2024 NCLifeSci Year in Review

Marking 30 years

During our 30-year watch as the NC Biosciences Organization, North Carolina has grown to become the fourth largest biohub in the country.

The creation of the NC Biotechnology Center in 1984 was a catalyst for the life sciences industry’s growth. The Biotechnology Innovation Organization formed in 1993 and held an early convention in Raleigh.

In 1994, a group of life sciences executives approached the firm of Womble Carlyle Sandridge & Rice about starting a trade association to monitor and influence state and federal legislation and regulation. Sam Taylor
took the assignment and eventually became the organization’s first president.

It’s hard to believe how far we’ve come since it was just Sam working solo and pro bono. The creation of BTEC at NC State and BRITE at NC Central is a direct result of work done by Sam and NCBIO. The organization helped create the NC General Assembly’s Joint Legislative Life Sciences Caucus eight years ago, and the industry has had a focused group of legislators willing to learn about and support us ever since.

We lost Sam in 2021, but the dramatic expansion and success of the life sciences industry in the state continued unabated. In 2022 we began a strategic planning process to re-examine our role as the industry’s trade association. The NCBIO Board of Directors felt we needed to change our name to more
accurately reflect the scope and variety of the industry we represent.

NCBIO became NCLifeSci, the NC Life Sciences Organization, on Oct. 4 at the organization’s 2023 Annual Meeting. The board chose the new name to better align with the current size and diversity of the industry in North Carolina. And so 30 years later, NCLifeSci continues to focus on the important policy and advocacy work needed to keep North Carolina a key destination for life sciences companies to form, grow and expand, but we have also in that time, developed into a staff of seven that can focus on convening events, workforce development, cost-savings benefits, communications and more.

Today NCLifeSci works to ensure the life sciences industry is recognized as a key driver of North Carolina’s economy at the General Assembly and by the state’s Congressional delegation. The One NC Small Business
program, for example, is a recurring presence in the state budget that can be attributed to the support of the caucus chairs. At the federal level, we’ve seen the NC delegation work across party lines to support the industry, like this year’s EPIC Act introduced by Republican Rep. Greg Murphy and Democratic Rep. Don Davis, both from Eastern North Carolina.

This past year, we said goodbye to longtime friend and colleague Brenda Summers as she retired from her role as director of workforce programs after many years and many hats worn at the organization. We were
sorry to see her go, but we were also excited to welcome her successor and other new colleagues. Jenae Williams joined NCLifeSci as workforce and partnerships director, and Alexandra “Alex” Caruso came on board as our new executive assistant to the president and office manager.

We miss our old coworkers, but it has been wonderful getting to know and work with our new colleagues and fielding a full team to support our members. We have also enjoyed working with the members and supporters of this amazing industry as we all work together to bring new treatments and new opportunities to the citizens of North Carolina and the world.

Laura Gunter
President

NCBIO becomes NC Life Sciences Organization

At its 2023 Annual Meeting, the NC Biosciences Organization announced that it was changing its name to the NC Life Sciences Organization, or NCLifeSci for short.

The organization’s Board of Directors made the name change as part of a strategic planning process begun in 2022. The board chose the new name to better align with the current size and diversity of the industry in North Carolina, which has grown tremendously in the three decades since NCBIO was founded. The change to the new name went into effect Oct. 4 at the organization’s Annual Meeting.

“During NCBIO’s 30-year watch, North Carolina has grown to become the fourth largest biohub in the country,” said NCLifeSci President Laura Gunter. “The dramatic growth and success of the industry has led us to re-examine our role as a trade association. We felt we needed to change our name to more accurately reflect the breadth and variation of the industry we represent.”

In addition to the pharmaceutical and biotechnology sectors, life sciences is a broader term that encompasses agricultural technology, food science, medical devices, diagnostics, digital health, nutraceuticals, cosmeceuticals, environmental sciences, alternative fuels and more.

