2022 NCBIO Year in Review
From the NCBIO president | Laura Gunter
NCBIO President Laura Gunter
The life sciences industry in North Carolina has continued to thrive and propel the state’s economy forward with nearly 800 companies now operating in the state. The strong growth of the industry has increased pressure for the state to focus on workforce development. That’s one of the reasons I’m so proud of the success we have had in establishing the Samuel M. Taylor Memorial Scholarship Fund at the North Carolina Community Colleges Foundation Inc.
We have raised $220,000 in gifts and pledges toward our goal of $250,000 for the scholarship fund with leadership gifts coming from Alexandria Real Estate Equities, Biogen and Hatteras Venture Partners. Grifols, Novo Nordisk, FUJIFILM Diosynth Biotechnologies and Smith Anderson have also made significant contributions. More than 50 companies and individuals have made gifts or pledges to the
fund. We have put the money to work, and the fund began providing scholarships to students around the state pursuing training in the life sciences in 2021.
In this past year, we emerged from the isolation of COVID-19 thanks in no small part to the heroic work of the life sciences industry in developing vaccines, rapid tests and new treatments that have made the pandemic much more manageable. In spite of this success, we have faced tremendous pressure at the federal level with threats to intellectual property, the lifeblood of the industry, and a push to insert price controls with potential repercussions on innovation. As the pandemic waned, we continued to conduct benchmarking surveys to identify common practices among our members and to host calls to share information.
At the state level, I am especially gratified by our success in securing recurring NC budget dollars for the One NC Small Business Program, which will help our small emerging members who successfully compete for SBIR federal grants, and I am grateful for the continued interest in North Carolina’s innovative life sciences ecosystem by the NC General Assembly’s Life Sciences Caucus and its chairs, Sen. Paul Newton, Sen. Mike Woodard, Rep. Donna White and Rep. Robert Reives.
Finally, NCBIO welcomed Natacha Janvier, who joined us as our new membership director in November, and kicked off two major initiatives this past year designed to strengthen the organization and its membership. We are developing a strategic plan for NCBIO to better support our members as they work to improve health and lives worldwide with breakthrough innovations and technologies. We have also launched an effort to embed diversity, equity and inclusion within our offerings and resources so our members and the life sciences industry within the state of North Carolina will continue to thrive.
State advocacy
Life Science Caucus members Rep. Jamie Boles, Sen. Natasha Marcus, Rep. Rachel Hunt, Rep. Robert Reives (caucus co-chair), Rep. Mary Belk, Rep. Mike Clampitt, Rep. Kristin Baker, Rep. Wayne Sasser, Rep. Harry Warren and Sen. Mike Woodard (caucus co-chair) at the NC Research Campus in Kannapolis Feb. 23, 2022
Informing members of the General Assembly about the life sciences industry in North Carolina is a primary focus of NCBIO. As COVID vaccination rates rose and the pandemic ebbed, NCBIO was once again able to host our popular annual legislative reception that brings legislators and members together, and we were able to return to in person meetings and tours for legislators to communicate our members’ continuing contributions to healing, feeding and fueling the world.
Several of NCBIO’s legislative priorities made it into the 2021-22 and 2022-23 state budgets.
- The One North Carolina Small Business Program received a recurring appropriation of $2 million, the first time that the program has received recurring funds, which makes it part of the base budget going forward. An additional infusion of $3 million in nonrecurring funds for this fiscal year was also appropriated. The One NC Small Business Program provides matching funds to companies that apply for and win SBIR/STTR Phase I grant funds. Securing dependable funding for the One NC program was a priority for NCBIO this year.
- The NC Biotechnology Center received approximately $17.1 million for FY22 and for FY23 in a combination of recurring and nonrecurring funds and received an additional $500,000 recurring and $1 million nonrecurring funds during the short legislative session that wrapped up in July.
- The biosimilars sunset provision was repealed, which reinstated a communication requirement for pharmacists to inform physicians when they substitute an interchangeable biosimilar for a prescribed biologic.
- NC State University received $2 million for North Carolina’s participation in the National Institute for Innovation in
Manufacturing Biopharmaceuticals for both years of the 2021-2023 biennium.
Our messaging continued to focus heavily on the NC General Assembly’s Joint Life Sciences Legislative Caucus where Senators Paul Newton (R-Cabarrus, Union) and Mike Woodard (D-Durham, Granville, Person) and Representatives Donna White (R-Johnston) and Robert Reives (D-Chatham, Durham) continued to serve as co-chairs.
NC RESEARCH CAMPUS TOUR, February 2022. Caucus members toured the NC Research Campus and its Food Innovation Lab in Kannapolis along with local leaders and representatives of industry. GENE THERAPY, June 2022. Nearly two dozen legislators and staff members learned about the promise of gene therapies as potential treatments for rare diseases from Duke University’s Undiagnosed Diseases Network, the Duke-Margolis Center for Health Policy and Bleeding Disorders of North Carolina.
