November 2023 Update

Serving the NC Life Sciences Industry

ncbioscience.net

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After ten months, the NC General Assembly has adjourned but under terms that leave open the possibility of additional legislative work prior to the short session in April. 

 

The House and Senate both passed an adjournment resolution on Oct. 25. However, the resolution calls the chambers back to session on Nov. 29, again on Dec. 20 and each month thereafter. During these legislative openings, the General Assembly will only be able to consider certain types of bills and provisions, and leadership in both chambers have informed members that most, if not all, the sessions will be procedural unless notice is otherwise given.

NC Congressional districts passed by the General Assembly for use in the 2024 elections

The NC General Assembly passed new congressional and legislative maps on Oct. 25 that are likely to give Republicans at least three more seats in Congress and shore up their supermajority in the state legislature.

 

Democrats say the maps are gerrymandered, and they are likely to end up in the courts. However, the NC Supreme Court ruled in April that it would not hear cases based on claims of partisan gerrymandering.

 

The Congressional map will help determine which lawmakers will stay or go. The current makeup is an even 7-7 split between Democrats and Republicans. The new map favors Republicans in ten districts and Democrats in three, with one competitive district.

 

Candidate filing for the 2024 elections runs from Dec. 4 to Dec. 15. All 170 General Assembly seats will be on the ballot. The 2024 elections will also include North Carolina's governor and the rest of the 10-person statewide Council of State, from lieutenant governor to attorney general. More at Raleigh News & Observer

NCInnovation, a new nonprofit organization backed by $500 million in state funding, has hired four regional directors to lead its operations across the state.

 

The goal of NCInnovation is to support North Carolina universities that are not the state's Tier I research universities --  UNC Chapel Hill and N.C. State -- to help them commercialize their work and turn concepts into companies that create jobs in North Carolina.

 

The four regional directors will be based at UNC Charlotte, Western Carolina University, East Carolina University and N.C. A&T State University. They will work to connect industry, capital, and academia to inform university research portfolios and identify commercialization opportunities. They will also monitor and understand university research activities to orient NCInnovation's grant making opportunities, and collaborate with university leaders to help translate research into economic output. More at BusinessNC

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

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

The World Trade Organization is negotiating new rules on intellectual property rights for COVID-19 diagnostics and therapeutics. The talks have stalled in recent months, but there is renewed interest in moving forward.

 

The United States International Trade Commission recently published a report on the production, distribution and availability of COVID-19 diagnostics and therapeutics. The report found that high-income countries accounted for approximately 80 percent of government purchases of such products but cited IP as just one of a slew of barriers that low-income economies face in accessing COVID-19 tests and treatments.

 

The greatest obstacles to securing more vaccines and treatments, the report found, are high prices and a lack of price transparency. The commission report said expanding the TRIPS decision to cover diagnostics and treatments would increase the supply of generic versions of drugs and lower prices. However, the report also acknowledges that reduced patent protections could harm innovation, potentially delaying launches of new products.

 

Several WTO members are advocating for a prompt decision on whether to expand IP flexibilities for vaccines to include diagnostics and therapeutics. South Africa urged members to reach consensus by the General Council meeting in December. China stressed the ITC’s findings that IP barriers contributed to the gap between high- and low-income economies’ access to life-saving treatments.

On Oct. 26, three BIO and associated state CSBA-member companies joined a panel briefing for Congressional staff hosted by several CSBA affiliates to explain how recent changes to Section 174 of the tax code affects small biotech companies. Section 174 now requires companies to amortize R&D expenses when previously those expenses could be deducted in the same year they were accrued. 

 

The panel urged Congress to act before the end of the calendar year to pass legislation (H.R.2673/S.866) to restore the deduction. The panelists shared how the change hinders small company cash flow, discourages applying for federal grants and threatens the American innovation pipeline for new cures and agricultural breakthroughs. 

 

NCLifeSci and our CSBA partners CLS, Biocom, BioNJ, LSPA, MassBio, MichBio, and NewYorkBIO hosted this important event.

A federal court struck down a rule on Oct. 2 allowing insurers and pharmacy benefit managers to pocket copay assistance that drug manufacturers intended for patients.