In addition to these core industries, we also represent companies who provide core research, development and manufacturing capabilities on a contract basis, such as contract research organizations and contract
manufacturing organizations. CROs provide research and development services to pharmaceutical and biotechnology companies, while CMOs provide manufacturing services for drugs and medical devices.

The organization debuted a new doublehelix logo, new brand colors of green and orange and a new website URL, NCLifeSci.org.

New NCLifeSci Staff Members

NCLifeSci has welcomed three new staff members since the last Annual Meeting who have joined the organization alongside President Laura Gunter, Communications Director David Etchison, Membership Director Natacha Janvier and Events Director Amber Niebauer.

WORKFORCE AND PARTNERSHIPS DIRECTOR JENAE WILLIAMS. Williams spent nearly 20 years at Biogen in program and instructional design and supervisory roles. She has also been an adjunct instructor at NC Central University since 2016 teaching Good Manufacturing Practices as part of the BRITE pharmaceutical sciences curriculum.

BMF PROGRAM MANAGER BILL MONTEITH. Monteith retired as chief operating officer of Stride Bio before joiningNCLifeSci . Over his 42-year career, he has overseen the construction of and served as site head of at least six solid dose and biotech facilities.

EXECUTIVE ASSISTANT ALEX CARUSO. Caruso came to us from Employee Benefits Management Group where she spent nearly two years as a client engagement specialist handling the implementation of benefit programs. Prior to that, she worked for more than three years at MED-EL, a hearing-implant company.

STATE ADVOCACY

Life Science Caucus Co-chairs Sen. Paul Newton (R-Cabarrus), Rep. Robert. Reives (D-Chatham, Randolph) and Rep. Donna McDowell White (R-Johnston) are up for re-election in 2024 and did not face challengers in the March primaries. Sen. Mike Woodard (D-Durham) lost to a primary challenger and will leave the Senate after the November 2024 election. Newton continues to serve as Senate majority leader and Reives as the House minority leader.

The NC General Assembly capped the 2023 long session by passing a two-year state budget that expanded Medicaid in North Carolina to more than 600,000 North Carolinians. Overall, a number of NCLifeSci’s priorities fared well in the budget.

• Franchise tax. A rate change went into effect in 2024, and the budget caps the franchise tax beginning in 2025. The minimum tax for all corporations is $200 and the maximum is $150,000. C corporations will pay a flat fee of $500 for the first $1 million of their tax base and an additional $1.50 for every $1,000 that exceeds $1 million. S corporations will pay $200 for the first $1 million of their tax base and $1.50 for every $1,000 of the excess amount.
• Innovation funding. The legislature focused its start-up funding priorities on authorizing and funding NCInnovation, which will support state universities that are not R1 universities — i.e., all UNC System schools except UNC Chapel Hill and N.C. State — to help them commercialize their work and turn concepts into companies that create jobs in North Carolina. NCInnovation is funded by the investment proceeds generated by a $500 million endowment created from state reserve funds. The General Assembly maintains control over the endowment’s principal.
• NCBiotech. The NC Biotechnology Center received a recurring increase of $1 million with a nonrecurring appropriation of an additional $2 million during the first year of the biennium.
• One NC Small Business Program. The One NC program matches federal SBIR/STTR grants won by North Carolina companies. The program received no additional funding beyond its $2 million recurring appropriation.
• Water/wastewater grants. The legislature appropriated $2 billion in water, wastewater and sewer infrastructure grants, designating more than 200 specific and mostly rural high priority projects.

The budget was delayed for weeks as the chambers debated the authorization of gaming proposals that ultimately did not move forward, clearing the way for budget passage, triggering an earlier stipulation that the expansion of the Medicaid population in North Carolina would take effect along with the budget.

The 2024 short session of the General Assembly was uneventful overall with only minor adjustments made to the budget for 2024-2025.

FEDERAL ADVOCACY

NClifeSci and its national partners grappled with a full slate of legislative priorities at the federal level this year.

The life sciences industry received outstanding support from the North Carolina Congressional delegation who introduced or signed onto legislation addressing several important issues. However, a divided Congress, turmoil in the House’s leadership and a looming election stymied progress in most areas.

