July 2021 Update

Serving the NC Life Sciences Industry

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Did you miss out on BIO Digital 2021 held online June 10-11 and 14-18? The event spotlighted biotech’s transformative role and impact on today’s four key challenges: COVID, social justice, the economy and climate change.

It's not too late to enjoy the massive amount of content and information that came out of this event. BIO blogged about every session over four days, and NCBIO has boiled it down for you in this roundup of the speakers and sessions that made the event so important.

You can still catch up on this year's content in the BIO Digital Event Hub until July 18. Just register for a fee and watch on-demand whenever you like. Select sessions are also available at bio.org/bestofbio.

The Coalition of State Bioscience Institutes released the 2021 Life Sciences Workforce Trends Report in June 2021 at the BIO Digital Convention. The report provides a national snapshot of the current and anticipated talent needs of the nation’s dynamic life science industry.

The report leverages intelligence drawn from interviews with industry executives across the nation, a national human resources hiring survey and real-time job postings analysis to frame key themes, challenges and opportunities for the life science industry from a workforce and talent perspective. NCBIO members participated in the survey that informed the report, and ten North Carolina executives were interviewed for it.

Visit the NCBIO website to get the report and watch a video that breaks down the findings.

If you have questions or concerns on any of these topics, please contact Laura Gunter.

The NC Senate voted 32-17 to approve its proposed state budget (SB 105) with enough support to override a potential veto from Gov. Roy Cooper.

The bill incorporates the tax provisions passed by the Senate in HB 334, with one modification. HB 334 reduced the personal income tax rate from 5.25% to 4.99% for taxable years beginning on or after January 1, 2022. SB 105 would continue to reduce the rate from 4.99% to 3.99% over the 2022-2025 taxable years.

The package includes a corporate income tax phase out over the next five taxable years, beginning in 2024. It also simplifies the franchise tax base calculation, and for some taxpayers, reduces the amount of franchise tax due by eliminating the two tax bases calculated using property values. The franchise tax change is effective for taxable years beginning on or after January 1, 2023, and applies to the calculation of franchise tax reported on the 2022 and later corporate income tax returns.

The Senate budget would give 3% average raises to teachers and most other state employees over the next two years. It also doles out $5.4 billion in federal American Rescue Plan Act funds for coronavirus relief.

Senate lawmakers have allocated a nonrecurring $2 million in the state budget for the One North Carolina Small Business Program to increase state grants to businesses that win federal SBIR/STTR grants. There are also grants available to help companies apply for these federal funds.

A bill passed by the House (HB 965) sought $2 million in recurring funds and $7 million in nonrecurring dollars for the program. Nonrecurring funds must be appropriated in each budget and do not carry over from budget to budget.

Both HB 965 and the Senate budget would also help North Carolina businesses by funding the entire cost of submitting the applications for SBIR/STTR grants if the business is in one of the state’s poorer Tier One or Tier Two counties — up from 50% in the current program. The maximum grant would increase from $3,000 to $12,000. For businesses that win a federal grant award, the state’s matching dollars would increase from a maximum of $100,000 to $200,000.

NCBIO is working to ensure that the full $9 million for the program is included in the House version of the budget that would then be reconciled with the Senate's in conference committee. There is good support for this amount from the speaker's office.

The House Energy and Public Utilities Committee met to discuss HB 951, a bill that proposes changes to the electric grid and power generation in the state. The bill proposes closing various coal-fired plants and provides a plan to reliably replace that energy generation.

There is some opposition to the bill. One estimate suggests it could cause 50% rate hikes over the next 10 years. Some conflict also comes from a reliance on natural gas as the replacement energy source in some instances, but the legislation also adds an additional 777 megawatts of generation capacity from renewable energy to the program. NCBIO is monitoring this bill.

BIO led nearly 300 biotech CEOs from companies big and small around the globe in signing a declaration. Michelle McMurry-Heath, M.D., Ph.D. made clear: “Many of the companies who signed this letter have no assets other than their intellectual property, so this declaration is an important signal we won’t just allow our hard-earned science to be poached.”

NCBIO signed the letter, along with CEOs from NC companies that include 21MedTech, 9 Meters Biopharma, BioKier, Statera Environmental, Vestaron, ZY Therapeutics and Zymeron Corporation. MORE >>

The U.S. Innovation and Competition Action of 2021 (S.1260), formerly known as the Endless Frontiers Act, passed in the Senate on June 8. The act authorizes $110 billion for basic and advanced technology research over a five-year period. The bill would provide $57 billion for the National Science Foundation's regular research activities, $29 billion for the new technology directorate and $17 billion for the Department of Energy's national labs over five years. One of the key technology focus areas of the new directorate includes biotechnology and synthetic biology.

