2022 NCBIO Year in Review
From the NCBIO President | Laura Gunter
I look back on the past twelve months of NCBIO’s work, and what stands out most to me is how much time and effort we have put into looking forward. The year was perhaps most notable for the completion of our new strategic plan for the organization, which was approved by the Board of Directors in May. The plan serves as a guide for the organization to refocus on serving an industry that has grown much larger and more diverse by better aligning our efforts with the needs of the life sciences. You can read more about the plan farther along in this review.
North Carolina was named the top state for business by CNBC in 2023 for the second year in a row and was recognized as the fourth
largest bio hub in the ation by Fierce Biotech. Life sciences and related companies from around the world announced new or expanded facilities by the end of 2022 that will bring more than $2.1 billion in investment and over 2,700 new jobs to the state. North Carolina’s life sciences companies provide high quality jobs with average annual wages of $112,000, nearly double the $60,000 private-sector average (2021 numbers).
In other good news, we surpassed our $250,000 fund-raising goal for the Samuel M. Taylor Memorial Life Sciences Scholarships for life sciences students enrolled in NC Community Colleges. Awards have already been made to three classes of Taylor scholars. Five scholarships were awarded in the fall of 2022 and of 2023, and three students received awards in 2021.
Finally, we said goodbye and thank you to BMF Program Director John Wagner, who retired from his role over the summer. Wagner gave eight years of service to NCBIO and the BMF, made many friends and left our industry stronger than when he started. William “Bill” Monteith was selected replace Wagner as BMF program manager. Monteith retired after 42 years in the industry with companies such as Stride Bio, Cellectis, Dendreon and Wyeth. During his career, he oversaw the construction of six solid-dose and biotech facilities and served as their site head.
We look forward to implementing the strategic plan and to an exciting and busy year ahead. If we can be of service or assistance to your, please don’t hesitate to contact us.
Keeping members of the General Assembly apprised of the achievements and importance of the life sciences industry in North Carolina continues to be a priority for NCBIO.
North Carolina Republicans gained a supermajority in the NC Senate in the November general election and achieved a supermajority in the House when one representative switched parties to provide the single lacking seat.
Life Sciences Caucus co-chairs Sen. Paul Newton (R-Cabarrus, Union), Sen. Mike Woodard (D-Durham, Granville, Person), Rep. Donna McDowell White (R-Johnston), and Rep. Robert Reives (D-Chatham, Durham) were all reelected. The Senate Republican Caucus chose Newton to be Senate majority leader, and Reives was elected to another term as House minority leader. Woodard announced that he would be running for mayor of Durham in the 2023 elections, and he does not have to give up his Senate seat to do so.
The General Assembly struggled to deliver a two-year state budget during the 2023 session but was able to finally pass the legislation on Sept. 22, which paved the way for the state to expand Medicaid to cover as many as 600,000 more North Carolinians. Gov. Roy Cooper allowed the budget to become law without his signature. The budget included tax cuts, reducing the personal income tax rate to 3.99% by 2025 or 2.49% if revenue collection goals are met. For certain corporations, the budget lowers the franchise tax. The legislation included $2 billion for rural water and sewer projects across the state.
NCBIO continues to advocate for the One NC Small Business Fund, which received the $2 million in recurring funds that was secured during the last budget cycle, and for the NC Biotechnology Center. NCBiotech received a recurring increase of $1 million and will receive $18.1 million in this fiscal year and $16.1 million in the next. NCBIO is also leading discussions around water and wastewater management across the state.
NCBIO was once again able to host our popular annual Legislative Reception bringing legislators and members together, which was well attended by members of both chambers this year. The caucus co- chairs also joined us for a Q&A with our members at the Legislative Luncheon and Forum in August.
LIFE SCIENCES CAUCUS
“TEConomy Report of the Life Sciences Industry in North Carolina,” TEConomy Partners, Eli Lilly
“Workforce and Supply Chain in the Life Sciences,” Astellas Gene Therapies, Frontier Scientific Solutions, Grifols, Thermo Fisher Scientific
“Early-Stage Innovation Support,” First Flight Venture Center, NCBiotech, NC Board of Science, Technology & Innovation
“Federal and State Policy Themes in Agricultural and Environmental Biotechnology,” BIO, NCBiotech, NC Plant Sciences Initiative, Pairwise
SAM TAYLOR SCHOLARSHIP
NCBIO surpassed its goal of raising $250,000 to create a scholarship fund at the NC Community College Foundation for students pursuing degrees and certifications in the life sciences in honor of the late Sam Taylor, a co-founder and long-time president of the organization who died in 2021.
