December 2022 Update

Serving the NC Life Sciences Industry

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North Carolina Republicans came within one seat in the House of gaining a supermajority in the state General Assembly. The GOP did gain a supermajority in the North Carolina Senate, holding 30 of 50 seats. A supermajority is when a party holds two-thirds of the seats in the legislature, which gives it enough votes within the party to override a veto from the governor.

 

Life Science Caucus co-chairs Sen. Paul Newton (R-Cabarrus, Union), Sen. Mike Woodard (D-Durham, Granville, Person), Rep. Robert Reives (D-Chatham, Durham) and Rep. Donna McDowell White (I-Johnston) were all reelected.

 

The Senate Republican Caucus chose Newton to be Senate majority leader. Reives has said he will see another term as House minority leader. House Democrats will meet to select their leaders on Dec. 5.

During the second-to-last State Board of Community Colleges meeting of 2022, board members allocated more than $16 million to support the bioscience industry.

 

The board approved the allocation of nearly $16.5 million to 10 community colleges and the system office to support the bioscience industry sector. The funds came from the Build Back Better Regional Challenge Grant from the U.S. Department of Commerce Economic Development Administration. $15 million will go to the 10 colleges, and $1.4 million will be retained by the system office to administer the grant. More at EdNC

After the Nov. 8 midterm elections, the U.S. House of Representatives will be controlled by Republicans by a slim majority. Republicans currently hold 220 seats to the Democrats' 213 with 218 seats needed to form a majority. Vote counting continues in some states, and the last two seats are expected to go to Republicans.

 

Republican U.S. Rep. Ted Budd won North Carolina's open Senate seat. The three-term House member defeated Democrat Cheri Beasley and will succeed retiring GOP Sen. Richard Burr.

 

In House races, Democrat Wiley Nickel defeated Republican Bo Hines in North Carolina's 13th Congressional District. The newly redrawn 13th District was considered one of the most competitive in the state. The district includes the southern half of Wake County, all of Johnston County and parts of Harnett and Wayne counties. Nickel?s win creates a 7-7 split in the state?s delegation, marking the best showing for state Democrats after a decade of trailing the GOP in an otherwise closely divided state.

 

In another key area, Democrat Don Davis, who served six terms in the N.C. Senate, has become the new representative for North Carolina's 1st Congressional District. Davis replaces retiring Rep. G.K. Butterfield, who served as a congressman for almost 20 years. District 1 runs from Rocky Mount to Elizabeth City and borders Virginia. Democrat Valeria Foushee, who has served in both the NC House and Senate, succeeds long-time Rep. David Price in the 4th Congressional District.

 

Democrats have retained Senate control for the next two years with 50 seats and the tie-breaking vote of Vice President Kamala Harris. Overall, the political parties each held their current seats, except for one Democratic pickup in Pennsylvania with John Fetterman?s defeat of Mehmet Oz. A runoff in Georgia for the final Senate seat between incumbent Sen. Raphael Warnock (D) and Herschel Walker (R) is pending, leaving one seat still undecided.

 

Congress is back in session as it needs to finalize the appropriations process (likely in an omnibus package that will have lots of legislative measures tacked on) and the National Defense Authorization Act, among other issues.

 

The 118th Congress will be sworn in on Jan. 3, 2023.

A group of 14 House New Democrats, including NC Rep. Deborah Ross, told U.S. Trade Representative Katherine Tai that a World Trade Organization decision on intellectual property rights for COVID-19 vaccines could have ?unintended adverse consequences? if extended to tests and treatment.

 

In a Nov. 10 letter to Tai, the lawmakers said they were ?concerned that an extension of the TRIPS waiver for COVID-related therapeutics and diagnostics will have unintended adverse consequences, such as hampering American manufacturing and shifting jobs to foreign countries.? The signatories include House Ways & Means Committee members Bradley Schneider (IL), Ron Kind (WI), Stephanie Murphy (FL), Stacey Plaskett (VI) and Terri Sewell (AL).