Sen. Mike Woodard, co-chair of the Life Sciences Caucus, talks with IQVIA representatives at the 2022 NCBIO Legislative Reception.
LEGISLATIVE RECEPTION, June 2022. NCBIO held its 2022 Legislative Reception on June 22 at the North Carolina Museum of History in Raleigh. The event was well attended by NCBIO members who were joined by a number of state senators. Unfortunately, the House was in session until late into the evening, and many representatives were unable to attend.
At the Aug. 31, 2022, NCBIO Legislative Forum, the co-chairs of the NC Life Sciences Caucus (Sen. Mike Woodard, Rep. Donna White, Rep. Robert Reives and Sen. Paul Newton) took questions from members.
LEGISLATIVE LUNCHEON AND FORUM, August 2022. NCBIO hosted a luncheon and forum at NCBiotech where the co-chairs of the Life Sciences Caucus discussed ongoing economic development initiatives, regulatory issues, the One NC Small Business Program, workforce development, science and technology education and more.
Taylor scholarship fund reaches $220,000 in gifts, pledges
NCBIO President Laura Gunter with Robert Voissem Jr., an inaugural recipient of the Sam Taylor scholarship; Thomas Stith, NC Community College System president; and Emily Sisk of NC BioNetwork at the 2021 NCBIO Annual Meeting.
The Samuel M. Taylor Memorial Scholarship Fund created by NCBIO at the North Carolina Community Colleges Foundation Inc. has exceeded $220,000 in gifts and pledges. NCBIO has set goal of raising $250,000 for the fund to support students enrolled in programs that support the life sciences in North Carolina.
Three scholarships from the fund were awarded to students enrolled in the fall of 2021 and five more have been given to students enrolled in the fall of 2022. NCBIO created the scholarship fund in memory of Sam Taylor, a founder and president of NCBIO. Taylor died of pancreatic cancer in February 2021.
Taylor was honored at the opening of Wake Tech’s Lilly Science and Technology Center by having the building’s BioWork Lab named for him.
Leadership Gifts
EXECUTIVE LEVEL
- FUJIFILM Diosynth Biotechnologies
- Grifols
- Novo Nordisk
- Smith Anderson
- Thermo Fisher/Patheon
SUSTAINER LEVEL
- G1 Therapeutics
- Mullen, Jim and Justine
- NCBIO
- NCBiotech
- Pairwise
- Wagner, John
- Wyrick Robbins
FRIENDS LEVEL
- 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
SUPPORTER LEVEL
- 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
- Novozymes
- O’Brien Atkins
- Pappas Capital
- RTI International
- StrideBio
- Ward, Eric & Gerty
- Womble Bond Dickinson
Federal advocacy
Rep. Deborah Ross took questions from NCBIO members about immigration, IP, workforce and more at a Feb. 14 roundtable at NCBiotech.
Our typical federal fly-ins and other in-person activities continued to be cut back during the pandemic. Despite the challenges, NCBIO continued regular communications with the NC Congressional delegation and worked closely with member company federal representatives as we aggressively share the value of North Carolina’s strong life sciences industry with law and policy makers. NCBIO also advocated specifically for individual member companies when particular concerns or opportunities were raised. Please continue to reach out on issues where we might be helpful.
- NCBIO joined forces with public and private universities, businesses, nonprofits, trade associations and state government working to bring the new Advanced Research Projects Agency for Health headquarters to North Carolina. ARPA-H received $1 billion in inaugural funding from Congress to accelerate biomedical and health research in the U.S.
- In April, the Centers for Medicare and Medicaid Services issued a National Coverage Determination limiting coverage of the Alzheimer’s disease treatment Aduhelm — along with other drugs like it — to clinical trials only. NCBIO joined with CSBA and other national organizations in a letter to the CMS protesting the decision. The NCD set a dangerous precedent, restricting access to a promising class of new amyloid-focused therapies and to drugs approved by the FDA under the Accelerated Approval pathway.
- The World Trade Organization agreed to a waiver of certain requirements concerning compulsory licensing for COVID-19 vaccines. Developing countries that want access to patented COVID vaccine technology no longer need to contact the patent holder before issuing a compulsory license. As the U.S. headed down a slippery slope toward giving away American innovation, NCBIO joined BIO and other groups to point out that vaccine supply is no longer the limiting factor in getting populations vaccinated.
- The Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946) introduced by Rep. Richard Hudson (NC-08) achieved a significant milestone, earning the support of a bipartisan majority of members in the U.S. House of Representatives with 219 co-sponsors. This bipartisan and bicameral bill will allow for multi-cancer early detection tests to be covered by Medicare in a timely manner upon approval by the FDA and once a clinical benefit is shown.
