July 2024 Update

Serving the NC Life Sciences Industry

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The General Assembly adjourned June 28 with only minor adjustments in place for the 2024-2025 budget year.

 

While budget changes are common during legislative short sessions to respond to increases or decreases in revenue or changing priorities, the vast majority of state spending is guided by the two-year budget put into place in October. If there is no agreement on making adjustments, spending for the second year of the budget goes into effect as planned.

 

House Speaker Tim Moore said the two chambers were only $30 million apart, but Senate leader Phil Berger put the difference at more than $800 million. The Senate’s proposal didn't contain additional raises for teachers or state employees on top of the raises that were included in last year’s budget. The House’s proposal would have added an additional 1% raise from the 2023 budget, while giving most state employees an additional 4% this year.

 

Both House and Senate bills would provide millions for private school vouchers after a surge in demand for the Opportunity Scholarship program created after Republicans removed income eligibility limits last year. Gov. Roy Cooper is expected to veto any budget containing expanded funding for private school vouchers, but Republicans have enough votes to override his veto.

 

The legislature did adopt two mini spending bills to implement teacher raises already approved and to provide stop-gap funding for child care centers.

 

The adjournment resolution gives several windows for legislators to return to Raleigh should circumstances change and also contemplates a lame-duck session after the election to work on substantive issues. More at News & Observer

Rep. Donna White, Sen. Mike Woodard and NCLifeSci President Laura Gunter

The North Carolina life sciences community gathered at the Durham Museum of Life and Science on Wednesday, June 12, to honor Sen. Mike Woodard, who will not be returning to the NC Senate in November.

 

NCLifeSci and the museum hosted the event to thank Woodard for his service, his leadership as co-chair of the Legislative Life Sciences Caucus and his support for policies that have underpinned the continuous growth of the life sciences industry in North Carolina. 

Life Sciences Caucus Co-chairs Sen. Paul Newton, Rep. Robert Reives and Rep. Donna White 

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

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

The FDA released long-awaited draft guidance June 26 describing how drug and device companies should approach enrolling clinical trial participants to ensure greater diversity and improve the quality of their data.

 

The guidance outlines when and how trial sponsors must submit diversity action plans for those studies that include enrollment goals to improve the participation of "underrepresented populations" and how those goals will be met.

 

"Underrepresented populations" include people of various races, ethnicities, age groups and sexes, as well as pregnant or lactating individuals, according to the guidance. The agency also encouraged drug and device makers to consider other factors that can lead to health disparities, such as geographic location, socioeconomic status, gender identity and physical and mental disabilities.

 

The FDA will take public comment on the guidance for 90 days after it's published in the Federal Register. Manufacturers will be required to submit diversity action plans for certain studies in which enrollment begins 180 days after publication of the finalized guidance.

A proposed law aimed at restricting Chinese biotech firms from doing business in the US failed to be attached to a major spending bill. This bill, called the BIOSECURE Act, would prevent certain Chinese companies and businesses using their products from receiving federal funding and limit their ability to operate in the US.

 

A proposed amendment that would have set up a vote to tack the legislation onto the National Defense Authorization Act didn’t make it through the House Rules Committee’s amendment process. 

 

The law's supporters say they are concerned about China's access to American genetic data and its potential for misuse. 

 

While the Act failed to be included in this spending bill, it could still be passed in the future if added to a different bill. The Senate could still add it to its version of the defense package.

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) on June 12 vowed to move forward on bills extending access to a pediatric-rare-disease voucher program despite not including it in a markup.

 

Rodgers said legislation to reauthorize the pediatric rare disease priority review voucher program remains a top priority and is aiming for “broad, bipartisan support” despite it not being in the markup. The program intends to incentivize the development of treatments for rare pediatric diseases by speeding up the regulatory process.

 

Lawmakers said they are optimistic that a bipartisan deal can be reached. The program expires at the end of September.

A new report from TEConomy Partners highlights the significant contribution of the U.S. industrial bioeconomy to the American economy.

 

In 2023, this sector generated over $210 billion for the GDP and supported nearly 644,000 jobs. Notably, each bioeconomy job creates additional jobs in related industries, resulting in a strong job multiplier effect.

 

The report focused on the bioeconomy subsector producing industrial bioproducts and outputs, including biofuels. It did not include biopharma or firms directly producing food or beverages. North Carolina ranks ninth in direct industrial bioeconomy employment with approximately 1,700 jobs.

