March 2024 Update

Serving the NC Life Sciences Industry

nclifesci.org

919.281.8960

The legislature remains dormant as House and Senate members focus on fundraising for their primary and general election campaigns. 

 

Primary election - March 5

March 5 is the primary election for all congressional and state races. This will significantly narrow the field of candidates and establish likely winners in districts that lean heavily Republican or Democrat. 

 

Skeleton sessions - March 13-14 and April 10-11

No legislative business

 

Bills must be submitted to bill drafting - April 15

 

Short session convenes - April 24

 

Bill introduction deadline - May 2

 

General Election - Nov. 5

Nov. 5 is the general election for all candidates in North Carolina. Those elected to Congress, the Council of State and the General Assembly will begin their terms January 2025.

 

The state's revenue collections are in line with budget expectations, so we do not expect there to be significant additional funds available for lawmakers to allocate. NCLifeSci will continue to advocate for our funding priorities during the short session, which include the NC Biotechnology Center and the One NC Small Business Program.

Since the launch of North Carolina’s Medicaid expansion on Dec. 1, more than 314,000 people have gained access to Medicaid services with a larger number of enrollments coming from the state's rural counties, according to the Department of Health and Human Services.

 

The state’s total Medicaid population has now surpassed 3 million people. Medicaid expansion was initially passed in March 2023 but was tied to the enactment of the state budget.

 

The expansion extended coverage to adults who make up to 138 percent of the federal poverty level based on their household size. The previous limit was 100 percent.

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

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

The Senate passed a temporary spending bill on Feb. 29 to avoid a government shutdown on March 2, buying time for Congress to finalize individual spending bills for the 2024 fiscal year.

 

Congress now has until March 8 to pass the first six bills, which cover the departments of Agriculture, Energy, Veterans’ Affairs and Transportation. Reaching an agreement on the remaining bills, including those for the military and domestic programs, by the next March 22 deadline may be more challenging. Both chambers still need to agree on funding levels and specific policies within each spending package.

 

The Senate approved the spending bill by a vote of 77-13. Earlier Thursday, the House passed the stopgap in a 320-99 vote. This is the fourth stopgap bill passed this fiscal year due to delays in finalizing the budget. 

 

Negotiations continue on the remaining spending bills, with sticking points like border security funding for the Department of Homeland Security.

 

A fix for R&D tax amortization was not part of the spending bill. The U.S. House of Representatives passed HR 7024, The Tax Relief for American Families and Workers Act of 2024, on Jan. 31 by a vote of 357 to 70. The bill reinstates domestic research expensing under IRC Section 174 retroactive to 2022, extends 100% bonus depreciation, increases the refundable Child Tax Credit and terminates the Employee Retention Tax Credit. The bill is being considered by the Senate, and while the fix for the amortization issue has bipartisan support, the other elements of the legislation face considerable opposition.

 

If you have examples of how the R&D amortization effects your business, please share with them with Laura Gunter.

Lawmakers released the text of a deal on Sunday to fund the Food and Drug Administration and the Department of Veterans Affairs through the end of the fiscal year.

 

However, a bipartisan proposal to regulate pharmacy benefit managers was not included nor was reauthorization of the Pandemic and All-Hazards Preparedness Act included, although some smaller provisions were extended.

 

The deal includes $6.7 billion for the FDA, which is similar to previous funding levels, and $307 billion for the VA, which is a $24 billion increase, including additional funding from the debt-ceiling deal.

 

Congress must approve the deal by March 8 and send it to President Joe Biden for his signature. Funding for other government agencies, including the Department of Health and Human Services, expires on March 22.

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. 

At the 13th World Trade Organization Ministerial last week in Abu Dhabi, the WTO did not agree to expand THE TRIPS waiver of IP rights for COVID-19 vaccines to COVID diagnostics and therapeutics.

 

BIO and other life sciences organizations pointed out that the proposed expansion would have implicated not just final products but their full supply chains due to potentially broadly covering any patent required for the production and supply of products in  the scope of the waiver. 

 

“An expanded waiver also raises broader systemic risks, undermining U.S. technology leadership against global competitors such as China by allowing them a channel to unfairly seize American innovation to benefit their own domestic economies and workers," BIO wrote in a letter to the Biden Administration.

 

"Finally, expansion of the waiver would embolden countries that are seeking to replicate the IP waiver concept in other international fora and for different types of technologies, including energy and environmental technologies,” the letter continued.

 

BIO has suggested that the WTO focus on more effective measures for increasing access to COVID treatments:

• Require faster sharing of information ? such as a virus’ genome ? across international boundaries to allow scientists to start their work sooner.
• Make it easier to trade and send materials for vaccine and therapeutic production around the globe, such as through the reduction of tariffs and other trade barriers.
• Address health-system disparities, which during COVID caused vital vaccines to go to waste when some countries couldn’t get them into people’s arms in a timely fashion.