 

The Notice of Benefit and Payment Parameters for 2021 allowed insurers and PBMs to use copay accumulator programs to prevent manufacturer assistance (like copay cards and coupons) from being counted toward patients’ copay.

 

Drug manufacturers provide copay assistance to reduce out-of-pocket costs for patients. But insurers and PBMs skim from that assistance, ultimately making patients pay more for prescriptions.

 

The HIV+Hepatitis Policy Institute sued Health and Human Services in the U.S. District Court in Washington, D.C. to void the NBPP.

 

The court agreed with the plaintiffs, saying the NBPP conflicts with CMS and Affordable Care Act definitions of cost sharing and “is arbitrary and capricious for a variety of reasons, including that it defines the same statutory and regulatory language in two conflicting ways.”

Insurers must abide by the previous federal rule, allowing copay accumulators only for brand-name drugs with a generic equivalent, when permitted by state law.

Sen. John Barrasso (R-WY) and Sen. Tom Carper (D-DE) introduced the ORPHAN Cures Act (S. 3131), a companion to last month’s House bill introduced by Rep. Wiley Nickel (D-NC) and Rep. John Joyce, M.D. (R-PA).

 

The Inflation Reduction Act 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.

 

The ORPHAN Cures Act changes the incentive structure within the IRA to encourage follow-on investment into orphan drug development. Reversing IRA’s perverse incentives will eliminate the significant barrier created that would prevent new waves of rare disease drug innovation. 

Bernie Sanders (I-Vt.) has been blocking President Joe Biden's pick to lead the National Institutes of Health, Monica Bertagnolli, M.D., in an attempt to rally Democrats and the president to do more to lower drug prices, but his colleagues on the Senate Health, Education, Labor and Pensions Committee joined forces with Republicans to advance the nomination.

 

Sanders' opposition to Bertagnolli was based on his belief that she would not act aggressively against the pharmaceutical industry. Bertagnolli declined to say what steps, if any, she’d take to lower drug prices as the Senate HELP Committee considered her nomination. 

 

"If you are confirmed to be the next NIH director, will you commit to reinstating and expanding the reasonable pricing clause in NIH contracts?" Sanders asked during confirmation hearings.

 

Taxpayers deserve a fair return on their investment, Bertagnolli responded. She agreed to broadly ensure that benefits of NIH research are affordable and available but stopped short of making the commitment Sanders asked of her.

 

"I cannot give further specifics at this time about the execution of that plan," she said.

Bertagnolli similarly told ranking member Bill Cassidy (R-La.) that she couldn't commit to not using the reasonable pricing clause if confirmed.

 

In the end, Sanders allowed his panel to vote on Bertagnolli and said he would not lobby Democrats to oppose her. She was confirmed by the Senate Health, Education, Labor and Pensions Committee by a vote of 15-6, with five Republicans joining all 10 Democrats.

The Advanced Research Projects Agency for Health announced a new initiative called Advancing Clinical Trial Readiness to improve the nation's ability to conduct clinical trials safely, quickly and equitably.

 

The goal of ACTR is to enable 90% of all eligible Americans to take part in a clinical trial within a half hour of their home. To achieve this goal, ACTR will work with a diverse array of stakeholders to advance, integrate and extend clinical trial capabilities that overcome challenges in evaluating new technologies, therapies and platforms. ACTR will also focus on making clinical trials more accessible to people living in all parts of the United States, regardless of their socioeconomic status.

 

ARPA-H is currently seeking feedback on the ACTR initiative from all organizations with relevant experience and expertise. The deadline to provide feedback is Dec. 1. Following the feedback period, ARPA-H will release the final initiative description and funding opportunity.

A proposed new rule on Medicaid drug coverage is detrimental to patients and the commercial sector, the Council of State Bioscience Associations told the Centers for Medicare and Medicaid Services.

 

CSBA is a collection of BIO affiliates around the country who work collectively to support the life sciences industry at a national level. NCLifeSci is a CSBA member.

