January 2022 Update

Serving the NC Life Sciences Industry

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• Clinical Trials Forum explores patient recruitment (video available)
• $5 million in SBIR/STTR matching funds available soon
• OSHA vaccine mandate back on (for now)
• Gunter named to CSBA board
• JPM conference goes virtual

... and more

Patients and research organizations came together at the NCBIO Clinical Trials Forum to talk about ways to improve clinical trials to make recruiting and retaining patients easier. The forum was held Wednesday, Dec. 8 at the NC Biotechnology Center.

Matthew Roberts, practice group leader, health care and public policy practice groups, Nexsen Pruet served as moderator for a panel comprising 

• Heather-Elizabeth Brown, a “long-haul" COVID-19 patient; 
• LaQuinta Jernigan, executive vice president, North America for mdgroup; 
• Renée Leverty, program lead, stakeholder engagement, Research Together, Duke Clinical Research Institute;  
• Katie Shaw, senior director, global patient and site solutions, IQVIA; and 
• Eric South, founder of the Gladiator Project and a glioblastoma multiforme patient. 

The NCBIO Clinical Trials Forum was possible thanks to the generosity of these sponsors.

As soon as the new state budget for Fiscal Year 2022 is certified, $5 million in matching funds will be available to North Carolina companies applying for federal Small Business Innovation Research Program or Small Business Technology Transfer awards.

On Nov. 18, the legislature and governor enacted a two-year budget that includes $5 million a year for the One NC Small Business Program. For the first time, the program's funding includes $2 million in recurring funds that will be available each year, along with an additional $3 million appropriated for FY 2022 and for FY 2023. 

According to the NC Department of Commerce, the budget still has to be certified before One NC Small Business Program solicitations can be issued. Certification may not be complete until early-mid January. As soon as it is complete, solicitations for both the Phase I SBIR/STTR Incentive Program and the Phase I SBIR/STTR Matching Program will be available. 

The SBIR/STTR Phase I Incentive Funds Program provides reimbursement to qualified North Carolina businesses for a portion of the costs incurred in preparing and submitting Phase I SBIR or STTR proposals to federal agencies.  

The SBIR/STTR Phase I Matching Funds Program awards matching funds to North Carolina businesses who have received a federal Phase I Small Business Innovation Research Program or Small Business Technology Transfer award. 

Companies compete for funding under these programs by submitting proposals in response to solicitations issued by participating federal agencies. The federal SBIR/STTR Program provides for funding competitions in two phases that are relevant to the North 
Carolina program:  

• Phase I - to conduct feasibility research (awards are generally $50,000–$250,000 for six 
  months to one year) 
• Phase II - to expand and develop phase I results and develop commercially viable innovations (awards are generally $750,000 for two years).

More information about the federal SBIR/STTR Program may be found at sbir.gov.

A Wake County Superior Court panel of three judges heard arguments on legislative and congressional districts Jan. 3-6. The NC Supreme Court instructed the three-judge panel to reach a decision by Jan. 11. Whatever the decision, it is expected to be appealed to a higher court.

If the Republican-drawn maps stand, the party is likely to win 10 or 11 of the 14 U.S. House races up for grabs in the 2022 midterm elections.

If the Supreme Court ultimately finds the maps unconstitutional, the court will decide who should redraw the maps and when the maps take effect. The delay created by the litigation over the maps and the scheduling of primary election will also affect the start date of the legislative short session, which typically begins in mid-May.

This week, NC Senate and House leaders assigned Life Sciences Caucus co-chairs Sen. Mike Woodard (D-Durham) and Rep. Donna White (R-Johnston) to the Joint Legislative Committee on Access to Healthcare and Medicaid Expansion, a committee that was established in the 2021 budget.

In the ongoing legal battle over the Occupational Safety and Health Administration’s emergency temporary standard on COVID-19 vaccination and testing, the United States Court of Appeals for the Sixth Circuit has allowed OSHA to move forward — for now — with enforcement. However, the U.S. Supreme Court is set to hear challenges today, Jan. 7, to the vaccine-or-test requirement and to the CMS requirement for health care workers.

The core of the order is the requirement that employers with more than 100 employees must implement and enforce a mandate that employees be fully vaccinated against COVID-19 by Jan. 4 or to submit to weekly COVID-19 testing and wear a mask.