 

"The expansion of a TRIPS waiver risks the transfer of innovative technologies and jobs to foreign countries. As you formulate the U.S. position on extending the TRIPS waiver to COVID-related therapeutics and diagnostics, please consider these possible consequences of your decision," the authors wrote. They asked Tai to respond to seven questions asking about the effect of the TRIPS waiver on vaccine supply and on American businesses along with possible alternatives for meeting the administration's goals.

 

?Coming on the heels of the bipartisan Senate letter on the same subject, it is clear that opposition to the expansion of the TRIPS waiver to therapeutics and diagnostics is bipartisan,? says David Lachmann, BIO?s senior director of federal government relations. NC Senators Richard Burr and Thom Tillis signed last month's Senate letter.

 

The New Democrat Coalition is made up of more than 94 Democrats who consider themselves to be supportive of economic growth, innovation and fiscally responsible policies and seek to bridge the gap between left and right by challenging outmoded partisan approaches to governing. 

The U.S. Department of Health and Human Services signaled it will extend the COVID-19 public health emergency beyond Jan. 12.

 

Many health care stakeholders recently urged the Biden Administration to maintain the PHE and related policies through the winter to help address a potential COVID surge and to grant states more time prepare for the Medicaid redetermination process slated to restart once the emergency ends. The move also provides the telehealth industry additional time to convince Congress to further extend, or make permanent, regulatory flexibilities that vastly expanded virtual care during the COVID-19 pandemic.

 

In the past, HHS has extended the PHE in 90-day increments, so the PHE is now expected to be extended until mid-April. HHS most recently extended the PHE on Oct. 13, which carries the emergency through Jan. 12.  

The Senate passed bipartisan legislation Nov. 28 that would codify a U.S. Patent and Trademark Office program to accelerate patent reviews that address global humanitarian needs.

 

The measure (H.R. 5796), known as the Patents for Humanity Act, would put into law a pilot program that provides an acceleration certificate to expedite patent reviews and appeals. The annual competition provides awards in five categories: medicine, nutrition, sanitation, household energy, and living standards.

 

The Senate passed the bill by unanimous consent as amended; the House passed a similar version earlier this year with broad support. The bill now goes back to the House.

The NCBIO Board of Directors met Thursday, Nov. 17, at the Wake Tech RTP Campus.

 

Members of the Board's Executive Committee were approved. They are Neal Fowler (chairman) of Pathalys Pharma, Tom Adams of Pairwise, Daniel Amburn of UCB, Sinu Bhandaru of Precision Biosciences, Chris Capel of Smith Anderson, Bill Edwards of Merz, Tom Fagley of Hughes Pittman & Gupton, Bennett Love of BioKier, Mike McBrierty of Biogen, Julie Meigs of Womble Bond Dickinson, Scott Sewell of Cook Medical, Susan Thompson of IQVIA and Christine Vannais of FUJIFILM Diosynth.

 

The board was updated on the organization's strategic planning process and budget, the value afforded by the BIO Business Solutions program, state and federal policy goals and the status of the Sam Taylor Scholarship Fund, which has received $225,000 in gifts and pledges.

The board unanimously approved and welcomed the following new members:

• AES Clean Technology's sole focus for over 35 years has been providing cleanrooms and critically controlled environments. 
  
• Clancy & Theys is headquartered in Raleigh and known nationwide for its excellence in the construction industry and is among the nation?s Top 100 CM at-Risk providers.
  
• E4H Architecture's future-focused strategists and visionary health architects create flexible, state-of-the-art facilities designed to enhance the well-being of patients, staff and families.
  
• Facility Logix, LLC one of only a few leading facility-related consulting services firms in the country that specializes only in the life sciences industry.
• GXP Storage, LLC provides flexible off-site GXP compliant storage in restricted access facilities located in North Carolina to meet the growing needs of our life science clients.
  
• IngateyGen, LLC works to deliver innovative, allergen-free peanuts with improved safety and nutritional value that offer enhanced health and wellness benefits for consumers.
  
• TeamLogic IT is a national provider of technology services and solutions for businesses of all kinds. 
  
• McGough brings six generations of experience to prominent, distinctive and complex projects from renovations to new construction.
  