 

The report emphasizes several key strengths of the U.S. industrial bioeconomy:

• Domestic focus: It relies on local suppliers and materials, boosting the domestic economy.
• Unique advantages: The U.S. has a strong agricultural sector and scientific expertise, making it well positioned for bioeconomy leadership.
• Job creation: This sector is a consistent source of high-paying domestic jobs and manufacturing strength.

Novo Nordisk announced plans to invest $4.1 billion dollars to build a second fill and finishing manufacturing facility in Clayton and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases.

 

Marking one of the largest manufacturing investments in Novo Nordisk’s history, the expansion will add 1.4 million square feet of production space for aseptic manufacturing and finished production processes, doubling the combined square footage of all three of the company’s existing facilities in North Carolina. It will also add 1,000 new jobs, besides the nearly 2,500 Novo Nordisk employees already working in the region, a central hub for innovation and biotechnology in the United States.

 

Using state-of-the-art technology, roof-top solar panels and innovative water strategies, the facility is designed in an efficient and environmentally sustainable way to deliver the highest-quality products to patients around the world. The goal is to obtain LEED Gold certification, recognized as a standard of excellence in constructing healthy, efficient, carbon and cost-saving green buildings. More at Novo Nordisk

 

The 2024 BIO International Convention kicked off June 3 in San Diego as industry representatives converged on Southern California for a week of inspiring keynotes, educational panels and partnering meetings.

 

More than 18,500 people registered for the event, and 60,000 partnering meetings were scheduled. President Laura Gunter and Membership Director Natacha Janvier attended on behalf of NCLifeSci.

 

Here are some of the highlights of the event.

• BIO 2024: Can data improve clinical trial diversity?
• BIO 2024: What patient advocates said about AFPs, Medicare Part D and more
• BIO 2024: Investing in women’s health is an untapped gold mine
• BIO 2024: Education can improve regulation, biotech innovators say
• BIO 2024: PDABs and IRA pose a murky threat to patient access
• ARPA-H offers fast, flexible support to biotech startups, panelists tell BIO 2024
• FDA’s Califf talks supply chains, clinical trial diversity, and America’s health
• BIO 2024: Amgen CEO Robert A. Bradway on the impact of policy on the innovation ecosystem
• BIO 2024: Viola Davis and Aaron Lazar share lessons on life and legacy
• Biotech needs to polish its message as elections approach, experts say
• Gene therapy is the future of medicine, but payment models have to catch up
• BIO 2024: U.S. officials describe national security partnership with biotech

The North Carolina booth at BIO 2024 was spearheaded by the NC Biotechnology Center and was well positioned at the main entrance. Partner meetings were held for four days and focused on educating organizations about the benefits of having operations in North Carolina and getting connected to the North Carolina life sciences ecosystem. Approximately 325 attended the North Carolina reception.

Afreen Allam, founder and CEO of SiNON Nano Sciences, presented at the BIO 2024 Start-Up Stadium. SiNON has developed a patented tunable carbon nanoparticle that acts as a Trojan horse drug-delivery platform to move drugs across the blood-brain barrier in order to treat many different neurological diseases.

NCLifeSci President Laura Gunter with economic development officials from the Town of Holly Springs

NCLifeSci hosted an online panel discussion, "Our Differences for the Better - Neurodiversity at Work," on Thursday, June 13. More than 50 attended.

 

The term “neurodiversity” is used to describe the range of natural variation in human brain functions involved in learning, thinking and processing information.

 

Melanie Sanders of The Diversity Movement moderated a panel that included

• Tanya Garcia, business systems manager at Pfizer;
• Nicole Griffin, PGS DEI disability program manager, Pfizer; and
• Lindsay Wrege, owner of 321 Coffee.

Lindy Biosciences, McDonald York Building Company and mdgroup sponsored the event, which allowed NCLifeSci to provide coffee from 321 Coffee to select participants.

The NCLifeSci Biomanufacturers Forum met Tuesday, June 25, at the NC Biotechnology Center to focus on the topic, "State Infrastructure: Current State, Future Possibilities." Attendees heard presentations exploring North Carolina's power, water, transportation and other infrastructure delivered by representatives of Duke Energy, the NC Department of Environmental Quality and the NC Chamber Foundation.