Leadership gifts to the fund came from Alexandria Real Estate Equities, Amgen, Biogen and Hatteras Venture Partners. Frankel Staffing Partners, FUJIFILM Diosynth Biotechnologies, Grifols, Novo Nordisk, Smith Anderson and Thermo Fisher also made significant contributions to the scholarship fund.
The Samuel M. Taylor Memorial Life Sciences Scholarships are for students enrolled in agricultural biotechnology, biopharmaceutical technology, biotechnology, bioprocess technology, clinical trials research associate, facility maintenance technology and medical laboratory technology programs in the state’s community colleges.
Awards have been made to three classes of Taylor scholars for a total of 13 scholarships provided to date.
- FUJIFILM Diosynth Biotechnologies
- Novo Nordisk
- Smith Anderson
- Thermo Fisher
- Aerie Pharmaceuticals
- G1 Therapeutics
- Mullen, Jim and Justine
- Wagner, John
- Wyrick Robbins
- Alexandre, Leslie
- Anderson, Peyton
- BioLabs NC
- Cook Medical
- Fagley, Tom
- Fowler, Neal
- Frankel Staffing Partners
- Gunter, Laura and Mark
- Gupton, Tim
- Lee, Ken R
- Love, Bennett
- O’Brien Atkins
- Pappas Capital
- RTI International
- Ward, Eric & Gerty
- Womble Bond Dickinson
- Almeida, Tony
- Arp, Louis and Laura
- Broadus-Meigs, Julie
- Constantino, Mike
- deBethizy, Don
- Etchison, David
- The Forsyth Tech Foundation
- Green, Gary
- Jones, Beth
- Gardner, Maeve
- Nichols, James “Jim” and Barbara “Babs”
- Read, Russ
- Sewell, Scott
- Shope, Gary
- Staab, Tom
- Summers, Brenda
- Tolson, Norris
- Triangle Community Foundation
- Young, Peter
After the Nov. 8 midterm elections, the U.S. House of Representatives was controlled by Republicans by a slim majority while the Democrats maintained control of the Senate.
Republican U.S. Rep. Ted Budd won North Carolina’s open Senate seat. The three-term House member defeated Democrat Cheri Beasley and succeeded retiring GOP Sen. Richard Burr.
In House races, Democrat Wiley Nickel defeated Republican Bo Hines in North Carolina’s competitive 13th Congressional District. Nickel’s win created a 7-7 split in the state’s delegation by party.
With both the pandemic and the 2022 election in its rearview mirror, Congress was ready to get back to work, and NCBIO was there to educate lawmakers on our critical issues, alongside our national partners. NCBIO traveled to D.C. for Tarheel Circle events, which bring North Carolina delegation, staff and stakeholders together, as well as for the AdvaMed and BIO fly-ins in March and the July We Work for Health fly-in to meet with each office of the state’s Congressional delegation.
Lawmakers and staff made visits to our members’ facilities in North Carolina, including roundtable events focused on the Inflation Reduction Act and the R&D tax amortization policy. NCBIO began sending a monthly newsletter to Congressional staff detailing the successes and contributions of North Carolina’s life sciences community.
In Washington, Congress approved a $1.7 trillion omnibus bill in late December to fund the federal government through September. A bipartisan package of reforms from the PREVENT Pandemics Act championed by Sen. Richard Burr was included and sought to improve the country’s preparation for the next pandemic. That proposal sets up a mission control in the White House to coordinate the federal response to outbreaks and requires Senate confirmation of the Centers for Disease Control and Prevention director.
A push to include provisions of the proposed VALID Act, which would have created a new category of medical products called in vitro clinical tests and allowed the FDA to oversee tests regardless of
whether they came from clinical laboratories or from commercial companies, was not successful nor was the PASTEUR Act included, which would have helped bolster the antibiotic market to combat an increasingly serious threat of antimicrobial resistance.
NCBIO and its allies continued to push back against the drug-price “negotiations” authorized by the Inflation Reduction Act for Medicare as a number of advocacy organizations and drug companies went to court to block the policy. A new study estimated that there would be 237 fewer FDA approvals of new medicines over the next decade and 1.1 million lost jobs if proposals to expand government-mandated drug pricing policies are fully implemented.
- In March, the NIH rejected a petition to use so-called march-in rights to take ownership of patents tied to the prostate cancer drug Xtandi. HHS and the Department of Commerce launched an interagency review of the government’s authorities under the Bayh-Dole Act, which grants the march-in rights.