• NAI Tri Properties is a trusted partner with 29 years of experience and the local insight and industry expertise to professionally manage all your commercial real estate needs. 
  
• Neurocrine Biosciences, Inc. has applied its unique insights into neuroscience to advance medicines for neurological, endocrine, and psychiatric disorders for three decades. 
  
• Oerth Bio, LLC designs targeted protein modulators specifically for plant health applications by harnessing a naturally occurring protein recycling system. 
  
• PHC Corporation of NA is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in development and manufacturing of laboratory equipment.
  
• Sikich is one of the largest CPA firms in the United States and specializes in technology-enabled professional services.
  
• SpiraTec Solutions, Inc. develops comprehensive process control solutions for industries such as (bio)pharmaceuticals, chemicals and petrochemicals. 
  
• TimelyText, Inc. provides instructional designers, technical writers, marketing content writers, corporate communicators, and project managers on a contract basis.
  
• uMotif provides the next generation eCOA/ePRO and engagement platform designed to power clinical, post-marketing and real-world research.

Following the meeting, Wake Tech President Scott Ralls spoke briefly to the board and new member guests. Board members were then given a tour of the campus's new Lily Science and Technology Center, which houses the Sam Taylor BioWork lab, RTP Bio, the Fujifilm Diosynth Biotechnologies Early College Suite and the Amgen Co-Laboratory. 

New NCBIO member representatives

Board members explore the Sam Taylor BioWork Lab

The North Carolina Biotechnology Center awarded 23 grants and loans totaling over $1.4 million to bioscience companies, universities and nonprofit organizations in the first quarter of its fiscal year.

 

The awards, made in July, August and September, will support life sciences research, technology commercialization and entrepreneurship throughout North Carolina. The funding will also help companies attract follow-on funding from other sources.

 

Twenty-five bioscience companies that previously received loans from the Biotech Center raised $256 million in follow-on funding from other sources in the first quarter, according to research by the Biotech Center?s Life Science Intelligence staff.

 

Universities received research grants totaling $863,093 from three programs.

 

Three universities and one nonprofit organization received grants totaling $28,250 to sponsor regional events or national meetings in the life sciences. 

 

NCBiotech awarded the City of Greenville a $100,000 Partnership Development Grant to expand the Pharma K12 program. It provides local high school graduates the opportunity to train at the NC Pharmaceutical Services Network at Pitt Community College and interview for careers at Thermo Fisher Scientific. More >>

GRAIL?s Galleri multicancer early detection test was included in Time Magazine's Best Inventions of 2022 list.

 

The magazine reported that Galleri can screen for over 50 types of cancers ? about 10 times as many as can be screened for with current recommended tests. Galleri?s machine learning technology looks for circulating tumor DNA from a blood draw and claims a low false positive rate and high positive predictive value. In the recent Pathfinder study, about 50% of the detected cancers were early stage. More at GRAIL

Sheila Mikhail, CEO and co-founder of the pioneering gene therapy company AskBio and a member of the NCBIO Board of Directors, was honored as one of 20 ?Fiercest Women in Life Sciences 2022? by industry publication Fierce Pharma.

 

Mikhail was named the Overall U.S. Entrepreneur of the Year by Ernst & Young (2021), received the Distinguished Alumni Award ? Entrepreneurial from the Booth School at the University of Chicago (2022), was recognized as one of the 100 Most Intriguing Entrepreneurs by Goldman Sachs (2020), was listed on the Inc. Female Founders 100 (2020) and earned Springboard Enterprise?s Northstar Award (2019). More at NCBiotech

To be included in member news, send information about your organization to David Etchison.