 

The evening's presenters were

• David Lambert, director of intergovernmental affairs and economic development, Department of Environmental Quality;
• Dana Magliola, senior director, infrastructure competitiveness, North Carolina Chamber Foundation;
• Dan Maley, vice president of region services for Carolinas East Power Grid Operations, Duke Energy; and
• Melanie Shipley, manager of the Eastern NC Large Account Management Team, Duke Energy.

Joe Lanier, principal with Milestone Strategies, provided an update on budget negotiations between the NC Senate and House, saying that a budget deal before the General Assembly adjourns for July and August was very unlikely.

 

BMF Program Manager Bill Monteith highlighted NCLifeSci's efforts to promote workforce development through the NC Community Colleges, and Jenae Williams, NCLifeSci partnerships director, discussed the importance of NCBioImpact 2.0 a website and network that connects jobseekers and current life sciences professionals with training and opportunities within the field.

The North Carolina Biotechnology Center awarded 71 grants and loans totaling $2,757,090 to universities, bioscience companies and nonprofit organizations in the third quarter of its fiscal year.

 

The awards, made in January, February and March, will support life science research, technology commercialization and entrepreneurship throughout North Carolina. The funding will also help universities and companies attract follow-on funding from other sources.

 

Seven bioscience companies received Small Business Research Loans totaling $1,750,000 to advance their research, product development, commercial viability and funding efforts.

• Cytex Therapeutics (now doing business as CytexOrtho) of Durham received $350,000 for first-in-human clinical studies of a novel biphasic implant designed to repair lesions in the hip joint for patients who are too young or active for total hip replacements.
• SonoVascular of Chapel Hill received $350,000 for first-in-human clinical studies of a novel, pharmaco-mechanical SonoThrombectomy intravascular system to treat venous thromboembolism, or blood clots.  
• AccuNovo Biotechnologies of Chapel Hill received $250,000 for development of a pair of targeted precision radiopharmaceuticals that allow for diagnosis, therapy and post-treatment assessment of prostate cancer patients, especially those who do not express prostate specific membrane antigen or do not respond to PSMA-based treatments.
• Calidar of Durham received $250,000 to conduct a first-in-human study of a 4D Mammography technology that uses X-ray diffraction for imaging breast cancer.
• Sable Fermentation of Durham received $200,000 to fund a biomanufacturing plant that was designed to scale fermentation of biotechnology products from lab to commercial levels.
• Hedros Biotechnology of Raleigh received $200,000 to support commercialization of a bacteriophage-based anti-microbial product for disease control in food-animal production, targeting antimicrobial-resistant bacteria.
• OpiAID of Wilmington received $150,000 to deploy a solution that provides timely and actionable data to support clinical decision making for improved outcomes in people being treated for substance use disorder.

Six bioscience companies that previously received loans from NCBiotech raised more than $7 million in follow-on funding from other sources in the third quarter, according to research by the NCBiotech’s Life Science Intelligence staff.

 

Leading the way was Research Triangle Park-based EpiCypher, which won four research grants from the National Institutes of Health totaling nearly $3.5 million. The company, a pioneer in epigenetics and chromatin biology, provides technologies and services for research and epigenomics-based drug development. More at NCBiotech

The Council of State Bioscience Associations, of which NCLifeSci is a proud member, rolled out a new logo at the CSBA Summer Meeting in San Diego. The CSBA combines the voices of BIO affiliates into a national network advocating for innovation and a thriving bioeconomy.

Biogen announced that the European Commission has granted approval for TOFIDENCE for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. More >>

 

Biogen and Delta Flight Products will collaborate to inform future enhancements to the air travel journey for passengers with reduced mobility. In the U.S. alone, approximately 5.5 million individuals rely on wheelchairs for mobility. More >>

 

CSL Seqirus was selected by to complete the fill and finish process of pre-pandemic vaccine for the U.S. government as part of the National Pre-Pandemic Influenza Vaccine Stockpile program. More >>

 

IQVIA announced the launch of One Home for Sites, a new technology platform that acts as a single sign-on and a single dashboard for the key systems and tasks a clinical research site needs to perform across all of the clinical trials it is conducting. More >>

 

Eisai and Biogen announced that the humanized anti-soluble aggregated amyloid-beta monoclonal antibody “LEQEMBI” for treatment of mild cognitive impairment due to Alzheimer’s disease has been launched in China. More >>

 

Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application for monthly lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous maintenance dosing. More >>

 