 

Proposed rule CMS-2434-P would require manufacturers to aggregate, or “stack,” price concessions provided to separate entities across the supply chain when determining the Best Price through the Medicaid Drug Rebate Program. The new rule would also expand the definition of a covered outpatient drug with a particular effect on coverage for drugs administered in inpatient settings.

 

It’s not feasible to track discounts throughout the supply chain for price stacking, and it will harm drug development, said the letter from 48 CSBA members to CMS Administrator Chiquita Brooks-LaSure. The COD change could restrict patient access to innovative treatments, the letter adds.

 

“This sweeping proposal represents a statutory overreach and will result in upending more than thirty years of historical precedent,” the letter said. “CMS has greatly underestimated the negative downstream impacts this proposed rule would have on the drug manufacturing supply chain, critical government healthcare programs such as 340B, and ultimately the patients our members seek to treat.”

The Food and Drug Administration launched a campaign to support innovation in animal biotechnology, veterinary products and animal feed through greater regulatory flexibility, predictability and efficiency.” The Animal and Veterinary Innovation Agenda released by FDA’s Center for Veterinary Medicine has four objectives to foster product development and implement smart, risk-based approaches to regulating modern animal and veterinary products.

• Support technologies and products addressing priority needs.
• Align regulatory pathways to the modern landscape.
• Enhance the One Health workforce for the future of innovation.
• Address gaps in new technologies and emerging health threats.

The FDA is planning to reassess its animal and veterinary product review programs and processes and adjust them, where appropriate, to account for the diversity of products developed using innovative technologies. More at FDA

The FDA on Oct. 11 announced it is creating an advisory committee tasked with providing outside expertise on digital health technologies, including artificial intelligence, digital therapeutics and wearables.

 

The agency is soliciting nominations for industry representatives, consumer organizations and voting members to the new digital health advisory committee. The FDA aims to have the outside panel fully operational in 2024. Once filled, the digital health advisory committee will have nine core voting members. Temporary members can be added for individual meetings.

The Inflation Reduction Act was a hot topic on day one of the BIO Patient and Health Advocacy Summit with patient advocates discussing the effect on drug development for orphan and rare disease.

 

The IRA exempts orphan drugs for rare diseases from price negotiations but only if the drugs are approved for a single indication, which creates less incentive for drug manufacturers  to test whether a new drug can treat other indications.

 

“Once these orphan drugs apply for a second designation, even though there is no revenue associated with it, they will become negotiable,” said Karin Hoelzer of the National Organization of Rare Disorders. “We think that it has a tremendous chilling effect on the pipeline, in particular for the small biotech where we get a lot of really big innovation in the orphan drug space.”

 

“My main concern about the IRA is those 95% of patients that have no treatment right now will have to wait longer,” said Jamie Sullivan of the EveryLife Foundation for Rare Diseases. “And our mission is to get people the right treatment at the earliest possible moment.”

 

The House of Representative's bipartisan Optimizing Research Progress Hope and New Cures Act, cosponsored by Rep. Wiley Nickel, changes the incentive structure to encourage follow-on investment into orphan drug development.” The Senate companion to the legislation was introduced on Oct. 25. More at BIO

Three Triangle area public school systems, in partnership with community college systems and several supporting companies, have stepped up to offer their students a certificate program to help them prepare for careers in biomanufacturing.

 

Starting in Spring 2024, Johnston County Public High Schools and Durham Public Schools will offer BioWork, a statewide certificate program that teaches the fundamentals of working as a process technician in the biotechnology, pharmaceutical, or chemical manufacturing facilities. 

 

Johnston Community College and Johnston Country Public Schools, with support from Novo Nordisk and Grifols, are partnering to offer BioWork in all of Johnston County’s traditional public high schools.

 

Early college students in Wake County also have the opportunity to complete BioWork. Last week BioWork students at Wake Tech, Wake County Public Schools' Wake Early College for Information and Biotechnologies, and biopharma students at Vernon Malone College and Career Academy received lab coats donated by FUJIFILM Diosynth Biotechnologies. The company is sponsoring 500 lab coats for current and future biotechnology students. More at NCBiotech

Womble Bond Dickinson warns that, beginning January 1, 2024, many domestic and foreign entities registered to do business in the United States must comply with new information reporting requirements under the federal Corporate Transparency Act.

