April 2024 Update

Serving the NC Life Sciences Industry

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The March 5 primary election resulted in the defeat of Sen. Mike Woodard (D-Durham), a co-chair of the General Assembly's Life Sciences Caucus. Democrat challenger Sophia Chitlik received 57% of the vote in the Durham County Senate district. Woodard has been an enthusiastic advocate for the life sciences industry and an effective partner for NCLifeSci.

 

The other caucus co-chairs ? Sen. Paul Newton, Rep. Robert Reives and Rep. Donna White ? are all up for re-election this year but did not face primary challengers.

 

There will be significant changes in both chambers with several senior leadership positions opening up. NCLifeSci will be busy working with the Life Sciences Caucus to educate new members and develop new champions. While we do this every election cycle, the need will likely be greater now as we prepare for the General Assmbly's long session in 2025.

In the Senate, there are several seats that are considered to be either safe Republican or Democratic seats where the primary election winner will be strongly favored in the general election.

• In District 3, Senator Jim Perry (R-Lenior) is not running for re-election. In the Republican primary, Bob Brinson defeated former NC House member Michael Speciale for the seat. In a district that leans heavily Republican, Brinson is favored to be the district’s new senator.
• Senator Joyce Krawiec (R-Forsyth) in District 31 is retiring. Her likely replacement is former Forsyth County/Winston-Salem School Board Chair Dana Caudill Jones, who was unopposed in the Republican primary.
• In newly drawn District 41, Sen. Natasha Marcus (D-Mecklenburg) is no longer resident to the district and running for insurance commissioner. In a district that leans heavily Democratic, primary winner Caleb Theodros (D) is likely to take over the seat following the November election.
• Sen. Dean Proctor (R-Catawba) is not running for another term. His likely replacement is the winner of the Republican primary, Mark Hollo.

Senate’s most competitive districts

Two incumbent senators, Sen.Lisa Barnes (R-Nash) and Sen. Danny Britt (R-Robeson) will run for re-election in districts that are nearly evenly divided between Republican and Democrat voters. Barnes will run against James Mercer (D) and Britt will run against Kathy Batt (D).

 

There are three more districts considered to be toss ups with open seats: District 13, District 18 and District 42.

• Sen. Lisa Grafstein (D-Wake) is running for District 13. Originally “double-bunked” during the redistricting process, she moved across the county to the newly drawn open seat and will face Scott Lassiter, the winner of the Republican primary.
• In District 18, Rep. Terrence Everitt (D-Wake) will face off against Ashlee Bryan Adams.
• Senate District 42 was left open by Sen. Rachel Hunt (D-Mecklenburg) running for lieutenant governor. Woodson Bradley (D) and Stacie McGinn (R) are the respective nominees in this closely divided district.

In the NC House, five Republican members announced their retirement. All five districts lean heavily Republican, so the winner of the Republican primaries are the likely candidates to win the November election. The presumed new members are

• District 59: Alan Branson (R), replacing Rep. Jon Hardister;
• District 62: John Blust (R), replacing Rep. John Faircloth;
• District 64: Cody Honeycutt (R), replacing Rep. Wayne Sasser;
• District 83: Grant Campbell (R), replacing Rep. Kristen Baker; and
• District 94: Blair Eddins (R), replacing Rep. Jeffrey Elmore.

In addition to these five districts, both District 95 and District 111 were left open as both Rep. Grey Mills (R-Iredell) and Speaker Tim Moore (R-Cleveland) are running for Congress. These are Republican leaning districts, and the winners of the Republican primary, Todd Carver (District 95) and Paul Scott (District 111), are heavy favorites to win in November.

 

Five Democrats in the NC House also announced their retirement. All five members represent heavily Democratic districts. Come November, their likely replacements will be

• District 33: Monika Johnson-Hostler (D), replacing Rep. Rosa Gill;
• District 42: Mike Colvin (D), replacing Rep. Marvin Lucas;
• District 100: Julia Greenfield (D), replacing Rep. John Autry; 
• District 104: Aisha Dew (D), replacing Rep. Kelly Alexander; and
• District 116: Former NC House member Brian Turner (D) replacing Rep. Caleb Rudow (D-Buncombe).

Finally, Rep. Tricia Cotham (R-Mecklenburg), who currently is serving in District 112, has opted to run in District 105, a much friendlier district for Republicans. She will be up against Nicole Sidman (D) in the general election. Jordan Lopez (D) is unopposed and will be the new representative in District 112.