The House Energy and Commerce Health Subcommittee held a hearing Feb. 29 to consider legislation focused on rare diseases, including proposals to modify the Inflation Reduction Act to expand the exclusion for orphan drugs and change the period for when Medicare could negotiate the prices of certain single-source drugs. 

 

The hearing addressed three legislative priorities ? the ORPHAN Cures Act, the MINI Act, and the Creating Hope Reauthorization Act ? where several committee members spoke favorably. Creating Hope reauthorizes the Pediatric Rare Disease Priority Voucher Program, which provides critical incentives to promote R&D for drugs to treat rare diseases affecting children. The MINI Act would increase the protection from IRA drug price controls for drugs made with genetically targeted technology, often referred to as complex small molecules, to 13 years post-FDA approval.

 

Rep. John Joyce, M.D. (R-PA) said that the ORPHAN Cures and the MINI Act “represent narrow and concise fixes to the IRA.” The committee will continue to work on IRA fixes so those living with rare diseases can benefit from innovative treatments. Watch the highlight of Rep. Joyce, cosponsor of the ORHPAN Cures Act here.

 

NCLifeSci continues to support these efforts, as well as the newly filed EPIC Act, which brings negotiation parity to all small molecule drugs by moving their protection from IRA drug price controls to 13 years.

The House of Representatives passed legislation that bans the use of quality-adjusted life years in federal programs like Medicaid and veteran's health care.

 

This move was supported by advocates for people with disabilities who argue that QALYs unfairly discriminate against them by undervaluing the potential benefit of treatments.

 

QALYs are a metric used to assess the effect of drugs on both health outcomes and quality of life. While currently not used to directly determine coverage in Medicare, it could be used in other programs to decide if a treatment is cost effective enough to fund.

 

Supporters of the ban say that QALYs are discriminatory because they undervalue the lives of people with disabilities. Critics say that that the bill's broad language could have unintended consequences, such as allowing drug companies to charge more and undermining the administration's efforts to lower drug prices.

The QALYs ban passed the House with support primarily from Republicans. It faces an uncertain future in the Democrat-controlled Senate.

The Federal Trade Commission supports a Biden administration plan for asserting the government’s right to seize patents of certain drugs developed using taxpayer funding, it said in a Feb. 6 letter.

 

The three Democratic commissioners wrote that the proposal to use march-in rights could be a “check on inflated pharmaceutical prices” and “benefits from being appropriately expansive and flexible.”

 

However, 28 Democratic and Republican members of Congress this week sent a letter to President Joe Biden cautioning against the use of march-in rights under the Bayh-Dole Act of 1980 ? a law they referred to as the “foundation of public-private partnerships” in the U.S. The signatories from North Carolina were Sen. Ted Budd, Sen. Thom Tillis, Rep. Don Davis, Rep. Deborah Ross and Rep. Wiley Nickel.

 

Using march-in rights to try to lower drug prices has been debated for years, but it has never been done as doing so was never the intent of the Bayh-Dole Act. The FTC’s support of the controversial move could help advance the administration’s goal of making it happen.

 

The National Institute of Standards and Technology released a draft framework that added price to the factors agencies can consider when deciding whether to exercise march-in rights. 

 

In their letter, the lawmakers contend march-in rights wouldn’t be effective in the first place. Of the 361 medications approved by the FDA between 2011 and 2020, just five ? or fewer than 2% ? could be subject to full march-in rights because they were developed with government funding, they said.

 

NIST’s draft framework would also have “serious unintended consequences,” subjecting companies across industries to pricing challenges by “rival businesses and even our foreign competitors and adversaries,” they wrote.

 

The FTC, which typically comprises five commissioners, has been without a Republican member since Christine Wilson resigned last 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 high-stakes meetings this summer before final prices are set.

 

If CMS does not accept a company's counteroffer, the two sides will meet up to three times to negotiate a so-called maximum fair price that will take effect in 2026. Details of price offers for the 10 selected drugs are not required to be made public.

 

The latest deadline in the negotiations comes as drug companies and industry groups continue to fight the process in court.

 

Some of the affected drug companies as well as industry groups PhRMA and U.S. Chamber of Commerce filed nine lawsuits seeking to delay or strike down the negotiations.

 

A federal judge ruled last month that PhRMA did not have legal standing to sue over the negotiations. On Friday, AstraZeneca suffered an initial loss in its lawsuit. The other lawsuits continue to make their way through courts across the nation. A judge in New Jersey is set to hear arguments on Thursday in four lawsuits.

 

The negotiations window for the first set of drugs ends on Aug. 1. CMS is required to release an explanation of the final prices no later than March 1, 2025.