The House approved the National Science Foundation for the Future Act, which passed with much less fanfare that USICA. The House bill would more than double NSF funding over five years to approximately $18 billion by FY 2026. With the House passage, lawmakers will need to work out differences between the two competing versions to expand the federal government's research and development spending. Whether that process includes a formal conference remains to be seen. However, with both bills getting broad bipartisan support in both Chambers, hopefully we’ll end up with a final bill that will significantly increase research funding for biotechnology.

The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act would help address R&D funding gaps. The bill was reintroduced in late June by Sens. Michael Bennet (D-CO) and Todd Young (R-IN) and Reps. Mike Doyle (D-PA) and Drew Ferguson (R-GA); it was first introduced late last year. This legislation is a top priority that BIO has been engaged on. MORE >>

The Centers for Medicare and Medicaid Services announced Daniel Tsai as deputy administrator and director of Center for Medicaid and CHIP Services. Tsai comes from Massachusetts where he served as the assistant secretary for MassHealth and Medicaid director.

To be included in Member News, send information about your organization to David Etchison.

AskBio announced that the FDA has granted Fast Track Designation for AskBio's LION-101 gene therapy program, a novel recombinant adeno-associated-virus-based vector being developed as a one-time intravenous infusion for treating limb-girdle muscular dystrophy type 2I/R9. MORE >>

BD has partnered with USA Swimming, the national governing body for the sport of swimming in the United States, to provide COVID-19 testing at USA Swimming events. MORE >>

Biogen and Eisai announced that the FDA has granted accelerated approval for ADUHEL (aducanumab-avwa) as the first Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. MORE >>

Biogen Inc. announced topline results from its Phase 2 TANGO study of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer’s disease. MORE >>

Chimerix received FDA marketing approval for the tablet and oral suspension formulations of its smallpox treatment TEMBEXA (brincidofovir). MORE >>

Eisai and Biogen announced that the FDA has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of Alzheimer’s disease. MORE >>

G1 Therapeutics, Inc. appointed Alicia Secor to its board of directors. Secor currently serves as president and chief executive officer of Atalanta Therapeutics, Inc. and is a member of its board of directors. MORE >>

Glycan Therapeutics is now offering heparan sulfate analysis from biological samples. As little as 1 ml of biological fluid or a few milligrams of tissue is sufficient for an accurate analysis. MORE >>

Grail Pharma released the results of its final study showing its cancer-tracing blood test found it was accurate at detecting a range of different tumors at early stages with just a 0.5% false positive rate. MORE >>

Grifols will donate nearly 100 acres of land to the town of Clayton and Johnston County Community College to allow the college to expand its campus. MORE >>

Heat Biologics will expand its research and development facilities in Morrisville. The expansion will support the addition of enhanced research and development capabilities including in-house synthesis of antibodies and other drugs/reagents as well as an expanded vivarium for onsite pre-clinical studies. MORE >>

Kriya Therapeutics announced that Ilise Lombardo, M.D., has joined the company as chief medical officer. Lombardo will lead Kriya’s clinical and medical organization responsible for advancing a pipeline of gene therapy candidates across multiple therapeutic areas. MORE >>

NC Biotech executive board member M. Michelle Berrey, M.D., has been appointed  president of research & development and chief medical officer at New-York-based Intercept Pharmaceuticals, Inc. MORE >>

Novan closed its public offering of 3.6 million shares of common stock at a public offering price of $11.00 per share. The gross proceeds from the offering were approximately $40 million. MORE >>

Sage Therapeutics, Inc. and Biogen Inc. announced that the WATERFALL Study in patients with MDD met its primary endpoint with zuranolone (SAGE-217/BIIB125) 50 mg showing statistically significant improvement in depressive symptoms. MORE >>

Thermo Fisher Scientific will begin making “hundreds of millions of doses” of Moderna's COVID-19 vaccine at Thermo Fisher's Greenville facilities this summer under an agreement with Moderna announced in early June. MORE >>

NCBIO members are eligible for BIO Business Solutions volume-based discounts and favorable contract terms to help you save on products and services you already use. How does it work? Here it is in four simple steps!

• Browse our cost-savings programs – from lab supplies and equipment, research-grade microscopes, office supplies, shipping, insurance, research services and more.
• Contact us – Fill out a short inquiry form to let us know which cost-saving options you’re interested in hearing more about.
• Sign up – Depending on the program, you can enroll yourself, talk to the partner for more information, and/or start a free trial.
• Enjoy the benefits – Once your account is set up, your savings will be in place. If you have questions or need support, our team is always here to help! 