However, in light of the numerous legal challenges and the uncertainties caused by the conflicting decisions in federal court, OSHA has stated that it will exercise its “enforcement discretion” to give employers some additional time to comply with deadlines published in the original order. OSHA said that it will not issue any citations for noncompliance with its vaccine and testing requirements before Jan. 10 and will not issue citations before Feb. 9 so long as employers are attempting to comply in good faith.

No final decisions have been reached regarding the government contractor vaccine mandate. The nationwide injunction remains in effect, and separate, more limited injunctions have been issued by other federal courts.

For more details, check out these posts from our employment law members, Womble Bond Dickinson and Smith Anderson.

The United States Patent and Trademark Office published a notice in the Federal Register announcing an extension of its COVID-19 Prioritized Examination Pilot Program. Requests that are compliant with the program’s requirements and are filed on or before March 31 will be accepted.

NCBIO President Laura Gunter has been elected to the Board of Directors of the Council of State Bioscience Associations. Gunter will serve a two-year term beginning 2022.  

“We are thrilled to announce our new slate of incredibly accomplished and esteemed board leaders for the next exciting phase of CSBA,” said Michele Oshman, executive director of CSBA and vice president of external affairs at the Biotechnology Innovation Organization. “From the global threats of pandemics and climate change to the growing impact of bioscience on local jobs and economies, our industry faces many important challenges today. We look forward to continuing to work together across our new board leadership, members, and stakeholders to confront these threats and expand opportunities for innovation.” 

MORE >>

The NC Biotechnology Center and a statewide coalition of public and private partner organizations including NCBIO will receive up to $500,000 in phase 1 of the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge.

The award supports the further development of a plan to expand, connect, scale and promote the state's life sciences manufacturing cluster to power the transformation of North Carolina’s economy and communities. It brings together stakeholders from academia, industry, state and local government and other nonprofits and includes seven complementary and aligned projects organized under a singular vision.

NCBiotech and its partners now advance to phase 2 of the challenge with plans to submit seven synergistic projects including developing innovation and technology development and increasing industry awareness and accessibility of training programs. The projects are all centered on expanding job opportunities in the life sciences.

MORE >>

Jerry Barker, Novex; Chandler Conley, PSC Biotech; Natacha Janvier, NCBIO; Laura Gunter, NCBIO; Mark Beamer, Avantor; and Doug Drabble, Novex

Mark Beamer, Avantor; Natacha Janvier, NCBIO; Laura Gunter, NCBIO; Chandler Conley, PSC Biotech; and Russ Read, NCBW

NCBIO President Laura Gunter and new Membership Director Natacha Janvier traveled to Winston-Salem on Dec. 7 where they visited CDMO Novex Innovations. They also met with local members and prospects at a lunch meeting hosted by NCBIO board member Russ Read, executive director of the National Center for the Biotechnology Workforce at Forsyth Tech.

NC Secretary of Commerce Machelle Sanders spoke at the Dec. 15 ribbon-cutting ceremony for Pfizer's new manufacturing facility in Durham. The $68.5 million, 85,500-square-foot plant near the intersection of Interstate 40 and Interstate 540 will be home to Pfizer’s BioTherapeutics Pharmaceutical Sciences group. More >>

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

BioAgilytix announced the global private equity firm Cinven, based in London, will acquire a majority stake in the company from current majority stakeholder, Belgium-based private investment firm Cobepa, which will remain a minority investor. More >>

Biogen Inc. and TheraPanacea are collaborating in multiple therapeutic areas in neuroscience to further build on the companies’ existing relationship with the aim of leveraging machine learning and artificial intelligence analysis to develop digital health solutions. More >>

Mispro Biotech Services will open a new full-service vivarium research facility in Research Triangle Park early next year. More >>

The North Carolina Biotechnology Center and a statewide coalition of public and private organizations that includes NCBIO are a Phase 1 recipient of up to $500,000 in the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge. More >>

Nexsen Pruet has shared an article on how COVID-19 is affecting the clinical trials industry authored by Matthew Roberts, NP's health care and public policy practice group leader. More >>

PPD, Inc. was named one of the “Best Workplaces in Greater China 2021” for the second consecutive year by Great Place to Work for successfully creating an inclusive workplace experience for employees. More >>

Sanesco is offering COVID-19 testing packages to help businesses manage their COVID-19 risk. Contact them for more information through this link.