G1 Therapeutics has been added to the broad-market Russell 3000 and small-cap Russell 2000 Indexes as of the conclusion of the 2024 Russell US Indexes annual reconstitution effective July 1. More >>

 

G1 Therapeutics' CFO John W. Umstead V was named as one the the Triangle Business Journal's 40 under 40 Awards winners. More  >>

 

The PPD clinical research business of Thermo Fisher Scientific announced the expansion of its central laboratory operations in Kentucky dedicated to accelerating pharmaceutical and biotech customers’ delivery of safe, effective medicines to patients. More >>

 

PQE Group released  its first-ever Sustainability Report (FY 2023) offering insight into PQE Group's sustainability endeavors, with a primary focus on its Italian Headquarters, while  encompassing all 45 global subsidiaries. More >>

 

PQE Group announced the consolidation of its new Regulated Artificial Intelligence & Data Analytics Division operating since the initiation of AI based tools in the industrial space. The new division is designed to enhance business process efficiency and effectiveness while ensuring regulatory compliance. More >>

 

Ultragenyx reached an agreement with the FDA that cerebral spinal fluid heparan sulfate is a reasonable surrogate endpoint that could support submission of a biologics license application seeking accelerated approval for UX111 (ABO-102) AAV gene therapy for the treatment of Sanfilippo syndrome (MPS IIIA). More >>

 

WTVD ABC 11 interviewed KBI Biopharma representatives on the role of a CDMO in North Carolina's life sciences industry and talked to NCLifeSci President Laura Gunter and J. D. Mowery, president and CEO of KBI Biopharma, about the growth and status of the industry compared to peer markets in California and Massachusetts and the role of a CDMO. Watch at ABC11.com

Register now and join us for lunch and a panel discussion, "Leasing Lab Space: Pitfalls and Lessons Learned," at the NCLifeSci Lab Space Luncheon and Forum to be held Tuesday, July 23, at the NC Biotechnology Center from 11:30 a.m. to 2 p.m.

 

The panel will feature lab space tenants who will discuss their experiences with moving into new spaces, the process of moving and the timeline.    

• Chase Brett, associate director, facilities and engineering, Life Edit Therapeutics
• Hortense Dodo, president, IngateyGen
• Matt Goodrich, corporate real estate advisor, Davis Moore (moderator)
• Additional panelists to be announced.

Thank you to Clean Harbors, Flagship Lab Services and Longfellow Real Estate Partners for sponsoring this event. If you are interested in sponsoring the Lab Space Forum, contact Membership Director Natacha Janvier for more details.

Trying to get your teams to innovate, be more productive and create deeper employee engagement? Inclusive leadership is the missing ingredient that separates the top-performing teams and organizations from everyone else.

 

More than just a passing trend, inclusive leadership skills can make or break collaboration, innovation and execution. Many leaders may be aware of what it takes to lead inclusively but may not know how to put it into practice.  

 

Join The Diversity Movement and NCLifeSci as we share inclusive leadership tips and strategies needed to create high performing teams that move their organizations forward. Our panelists will share their experiences in leveraging data, technology and humanity to build teams that balance people and performance.

 

Wednesday, July 24

4-6 p.m.

NC Biotechnology Center

 

Seats are limited. Reserve yours today.

Alcami Corporation is co-hosting a Talk & Tour event with the Parenteral Drug Association’s Southeast Chapter on July 25 at the North Carolina Biotechnology Center from 12:30 ? 5 p.m. Alcami personnel will share key learnings in sterile fill-finish manufacturing, CDMO microbiology capabilities and lab biologic capabilities, as well as project streamlining with a focus on oncology. The event includes tours of Alcami’s four cutting-edge sterile fill-finish suites in the heart of RTP (with transportation provided) plus a networking reception and heavy hors d’oeuvres. 

 

The event is open to the public at a cost of $25 for PDA members, $35 for nonmembers and $10 for students. All registration fees will be donated to the Leukemia & Lymphoma Society’s Light the Night Fundraiser. Funds raised through Light the Night enable the LLS to fund treatments for all forms of blood cancers. 

After more than five years in organizing Data Privacy for Life Science Summit in Europe, MyData-TRUST is bringing its concept to the U.S. Join them for their first edition of the U.S. Data Privacy for Health 2024, taking place Sept. 10 at the NC Biotechnology Center.

 

The perfect occasion to meet other data privacy officers, privacy experts, lawyers and clinical professionals ? all with the same goal: Share knowledge, discuss challenges and find solutions for their Global Data Privacy in the Life Sciences Industry.

