Saturday, April 13, 2024

Round table: Life sciences, chain reaction

The biomanufacturing industry makes products that sustain and improve life for many people. But creating vaccines, medications and therapeutics requires the right ingredients at the right time. The pandemic is rewriting how many companies do business. Whether securing raw materials, working with clients or training workers, the industry is evolving. Business North Carolina magazine, along with North Carolina Biosciences Organization, invited six leaders to discuss their industry’s current status, its biggest needs and where it’s headed.


BioNetwork Capstone Center, BTEC, Fujifilm Diosynth Biotechnologies, Nexsen Pruet and North Carolina Biosciences Organization sponsored the discussion.

Business North Carolina Publisher Ben Kinney moderated the discussion.
The transcript was edited for brevity and clarity.


What makes North Carolina so attractive to biomanufacturers? Why do they thrive here?

GILLESKIE: The industry’s workforce includes technicians and mechanics along with scientists and engineers. No one educational institution can provide them all. So, NCBioImpact — a consortium of community colleges and universities that’s focused on workforce development — is a big selling point for the state. If I’m the CEO of a biomanufacturer, my biggest concern is likely staffing. North Carolina is in as good a position as any place in the world to meet that need.

WAGNER: I worked for Merck. After we chose North Carolina for our new plant in 2004, I was called to company headquarters. Representatives from Georgia and Virginia wanted to know why they weren’t selected. All three economic development packages were similar; it came down to NCBioImpact and the investment to train and sustain a workforce. They agreed North Carolina did a better job. Brick and mortar can be done anywhere, and somebody will always offer you as much or more money. But this industry is about people. At 2 a.m. on a Saturday, when you’re running a batch worth a million dollars, you’re not worried about saving $1 an hour on pay. You want the person who will make the correct decision so you don’t lose it. We care about labor costs but having qualified workers is most important. You can automate all you want, but you still need qualified workers to run your operation. North Carolina has invested in its people. Look at its economic history — tobacco to textiles to technology to biopharma. Its workforce has morphed, retraining to meet the needs of the industries that are working here right now.

EDGETON: North Carolina has had incredible foresight over a long period of time for growing this industry by building a strong ecosystem. When we talk or work with site selectors, we’re not only the Biotech Center. We’re all the people who we work with statewide. It’s a collaborative effort, something we hear from recruiters that many other states lack. We’ve driven down the corporate tax rate, which makes us more competitive. We’re fortunate to have four level-one research universities. They generate an enormous economic impact and many ideas. And there is a great quality of life. I love talking to people from companies overseas who once worked in North Carolina. If they could move back, they say their family would pack immediately. You like to hear that kind of endorsement.

ROBERTS: North Carolina’s sustained commitment to the industry. We work in multiple states, so I can compare. The university system, the community college system, various collaborations and financial support from the legislature have all helped the industry.

How did the industry respond to the pandemic?

ROBERTS: It has been about resiliency for our clients. We’re more than a year into the pandemic, and there has been growth during that time. They turned economic and health threats into opportunities. There are many examples of companies pivoting, such as manufacturers converting production to hand sanitizer or personal protective equipment. We heard many questions about procuring or selling PPE.

VANNAIS: The pandemic affected operations and changed our employee safety programs. Things changed quickly in the first three to six months. It was challenging to keep operations going while implementing COVID countermeasures such as adjusting shifts, adding social distancing, requiring masks and more. We responded to individuals who had health concerns for themselves, their employees, their families and their colleagues. It was tremendously helpful to have occupational health nurses on-site supporting our organization. We made contingency plans, including training people as backups to ensure batches that were in process could be completed. Then we could pause until everything was ready and everyone was healthy before resuming production. It took a 115% effort and dedication to close gaps, including sending data to clients off-site who usually are on-site during critical process validation batches. As a client-based organization, building trust with our clients is a core value, which we leaned on during this challenging year. Transitioning some functions to videoconferencing is fine. However, most other functions, such as being in a manufacturing suite or laboratory, continued with countermeasures. We evolved over the entire year. We learned lessons, some of which will continue. We also learned that some things have to be done in person such as training new employees. We onboarded more than 100 people last year.

