • ​Todd Durham, senior vice president, clinical and outcomes research, Foundation Fighting Blindness
  • Jude Samulksi, co-founder, AskBio
  • Josh Sommer, executive director, Chordoma Foundation

There will also be opportunities to network during the break(s) and lunch. Schedule is subject to change.

Thank you to our current sponsors.

Podcast - Maynard Nexsen
Platinum - American Laboratory Trading, Avantor, Azzur Group and Kymanox
Gold - FUJIFILM Diosynth Biotechnologies, Grifols, Novartis, Smith Anderson and The Conafay Group
Silver - AdvaMed, BioCryst, Eli Lilly and Company, Flad Architects, KBI Biopharma, New England Biolabs, PHC Corporation of North America, UCB and UniFirst
Bronze - BIO, Marsh McLennan Agency, Mispro and Novonesis

If you are interested in sponsoring the Annual Meeting, contact NCLifeSci Membership Director Natacha Janvier. 

• BIO 2024 Advanced Partnering & Know Before You Go (5/1/2024)
• Brews + Bytes Charlotte hosted by NC TECH (5/2/2024)
• Brews + Bytes Triangle hosted by NC TECH and NEW (5/9/2024)
• Occupational Safety and Health Spring Institute hosted by NC OSHERC (5/13/2024 to 5/17/2024)
• NCLifeSci Legislative Reception 2024 (5/14/2024)
• NCLifeSci Medical Device Luncheon and Forum: Navigating the VALID Act (5/21/2024)
• State of Technology EXPONENTIAL (Triangle) hosted by NC TECH (5/23/2024)
• Courageous Conversation: The Future of Work & Your Early Talent Pipeline hosted by Triangle DEI Alliance and Raleigh Chamber (5/30/2024)
• Our Differences for the Better - Neurodiversity at Work hosted by NCLifeSci (6/13/2024)

Clean Harbors introduces the industry's first all-in-one solution for managing PFAS, the Clean Harbors Total PFAS Solution. Their program covers every aspect of the PFAS lifecycle, offering a seamless in-house service to help you handle the challenges of today's complex and evolving regulatory landscape.

Their comprehensive services include:

• PFAS Sampling
• PFAS Analysis
• Drinking Water Solutions
• Industrial Water Solutions
• Soil Remediation
• AFFF Management
• Waste Transportation
• Disposal and Destruction (99.9999% of PFAS ? including PFOA, PFOS, PFHxS, Gen-X PFAS, and AFFF concentrate.)

What are the current risks life science companies face? Supply chain and cyber disruptions are at the top according to Aon's Global Risk Management Survey.

 

Read the insights and learn how to prepare in Aon's recent newsletter

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