Life Sciences Section from 2021 SCBIZ Summer Issue

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New frontiers

Summer 2021

S.C.’s life sciences sector poised for growth, success

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LIFE SCIENCES: WHAT IS IT AND WHY IS IT SO HOT By Jim Tatum, Associate Editor

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o say that South Carolina’s life sciences industry sector is growing is something of an understatement. Words like “booming” and “exploding” are far more accurate, say industry insiders. Just what is the life sciences industry and how did it come to be one of South Carolina’s hottest industry sectors? While the life sciences industry does not have any officially accepted singular definition by the U.S. government, it can be generally defined as “encompassing firms in the biotechnology, biomedical, pharmaceutical, biomedical

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technologies and devices, life systems technologies, and food processing fields, as well as any involved in various stages of research, manufacture, and distribution of products in these fields,” according to SCBIO’s 2020 annual report. Both SCBIO, the nonprofit organization dedicated to promoting, nurturing and developing the life sciences industry, and the state of South Carolina recognize seven primary fields within the sector, including drugs and pharmaceuticals, medical devices and equipment, digital health solutions,

research, medical and testing laboratories, bio-science related distribution, bio agriculture, and life sciences ecosystems support. According to a 2017 study done for SCBIO by the Darla Moore School of Business at the University of South Carolina, annual employment growth within the life science industry averaged approximately 1.7 percent — more than twice that of the rest of the state (0.8%) between 2005 and 2017. At that time, the report identified some 407 companies in the sector employing more than 40,000


to nurture and grow the state’s life sciences ecosystem, Ford said. “It really is all about telling the story of the life sciences industry in South Carolina, how it improves life for South Carolinians, and ultimately, the world,” Ford said. “We learn more and more every day; consequently, the story grows and develops.” With the data, SCBIO can enhance recruitment opportunities as well as workforce development opportunities, she said. The organization can help foreign companies who want to establish a presence in the U.S. in a variety of ways, from navigating complicated regulatory issues to networking with existing entities in the industry. “We knew life sciences was making a big impact,” Ford said. “But the 2017 study was the first time we have actually had quantifiable data. That has helped us refine SCBIO’s role and sharpen our focus.”

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people and generating an $11.8 billion economic impact. “It’s exciting to see and be part of this growth,” Erin Ford, SCBIO interim CEO director, said. “The numbers have greatly increased since 2017.” In fact, life sciences is now the fastest growing industry sector in South Carolina, Ford said. SCBIO has been in existence since 2004, Ford said. Over time, and with direction from new leadership, the organization evolved and expanded, developing not only more opportunities for advocacy but for economic development. “It really became a different organization,” Ford said. “Having that data from the 2017 report really helped us showcase the industry. As people wanted to learn more, we as an organization continue to learn more.” Ultimately, SCBIO is about finding creative ways to put all the elements together

TRENDING: LIFE SCIENCES IN S.C.

A map of companies and organizations in South Carolina that work in the life sciences sector shows a presence in 42 of 46 counties statewide. (Graphic/SCBIO)

The report provided names and numbers, identifying companies in the sector as well as quantifying numerical data. With that information, SCBIO has been able to better sharpen its focus and expand its role, she said. According to SCBIO and the S.C. Department of Commerce, the industry currently provides: • More than 700 life science firms; more than 43,000 direct and indirect jobs • Average salary $78,000+ • Supporting $7 billion+ in economic activity • Generates $12 billion annual total economic impact to S.C., over 40,000 jobs in total, $2.5 billion in S.C. labor income • 2.9 industry multiplier • S.C. inventors have earned more than 400 patents and licensed technologies in the past five years Dr. Joseph Von Nessen, research economist with the Darla Moore School of Business at the University of South Carolina, authored the 2017 industry report for SCBIO. According to Von Nessen, several factors have driven the sector’s growth and impact. One of those drivers is the growing demand for health care and health-related services; South Carolina has a larger than average population of retirees and seniors, with more relocating to the state every year. Another is South Carolina’s positive business climate, which, of course, helps all sectors. This includes the state’s inherent infrastructure, from the ports to the highway and rail systems, technical college system, high quality of life and reasonable cost of living and doing business. The industry also has a high multiplier effect, 2.9 percent, which means that for every 10 life science jobs created, 19 more are created in related areas, Von Nessen said. “Companies in the life sciences sector often rely heavily on local suppliers, which leads to more secondary job creation,” Von Nessen said. “And when you put the relatively high wage jobs that the life sciences sector supports together with a higher multiplier effect, you’re going to get a recipe for strong growth potential.” Another important factor, especially for life sciences, is a growing overlap between the industry sector and manufacturing. For example, precision manufacturing in