• Antimicrobial resistance. The PASTEUR Act would address market problems to encourage the development of antimicrobials. The bill was introduced in the Senate but did not make it out of committee.
  
• ARPA-H. After much anticipation over the form the Advanced Research Projects Agency for Health would take and where it might be located, ARPA-H announced the launch of ARPANET-H, a nationwide health innovation network anchored by three ARPA-H regional hubs: the Customer Experience Hub in Dallas, the Investor Catalyst Hub in Cambridge and the Stakeholder and Operations Hub in Washington, D.C.
• BIOSCECURE Act. A proposed law aimed at restricting Chinese biotech firms from doing business in the U.S. 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. Congress did not attach to the defense appropriations bill passed in May.
  
• Ethylene Oxide. The Biden administration issued a final regulation on March 14 to cut emissions of ethylene oxide. The Environmental Protection Agency’s final rule is the first update to EtO regulation in 30 years and will reduce ethylene oxide emissions by 90 percent, according to the agency. To accommodate concerns from the medical device industry and the FDA that the rule could cause disruptions in the supply of vital medical equipment, the EPA extended the compliance deadline to two to three years, the maximum length of time allowed under the Clean Air Act.
  
• Bayh-Dole and March-in Rights. The Biden administration has continued to claim that it has the authority under the 1980 Bayh-Dole Act to seize patents of certain medications developed with public funds that it deems excessively expensive although the administration has not done so. In February, 28 Democratic and Republican members of Congress sent a letter to President Joe Biden cautioning against the use of march-in rights. The signatories from North Carolina were Sen. Ted Budd, Sen. Thom Tillis, Rep. Don Davis, Rep. Deborah Ross and Rep. Wiley Nickel.
  
• ORPHAN Cures Act. Rep. Wiley Nickel (D-NC) and Rep. John Joyce, M.D. (R-PA) introduced the Optimizing Research Progress Hope And New Cures Act, a welcome and bipartisan fix to the Inflation Reduction Act’s negative impact on the development of drugs to treat rare diseases. The IRA exempts orphan drugs for rare diseases from price negotiations but only if the drugs are approved for a single indication. Drug manufacturers are not encouraged to test whether a new drug can treat other indications.
  
• Pharmacy Benefit Managers. Over the past 12 months, Congress has been taking a close look at the practices of pharmacy benefit managers, but efforts to reform the practices of PBMs have stalled. Both the House and Senate have passed bills addressing PBM practices, but disagreements over the scope of reforms have prevented a compromise.
  
• Pandemic and All Hazards Preparedness. The PAPHA Reauthorization Act, which will help us get ready for the next pandemic, has been reviewed by committees in the House and Senate and awaits consideration by the full bodies. 
  
