Nephron expanding again in Columbia, SC see more
With promising news about a COVID-19 vaccine making headlines, Lou Kennedy had reason for optimism during a beam-raising ceremony marking a milestone for a $215.8 million expansion at Nephron Pharmaceutical Corp.’s Saxe-Gotha Industrial Park campus.
Part of the expansion is a 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that Kennedy, Nephron owner and CEO, expects to be operational around March 2021. She said Nephron is actively looking for a vaccine production partner to provide the ammunition for the pre-filled sterile syringes that make up the booming 503B Outsourcing Facility arm of the company.
“It’s a Chamber of Commerce day,” Kennedy said after signing the final beam of the 240,000-square-foot Kennedy Innovation Center’s steel skeleton on Tuesday morning. “This marks a milestone in 2020. This is good news. This is giving us the space to continue to grow.”
Newly elected President's plans have major bearing on the medtech industry see more
While former Vice President Joe Biden and the team he builds won't take office for another two months, the campaign’s plans for COVID-19, healthcare and other policy areas offer clues to how changing tides in Washington may impact the medtech industry.
In approaching the top task at hand — getting the pandemic under control — the Democrat's plan includes proposals with implications for the industry, from how diagnostic testing is covered to access to telemedicine services.
In some ways, the act of swapping out administrations, regardless of who's in power, means device makers can anticipate shifts at key government agencies like the FDA.
Southeast Life Sciences Launches SE Color, initiate action to encourage minorities to participate in Clinical TrialsSE Color initiates “We Are In” Campaign to encourage minority participation in Clinical Trials see more
On September 9, Southeast Life Sciences announced the formation of SE Color, an organization dedicated to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities.
The founding advisory board members are Jayne Morgan MD, Clinical Director, Covid Task Force at Piedmont Healthcare, Kornelius Bankston, Managing Partner with techPLUG, and John Newby, Chief Executive Officer for Virginia BIO. As executive director of Southeast Life Sciences, Jason Rupp will staff the organization.
SE Color’s initial effort will focus on increasing the number of minorities in clinical trials. In an article published in Healthcare Tech Outlook, Dr. Morgan notes that, “African Americans make up 13.4 percent of the US population, yet only 5 – 7 percent of clinical trial participants nationally.”
Dr. Morgan further states, “Nearly every advance in medicine today was first evaluated in a clinical trial. Clinical trials offer our best and most forward thinking and can be the gateway to provide earlier access to life saving medicines and therapies years ahead of FDA approval. Equitable participation in clinical trials is therefore a critical call to action in ensuring that medicines, devices, and vaccines that are developed are relevant to all populations.”
Although there are many aspects to facilitate minority recruitment in clinical trials, SE Color will initially focus on education through the “We Are In” campaign. The initial priority will be to share information on clinical trials available throughout the southeast. SE Color will partner with state associations in the region to ensure we have updated information and extend the network.
Southeast Life Sciences recognizes the great need for effort in these areas and though we will only be one part of the solution, we will be part of it. In closing, Bankston adds “I believe the greatest social injustice in modern history is health inequalities which disproportionately impact people of color. We can create more effective therapeutics, applications and medicines for all populations- by addressing the systemic issues in clinical research.”
VentureSouth Named Top Ten see more
Compliments of MidlandsBiz
VentureSouth announced that it has been recognized as one of the top 10 angel investment groups in North America for the 3rd time.
The ranking comes from the Angel Capital Association, which released its 2020 Angel Funders Report this week. VentureSouth was recognized in the study as a top 10 angel group based on both total investments (30) and capital deployed ($12.7M) in 2019. VentureSouth was also recognized as a top 10 group by the ACA in 2018 and by CB Insights in 2014.
The Angel Capital Association is the largest association of angel groups in the world, with more than 250 angel groups and other early stage investors with over 14,000 members. Its members include many of the leading angel groups in the world.
VentureSouth was listed in this year’s top 10 alongside some of the largest and most well-respected angel groups in the US and Canada, including Tech Coast Angels in California and New York Angels and Golden Seeds in New York.
VentureSouth Managing Director Paul Clark commented: “We are honored to be recognized again as a top 10 angel group by the ACA and are proud that the repeat award recognizes our continued growth and the consistency of our approach to early-stage investing. We appreciate our highly engaged investors who are helping us accelerate investments in promising ventures across the Southeast.”