 

House’s most competitive districts

At least four incumbent Republican members will have competitive races in the general election in their newly drawn districts:

• Rep. Bill Ward (R-Pasquotank) vs former Rep. Howard Hunter (D)
• Rep. Ken Fontenot (R-Wilson) vs Dante Pittman (D)
• Rep. Allen Chesser (R-Nash) vs Lorenza Wilkins (D)
• Rep. Frank Sossaman (R-Vance) vs Bryan Cohn (D)

In addition, at least two open seats that will have competitive races. In District 35, Mike Schietzelt (R) and Evonne Hopkins (D) will be vying for the seat. In District 98, the Northern Mecklenburg seat left open by Rep. John Bradford (R-Mecklenburg), Melissa Bales (R) will be running against Beth Helfrich (D).

 

On the Democratic side, Rep. Diamond Staton Williams (D-Cabarrus) and Rep. Lindsey Prather (D-Buncombe) are both especially vulnerable after redistricting. In the fall, Staton-Williams will run against Jonathan Almond (R), and Prather will be challenged by Pratik Bhakta (R).

State community college leaders want to restructure the system’s funding model to make it more responsive to the workforce needs of North Carolina employers.

 

The price tag for the first year of the Propel NC project would be about $100 million, in addition to the $1.5 billion already budgeted for the community college system in the 2024-25 fiscal plan. If lawmakers commit the funds needed, the changes would roll out in fall 2024, System President Jeff Cox said.

 

Under the current 2011 funding model, community colleges receive more funding for two-year degree programs than for nondegree or continuing-education courses. Shorter, more tailored training programs in specific areas like biotech and manufacturing are funded by the state at a lower level despite the higher demand for them.

 

Propel NC would remove the distinction between degree and nondegree workforce training courses, aligning them instead by the sectors they serve. The state funding level would be the same either way.

 

Under the current funding model, colleges also receive more funding for courses that are expensive to offer, like nursing. It’s known as the tier system. But the extra tier funding still doesn’t cover the actual cost. That limits the number of seats schools make available. The system loses money on every nursing student it adds, Cox said, despite the need for those students.

 

Under Propel NC, the funding for nursing programs would be enough to make them sustainable, allowing schools to increase enrollment to respond to market demand.

 

The system is asking lawmakers for $68.6 million a year to increase funding for high-demand, high-wage workforce sectors to boost instructor wages in high-demand programs to make them more competitive with the private sector.

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

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

NCLifeSci will be participating in BIO’s Legislative Fly-In on Tuesday, April 16, and Wednesday, April 17, in Washington, D.C. This is a valuable opportunity to discuss issues important to the biotech community with members of Congress, and several of our member companies are participating.

 

We plan to address a number of issues, including R&D tax amortization, the IRA small molecule penalty, rebate rules, the overall innovation economy and intellectual property. If you would like to attend, there may be a few slots left, so please contact us if you're interested.

Congress again just made its deadline and passed a $1.2 trillion spending deal on March 22. The six-bill bundle, which includes funding for the Department of Health and Human Services, passed the Senate 74-24. In the House, more Democrats voted for the measure than Republicans.

 

Overall defense funding will increase by about 3 percent under the package, while nondefense funding will remain about even with current levels because of bipartisan budget caps that President Joe Biden and House Speaker Mike Johnson reinforced in January.

 

Funding for HHS increased less than 1 percent overall. However, a 1 percent cut across the board that was to go into effect April 30 was averted.

 

These are some of the health-related elements of the budget deal:

• PEPFAR, a longtime bipartisan global AIDS program, was reauthorized for one-year instead of its traditional five-year deal. Republicans had claimed Biden uses the program to back abortion rights, which the administration and outside experts deny.
• No new anti-abortion riders were added to the package. The longstanding Hyde Amendment banning federal funding for abortion remains in effect.
• Alzheimer’s disease was a priority. The deal “notes disappointment” with CMS limitations on coverage for new Alzheimer’s treatments and calls on the agency to change its decision. It also gives a $100 million boost for Alzheimer’s research, which comprises a third of the increase in funding received by the NIH.
• Pharmacy benefit manager, transparency and site-neutral payment reforms weren’t included in the package despite bipartisan interest from key committee leaders. Expect these priorities to be revisited in an end-of-year package along with the future of telehealth and hospital care at home.

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.

 

The administration and drug makers are currently negotiating prices of 10 drugs under Medicare. If the negotiations are successful, the prices would take effect in 2026. The number of drugs subject to negotiations would eventually increase to 20. Several lawsuits in federal court are currently challenging the drug pricing program.