 

The CTA aims to combat money laundering, terrorism financing, and illicit activities. “Reporting Companies” must file and maintain a report with the Financial Crimes Enforcement Network that includes identifying information for Reporting Companies, beneficial owners, and company applicants. The reporting requirements have implications for a wide range of entities and may require extensive data-gathering and monitoring efforts. Learn more at WBD

Updated regulatory working groups announced today by the Biotechnology Innovation Organization reflect the rapidly increasing diversity and impact of BIO’s Agriculture & Environment membership and ensure that all member companies’ regulatory and policy needs are met.

 

BIO’s Agriculture & Environment regulatory working groups now include an Agricultural Biologicals Working Group and a Biobased Manufacturing Working Group, as well as a Plant Working Group and an Animal Working Group.

 

The major change in the working group structure is the creation of the Agricultural Biologicals Working Group and the Biobased Manufacturing Working Group, which reflects the growth of both sectors. The agricultural biologicals sector includes, but is not limited to, food ingredients, enzymes for food processing, alternative proteins, and small molecules and microbes for crop inputs. The biobased manufacturing sector includes biobased energy, biochemicals, bioplastics, biobased materials and other products of industrial biotechnology. More at BIO 

Amgen completed its acquisition of Horizon Therapeutics Oct. 6 for $116.50 per share in cash, representing a transaction equity value of approximately $27.8 billion. More >>

 

Atsena Therapeutics has rasied $24.5 million from investors to support the development of its subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis, a condition that leads to progressive vision loss and has no approved treatments. More >>

 

BioCryst Pharmaceuticals, Inc. announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases. More >>

 

Cambrex completed its $38 million capacity expansion at its small molecule active pharmaceutical ingredient manufacturing facility in High Point that doubles the facility’s manufacturing capacity. More >>

 

G1 Therapeutics, Inc. announced that COSELA® (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology small cell lung cancer guidelines for patients with untreated or previously treated extensive-stage small cell lung cancer. More >>

 

IQVIA and the Coalition for Epidemic Preparedness Innovations today announced a strategic collaboration to advance the 100 Days Mission to enhance the world’s preparedness to rapidly conduct life-saving clinical research for vaccines and other biological countermeasures. More >>

 

Johnson & Johnson Innovative Medicine's Rocio Lopez received a 2023 Leaders in Diversity Award from the Triangle Business Journal. More >>

 

Novo Nordisk will collaborate with GE HealthCare to further advance the clinical and product development of peripheral-focused ultrasound, which activates the nervous system to stimulate a response that may be able to treat disease. More >>

 

Novo Nordisk announced that the FDA has approved Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference therapy, to lower urinary oxalate levels in patients with primary hyperoxaluria type 1 and relatively preserved kidney function. More >>

 

Syneos Health, Inc.'s Raymond Huml received a 2023 Leaders in Diversity Award from the Triangle Business Journal. More >>

 

Syneos Health, Inc. has appointed Colin Shannon as its chief executive officer, succeeding Michelle Keefe, who will continue as a key member of the Syneos executive leadership team. More >>

 

Thermo Fisher Scientific and Boehringer Ingelheim Pharmaceuticals, Inc. announced a companion diagnostic partnership to develop CDx tests to help identify patients with non-small cell lung cancer with specific genomic mutations. More >>

 

UCB announced that ZILBRYSQ (zilucoplan) has been approved by the FDA for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody-positive. More >>

 

UCB announced that the FDA has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. More >>

This session, "Recruiting and Retaining Study Participants," will look at the use of AI/AIML in clinical trials, what AI options are being used, the use of connected devices and wearables, how we can streamline costs to make trials more affordable and when to start thinking and planning for study participants. Hann Yew, partner at McKinsey & Company, will moderate the session.

Panelists

• West Barnes, senior director of product management, IQVIA
• Tyler Van Horn, vice president of corporate strategy and chief of staff, Science 37
• Lana Wahid, associate chief of hospital-based clinical trials & research program, Duke University School of Medicine

Thank you to our sponsors ADP, Clancy & Theys Construction Company and YourBio Health. If you are interested in sponsorship, contact NCLifeSci Membership Director Natacha Janvier.