To learn more about VentureSouth, visit https://venturesouth.vc.
Zverse steps up for South Carolina see more
John Carrington remembers the chaos from the spreading coronavirus reaching his small Columbia, S.C., company about Saturday, March 14, three days after the World Health Organization declared Covid-19 a pandemic.
It started with a phone call from a hospital executive that Saturday saying the hospital was running critically short of personal protective equipment (PPE), ventilator parts, and ventilators altogether. “What can you do?,” the hospital executive asked.
The Zverse CEO recalled that the executive “was pretty urgent,” and the gist of the message was open-ended: “We need a lot of problems solved and fast, and how can you help?”
How indeed? Carrington couldn’t offer the hospital a catalog of PPE, or a catalog of anything.
His workers were specialists in being manufacturing enablers, providing software and a cadre of experts who linked customers with ideas with manufacturing partners to convert those ideas into objects as quickly and efficiently as possible.
Within days, the company would shift into designing its own face shields for use in hospitals, later designing other models for schools or other crowded spaces.
Zverse would go from being able to make 1,000 face shields a day using 3-D printers to making the heavy investments to build molds for injection molding that allowed its production rate to climb to 120,000 units per day within about a month. That process would typically take about two or three months.
In March, Zverse had 20 employees. By September, it had 80. It expects to end the year with 100 to 120 employees — more designers, product managers, account managers, customer service and support, shipping and logistics specialists.
“It’s been a wild ride,” Carrington said.
Zverse is just one of hundreds of South Carolina businesses that were called to action by the pandemic and responded with innovations to help their customers and communities in a time of need. Several of those companies in the biotech field were highlighted in an Aug. 25 webinar by SCBIO, a not-for-profit industry association promoting the life sciences in South Carolina.
The others were:
VitaLink Research, a clinical research site network based in Greenville. VitaLink was commissioned by Moderna to conduct its Covid-19 vaccine study in South Carolina.
Vikor Scientific LLC, a Charleston testing laboratory founded in May 2018 by physician and entrepreneur Shea Harrelson and medical entrepreneur Scotty Branch. Its lab is accredited by the Centers for Medicare and Medicaid Services under its Clinical Laboratory Improvement Amendments (CLIA) certification. They have dedicated 2,000 square feet of its new 22,000-square-foot facility to Covid-19 testing. In late August it was testing about 10,000 Covid-19 swabs per day, and had the capacity to test for 20,000 per day.
Nephron Pharmaceuticals Corp., a West Columbia manufacturer of medical products and a leading producer of medical products packaged into single doses using blow-fill seal technology. It is creating space at its Lexington County plant to manufacture vaccine doses when they become available. Since the pandemic, it has created a CLIA-certified lab for Covid-19 testing, and has a mobile lab that visits the University of South Carolina and several area employers.
Modjoul Inc., founded in Clemson in 2016 by Eric Martinez, CEO, and Jen Thorson, COO. Modjoul sells a platform designed to enhance worker safety by having them wear a device called a SmartBelt that tracks their movements. Linked software identifies movements that might be dangerous — from certain bending movements to overly fast cornering with a forklift. With Covid-19, it is enabling employers to use the devices to screen body temperatures and signal workers with a vibration if they are violating social distancing. In the event of an outbreak, the data can be used for rapid contact tracing.
“When you think about it, you’re able to reduce the amount of time businesses are shut down because you know who people have been in contact with,” Thorson said. “It’s one of those happy coincidences that we’re able to use our existing device, not only for safety, but also for that illness, contact tracing and social distancing.”
Thorson said her biggest lesson from the pandemic has been “don’t be afraid to pivot quickly.”
“We have a team of really smart people, and we can figure out almost any problem,” she said.
At Nephron Pharmaceuticals in Lexington County, one of their biggest lines is generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with Covid-19.
The company has grown from 75 employees with two products in 2001 to about 80 products and about 1,100 full-time employees, in addition to 900 part-time workers, interns and apprentices. It announced an expansion this year that will expand its buildings to cover 1 million square feet by early 2021. It expects to add 380 more full-time employees by 2024, and much of the hiring is now underway.
“We want them to be trained and ready as the new buildings come online,” CEO Lou Kennedy said.
About 110,000 square feet of its expansion is for manufacturing vaccine doses, antibiotics or other chemo-therapeutic agents. Nephron Pharmaceuticals is one of seven U.S. companies identified by the federal government as key to getting a vaccine produced — once one has been developed.