 

Biden also called on Congress to expand the $2,000 annual cap on out-of-pocket spending for Medicare enrollees granted under the IRA to private insurance, make expanded tax credits under the Affordable Care Act permanent and extend to commercial drug sales the rebates manufacturers must pay Medicare if their prices exceed inflation.

 

In his fiscal 2025 budget request, Biden is likely to ask Congress to limit cost-sharing to $2 for high-value generic drugs for all Medicare plans.

 

Such requests are likely a long shot in Congress. The Inflation Reduction Act passed out of Congress without a single Republican vote in 2022.

The Centers for Medicare and Medicaid Services rejected drug makers’ price offers April 2 for 10 medicines subject to Medicare price negotiations, kicking off a negotiation process created by the Inflation Reduction Act that is expected to stretch through the summer.

 

CMS sent out initial pricing bids to the nine manufacturers of the 10 drugs in February. All the companies rejected the government’s proposals and responded with their own price offers.

 

CMS and the drug makers have not made the price offers public, in part because that information is considered proprietary and possibly could affect the markets. 

 

A timeline from the agency shows the negotiations are expected to stretch through Aug. 1. CMS is expected to release final price offers by Sept. 1 that would take effect in 2026.

If a company does not accept the CMS offer, then it can decide to no longer participate in Medicare and Medicaid programs. The company could also be subject to an significant excise tax.

 

Several drug makers continue to fight drug negotiations in the courts.

 

Last month, a federal judge struck down a challenge to the negotiation process brought by AstraZeneca, saying that the company did not have legal standing to challenge the negotiation process. AstraZeneca has not said whether it would appeal the ruling.

 

Lawsuits brought by Janssen, Novartis, Novo Nordisk and Bristol Myers Squibb are also making their way through the courts. A federal judge heard oral arguments on all the cases in a combined hearing last month.

There is disagreement between the FDA and lawmakers on how to regulate laboratory-developed tests. The FDA wants to regulate LDTs as medical devices, but lawmakers are concerned about the cost and potential slow down of innovation.

 

Democrats generally support the FDA's effort for more oversight to ensure accurate tests.
Republicans argue the FDA is overstepping its authority, and the proposed rule would be too expensive for labs. Both sides agree legislation is preferable to FDA rule, but there is no consensus on the best approach.

The Verifying Accurate Leading-edge IVCT Development Act, or VALID Act, is suggested as a starting point for new legislation. The VALID Act was blocked in 2022 by House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.), forcing the FDA to develop its proposed rule, which is being expected in April. The rule is currently under review by the White House Office of Information and Regulatory Affairs.

Efforts to reform the practices of pharmacy benefit managers have stalled in Congress.

 

Both the House and Senate passed bills addressing PBM practices, but disagreements over the scope of reforms have prevented a compromise.

 

The House bill focuses on transparency, while the Senate bill proposes more extensive reforms, including requiring rebates to be passed to insurers and prohibiting spread pricing where PBMs charge insurers more for drugs than the PBMs reimburse pharmacies.

 

Both sides are pointing fingers at the other with Democrats accusing Republicans of obstructing broader reforms and Republicans accusing Democrats of rejecting effective measures. In the House, Democratic lawmakers are reportedly rejecting the Senate Finance Committee’s more aggressive reforms, and Republicans don’t want to mandate changes to PBM practices in the commercial market beyond Medicare.

Lawmakers are now considering a smaller package that doesn't include PBM reforms, focusing instead on other health care priorities.

 

Meanwhile, the Biden administration held a "listening session" on PBM reform on March 4 that included HHS Secretary Xavier Becerra, White House officials and private sector players like billionaire Mark Cuban, who founded an online pharmacy to circumvent the PBM model. The three largest PBMs were not invited to participate. 

The Biden administration issued a final regulation on March 14 to cut emissions of ethylene oxide from facilities that sterilize medical equipment.

 

Roughly half of all medical devices are sterilized using ethylene oxide, but federal scientists have concluded that even very small levels of chronic exposure are linked with increased risk of breast cancer and other cancers. The issue has raised public alarm in communities near the country's nearly 90 sterilization facilities, which are often located close to neighborhoods, schools and child-care facilities.

 

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. EPA said that would bring the cancer risk in nearby communities below the agency's benchmark safety threshold.