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At top, an SCBIO conference drew more than 400 attendees in 2020. SCBIO interim CEO Erin Ford (above) was among the speakers. (Photos/Provided)

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specialty medical devices also translates easily and effectively to other sectors such as automotive and aerospace. “Why do business in life sciences in S.C.? I think it’s kind of undiscovered country,” said Craig Niles, senior technical staff member at AVX’s Advanced Products and Technology Center. “The business climate, I think, in

South Carolina is very good for establishing and working with new businesses. We have a lot of good technical help from the local universities available to us, and groups like MUSC and Prisma Health that are strong in trying to promote innovation. Groups like SCBIO, for as long as we’ve been part of it, have been promoting sort of entrepreneurial

aspect of medical devices. We are fully mindful of their activities and always looking for ways to either support those activities or look at ways of expanding our product line via acquisition or some other partnering.” Lou Kennedy, CEO/owner of Nephron Pharmaceuticals and SCBIO board chair, called the state a hotbed of innovation, pointing to several examples of startups and expansions due to proximity of research and clinical facilities at institutions such as Clemson University, University of South Carolina and the Medical University of South Carolina. “I think the environment is ripe, and because we are a state that hasn’t (for the last 20 years) focused on health care and life science, we don’t have the onslaught of competition that Research Triangle Park (in North Carolina) has,” Kennedy said. “We’ve got this just ripe community to do all these kinds of things, and we’ve got the universities to support it, and the students and employees that want to do great things for the community and the world.”


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Nephron Pharmaceuticals in West Columbia has been active with projects related to research and development of COVID-19 vaccines. (Photo/Provided)

SOUTH CAROLINA AT FOREFRONT OF LIFE SCIENCE RESEARCH By Melinda Waldrop

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rom products to treat lupus to diabetes testing for dogs, South Carolina is home to cutting-edge life sciences research and development projects. The innovation driving the state’s $12 billion industry takes many forms but shares a common goal of pushing the boundaries of technology to benefit both companies and consumers.

ZYLO THERAPEUTICS

of the skin, serenely delivering its payload without requiring a cumbersome patch. Zylo’s “patchless patch” has applications in the cosmetics industry, with Zylo soon to announce a partnership with a European company, and in emerging health care products. The company received a $1.7 million grant from the National Institutes of Health to more effectively deliver nitric oxide, a substance naturally manufactured in the body that improves circulation but declines as people age. Zylo’s silica particles have been shown to sustainably release nitric oxide, helping with cardiovascular and blood flow issues, Pancoast said. Zylo also works with partners on prescribed medications, such as a product that helps with the cutaneous manifestation of plaques that form on the head and neck of lupus patients. And a new partnership with Silo Pharma will attempt to address neurological diseases through payloads delivering products such as ketamine, a pain reliever and common tool in the arsenal of

emergency room doctors. Lured to the Upstate from his native California by financing from angel investment group VentureSouth, Pancoast has been pleased with the public and private support his company has received in South Carolina and hopes to expand its workforce to dozens of employees. “We hope to, in the next year or two, be able to fill up our manufacturing space and become a growing fixture in the growing list of success stories in South Carolina,” he said.

CLEMSON UNIVERSITY Delphine Dean hasn’t spent much time outside her Clemson University lab in the past year. Dean, a bioengineering professor, is usually plenty busy developing medical devices for low-resource diagnostic settings through partnerships with in-state collaborators such as the Medical University of South Carolina, the University of South Carolina and Prisma Health, as well as organizations in India and Tanzania. Since last spring,

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Zylo Therapeutics, which recently moved from Clemson University’s CUBEInc. into a 12,500-square-foot facility of its own, is about overcoming barriers. The company, founded in 2017 by CEO Scott Pancoast, is pushing the topical delivery envelope for products including retinol creams, lidocaine and CBD oils. “Your skin is made to be a barrier. It doesn’t want things penetrating it and getting into your bloodstream,” Pancoast said. Zylo enhances a product’s bioavailability through engineered silica, similar to beach sand but smaller and finer. It allows a product to remain stable just underneath the surface