For all the latest news, promos and event information, follow BIO Business Solutions on LinkedIn.

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Software - Latest Agilent software, licensed to your lab
Panels - Cosmetic panels upgraded to latest instrument design

The FDA has suspended routine onsite domestic inspections until further notice in response to the COVID-19 pandemic. The FDA has signaled that they will implement alternative methods in order to continue inspections, including using remote applications. The FDA will be releasing a revision to their Inspection Manual to address their remote inspection procedures and requirements.

PSC Software recognizes the urgent need to continue both FDA inspections and other audits for its clients allowing their products to progress through the regulatory approval process while maintaining compliance. With this shift in how inspections will be performed, PSC Software has developed a new functionality in its industry-leading real-time inspection management software, ACE Inspection, to facilitate remote inspections and audits.

ACE Inspections will be available in July.

Tuesday, July 13
12:00 - 1:30 p.m.

The pandemic has caused employers to pause and rethink their return to work and office space need for employees. Many of these employees will return to work on site, but for others the remote environment may continue. For office space that is no longer needed, employers are repurposing those spaces for expanded lab and/or flex space.  And perhaps, landlords are more willing to repurpose space to fit laboratory needs.

Hear from our panel of experts as they help companies like yours navigate this journey.

• Sue Back, life sciences practice group lead, Davis Moore Advisors
• Crystal Booth, regional manager, PSC Biotech
• ​Pat Chisholm, senior vice president, BE&K Building Group
• Krista Covey, president, First Flight Venture Center (moderator)
• Blake Stevens, Ph.D., vice president, science and technology, Alexandria Real Estate Equities

​​Thanks to our sponsors: Alexandria Real Estate Equities, American Laboratory Trading, BE&K Building Group and Davis Moore Advisors.

Join NCBIO members in this virtual event to hear about best practices for engaging a diverse workforce in the life science industry. Hear from panelists on recruiting and attracting a diverse workforce and retaining and engaging diverse employees.

More details about the speakers will be released in the coming weeks.

Event co-chairs are Shaylah Jones, government & public affairs, Novo Nordisk, and Neil Jones, vice president, corporate strategic partnerships, Lindy Biosciences.

Join us for NCBIO’s Annual Meeting on Tuesday, Oct. 5. This year’s Annual Meeting is a hybrid event that can be attended virtually or in person and is scheduled from 8:15 a.m. to 3:30 p.m.

North Carolina features a critical mass of life science companies. Join us to hear from four homegrown companies from various sectors as they share their stories on navigating the stages of success.

• Juliana Blum, Ph.D., co-founder and executive vice president, corporate development, Humacyte
• Gil Golden, M.D., Ph.D., executive vice president and chief medical officer, United Therapeutics
• Ken Reali, chief executive officer, Bioventus
• Speaker TBD, AgBiome

The Biomanufacturing Training and Education Center at NC State is excited to be resuming their professional development program. While filling fast, registration remains open for several 2021 professional development courses:

Hands-on learning opportunities include training in filtration (Oct. 26-29), raw materials testing (Dec. 1-3), and protein precipitation and crystallization (Dec. 14-16). In addition, BTEC's expanded online training options include fundamentals of biomanufacturing (ongoing), latest trends in downstream processing (ongoing), chemical modification of protein therapeutics (Sept. 7-10), and upstream process development (Oct. 11-22).

Contact Erica Vilsaint to register and learn about available discounts.

• BTEC Hands-On cGMP Biomanufacturing Operations Course (6/29/2021 to 7/2/2021)
• BTEC Analytical Methods for Raw Materials Testing Course (7/7/2021 to 7/9/2021)
• Larger than Life Science: Make it Newsworthy - Best Practices for Getting the Word Out hosted by LaunchBio (7/8/2021)
• Problem Solving with Prototypes hosted by Hangar6 (7/13/2021)
• NCBIO Lab Space Forum: Changing Landscape of Office and Lab Space (7/13/2021)
• BTEC Analytical Methods for Gene Therapy Vector Characterization and Testing Course (7/20/2021 to 7/23/2021)
• National AgTech Forum: Food Safety Innovation in Produce - Staying Ahead of the Curve hosted by NCBiotech (7/21/2021)
• BTEC Automation and Process Control of Yeast Fermentation Course (7/27/2021 to 7/30/2021)
• BTEC Biopharmaceutical Lyophilization and Spray Drying Course (8/3/2021 to 8/6/2021)
• BTEC Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy Course (8/3/2021 to 8/6/2021)

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