 

To accommodate concerns from the medical device industry and the Food and Drug Administration that the rule could cause disruptions in the supply of vital medical equipment, the EPA extended the compliance deadline to the maximum length of time allowed under the Clean Air Act. That affords larger facilities two years to make the necessary upgrades, while smaller facilities get a default of three years with ability to make the case to the agency for a fourth.

 

The rule addresses ethylene oxide emissions. In addition to mandating the use of stringent emissions control technologies on smokestacks and vents ? which are already in place in facilities around the country ? it also imposes a new requirement that sterilized materials be routed through an enclosure device that can capture ethylene oxide that is off-gassing.

 

The rule also imposes rigorous, continuous monitoring for most facilities with the monitoring data reported to the EPA quarterly and made public. The EPA said it expects no facilities to close as a result of the new regulation. More from Associated Press >>

The U.S. House of Representatives took steps to promote capital formation for innovative startups with the passage of H.R. 2799, the Expanding Access to Capital Act.

 

The legislation includes the text of H.R. 2624, the Helping Startups to Grow Act, which would extend regulatory relief under the JOBS Act for Emerging Growth Companies for an additional five years. The bill will extend the EGC exemption period for an additional five years, bringing the total regulatory relief period to 10 years. This is especially important for biotech startups who are often in the lab without an FDA-approved product for a decade and therefore generating no revenues.

 

This targeted fix will keep the regulatory costs of being a public company lower for longer without sacrificing the investor protections that become relevant once a company goes into production and expands its operations.

 

The House also adopted a bipartisan amendment offered by Rep. Ann Wagner (R-MO) along with Reps. Gregory Meeks (D-NY), Wiley Nickel (D-NC) and David Scott (D-GA), which would enhance liquidity in private markets by allowing closed-end funds to invest in private securities.

Jenae Williams

Alex Caruso

Jenae Williams joined NCLifeSci as workforce and programs director and successor to Brenda Summers.

 

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. Williams holds a bachelor's degree from Penn State University.

 

Alexandra "Alex" Caruso is the new office manager for NCLifeSci and executive assistant to the president.

 

Caruso came to NCLifeSci 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, first as a reimbursement representative and then as operations coordinator. Caruso studied journalism at Ohio University.

Panelists for the NCLifeSci Emerging Company and Technology Forum 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.

 

The forum focusing on access to capital was held at the NC Biotechnology Center on Thursday, March 14, and was moderated by Drew Cutshaw, senior associate and medical officer at Pappas Capital.

 

The event was sponsored by RESI South, SmaBio Labs, TriNet and Wyrick Robbins.

The panelists were

• Johanna Grossman, head of health care and life sciences, capital markets, New York Stock Exchange;
• Eric Heil, managing partner, Medical Excellence Capital;
• Emil Runge, director of programs, First Flight Venture Center; and
• Anita Watkins, managing director, Rex Health Ventures.

More at NCLifeSci >>

The life sciences industry across the U.S. is on track for a record year in terms of completed projects, according to data from CommercialEdge. The Triangle is positioned well within this national trend.

 

Nationwide, life sciences completions are expected to reach record highs in 2024.
The Triangle ranks No. 6 among U.S. markets with the most active life sciences construction, with over 1 million square feet underway.

Nearly 1 million square feet of this space is expected to be completed in the Triangle by the end of 2024. This translates to a 14.8% increase in the Triangle's life sciences inventory for the year, followed by an additional 16.9% growth projected after 2024.

The Triangle has also seen significant growth over the past decade, adding 1.7 million square feet of life sciences space, a 37% increase.

 

While the pace of new project announcements is slowing down, 2024 is expected to be a banner year for life sciences construction completions in the Triangle.

BD (Becton, Dickinson and Company) was named to Fortune's 2024 list of America's Most Innovative Companies. More >>

 

BD (Becton, Dickinson and Company) announced that Rian Seger has been named president of the BD Surgery business unit, effective April 1. More >>

 

Biofidelity successfully completed a $24 million financing round to accelerate the growth of its ASPYRE®-Lung test that can detect biomarkers for non-small cell lung cancer. This brings the total funding raised to $60 million since its founding in 2019. More >>

 

Eisai and Biogen announced that Eisai submitted to the FDA a supplemental biologics license application for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous maintenance dosing for the treatment of early Alzheimer’s disease. More >>

 

Humacyte, Inc. announced the pricing of an underwritten public offering of 13,400,000 shares of its common stock at a public offering price of $3.00 per share with proceeds from the offering expected to be $40.2 million. More >>

 