 

Baebies has received FDA 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase deficiency. The test is run on the FINDER platform, which features a toaster-sized instrument and a disposable cartridge. More >>

 

Biogen appointed Christopher A. Viehbacher as president and CEO and a member of the Board of Directors, effective Nov. 14. Viehbacher succeeds Michel Vounatsos, who had led the company since 2017. More >>

 

Chiesi USA had an article published describing a health economic model comparing selective early rescue surfactant administration versus standard surfactant administration for infants with respiratory distress syndrome. More >>

 

Chiesi USA is sponsoring the American Society of Health-System Pharmacists Advantage initiative to support pharmacy technician recruitment and retention. More >>

 

G1 Therapeutics, Inc. closed an underwritten public offering of 7,700,000 shares of its common stock at a public offering price of $6.50 per share, receiving $50,050,000 in gross proceeds from the offering. More >>

 

IQVIA announced a long-term collaboration with Clalit, the largest health services organization in Israel, to launch the first Prime Site in the country. More >>

 

Kriya Therapeutics, Inc., has acquired Redpin Therapeutics, Inc., a privately held biotechnology company developing regulatable gene therapies for intractable diseases of the nervous system. More >>

 

Oerth Bio and Yara International announced a first-of-its-kind collaboration applying Oerth?s novel protein degrader technology to crop efficiency applications to boost plant resilience to combat escalating climate stress impacting crop production and farm economics. More >>

 

Opus Genetics announced that the FDA has cleared its Investigational New Drug application for a Phase 1/2, first-in-human clinical trial of OPGx-001 in patients with Leber congenital amaurosis resulting from biallelic mutations in the LCA5 gene. More >>

 

SAS and the Regenerative Medicine Development Organization SAS are collaborating on the ReMDO RegeneratOR Test Bed, a novel regenerative medicine endeavor in North Carolina. More >>

 

Smith Anderson was recognized by LMG Life Sciences in the Licensing and Collaboration category in its 2022 rankings, the only law firm headquarterd in North Carolina to be included. Additionally, two Smith Anderson attorneys were recognized as Life Sciences Stars. More >>

 

Registration for BIO Partnering @ JPM 2023 is now open. During JPM week, maximize your potential and schedule meetings with BIO One-on-One Partnering. BIO?s system allows you to use

• BIO?s in-person meeting space at the San Francisco Marriott Marquis,
• your own in-person meeting space in San Francisco,
• BIO-provided Zoom links, and
• your own video call link.

Don't miss this opportunity to directly connect with partners, industry leaders and supporters. Want some prep so you can get the most out of JPM Week 2023? Check out this Navigating Network Events webinar Dec. 13 from 1-2 p.m.

Join NCBIO members and legislators for an evening reception highlighting the state?s life sciences industry. You will have the opportunity to discuss workforce training, life science program funding, innovation and tax policy and other topics of interest with legislators and policy makers.

 

If you are interested in sponsoring this event, please contact NCBIO Membership Director Natacha Janvier.

As an active member of NCBIO, you are eligible for a $200 discount on premier or general registration rates for BIO International 2023. And if you redeem your code during early bird registration, your total savings may exceed $400. Contact NCBIO Membership Director Natacha Janvier for the link to request your discount code. 

 

Codes must be requested by Dec. 19. There are no exceptions.​ Codes will be distributed to individual requesters on Jan. 13.

• TAXparency - Understanding Tax Credits and Incentives for Biotech Startups hosted by LaunchBio (12/1/2022)
• Expanding Reach and Impact: Using Tech to Innovate Decentralized Clinical Trials hosted by LaunchBio (12/8/2022)
• Navigate Networking Events at JPM Week  (12/14/2022)
• 41st Annual Healthcare Meeting hosted by JPM (1/9/2023 to 1/12/2023)

Finance and administration teams oversee day-to-day matters and move the business forward. Are you making the most out of the finance services available to you?

 

Access business insurance, all-in-one HR, shipping, office supplies, compensation analysis, and more at discounted rates as a member of NCBIO.

 

Learn more about reducing your overhead costs at bio.org/save.

Did you know? NCBIO members receive exclusive benefits on surplus asset management with American Laboratory Trading. Whether it?s the need to upgrade equipment, relocate or liquidate an entire facility, ALT can develop a customized solution ? so you get the greatest ROI possible! Benefits include:

• 20% discount on surplus services
• 10% bonus on standard consignment split
• 10% rebate on buyer?s premium

Call ALT today to get started at (860) 691-2213 or visit www.alt.bio.

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