• Price fixing. President Joe Biden used his March 7 State of the Union address to ask Congress to expand the number of drugs that can be subject to Medicare price “negotiations” to at least 50 drugs a year. All drugmakers participating in the first-ever Medicare drug price “negotiations” rejected the Biden administration’s opening offers, choosing instead to make counteroffers and set the stage for a series of summer meetings when final prices were set. Drug companies and industry groups continued to fight the process in court without success.
• Rare Pediatric Disease Priority Review Voucher Program. This FDA program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases expires at the end of September. Legislation has been introduced in both the House and the Senate, but the bill was still in committee in August.
• R&D tax amortization. A 2017 tax rule that went into effect in 2022 requiring the amortization of research and development expenses over 5 years (15 for overseas R&D) has created significant challenges for many life sciences startups and small businesses. The activation of the new rule sparked a bipartisan effort to repeal the amortization requirement. Sen. Thom Tillis (R-NC) and Sen. Ted Budd (R-NC) co-sponsored the American Innovation and Jobs Act, which would restore full expensing for R&D costs. In the House, 197 representatives, including six NC Democrats (Don Davis, Valerie Foushee, Jeff Jackson, Kathy Manning, Wiley Nickel and Deborah Ross) and two NC Republicans (Chuck Edwards and Greg Murphy) cosponsored a similar bill. However, Congress failed to address the R&D deduction before adjourning in 2023, and R&D tax credits are now linked in legislation with changes to the child tax credit that are drawing opposition. Sen. Thom Tillis told NCLifeSci members at a CEO Roundtable there was unlikely to be any action on the issue before the election.
• Small-molecule penalty. The Inflation Reduction Act created an arbitrary distinction between biologics and small-molecule drugs. Biologics were granted 13 years of exemption from price controls, while small-molecule drugs were granted just nine years North Carolina Reps. Greg Murphy, M.D. (R-NC), and Don Davis (D-NC), along with Rep. Brett Guthrie (R-KY), introduced the bipartisan EPIC Act to provide small-molecule drugs with the same number of years of protection from government price “negotiations” as biologics receive.
• Transitional Coverage for Emerging Technologies. TCET is a three-year-old CMS proposal that would create an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics to improve on the average of five years it takes for medical technologies to achieve nationwide coding, coverage and payment.
• TRIPS Waiver. While the White House previously agreed to allow COVID vaccines to be produced without a license from the vaccine patent holders, the Biden administration ultimately did not follow through on suggestions that it would do the same for COVID diagnostics and therapeutics.

CSBA Fly-in, April 2024. NCLifeSci and 28 other CSBA organizations participated in the BIO Fly-in April 16 and 17.Patrick Jordan of Mycovia , Neil Jones of Lindy Biosciences, Shaun Venable of Biogen, NCLifeSci President Laura Gunter and Jannie Oosthuizen of Merck stopped in to thank Rep. Don Davis (above, third from right) for co-sponsoring the EPIC Act, along with Rep. Greg Murphy, M.D., that would remove the IRA’s small-molecule penalty.

CEO Roundtable, June 2024. Sen. Thom Tillis and Sen. Ted Budd talked with NCLifeSci members about the R&D tax credit, the small-molecule penalty in the Inflation Reduction Act and IP protection and answered member questions.

Tar Heel Circle, February 2024. NCLifeSci President Laura Gunter and lobbyist Joe Lanier were in Washington, D.C., Feb. 8-9, representing the state’s life sciences industry at a Tar Heel Circle luncheon that featured remarks by Sen. Ted Budd. The conversation touched on march-in rights as university representatives in attendance raised their concerns about significant changes to the interpretation of the Bayh-Dole Act. Gunter and Lanier visited the offices of several North Carolina lawmakers over the two days and had the opportunity to thank Rep. Greg Murphy and Rep. Don Davis for their introduction and sponsorship of the EPIC Act, which would bring parity to small- and large-molecule drugs for negotiation purposes under the Inflation Reduction Act.

AdvaMed Fly-in, March 2024. As part of the medical device industry’s annual policy outreach on March 5-6,
NCLifeSci visited a number of delegation offices with representatives from Cook Medical and Becton Dickinson, focusing on PFAS, EtO sterilization and TCET.

Forums & Networking

NCLifeSci continued to host informative forums and discussions designed to shed light on timely issues that are priorities for our members.

Lab Space Forum, “Leasing Lab Space - Pitfalls and Lessons Learned,” July 2024. A panel explored the intricacies of growing a life sciences company in rented Research Triangle Park office and lab space.

Medical Device Forum, “Diagnostic Testing - Will FDA’s Final Rule be the Final Word,” May 2024. Panelists discussed the FDA rule regulating laboratory-developed tests and the prospect of the VALID Act superseding the rule.

Emerging Companies and Technology Forum, “Access to Capital,” March 2024. Panelists discussed early-stage life science companies’ access to capital and incubation and emphasized the importance of building a network, leveraging the resources of your local ecosystem resources and connecting with potential investors
before raising money.

Clinical Research Forum, “Recruiting and Retaining Study Participants,” November 2023. A panel of experts explored the potential of AI and machine learning to improve clinical trials by reducing costs, improving speed and increasing the probability of success.