Some patients are struggling to get medications due to chronic drug shortages, especially generic drugs. Both Republicans and Democrats point to issues in the drug supply chain, including:

 

Manufacturers blame supply chain problems and excessive regulations for making it unprofitable to produce certain drugs. Lawmakers on both sides are concerned about the overdependence on foreign countries, particularly China, for drug supplies.

 

Republicans in Congress have proposed revising Medicare reimbursement policies to incentivize drug production, investing in domestic manufacturing through tax and trade policies and encouraging private-sector solutions like long-term contracts.

 

Democrats continue to support the Inflation Reduction Act that allows Medicare to "negotiate" drug prices, have suggested using the Defense Production Act to boost domestic production and want to address supply chain problems by reducing reliance on single-source manufacturers.

 

Lawmakers in various committees are exploring changes to Medicare reimbursement policies to address the shortage. The Senate Finance Committee proposes reforms to incentivize production of specific injectable drugs and to incentivize pharmacies to choose reliable suppliers. The House Energy and Commerce Committee focused on exempting certain drug makers from specific rebate programs.

NCLifeSci President Laura Gunter and lobbyist Joe Lanier were in Washington, D.C., Feb. 8-9 representing the life sciences industry at the most recent Tar Heel Circle luncheon, which featured remarks by Sen. Ted Budd. 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 (PDF).

 

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. 

Senator Budd was also in Winston-Salem on Tuesday, Jan. 30, to visit Cook Medical. (Right) Budd with NCLifeSci board member Scott Sewell, Cook's VP of external affairs and compliance officer. (Left) Budd tries out Cook's Hemospray Endoscopic Hemostat.

James Weekley and Julian Rives of Chapel Hill Solutions, Scott Hektner with Flagship Lab Services and Leslie Wolfe of KBI Biopharma were on hand to introduce their organzations to the NCLifeSci Board of Directors Feb. 15.

On Feb. 15 at their meeting at Alexandria Real Estate Equities' Center for AgTech in Durham, the NCLifeSci Board of Directors admitted at approved and welcomed the following six new members to the organization:

• Brinter Inc. 
• Chapel Hill Solutions 
• Duke University 
• GeoSera 
• Ten63 Therapeutics 
• TriNet 

Alexandria Real Estate Equities hosted the NCLifeSci board meeting and offered a tour of their new Center for AgTech after business was concluded.

The Research Triangle area is the hottest spot in the nation for biomanufacturing.

 

That’s the pronouncement from JLL, a Fortune 500 professional services firm that specializes in real estate and investment management.

 

The global firm launched a dedicated life sciences practice in its Raleigh-Durham office in October 2022 as the region’s multi-year expansion of the sector became international news. At the end of 2023 the company dubbed the Raleigh-Durham area the number-one biomanufacturing spot.

 

Though JLL has produced a life sciences industry report for years, this is the first one that has broken out the important biomanufacturing segment. More at NCBiotech

Biocair opened a new office in Bangalore, the company’s fourth office in India. Biocair first established operations in the country in 2021 with its corporate office in Mumbai and other locations in New Delhi and Chennai. More >>

 

Biogen Inc. announced the European Commission has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in patients 16 and older, making it the first treatment approved within the EU for this neurodegenerative disease. More >>

 

Clancy & Theys Construction Company has reached a milestone: 75 years in the industry as a privately owned, family-run construction firm headquartered in Raleigh. More >>

 

G1 Therapeutics announced that the independent Data Monitoring Committee recommended continuation of the Phase 3 trial evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer to the final analysis. More >>

 

IQVIA has been named to the Fortune World's Most Admired Companies list for the seventh consecutive year. More >>

 

NALA Membranes has closed on $1.2 million of a planned $3 million convertible note to help scale up its water-purification technology, move it out of the lab and into industrial operations. More >>

 

The North Carolina Biotechnology Center is turning 40 years old. NCBiotech was founded in 1984, the first organization of its kind, as a catalyst for technology-based economic development in life sciences. More >>

 

The North Carolina Biotechnology Center awarded 19 grants and loans totaling more than $1.5 million to universities, bioscience companies and non-profit organizations in the second quarter of its fiscal year. More >>

 

The PPD clinical research business of Thermo Fisher Scientific is adding mycoplasma and additional biosafety testing capabilities to its expanding portfolio of services at its good manufacturing practices lab in Middleton, Wisconsin. More >>

 

Resilience announced the expansion of the company’s clinical and commercial drug product manufacturing capabilities across its network, which includes expanding its drug product capabilities at the company’s RTP facility . More >>

The NC Community Colleges are seeking to attract part-time (adjunct) faculty from industry and held an information session for anyone interested at Alamance Community College on Feb. 29.