- NCBIO joined with our national partners in signing a letter to law makers urging Congress to reauthorize the SBIR and STTR programs that make competitive awards for small businesses to develop important new technologies.
- PDUFA/MDUFA were reauthorized for five years just as the user fee agreements were set to expire. NCBIO communicated the importance of these policies to the FDA and our industry to the NC Congressional delegation, particularly to Sen. Richard Burr, who was instrumental in getting a bill passed that was free of unwelcome riders.
- The Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946) introduced by Rep. Richard Hudson (NC-08) achieved a significant milestone, earning the support of a bipartisan majority of members in the U.S. House
of Representatives with 219 co-sponsors. This bipartisan and bicameral bill will allow for multi-cancer early detection tests to be covered by Medicare in a timely manner upon approval by the FDA and once a clinical benefit is shown. - NCBIO joined with our national partners in signing a letter to law makers urging Congress to reauthorize the SBIR and STTR programs that make competitive awards for small businesses to develop important new technologies.
- PDUFA/MDUFA were reauthorized for five years just as the user fee agreements were set to expire. NCBIO communicated the importance of these policies to the FDA and our industry to the NC Congressional delegation, particularly to Sen. Richard Burr, who was instrumental in getting a bill passed that was free of unwelcome riders.
Sen. Thom Tillis (pictured here visiting Novartis in Durham) addressed manufacturing capacity, China, intellectual property protections, workforce development and more with NCBIO members during an online roundtable Friday, Jan. 14.
NCBIO hosted two CEO Roundtables that brought NCBIO members together with members of North Carolina’s Congressional delegation. Sen. Thom Tillis joined members online for a virtual discussion covering manufacturing capacity, China, intellectual property protections and workforce development in January.
Rep. Deborah Ross discussed immigration reform, protection of intellectual property, the threat of antimicrobial resistance and workforce training at an in-person event held in February.
NCBIO continues to work with our national partners and communicate with North Carolina’s Congressional delegation to mitigate the effects of some of these policy decisions and to generate support for legislation that will benefit Americans by allowing the life sciences industry to grow and innovate.
Diversity, equity and inclusion
NCBIO President Laura Gunter, NCBIO DEI co-chair Neil Jones of Lindy Biosciences, keynote speaker Celeste Warren of Merck and DEI co-chair Shaylah Nunn-Jones of Novo Nordisk
NCBIO is committed to ensuring equity and continuing to embed DEI within our offerings and resources so members, their organizations and the life science industry within the state of North Carolina will continue to thrive and impact the world with breakthrough innovations and technologies.
The organization continued hosting events designed to give members the tools needed to create successful DEI programs in their companies.
Roadmap to Diversity, March 2022. NCBIO held its biggest DEI event to date at the at the NC Biotechnology Center March 9 as members gathered to seek inspiration and guidance in pursuing their companies’ diversity, equity and inclusion goals.
Some key takeaways from the discussions included the need to weave DEI into everything a company does; it can’t stand alone. Success requires DEI champions at the executive level, and it is important to align DEI goals with the organization’s business goals so that efforts can be properly resourced, evaluated and valued.
Building and maintaining a strong DEI program is hard, so be in it for the long haul. Commit to consistent, long-term communication and conversations to keep moving forward.
Fortunately, companies do not have to go it alone. Presenters encouraged NCBIO members to leverage their own internal resource and interest groups and to build partnership with external groups, such as schools and universities, nonprofits, advocacy groups and community organizations.
Roadmap to Diversity in Life Sciences: Mentoring Programs, June 2022. Representatives from BD, Beam Therapeutics and Biogen led an online discussion of the importance of mentors and mentoring programs in DEI initiatives.
Roadmap to Diversity in Life Sciences: Critical Conversations about DEI in the Workplace, September 2022. Certified Diversity Executive and author Donald Thompson, CEO of the Diversity Movement, hosted an online discussion with NCBIO members.
The year ahead
The coming year will be full of opportunities for the industry. To better serve our members and address the challenges they face, NCBIO is developing a strategic plan to guide the organization in years to come. The process is being led by a strategic planning committee made up of NCBIO board members working with Thinc Strategy.
In September, a statewide coalition of public and private partner organizations and institutions that includes NCBIO received a Phase 2 award totaling nearly $25 million for part of the project “Accelerate NC – Life Sciences Manufacturing” from the U.S. Economic Development Administration’s Build Back Better Regional Challenge. The award’s three component projects will establish six training hubs at North Carolina’s historically black colleges and universities and at the University of North Carolina at Pembroke delivering hands-on short courses on manufacturing biopharmaceuticals to an inclusive and diverse population. The grant will also expand enrollment in the NC Community College System’s BioWork program and increase the size of the faculty, and it will create ambassador and apprenticeship programs to increase awareness of life sciences manufacturing training and jobs.