Biotech Manufacturers Forum

June 2024. “State Infrastructure: Current State, Future Possibilities” was the topic, and 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.

March 2024. “Growing Your Life Sciences Workforce - Entry Level to Middle Management” updated members on BTEC 2.0, the NCSU Kenan Institute Fellows program and its effect on the K-12 pipeline and NCBiotech programs, including military outreach and apprenticeships implemented as the center’s data-driven response to workforce growth.

November 2023. Representatives from Kymanox, Human Ready and Metalytics explored the use of artificial intelligence in the life sciences and in biomanufacturing and shared insights into how the FDA is treating AI, how companies can improve efficiency with generative analytics and data storytelling and how AI can be used to model the activity in a bioreactor. Bill Monteith was introduced as the new BMF program manager.

Diversity, Equity and Inclusion

NCBIO continued its member-requested programming focused on diversity, equity and inclusion in partnership with The Diversity Movement.

January 2024. NCLifeSci members collected and delivered almost 500 books and over a thousand diapers and related products for Book Harvest and the Diaper Bank of NC.

June 2024. “Our Differences for the Better - Neurodiversity at Work” with presenters from Pfizer, The Diversity Movement and 321 Coffee.

2023 ANNUAL MEETING

NCBIO became the NC Life Sciences Organization at its 2023 Annual Meeting held Oct. 4 at the NC Biotechnology Center, and approximately 200 member representatives enjoyed networking and engaging panel discussions.

Novartis’ Emily Chee delivered the meeting’s keynote address and shared the promise of gene therapy as she described Novartis’ success in launching Zolgensma, a gene therapy for spinal muscular atrophy.

Following the keynote, experts discussed issues of concern in Washington, D.C., regulatory challenges facing food and pharma and the challenge patients have in getting and paying for care.

At the Oct. 3 Annual Dinner, NC Senate Majority Leader Paul Newton (R-Cabbarus), co-chair of the General Assembly’s Life Sciences Caucus and chair of the Senate Finance Committee Chair, shared his insights on leadership, culture and complacency in organizations.

Key takeaways from Newton’s talk were prioritizing long-term thinking when investing in North Carolina, focusing on “everyday excellence” and continuous improvement, putting others first to achieve personal and
organizational success and avoiding complacency by creating a culture of excellence and encouraging managers to prioritize their employees and trusting your management team.

THE YEAR AHEAD

As we look ahead to the next 12 months, all eyes are on the November elections. Whatever the results may be, NCLifeSci will adjust its heading to reflect the priorities of the organization’s strategic plan and focus on advocacy leadership, workforce development, making industry connections and offering valuable member services.

We will pay particular attention to the infrastructure needs of the state and our industry and encourage decision makers at all levels to come together to solve looming challenges in power, transportation, wastewater and communications infrastructure. The NCLifeSci Policy Committee and a new BMF committee will have addressing infrastructure challenges as a large part of their portfolio.

NCLifeSci will continue to advocate for traditional priorities, such as the NC Biotechnology Center and the One NC Small Business Fund, while adding a focus on broader issues of concern to our industry, such as access to capital and water and wastewater management. We will also continue to work with government and educational institutions at all levels to help meet the workforce needs of the state’s life sciences community, including the sector’s interest in educating and employing a diverse workforce.

At the federal level, NCLifeSci will continue to educate the state’s Congressional delegation on the issues that affect our industry. We will continue to oppose drug-pricing measures that don’t consider the entire pharmaceutical production, distribution and reimbursement system and to support strong intellectual property rights. As always, we will support the government-affairs work of PhRMA, BIO, AdvaMed and MDMA through advocacy targeted to North Carolina’s elected officials.

The NCLifeSci staff greatly appreciate the support we receive from our members, who never hesitate to lend a hand to our advocacy efforts, events and other activities. We will continue to provide regular networking opportunities and information-sharing forums for member companies. We look forward to working with
all of you in 2024-2025.