Longfellow recently completed the interior amenities at Triangle LIFE (now known as the Hue), which includes fitness facilities, locker room and meeting spaces. More than 70,000 square feet of lab space is available off Davis Drive in Morrrisville.  More >>

 

Precision BioSciences, Inc. announced a public underwritten offering of 2.5 million shares of its common stock to purchase up to 2.5 million shares of common stock at a combined offering price of $16.00 price per share for total gross proceeds of $40 million. More >>

 

Thermo Fisher Scientific Inc. and Bayer AG will develop next-generation sequencing-based companion diagnostic assays together. These CDx assays will help identify patients who may benefit from Bayer’s precision cancer therapies by offering decentralized genomic testing and rapid turnaround time. More >>

 

Thermo Fisher Scientific Inc. announced the launch of a new CorEvitas syndicated clinical registry in generalized pustular psoriasis. This registry, which is open to enrollment, is CorEvitas’ 10th syndicated disease registry. More >>

Register now for MDMA's flagship event, the 2024 MDMA Annual Meeting, which will be held April 17-19 in Washington, D.C.

 

MDMA is the leading voice for innovative and entrepreneurial medical devices companies, and this year's Annual Meeting will deliver key insights on issues facing our industry. As an NCLifeSci member, you receive discounted pricing. Contact Amber Niebauer for the discount code.

 

Attendees at this year's conference will hear from Congressional, federal agency and industry leaders on current and upcoming issues affecting our industry. Attendees also have an opportunity to visit Capitol Hill and meet with our Congressional delegation during MDMA's popular Congressional Fly-In.

 

Registration rates

• MDMA Members - $895
• State Member (with code) - $1,095
• Non-Members - $1,195

After signing up for Discover Your CDMO Partner with SmaBio Labs open house, further details will be sent to you via email. Please ensure you select your preferred date and time on the provided link. Forty-five minute slots are available from 9 a.m. to 4 p.m. on April 17, 18 and 19.

Join NCBiotech on April 25 for its Biomanufacturing and Process Development Group’s Fifth annual CGT Symposium and Vendor Show, a full-day event to learn about cell and gene therapy biomanufacturing progress and challenges via engaging presentations with Q&A, time to network and make new contacts.

 

There will be more than 40 sponsors and vendors with displays on current up- and downstream processing equipment, plus analytical instruments and assays to support your CGT business and career.

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, FUJIFILM Diosynth, 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 and
• 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 and
• Anna Abram, senior adviser, Akin Gump Strauss Hauer & Feld LLP.

If you are interested in sponsoring the Medical Device Forum, contact Membership Director Natacha Janvier for more details.

The BIO International Convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. Position yourself for success at this year's event, June 3-6, in San Diego! BIO is where business and breakthroughs converge ? and the BIO One-on-One Partnering system facilitates the connections that fuel our industry.

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 a discount registration code.

• Brews + Bytes Triad hosted by NC TECH (4/11/2024)
• MDMA Annual Meeting (4/17/2024 to 4/19/2024)
• U.S. Biopharma Workforce Partnership Conference hosted by NIIMBL (4/17/2024 to 4/18/2024)
• Discover Your CDMO Partner hosted by SmaBio Labs (4/17/2024 to 4/19/2024)
• Export University hosted by U.S. Commercial Service NC (4/17/2024)
• NCI SBIR/STTR Programs: Informational Seminar and One-on-One Meetings with NCI Staff (4/17/2024)
• BioAgTech World Congress hosted by NCSU and NCBiotech (4/22/2024 to 4/26/2024)
• Leaders Tell All: Mistakes and Lessons Learned on the Path to Inclusive Leadership hosted by The Diversity Movement (4/23/2024)
• BPD Cell and Gene Therapy Symposium & Vendor Show hosted by NCBiotech (4/25/2024)
• Brews + Bytes Triangle hosted by NC TECH (4/25/2024)
• IACUC hosted by NCABR (4/29/2024 to 4/30/2024)
• 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)

Did you know that NCLifeSci members receive 15% off list prices (plus a one-year warranty) on purchases from American Laboratory Trading, as well as significant discounts on surplus strategy services. 

The BIO-Brex program benefits just got even better.

 

As BIO's preferred spend management partner, Brex offers tailored rewards for life science related purchases through the Brex corporate credit card. NCLifeSci member companies use their Brex card for lab supply purchases, conference registrations and travel expenses.

 

Brex is now enhancing their offering with the Brex Business Account and new benefits like travel, expense and automated approval processes. 

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