Join the Intellectual Property Section of the NCBA for the In-house Counsel Event in Durham. Listen to presentations and enjoy food and drink with your colleagues.

 

With the Supreme Court’s recent decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), redirecting the legal analysis for enablement and creating considerations for written description, applicants and patentees need to recraft IP strategies for capturing early-stage technologies that functionally claim their invention. Julie Meigs, Ph.D. (Womble Bond Dickinson), and Bernard Brown II, Ph.D. (Michael Best), will offer guidance in the post Amgen v. Sanofi era.

 

Wednesday, Nov. 8 | 5 to 7 p.m.

It's a Southern Thing | 605 W Main St, Durham, NC 27701

Register by 5 p.m., Monday, Nov. 6

Robert A. Ingram, who died in March at age 80, was one of the most important leaders in North Carolina life sciences. He also believed in championing the next generation of leaders and took a special interest in identifying and mentoring women, many of whom have gone on to stellar careers in business, government and public service.

 

This free public event, sponsored by NCBiotech, pays tribute to this lesser-known aspect of his legacy, featuring some of the women he encouraged to dream big and make a lasting impact. The event includes the announcement of the first Robert A. Ingram Fellowship in Corporate Governance, selected by the NACD Research Triangle chapter and RTI International.

 

Friday, Nov. 10

8:30 a.m.

NC Biotechnology Center

The Diversity Movement is offering its Executive Presence Training to the public for the first time. This workshop is ideal for organizational leaders who want to hone their presentations skills, enhance their inclusive language and learn executive presence in order to exude positive energy and confidence. Leaders will get hands-on, one-on-one training in a group setting. It’s also a chance to meet and network with other TDM clients during this four-hour professional development workshop.

 

Monday, Nov. 13

9 a.m. to 1:30 p.m.

The Diversity Movement's Raleigh Office

Register today for MDMA's 2023 Reimbursement & Health Policy Conference being held in Washington, DC Nov. 8-9.  

 

MDMA is the leading voice for innovative and entrepreneurial medical device companies, and this year's Reimbursement & Health Policy Conference will deliver key insights on MedTech reimbursement and market access issues. 

• MDMA Members - $695
• State Members - $795
• Non-Members - $895 

Contact Amber Niebauer for a discount code worth $100 off the registration fee.

In conjunction with NCBiotech, NCLifeSci is hosting an opportunity to learn about the Pfizer Ignite Program, a new offering for biotech companies seeking a collaborative partner to help them advance the development of their promising breakthrough therapies. 

 

At this event, attendees will learn more about how Pfizer Ignite partners with early-stage biotech companies to accelerate their drug development. Attendees will also have the opportunity to speak with Pfizer leaders about the innovative new Ignite offering.

Sponsored by NCLifeSci, the focus of this year's NC Policy Forum will be biomarker testing and the critical role it plays in helping ensure patients receive effective treatment in a timely manner. Research, innovation and public policy changes around biomarkers have the potential to completely change the future of cancer care. Our event will bring together clinicians, advocates and patients to discuss the vast benefits biomarker testing provides in patient care and precision treatment.

 

Nov. 14, 10:30 a.m.
SAS Executive Briefing Center, Cary

The High Flyer Awards Luncheon celebrates and honors those companies and individuals who have contributed to high science, high impact innovation and the entrepreneurial ecosystem as a whole.

 

Join First Flight Venture Center in celebration of the entrepreneurial spirit at our Third Annual High Flyer Awards Luncheon on Nov. 17 from 11 a.m. - 1 p.m. at Prestonwood Country Club.

Join BIO's IP Task Force a lunch in support of Rep. Deborah Ross of North Carolina's Second Congressional District. 

Friday, Dec. 1
12 - 1 p.m.
La Collina
747 C St. SE, Washington D.C.

 

Respond to Amy Strathdee or Maddie Campbell at (202) 271-9682 or at MaddieC@StrathdeeGroup.com. 