- ARPA-H was established in March 2022 and became fully operational with the hiring of program managers and mission office directors. The agency will establish three hubs in different locations, one of them being in the Washington, D.C. area. In June, North Carolina learned that it would not be the site of an ARPA-H hub despite an intense lobbying effort led by the NC Biotechnology Center, RTI International and a consortium of other stakeholders, including NCBIO.
- The Tax Cuts & Jobs Act of 2017 changed the longstanding deduction for R&D expenditures to a mandatory five-year amortization for domestic R&D and a 15-year amortization for foreign R&D. NCBIO is supporting legislation in both chambers cosponsored by several members of North Carolina’s delegation to restore the deduction.
- The TRIPS waiver gained more attention from lawmakers, especially those on the Democratic side (which included Rep. Deborah Ross), who increasingly voiced their discontent with this flawed policy. The TRIPS waiver allowed the World Trade Organization to waive certain intellectual property rights for COVID-19 vaccines, and the WTO is still considering doing the same for COVID-related diagnostics and therapeutics.
- The Centers for Medicare & Medicaid Services is working with industry stakeholders, including medical device companies, as well as physician societies and patient groups to develop an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics called Transitional Coverage for Emerging Technologies.
- Congress is looking for more visibility into the practices of pharmacy benefit managers and into the 340B program. In the 340B program, hospitals are exploiting lax eligibility criteria and program guardrails to profit from the substantial 340B discounts that were intended to ensure low-income access to discounted prescription drugs and services. Congress was also concerned that PBMs are no longer serving the interests of patients by negotiating better prices for prescription drugs, especially as more drug stores and PBMs are being bought up by insurance companies.
DIVERSITY, EQUITY AND INCLUSION
NCBIO continued its member-requested programming focused on diversity, equity and inclusion in partnership with The Diversity Movement.
“Reflecting on DEI in 2022 and Looking Ahead at 2023,” November. The Diversity Movement reviewed the progress made and DEI trends in 2022 and talked about the directions DEI efforts will take in the next year.
“Top-Down Leadership Buy-In and Engagement,” February. Representatives from Amgen and Novo Nordisk covered strategies for getting C-level support for DEI initiatives.
“The Ups and Downs of the DEI Journey,” May. Panelists from Beam Therapeutics, IQVIA, Purdue Pharma and The Diversity Movement discussed DEI training, DEI in clinical trials, the business benefits of DEI and more.
“Rise and Fall of Employee-Led Groups,” September. Panelists from Frankel Staffing, Novozymes and The Diversity Movement explored business resource groups, employee led groups and affinity groups, as well as providing support for these groups.
2022 ANNUAL MEETING
The 2022 NCBIO Annual Meeting held Oct. 12 at the NC Biotechnology Center featured expert panels on locating in North Carolina, talent recruitment, financial trends and health equity and disparities.
The meeting returned to being fully in person this year after several years of being virtual or offering an online option due to the COVID pandemic.
The meeting featured multiple networking opportunities and four panel discussions.
- Success Stories: Talent Recruitment and Retention with FUJIFILM Diosynth, Lilly, Novozymes and StrideBio
- Financial Trends and Outlook with GSK, Incubate Coalition, JPMorgan, Pappas Capital and Solas Bioventures
- Health Equity and Disparity featured BIO, Biogen, ECU’s Center for Health Disparities, the Global Liver Institute and mdgroup
- Decisions to Locate and Expand in NC with Amgen, Economic Development Partnership of NC, FUJIFILM and Lilly
On Oct. 10 at the NCBIO Annual Dinner, Sen. Richard Burr was the guest of honor. He reflected on his 28-year career in Congress and discussed FDA reform, the nation’s response to future pandemics and the pitfalls of the country’s regulatory system.
FORUMS, WEBINARS AND NETWORKING
NCBIO continued to host informative forums and discussions designed to shed light on timely issues that are priorities for our members.
- Clinical Research Forum, November 2022. An expert panel comprising representatives from Care4Carolina; PPD, part of Thermo Fisher Scientific; IQVIA Biotech; and Ultragenyx talked about ways to lower the barriers that stop patients from participating in clinical trials and discussed strategies for achieving diversity. They also explored the role of patient advocates and gave special consideration to efforts focused on rare diseases.
- Emerging Companies Forum, March 2023. Panelists from Hatteras Venture Partners, the National Institutes of Health, the National Science Foundation, the NC Biotechnology Center and the U.S. Small Business Administration offered insights into the way their organizations choose investments, when to seek SBIR funding, engaging with a funding agency for the first time and more.