At the state level, NCBIO will continue to advocate for the NC Biotechnology Center and for additional funding for the One North Carolina Small Business Program, which provides matching funds for North Carolina businesses that receive federal SBIR and STTR awards.
Our agenda will once again include proposals to support the acquisition and retention of capital by small, innovation based NC companies. In the coming year, NCBIO is working with a growing network of angel investors to advocate for the reauthorization of the NC Qualified Business Venture tax credit or a similar mechanism for encouraging innovation across the state. At the federal level, NCBIO is very excited to be part of a coalition of leaders from public and private universities, businesses, nonprofits, trade associations and state government who have joined forces in an effort to bring the new Advanced Research Projects Agency for Health headquarters to North Carolina.
We will also continue to advocate for intellectual property protections, as well as work to educate several news members to Congress about the importance of the industry as Sen. Richard Burr, Rep. G. K. Butterfield, and Rep. David Price all retire.
2021 Annual Meeting
Nearly 200 people attended the 2021 NCBIO Annual Meeting held Tuesday, Oct. 5, at the NC Biotechnology Center with almost 120 choosing to be there in person and about 75 participating online.
Attendees heard discussions of drug pricing, the challenges of launching a startup, federal issues affecting the industry and the patient’s role in clinical trials. They also selected new board members and met the first recipients of the Samuel M. Taylor Memorial Life Sciences Scholarships.
The highlight of the meeting was a powerful presentation by Jude Samulski, Ph.D., president and chief scientific officer of AskBio, who told the story of his journey using adeno-associated virus to develop treatments for rare diseases, especially those that affect children.
Forums, webinars, networking and surveys
NCBIO was able to return to hosting in-person forums to provide members with unique learning and networking opportunities.
- Clinical Trials Forum, December Patients and research organizations (Duke Clinical Research Institute, IQVIA, mdgroup, Nexsen Pruet) came together to talk about ways to make recruiting and retaining patients easier for clinical trials.
- Emerging Company and Technology Forum, March 2022. Panelists from Mycovia Pharmaceuticals, Abingworth, Carolina Angel Network and Hatteras Venture Partners said that a high- quality board of directors and valuable outside partnerships are two advantages that biotech startups would do well to
- Medical Device Forum, May 2022. Representatives from MED1 Ventures, AdvaMed, Michael Best and Bioventus gave an overview of the FDA’s regulatory environment for medical devices both during the pandemic and now.
- Lab Space Forum, July Panelists from Azzur Group, Lee & Associates, Longfellow Real Estate Partners and Lincoln Harris shared strategies for meeting the booming demand for lab space in the Triangle and across North Carolina.
Biotech Manufacturers Forum
The NCBIO Biotech Manufacturers Forum focused on ensuring a strong workforce and sharing best practices on a variety of relevant topics and continued supporting members as they grappled with the consequences of the COVID-19 pandemic.
- November Representatives from the NC Community Colleges’ BioNetwork, the NC Pharmaceutical Services Network, BRITE at NC Central University, NC A&T University and North Carolina State University’s BTEC discussed their efforts provide biomanufacturers with a skilled workforce and the state’s citizens with access to high quality positions in the industry.
- February Representatives from FUJIFILM Diosynth Biotechnologies, Eli Lilly and Company and Project Farma shared what they had learned about commissioning new facilities and equipment during the during the COVID-19 pandemic.
- June Representatives of Merck and NCBIO discussed the supply-chain difficulties and issues the COVID-19 pandemic created for the bioscience industry at the quarterly NCBIO Biomanufacturers Forum meeting held at the NC Biotechnology Center.
- September Representatives from Actalent, the Durham Workforce Development Board and the National Institute for Innovation in Manufacturing Biopharmaceuticals covered hiring and workforce issues, and an NCBiotech official updated the forum on Build Back Better Grant awarded to bolster workforce development in the state.
BMF members broke out into small groups to discuss workforce development and talent acquisition at their September 2022 meeting.
NCBIO supporters
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.
Alexandria Real Equities
American Laboratory Trading
Aon
Aqui Tu+
Aranz Medical
AskBIO
Avantor, delivered by VWR
BE&K Building Group
Biogen
Bioventus
Brex
Chubb
The Conafay Group
Cook Medical
Davis Moore Advisors
Frankel Staffing Partners
The Diversity Movement
FUJIFILM Diosynth
Grifols
Hughes Pittman & Gupton
IQVIA Biotech
Jenkins Wilson Taylor & Hunt
Kymanox
Merck
Merz
Mispro Biotech
Marsh & McLennan Agency
Nexsen Pruet
Nikon
Novo Nordisk
Novozymes
Precision Biosciences
PSC Biotech
Smith Anderson
UCB
UniFirst