Levels

$5,000 Chair
$2,500 Host
$1,000 Supporter

Deborah Ross for Congress
c/o The Strathdee Group
PO Box 15096
Washington, DC 20003

Contributions or gifts to Deborah Ross for Congress are not tax deductible. We may accept contributions from an individual totaling up to $3,300 per election. Federal PACs may contribute up to $5,000 per election. Federal law prohibits contributions to the campaign from corporations, labor organizations and national banks; from any person contributing another person's funds; from foreign nationals who lack permanent resident status; from federal government contractors. Federal law requires us to use our best efforts to collect and report the name, mailing address,occupation, and name of the employer of individuals whose contributions exceed $200 in an election cycle.

For over two decades, the annual Genesis conference has brought key Life Science opinion leaders and stakeholders together to debate key trends, instigate deals and generate a vision of the future.

 

Genesis offers a high content mix of plenary talks and panels from key opinion leaders, 1-2-1 Partnering, an exhibition assembling an array of providers supporting the life science sector, ample networking opportunities and online Innovation Workshops.

 

NCLifeSci members can contact Amber Niebauer for a discount code worth 10% off the registration fee.

• Upstream Production Process Development for Biopharmaceuticals hosted by BTEC (10/23/2023 to 11/3/2023)
• Resilience in the Global Health Ecosystem hosted by NC Global Health Alliance (11/1/2023)
• NC Neurodiversity College Career Summit hosted by NC Business Committee for Education and Duke University (11/3/2023)
• Reimbursement and Health Policy Conference hosted by MDMA (11/8/2023 to 11/9/2023)
• NCLifeSci Clinical Research Luncheon and Forum: Recruiting and Retaining Study Participants (11/8/2023)
• Creating a Compelling Pitch and Presentation hosted by LaunchBio (11/8/2023)
• Carolina Startup Connect hosted by Innovate Carolina (11/8/2023 to 11/9/2023)
• In-House Counsel Event hosted by NC Bar Association (11/8/2023)
• Export Coffee Talk: Using Digital Outreach to Increase International Sales hosted by EDPNC (11/9/2023)
• Round Table Dinner hosted by NC Regulatory Affairs Forum (11/9/2023)
• CEO Center Program at MEDICA  (11/13/2023 to 11/16/2023)
• Executive Presence Workshop hosted by The Diversity Movement (11/13/2023 to 11/14/2023)
• Pfizer Ignite: Creating Partnerships to Enhance Program Value and Accelerate Therapies (11/13/2023)
• The Future of Cancer Care: Biomarker Testing hosted by American Cancer Society Cancer Action Network (11/14/2023)
• Export Education: International Documentation hosted by EDPNC (11/16/2023)
• The Right Fit: How to Identify and Approach the Right Investors hosted by LaunchBio (11/16/2023)
• NC Community hosted by RTP (11/16/2023)
• High Flyer Awards Luncheon hosted by First Flight Venture Center (11/17/2023)
• Negotiating Deals and Building Strong Investor Relationships hosted by LaunchBio (11/29/2023)
• Genesis: Maximising Returns from Life Science Innovation hosted by One Nucleus (12/7/2023 to 12/8/2023)

Did you know that only about 33% of eligible biotech companies are taking advantage of the R&D tax credit?

 

If you’re developing, modifying, designing, supporting, or supervising research activities, here are just a few R&D activities that generally qualify for this tax credit:

• Product design, development, and testing new scientific theories and research methods
• Designing new drugs, chemical compounds or medical devices
• Design and execution in experiments or trials
• Creation of therapeutics, repurposing or reformulating existing drugs
• Prototypes of new products or extending the shelf life of existing products
• Establishing new technologies to further telemedicine
• Creating or improving engineering processes

This is a limited time promotion! Nikon is eager to help accelerate your research! That's why for a limited time, they're offering a free consultation and up to four hours of microscope-based imaging.

 

The Nikon BioImaging Lab provides contract research services for microscope-based imaging and analysis. Capabilities include not only access to cutting-edge microscopy instrumentation and software but also the services of expert biologists and microscopists who are available to provide quality cell culture, sample preparation, data acquisition and data analysis services. 

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