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TRENDING: LIFE SCIENCES IN S.C. Above, a technician at Clemson’s CLIA lab handles a vial as part of the lab’s COVID-19 testing program. At right, Lou Kennedy, CEO of Nephron Pharmaceuticals. (Photos/Provided)

she’s also been charged with developing and running Clemson’s COVID testing, which topped 20,000 tests a week during this spring semester. When she’s not overseeing 4,000 COVID

milk using specialized fibers to trap viral particles and oxygen sensors made from hearing aid batteries that test the function of respirators. Student researchers in Tanzania also helped design neck braces out of basket-

“... We only expect it to grow here. The network that we have is strong. There seems to be good support at the state level.”

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— Craig Niles, AVX Corp., on the future of life sciences in S.C.

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tests a day, Dean is directing student projects including low-cost, easy-to-manufacture diabetes testing strips that test saliva. The method, developed when a Clemson student doing research in Tanzania found it difficult to get testing supplies, has been adapted to work for dogs in a product called VetTab, produced through Greenville-based Accessible Diagnostics. Other projects under Dean’s purview are a breast pump that scrubs HIV from breast

weaving materials used by an artisan group that had set up shop outside a local hospital. “On the COVID side, it’s been really rewarding to help Clemson University and the Clemson community,” she said. “On just technology development in general, it’s nice to see things get out the door and get used.”

NEPHRON PHARMACEUTICALS One of the eight projects that West Columbia-based Nephron Pharmaceuticals

Corp. has in various stages of development with large pharma companies can be found on at your local pharmacy — if it’s in stock. Nephron produced the vials of solution in Abbott Laboratories’ at-home COVID test and is also doing development and regulatory work for NeuroRX, a company with a COVID therapy product currently in National Institutes of Health clinical trials. Nephron is also teaming up with Clemson University and the University of South Carolina to study production of the raw materials in nitrile gloves, owner and CEO


AVX

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At AVX Corp., the future lies in miniaturization and improved performance. The Greenville-based electronics manufacturer designs and produces components that seem, on the surface, similar to the nuts and bolts of a standard cell phone. But its products, which include parts for pacemakers and defibrillators, must be almost infallible and able to fit into any space. After helping expedite parts for ventilator construction during the pandemic, AVX is turning its attention to a health care field featuring fewer doctor visits. “You have to have access to technologies like telemedicine and remote monitoring and simplified ways of people being able to access their own health without direct contact with a health care provider,” said Craig Niles, a technical staff senior member at AVX’s Advanced Products and Technology Center. “Those things are part and parcel of what we would like to promote by being able to make better and smaller sensing devices.” Niles’ niche lies in developing new, performance-enhancing materials. Ceramic materials, for instance, can withstand stronger electrical fields and store more charge, functions necessary as wireless communication frequencies evolve past 5G into 6G. Niles, at AVX since 1988, is eager to oversee more life science advances in South Carolina. “I don’t mean to downplay the existing market, but we only expect it to grow here,” he said. “The network that we have is strong. There seems to be good support at the state level, and the business climate suggests that this would be a good place for some of these developments to be made.”

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Lou Kennedy said. And the company is in talks with two potential partners to use its 110,000-square-foot vaccine production wing, part of Nephron’s $215.8 million expansion of its Saxe-Gotha Industrial Park campus. “South Carolina’s got a lot of innovation going on,” Kennedy said. “There’s a lot of excitement and growth on this side of the (Congaree) river.”

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TRENDING: LIFE SCIENCES IN S.C.

Clemson’s Yue “Sophie” Wang is spearheading Clemson University’s partnership with Nephron Pharmaceuticals to develop a robotic arm used to fill syringes. (Photo/Provided)

INDUSTRIES, SCHOOLS MITIGATE LIFE SCIENCE WORKFORCE GAP By Molly Hulsey

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outh Carolina’s life science sector, once falling behind the automotive and aerospace industries in growth, charges ahead with a momentum that creates twice as many jobs each year as the state economy as a whole, according to an economic impact report from University of South Carolina Research Economist Joseph Von Nessen. And with life science jobs paying on average more than $78,000 yearly, it is evident that in the race to woo employees in a state with a 5.3 percent unemployment rate, the sector has an edge. But since 2017, the number of life science firms has doubled across the state, and universities, industry organizations and companies are banding together to ensure that the most critical resource — human

mhulsey@scbiznews.com capital — can keep up with the demand. “It has historically been the majority of the time that you find a qualified person, they already have a job in M and L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company serving the manufacturing sector, and a former staffing professional. He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field. “All I’ve heard since the pandemic is (that) it has been hard to even find available people, much less available and qualified people,” he said. Especially within the often-specialized needs of the life science industry.