GILLESKIE: It was a year of change for BTEC, which offers courses to N.C. State students and professionals and operates a variety of labs and a simulated good manufacturing practices manufacturing area. They all came to a halt in March 2020, when N.C. State limited the number of people on campus and courses went online. We were forced to change our hands-on mindset and quickly create a virtual lab experience. I can’t say virtual labs are better; I look forward to the return of hands-on labs, which started during the recent spring semester. But the move made us question if all our offerings had to be hands-on. We found opportunities for online courses, especially for professionals, that we wouldn’t have considered a year ago. And we’re getting better at it now that we have demonstrated that we can do it. There’s demand: Several companies have requested online training. We’ll continue our hands-on approach and post more quality content online, allowing us to reach more people. In addition to online training, we partnered with other organizations in producing hand sanitizer. We supply much of what’s used at N.C. State. And I would say there’s a better understanding of biopharmaceuticals, particularly vaccines. We train students on vaccine manufacturing, and I am now in the position to discuss current events and biopharmaceuticals in class. I didn’t think that way a year ago.

ISENHOUR: The biggest challenge for us is envisioning what education will look like moving forward. Much of our training revolved around clean rooms and other equipment that was on campus. We were trying to create a more immersive environment for our students and industry partners. That disappeared quickly as industry focused on maintaining their outputs. So, we went to work on virtual learning. Many of our industry trainers retooled, becoming online-learning specialists. Our partners have appreciated that pivot. An arm of BioNetwork does digital learning. It was a piece of the training puzzle before the pandemic. Now it’s a huge chunk of the puzzle. Will companies want us to stay virtual, go back to in-person or create a hybrid of the two moving forward? That’s a question that all secondary educational entities are pondering. We have to listen to the industry. And we’re doing that now.

EDGETON: The state deemed the industry essential, so production and operations continued. Growth has been rapid over the past year. We did a study two years ago. Based on interviews with the industry’s 58 largest employers, we would need between 5,000 and 7,000 new workers over the next five years. We announced 2,800 new jobs last year.

WAGNER: Those jobs are [well-paying] and stable. Hiring 1,000 people is a billion-dollar investment. You don’t move that quickly, as some industries do, chasing $1 an hour less pay or similar things. The leaders of these companies are smart. They figured out how to operate during the pandemic. But their processes are complex. Workers are worried about their families and their co-worker who sneezed. Those are distractions, and the more workers are distracted the greater the risk. You can’t lower your guard. It’s like texting while driving. You may get away with it 10 times, but the 11th time is catastrophic. So management and supervisors on the factory floor played an important role, keeping workers focused on their jobs. Our role was advocating for biomanufacturers and helping them interpret new rules and their unintended consequences, which could be catastrophic in a manufacturing environment. The pandemic will make businesses better. Weak points and opportunities have been uncovered. The challenges came with supply chain backward, where companies have less control. This isn’t an industry where you can change suppliers because your regular one is out of stock. Suppliers have to be validated. The pandemic pointed to the importance of securing your entire supply chain. Demand increased for critical materials. Inventory levels are usually high, ensuring companies are covered for the short term. And the government has stockpiles of some critical materials. But past a couple months, you’re relying on ongoing production, which is challenged during the pandemic. I never experienced anything like this in my 10 years running a plant. It’s like pilots. They fly on autopilot all the time. But when they don’t, you want an experienced person at the controls.

How did the pandemic affect the industry’s supply chains, short and long term?

GILLESKIE: The pandemic has made sourcing raw materials and consumables a challenge. BTEC has had a difficult time getting its hands on materials needed to run labs. Much of the supply chain has been rerouted to COVID vaccine production.

VANNAIS: In 2020, we supported more than 50 different projects in North Carolina. One of them is the manufacturing of the Novavax COVID-19 vaccine candidate. Since July, we have been manufacturing 24/7 under management and support of Operation Warp Speed. That included on-site help with the supply chain. That was vital, because we needed every component to run each batch. But with all COVID-19 therapies and vaccines drawing from that supply chain, it is and will continue to be a challenging situation. You must have everything on hand before you start a batch. You’re not going to start a batch at risk. So a single consumable, a single salt, the media can prevent a batch from starting. There are many places where a supply chain delay can impact production. Many items have been single sourced in the past. Do we want to continue that way or should we find alternatives, qualifying two or three vendors or systems? That would add redundancy. We’re evaluating if that’s the new business model or simply a midterm plan until the supply chain is restored.