Thermo Fisher Scientific Inc. completed its acquisition of PPD, Inc. for $17.4 billion. PPD's common stock ceased trading on Nasdaq, and PPD will become part of Thermo Fisher's Laboratory Products and Services Segment. More >>

United Therapeutics was named to Newsweek’s list of America’s Most Responsible Companies 2022. This award is presented by Newsweek and Statista Inc., the statistics portal and industry ranking provider. More >>

The J.P. Morgan Healthcare Conference is moving to a virtual experience, and BIO One-on-One Partnering offers the flexibility you need to network with a wide audience. With the BIO system, you can:

• Quickly find contacts and companies using our robust search feature.
• Conveniently schedule virtual meetings with BIO Zoom links.
• Access easy-to-use time zone features and automated calendar updates.

Still traveling to San Francisco during JPM week? You can schedule in-person meetings at locations of your choosing.

We’ve recently seen an uptick in investor registrations and meeting requests. Hurry! You don’t want to miss out on this unique opportunity to make connections.

Contact Amber Niebauer to get $100 off the registration fee.

Join BIO Feb. 14-17 for the 2022 BIO CEO & Investor Conference. It’s a vital opportunity for meaningful networking and important programming about topics that matter.

• Powered by BIO One-on-One Partnering: one of the most advanced and easy-to-use partnering platforms to maximize your connections, whether in-person or virtually
• Policy: Implications of Biden administration health-care policy initiatives on biotech
• Business: ESG investor expectations as well as IPO and SPAC trends
• Innovation: Oncology therapeutic frontiers on the latest trends in deal-making, clinical innovations and US Congressional agenda for biotech

Are you currently raising and looking for customers or even talent? There is no better place to promote your company than on a Venture Connect stage.

This is not just a conference to find capital, this is a summit that will elevate your company and propel your growth forward.

CED is reinstating a live, in-person event where life science and technology communities intersect. This summit aims to highlight innovation across the Southeast and create an environment where powerful connections are made. Founders/CEOs will have the opportunity to connect with their audience in a live format unlike any other pitch event.

The deadline to apply is Jan. 17.

Start-Up Stadium applications are open!

The goal of Start-up Stadium is to increase your start-up's engagement and visibility with investors, state and regional affiliates and early-stage companies at the beginning of their lifecycle with fewer than 20 employees.

During the upcoming 2022 BIO International Convention in San Diego, investor judges will attend live start-up presentations and engage in Q&A/feedback with start-up finalists.

The opportunities are limitless with the ability to:

• Network with over 8,400 companies with the opportunity to schedule in-person and virtual meetings with BIO’s renowned One-on-One Partnering System
• Attend invigorating sessions and cutting-edge company presentations covering more than 18 different educations tracks with over 800 speakers
• Build critical dialogues with representatives from over 65 countries and 49 states to establish your company as an international expert

• Clinical Supervision Workshop Series hosted by UNC-Wilmington (1/8/2022)
• Annual Healthcare Conference with BIO Partnering hosted by J.P. Morgan (1/10/2022 to 1/14/2022)
• Export Education: Export 201 hosted by EDPNC (1/11/2022)
• Biosafety Fundamentals Course for Laboratory Personnel hosted by NCABR (1/19/2022)
• Annual Forum on Economic Development hosted by EDPNC (1/25/2022)
• Precision Medicine World Conference (1/26/2022 to 1/28/2022)
• Outlook for Tech hosted by NC TECH (1/28/2022)

BIO Business Solutions provides significant cost savings to NCBIO member companies on a wide variety of products and services, including lab supplies, insurance, shipping, office supplies and more.  

The BBS team continuously works to offer competitive pricing and favorable terms so you can focus on your organization’s core mission. With almost $724 million in purchasing power, the BIO Business Solutions program helped over 4,600 member companies save more than $590 million in 2020.

All the heavy lifting is done for you.

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

From forms and software to storage and shredders, Office Depot has the solutions for NCBIO members to make tax season less taxing.

We're partnered with Airgas to provide customized solutions for gas, equipment and cryogenic equipment storage with guaranteed savings to NCBIO members.

Our partner Avantor serves as a leading global provider of product and service solutions to laboratory and production customers in the pharmaceutical, biotechnology, industrial, education, government and health care industries.

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