SCBIO and its 100-people strong Workforce and Development Task Force has been formulating an initiative that will spark this interest beginning at the age of 5, especially among young women, and feed the flame with sector-specific curriculum plans at the college-level and scholarship programs. Interim SCBIO CEO Erin Ford said the workforce will pilot a Life Science Certificate program with two-year technical colleges across the state. So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field. “I am hopeful that we will have a course that will happen at one of these schools by


like Poly-Med, and Ford forsees a possible apprenticeship route on a case-by-case basis in the years ahead. For Spartanburg Community College, hosting a medical device company that is literally in-house at its soft-landing incubator, the Sparks Center, seemed to be the obvious step toward encouraging local economic and workforce development. Earlier this spring, Epica International, a robotics and medical-imaging developer, established its corporate base and incoming assembly operations facility within the Sparks Center, partially due to the area’s workforce and research university presence. “We could get a warehouse lots of places,” said company founder and director Greg Stotenburgh. “Being able to have access to those people and the facilities for training and everything else — that’s huge.” Spartanburg Regional Health will be the first hospital to install the company’s newest development, a mobile CT scanner with High Definition Volumetric Imaging with fluoroscopy and digital radiography features that can be wheeled to a patient. “Hopefully, we’ll be creating some training

on this piece of equipment for future employees that are using this, so that’s pretty exciting,” said Mark Forrester, vice president of economic development at the college. At the university level, Nephron Pharmaceuticals has already begun to partner with Clemson University’s Yue “Sophie” Wang in helping mitigate workforce and drug shortages with her creation of a benchtop robotic arm that will fill, cap and seal syringes at the Columbia outsourcing facility. Nephron CEO Lou Kennedy said the partnership will not only free up the five employees per airflow hood needed to fill syringes but will also help foster a talent pipeline to the company. The next phase of the project features the completion of a clean room on Clemson’s campus for the project: another step toward Kennedy’s plans to commercialize the robot. “We’re a young company and want to play a role in developing all of this great talent we have around us,” Kennedy said in a news release. “I decided it was time to put game day feelings aside and look at where our talent was really coming from.”

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the end of the year or early next year,” Ford said. Life science companies in each region have already offered some input to their needs and will continue to do so once the program launches: Trident Tech collaborates on the workforce demands of Charlestonarea companies Alchemy, Charles River Labs and Vikor Scientific while Tri-County Tech is partnering with Arthrex, Abbott Laboratories and Poly-med. Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise TriCounty Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation. “Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.” The course would help prime students for employment at partnering industries

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TRENDING: LIFE SCIENCES IN S.C. Partnerships formed during the pandemic helped Precision Genetics prepare to roll out its latest product, a genetics-based mental health treatment program, this summer. (Photo/Provided)

LIFE SCIENCE INNOVATION, DEMAND GROWS OUT OF PANDEMIC YEARS By Molly Hulsey

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or the state’s fastest growing industry, 2020 was both a paradigm shift and a call to action. As international supply chains faltered, local life science companies had to shoulder the brunt of a lack of raw materials that arose while market demand was intensifying. “We found out at the worst of the pandemic that over 90% of all active pharmaceutical ingredients, 97% of all antibiotics, 95% of all Vitamin C are all produced offshore,” said Sam Konduros, CEO of the Vikor Scientific’s new cannabis treatment startup, KOR Medical. One year out, industry leaders attribute the sector’s rapid mobilization — and the public-private links developed during that time — for new treatments and initiatives

Mhulsey@scbiznews.com as COVID-19 cases begin to flatline across South Carolina. “We are working actively with all those federal agencies that I mentioned: BARTA (Biomedical Advanced Research and Development), HHS, DOD, U.S. Development Finance Corp.,” said Konduros, then CEO of SCBIO. “There are funding mechanisms unlike anything I have ever seen available to qualifying companies that can truly meet the need and are capable. So whether it’s an existing South Carolina company that’s already strong and has demonstrated a track record that it can expand more easily utilizing some of those tools or some of the projects I’m talking about that would be literally onshoring, it gives us a lot more wind in the sails than normal.”