 

NCLifeSci members receive a 20% discount on their registration. Contact Amber Niebauer for the discount code. 

We look forward to gathering with NCLifeSci members for our 30th anniversary celebration at our Annual Meeting on Wednesday, Sept. 18. 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 panel featuring the Arthritis Foundation, Biotechnology Innovation Organization, Merck and the National Organization for Rare Disorders.
• Best Practices and Lessons Learned from AI panel with PPD, SAS and Womble Bond Dickinson.
• Past, Present and Future featuring Biogen, Brightseed Bio, the Chordoma Foundation, the Foundation Fighting Blindness and Jurata Thin Film.

There will also be ample networking opportunities. Register today for the early bird rate of $40 using the button below.

 

Thank you to our current Annual Meeting sponsors.

Podcast - Maynard Nexsen
Platinum - American Laboratory Trading, Avantor, Azzur Group and Kymanox
Gold - FUJIFILM Diosynth Biotechnologies, Grifols, Novartis, PSC Biotech, Smith Anderson and The Conafay Group
Silver - AdvaMed, Alexandria Real Estate Equities, 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, NIIMBL, Novonesis and Surplus Solutions

 

If you are interested in sponsoring the Annual Meeting, we have bronze sponsorships available. All other sponsor levels are sold out. Contact NCLifeSci Membership Director Natacha Janvier for more information.

Mark your calendars for the NC Biotechnology Center's Life Sciences Economic Development Summit and 40th anniversary celebration, an educational program and celebration of the  innovative, highly collaborative life sciences ecosystem.

The MedTech Conference in Toronto, Oct. 15-17, will help you look ahead and create new possibilities. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies.

 

Contact Amber Niebauer for a discount registration code.

Job hunting, hiring or just looking to expand your professional development skills? Attend the free Science & Technology Expo and Career Fair at SciX in Raleigh, Oct. 22-23. The SciX Conference offers this valuable opportunity for networking and career advancement within the spectroscopy and analytical chemistry community. Connect with prospective employers, explore new career opportunities and listen to career development talks from professionals in your field. This career fair will take place on Tuesday and Wednesday during the conference in the exhibit hall. 

We’re kicking off JPM Healthcare Week 2025 in style on Sunday, Jan. 12, from 4 to 7 p.m. at the Marker San Francisco. Hosted by AZBio, Biocom California, BioNJ, Bio Utah, Colorado Bioscience Association, Georgia Bio, Life Sciences Pennsylvania, MichBio, NCLifeSci, New York Bio, Oregon Bio, Virginia Bio and more, the State Bio Friends Reception kicks off the largest annual gathering of health care innovators and investors in the world.

 

This is a private reception by invitation only, and tickets are limited. If you are interested in attending, please contact Alex Caruso to be added to the list of possible attendees. 

NCLifeSci JPM Kickoff Reception Sponsors

• ON Helix: New Horizons for Bio Innovation hosted by One Nucleus (7/4/2024)
• Deep Tech Workshop Series with Plantd Materials hosted by First Flight Venture Center (7/11/2024)
• Go Global Road Show hosted by EDPNC (7/15/2024 to 7/18/2024)
• Export Coffee Talk: Cost Advantages of Co-Exhibiting in a North Carolina Trade Show Booth Overseas hosted by EDPNC (7/23/2024)
• NCLifeSci Lab Space Luncheon and Forum: Leasing Lab Space - Pitfalls and Lessons Learned (7/23/2024)
• Deep Tech Workshop Series Investor Panel hosted by First Flight Venture Center (7/23/2024)
• High Performing Teams through Inclusive Leadership hosted by The Diversity Movement and NCLifeSci (7/24/2024)
• Deep Tech Workshop Series with Wolfspeed hosted by First Flight Venture Center (7/30/2024)
• Preparing for Pandemics: Local Leadership for Global Impact hosted by NC Global Health Alliance and RTI International (8/7/2024)

NCLifeSci thanks Avantor for being a platinum sponsor of the 2024 NCLifeSci Annual Meeting.

Do you need a lab to benefit from BIO’s Costs Savings Program? Not at all! Life science and biotech companies need much more.

 

That is why NCLifeSci members can take advantage of significant savings through BIO Business Solutions on services like business insurance, office supplies and HR for companies of all sizes. 

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