 

The Community Colleges are particularly interested in employees who are close to retiring from industry with experience in bio/life science manufacturing, quality, maintenance, automation, laboratory technology, clinical research or another related area.

 

Along with Alamance, colleges represented at the event were Forsyth Tech, Wake Tech, Wilson Community College, Central Carolina Community College, Vance-Granville Community College, Durham Tech and Johnston Community College. The event was sponsored by the NCLifeSci, NSF ATE InnovATEBIO Center and the NC Biotechnology Center.

Jenae Williams (right), NCLifeSci's new director of workforce and partnerships, met her predecessor, Brenda Summers, at the Community Colleges event.

Join NCLifeSci on Thursday, March 14, for our Emerging Company and Technology Forum sponsored by Life Science Nation, SmaBio, TriNET and Wyrick Robbins. This panel will focus on "Access to Capital" and discuss funding mechanisms and provide an overview of expectations for 2024 and into 2025.

 

Our expert panel consists of

• Drew Cutshaw, senior associate and medical officer, Pappas Capital, as moderator;
• Johanna Grossman, head of healthcare & life sciences, capital markets, New York Stock Exchange;
• Eric Heil, managing partner, Medical Excellence Capital;
• Emil Runge, director of programs, DRIVe Initiative, First Flight Venture Center; and
• Anita Watkins, managing director, Rex Health Ventures.

Join First Flight Venture Center for their Third Annual March Madness Open House: Where Innovation Takes Center Court on March 22. This dynamic event brings together an ecosystem of high science, high impact entrepreneurs and supporters.

 

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

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.

Register and reserve your housing for the 2024 BIO International Convention in San Diego June 3-6. BIO is where business and breakthroughs converge, and we look forward to uniting a global network of business leaders, policymakers, investors and scientists again this June. 

 
Register before March 7. If you requested a discount code from BIO, you should have received that from them on Jan. 16. You can combine your discount with the early bird rate for additional savings. Additionally, we encourage you to book your housing early, too.

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: Mallinckrodt, Merck, Novartis and Smith Anderson. 

If you are interested in sponsoring the Legislative Reception, contact Membership Director Natacha Janvier for more details.

• FDA Forum hosted by MDMA (3/13/2024 to 3/14/2024)
• Research Triangle Life Science Real Estate Conference hosted by BISNOW (3/14/2024)
• NCLifeSci Emerging Company and Technology Forum: Access to Capital (3/14/2024)
• BIO Europe Spring with NC Booth hosted by EDPNC (3/18/2024 to 3/20/2024)
• North Carolina Global Health Careers Week hosted by NC Global Health Alliance (3/18/2024)
• North Carolina Global Health Careers Week hosted by NC Global Health Alliance (3/19/2024)
• Venture Connect hosted by CED (3/20/2024 to 3/21/2024)
• North Carolina Global Health Careers Week hosted by NC Global Health Alliance (3/20/2024)
• Diversity + Inclusion in Tech Summit hosted by NC TECH (3/21/2024)
• North Carolina Global Health Careers Week hosted by NC Global Health Alliance (3/21/2024)
• SBIR/STTR Application Tips & Resources to Support Your Small Business Research hosted by NCATS (3/21/2024)
• 3rd Annual March Madness Open House - Where Innovation Takes Center Court hosted by First Flight Venture Center (3/22/2024)
• NC Global Health Careers Week hosted by NC Global Health Alliance (3/22/2024)
• RESI South (3/25/2024 to 3/27/2024)

PSC Biotech has partnered with NCLifeSci and BIO to provide all member companies exclusive cost savings on electronic quality and audit management system solutions and professional consulting services. Through the BIO Business Solutions® Program, members of NCLifeSci and BIO will receive discounts on: 

• Quality Management Software: Adaptive Compliance Engine (ACE) and ACE Essentials,
• Audit and Inspection Management Software: AuditUtopia, and
• all professional services, including, but not limited to, commissioning, qualification and validation; computer system validation; automation system validation; quality assurance; regulatory affairs; technical writing; calibration; and project management support. 

NCLifeSci Member Benefits

• 10% discount on all professional consulting services for regulatory affairs; technical writing; audit; commissioning, qualification, and validation; computer system validation and IT; automation; calibration; engineering; and project management support.
• 35% discount on the initialization fee and user licenses for PSC Software Adaptive Compliance Engine (ACE), ACE Essentials and AuditUtopia. Subscriptions include the hosting, cloud storage, technical support, and upgrades to future versions of software.
• 21-day free trial of ACE, ACE Essentials and AuditUtopia or ACE Inspection. 

Get the critical resources you need to feed, fuel and heal the world with NCLifeSci and BIO Business Solutions. We partner with leading industry suppliers and test their services beforehand so you don’t have to. 

© Copyright 2023 North Carolina Life Sciences Organization