For Konduros, renewed focus on the life sciences aided him in his transition from a four-year stint as the CEO of SCBIO to the helm of the Vikor Scientific portfolio company after Vikor’s “explosive growth over the past three years.” In December, the Charleston company spent $1 million in expanding its production of COVID-19 testing kits. A few months later, Vikor launched Quantgene Serenity, an artificial intelligence-powered treatment designed to detect cancercausing mutations through a non-invasive blood sample. “People are now taking ownership of their health,” Vikor Co-Founder Scotty Branch said. The pandemic awakened a drive for self-care among consumers, he argued. Last April, SC Biz News reported how


TRENDING: LIFE SCIENCES IN S.C. Greenville-based manufacturer Softbox has long been a player on the life science field with its chilled shipping packages, but during the pandemic, it became one of Pfizer’s primary suppliers for ultra-cold shippers used to transport COVID-19 vaccines. Here, Prisma Health employees wheel in a Softbox shipper of one of the first Pfizer vaccine shipments. (Photo/Provided)

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Greenville-based Precision Genetics began its ascent to a COVID-19 test processing and reference center for some of the largest hospital systems in the state. At that time, the lab was processing more than 1,000 tests a day just for Prisma. A year later, CEO Nate Wilbourne added Bon Secours St. Francis Health System, Spartanburg Regional Health Care Systems, Lexington Medical Center, Roper St. Francis Health Care and the Medical University of South Carolina to the list of partners during the pandemic. “Word spread relatively quickly that we had automated the process to be able to capture COVID-19 testing orders: it was embedded into the medical record (and) our turnaround time was 24 hours or less, which was very important with the urgency around COVID testing,” Wilbourne said. “Once that word spread, it really did open a lot of opportunities for Precision to be able to start partnering with other health systems. We ended up last year signing contracts and doing reference work for COVID at the time for five of the largest hospital systems in South Carolina, to include MUSC, who we now have a partnership with on their molecular side.” Many of these partnerships, such as Precision Genetics’ tie to MUSC, were nonexistent before the pandemic, but are what will make the June release of the company’s newest product possible: an individualized mental health treatment plan based off genetic assays. The company had developed the assay for the project before the pandemic hit, but the testing partnerships with hospitals streamlined the process of linking hospitals’ patient databases with Precision Genetics’ system. According to Wilbourne, the new product will prompt physicians within the system to prescribe pharmaceuticals and treatment plans best suited for patients based on their genetic makeup and existing medications. He also argued that the pandemic helped generate a greater demand from both patients and hospitals for similar products, especially since mental health issues have come to the forefront following months of social isolation, job loss and other stressors. “What people realized in the pandemic

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over the past 14 months is the value of molecular data as it relates to patient care,” he said. The pandemic also pushed Vitalink’s services onto the national stage when the company became the only Upstate provider for the third trial of the Moderna COVID-19 vaccine. Before last March, Vitalink CEO Steve Clemons said that few people he spoke with really knew what he did or how clinical trials worked. And despite being “purpose-built for the pandemic” with a respiratory treatment focus, Vitalink was not a hub for vaccine trials. Then Vitalink became the only Phase III provider of the Moderna COVID-19 vaccine trial in the Upstate. “There has never been a time when people knew what we do like today,” he said. When Vitalink announced that it would pioneering a new frontier in 2020, roughly 1,200 Upstate trial participants signed up for the Moderna vaccine. Clemons said they could have served more if they had had the staff and resources at the time.

Vikor Scientific representatives say the life sciences industry has seen “explosive growth” over the past three years. In December 2020, the company spent $1 million in an expansion that grew its COVID-19 testing capabilities. (Photo/Provided)

“Our company was on a slower period when the tidal wave hit, and literally, I tripled my company size in the matter of about 30 days,” he said. Even as Vitalink’s work in readying the COVID-19 vaccine for approval begins to wane, its connection to Moderna and other players in the vaccine production world have not.

“Moderna came to us with some other types of studies down the road,” he said. “Moderna does a lot of things like flu vaccine and things like that. And really, leave COVID alone for a minute, between flu and RSV (respiratory syncytial virus) — which everyone thinks of RSV as a baby disease, but it’s really not — those are the other trials that we’re working on right now.”


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