- Medical Device Forum, May 2023. Representatives from Becton, Dickinson and Company; Boston Analytical; Kymanox; RTI Innovation Advisors; and YourBio Health shared ways of navigating regulatory and supply chain challenges.
- Lab Space Forum, July 2023. Experts from Crescent Communities, Flad Architecture, Jones Lang LaSalle, McDonald York Building Company and Research Triangle Foundation gave NCBIO members a look into the past, present and future of real estate in Research Triangle Park.
NOVEMBER. Representatives from FUJIFILM Diosynth and the NC Biotechnology Center discussed talent development in the state through programs such as Bio Jobs Hub, Build Back Better outreach and NIIMBL bioLogic.
MARCH. BMF attendees were updated on the $25 million Build Back Better Regional Challenge grant awarded in the fall to a statewide coalition that included NCBIO and was led by NCBiotech. Presenters representing the various organizations involved in the grant came from NCBiotech, BRITE at North Carolina Central University, BioNetwork and Central Carolina Community College.
JUNE. Members learned lessons of resiliency from McKinsey & Co., Novozymes and SAS and honored John Wagner, who retired after eight years of service to the group as BMF program manager.
NCBIO ADOPTS STRATEGIC PLAN
On May 16, the NCBIO Board of Directors adopted a new strategic plan for the organization by unanimous vote.
The plan was developed by the Board’s Strategic Planning Committee, who began their work in the summer of 2022 with the guidance of Thinc
Strategy and support of NCBIO staff.
Among the key findings of the planning process are that the organization
- has a diverse membership in terms of the size, type and in-state
- has a strong reputation for advocating for the industry;
- is known primarily for state-level advocacy work;
- is less known for its extensive workforce-development efforts;
- is seen as a force bringing industry together in the state; and
- offers good value for the benefits delivered.
In light of these findings, the Board modified the organization’s mission statement to reflect the distinct role NCBIO plays in the state’s life sciences community and to better connect the organization’s purpose to the value it delivers to members.
NCBIO advances the North Carolina life sciences industry and ecosystem, enabling our members to innovate and collaborate for success in a global marketplace.
We deliver policy and advocacy leadership, future-focused workforce development programs, industry connections and mission-driven member services.
With the updated mission, the approved plan identifies four key focus areas for the organization moving forward:
- Advocacy leadership
- Workforce development
- Industry connections
- Member services
THE YEAR AHEAD | 2023-24
In the coming year, NCBIO will be moving ahead as the NC Life Sciences Organization or NCLifeSci for short. NCLifeSci will adjust its heading to reflect the priorities of the organization’s strategic plan and focus on advocacy leadership, workforce development, making industry connections and offering valuable member services.
As the state’s budget picture comes into focus, NCLifeSci will continue to advocate for traditional priorities, such as the NC Biotechnology Center and the One NC Small Business Fund, while focusing on broader issues of concern to our industry, such as access to capital and water and wastewater management. We will also continue to work with government and educational institutions at all levels to help meet the workforce needs of the state’s life sciences community, including the sector’s interest in educating and employing a diverse workforce.
At the federal level, NCLifeSci will continue to educate the state’s Congressional delegation on the issues that affect our industry. We will continue to oppose drug-pricing measures that don’t take into account the entire pharmaceutical production, distribution and reimbursement system and to support strong intellectual property rights. As always, we will support the government-affairs work of PhRMA, BIO, AdvaMed and MDMA through advocacy targeted to North Carolina’s elected officials.
The NCLifeSci staff greatly appreciates the support we receive from our members who never hesitate to lend a hand to our advocacy efforts, forums and other activities. We will continue to provide regular networking opportunities and information-sharing forums for member companies. We look forward to working with all of you in 2023-2024.
Thanks to our Sustaining and Supporting Members for helping NCBIO deliver exceptional value to all our members.
THANKS TO OUR EVENT SPONSORS: NCBIO and its member organizations are grateful for the generosity of the sponsors who make our events and programming possible.
American Laboratory Trading
Alexandria Real Estate Equities
Avantor, delivered by VWR
Clancy & Theys
Frontier Scientific Solutions
FUJIFILM Diosynth Biotechnologies
Hatteras Venture Partners
Hughes Pittman & Gupton
Marsh McClennan Agency
Medical Moving Solutions
Mercury Business Services
Michael Best Strategies
Mispro Biotech Services
Marsh McLennan Agency
NC Research Campus
The Conafay Group