WAGNER: Everybody will think everything is fine once we’re out of the pandemic. But there will be a lag. There are buffer inventories at every link in the supply chain. But they are depleted when stressed. It takes a long time to refill supply chains, so some critical components will be hand-to-mouth for a while. Soon after the pandemic’s start, when emotions were running high, everybody was surprised at how reliant we’ve become on China for some critical items. What happens when it’s back to business and that emotion disappears? When there is emotion, costs aren’t a concern. But cost is important — that’s the reality. When the dust settles and heads cool, there should be some deep analysis around sourcing of critical components. Large corporations chase buying power, but sometimes the cheapest isn’t always the best. They also don’t focus on finding a local supply. And in situations such as the pandemic, that can be valuable. You can go and sit on someone’s desk, putting pressure on them, as opposed to them ignoring your call. An expansion of local suppliers could be a boon to the state.
ROBERTS: There’s a political push for repatriating supply chains. We have several clients who are working on that. We’ll see if it’s possible. Cost will be the deciding factor.

How is workforce training evolving to meet the industry’s needs?

ISENHOUR: The community college system and industry have a dynamic partnership in which the former customizes training using the latest technology to the latter’s needs and goals. It’s not something you’ll find everywhere. Most of the research and development, clinical trials and lab-based roles are found west of Raleigh, including Research Triangle Park. Most of the manufacturing is done from that point east. When I worked at Johnston Community College, I mapped the state’s major biomanufacturers. I wanted to see where my students could work and our training would be needed. Within an hour’s drive — which most people would make for a good job — is 75% of the state’s biomanufacturing. Major highways, including interstates 40 and 95, connect those companies and their communities, including Wilson, Clayton, Greenville and Four Oaks. They also connect both ends of the industry — scientific and manufacturing. Wake Tech had one degree, but you can’t get all that training to meet both lab technician and manufacturing skillsets in one two-year program. So, we let biotechnology remain the traditional pathway to lab and scientific careers and offered that on the county’s western side. On its eastern side the focus is manufacturing, so we target our new degree there. You have to be regional. You have to look at the needs. It’s about the partnerships and listening and being strategic about how you place programs.

GILLESKIE: There’s a great opportunity for outreach, spreading word of the biopharmaceutical industry, the products it makes, its prevalence in North Carolina, and its economic and societal impacts. N.C. State students usually start taking courses at BTEC as juniors or seniors. So, we reach out to freshmen and sophomores to recruit them into our program. There will be a big emphasis on vaccine manufacturing over the next few years. In addition, gene therapy, which has taken off here over the last five years, will continue to grow. Educational institutions need to be prepared for that. BTEC has recently added manufacturing of gene therapies to its capabilities. That capability wasn’t crucial when BTEC started 14 years ago.

VANNAIS: We need to find students from middle school through college. We need to find people who want to change careers. For example, those leaving the military. We need biopharma engineers and mechanics to work on large centrifuges and large 20,000L bioreactors. We’re building the largest end-to-end cell culture facility in Holly Springs, which will be highly automated. We need automation engineers and many other professionals and trades. Some of them might not be someone who traditionally signs up for a BioWorks program. During site selection for our new facility, workforce development set North Carolina apart. Over the coming years, hiring more than 700 colleagues will not be easy. The biopharma industry is a small community in the RTP region. Knowledgeable workers are moving within it; however, retention is critical for building workplace culture and increasing efficiency. When workers move in and out of a company, it has a hard time embedding and sustaining its culture. We want to reach a broader audience, filling jobs with community college and university graduates and people coming from other states.

What does the future hold for the industry?

EDGETON: This year will bring growth and a continued emphasis on cultivating talent. Interest in relocating to or setting up shop in North Carolina remains strong. There’s a lot of work to do on talent development. We launched Bio Jobs Hub, promoting the life-sciences sector’s good jobs to K through 12 students and those in community colleges and universities, and eventually at the Ph.D. level. We also worked with partners in Durham to start BULLS: Building Up Local Life Sciences, which is reaching out into the community, underscoring the jobs message. The opportunities are promoted on Durham buses right now.

ROBERTS: We should see more growth and collaboration among biomanufacturers and life-sciences companies. Some of this collaboration has already started happening in response to the pandemic and includes working together on supply chains and even working with folks that are in different sub-industries. Some of the trade associations facilitated that. The collaboration has been exciting.

WAGNER: There will be tremendous pressure to train more workers and on the state to pay for it. Everybody likes to get the jobs, but they bring responsibility. When I helped bring Merck to the state, the deciding factor was workforce development, including the Golden LEAF Foundation’s investment in NCBioImpact Network, which includes BTEC, Biomanufacturing Research Institute and Technology Enterprise at N.C. Central University and the community college system’s BioNetwork. The industry’s employment numbers jumped in the mid-2000s then stagnated for a while. We’re seeing a tsunami now. ■

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