“We know we’re going to need a heck of a lot of vaccines all at once if we’re going to get everybody healthy,” she said. “We are doing anything we can within our bandwidth to be patriotic Americans and help with the eradication of Covid-19.”
The New York Times first reported Jan. 8 on the emergence of a novel coronavirus in China’s Wuhan province. Two days later, China reported its first death from the virus.
The first case in the United States was confirmed Jan. 21.
On Feb. 11, the World Health Organization named the disease Covid-19.
By Feb. 26 there were 60 known cases in the United States, and Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, asked the American public to brace itself for a global pandemic.
That day President Trump said infections were “going very substantially down,” and that “we’re going to be pretty soon at only five people.”
Just two weeks later, when Covid-19 was declared a global pandemic, there were at least 1,240 people in 42 states and Washington, D.C., who had tested positive for Covid-19, and 37 had died.
Meanwhile, a wave of change was rolling toward Carrington’s 7-year-old company on Shop Road, named for its location by Columbia’s Norfolk-Southern railroad repair shops and better known for parking for UofSC football games.
His children were home from school, many offices were closing and employees were working from home — if at all.
“It was interesting,” he said. “We were not sure what this meant for us, let alone as a business, because a lot of our manufacturing customers’ factories shut down as well.”
After the weekend call from the hospital executive, Carrington tried to solve its first problem: The hospital needed fully protective face shields that could be worn in the intensive care unit, or other areas with dense aerosols.
“Literally overnight, we went from concept to prototype, rapid prototyping, multiple iterations,” Carrington said. “They were asking for 3,000 units, which was no problem. And they needed them immediately.”
The next day, Zverse got a call from a government agency that needed 10,000 face shields. And on the third day, another hospital system called needing 50,000 shields.
The second hospital system needed face shields that could be sterilized and reused because they were going through disposables at a rate of 5,000 per day for just one of its hospitals.
While 3-D printers are splendid devices for fast turnaround and multiple design changes, they are not designed for a lot of volume.
And 50,000 units is what Carrington defined as “a lot of volume.”
So, it was decision time.
More calls were coming in. “Once the word got out to a few people, we started getting direct messages from doctors, family members of nurses, who were all pleading for help, because there was no PPP at all,” Carrington said.
The mulling was not a long process. The company simply wouldn’t be able to keep up with demand using 3-D printers.
So after the call for 50,000 units, Carrington decided to move from the 3-D printing underway to injection molding, “which was a significant step, because it was a real capital investment during a time when everything was very uncertain.”
But he knew it would also allow Zverse to ramp up much more dramatically, “help a lot more people, help the company and give us a little bit more security.”
The actual injection molding would be done by outside manufacturers, but Zverse had to supply them with the molds.
According to Rex Plastics of Vancouver, Wash., an injection mold can cost $1,000 to $80,000 depending on size and complexity. A typical mold costs $12,000.
Zverse dealt with the issue by requiring its customers to pay half the cost up front. Hospitals typically pay net 30, or 30 days after invoice, but they quickly agreed. “These are different times,” Carrington said.
“We were able to get the first 5,000 units coming out of the first mold within about two weeks.”
In all, Zverse built about 24 tools for injection molding.
Carrington credited much of the company’s success to its network of manufacturers.
“We had all the right people in our ecosystem to accomplish all this.
“We sit in the middle of a lot of manufacturing capabilities. That’s what we’ve done forever,” he said. “This is the first time we took a product of our own and went to market with it.”
After injection molding was in place, Zverse spread the word that it had the capacity to make 100,000 units a day — mass manufacturing.
“We got flooded with orders from every hospital, every government agency you can imagine,” he said. “It was completely overwhelming.”
Carrington started calling his shareholders and others in his support network to solve emerging problems, like transportation logistics.
“That whole period was insane for everyone involved,” he said. “But it was super fulfilling.”
One of Zverse’s biggest contracts was for the U.S. Department of Veterans Affairs for 2 million face shields. At the time, there were reports about suppliers not being able to deliver equipment and PPE to the VA.
But Zverse supplied the order from April through June.
“That was a herculean effort to be able to deliver that on time,” he said. “The VA said we were one of the best suppliers that they had.”
In all, Zverse supplied 3 million of its health model ZShields over 75 days.
As businesses began trying to reopen in May, there was a broad need for some forms of barriers and PPE —a need that is likely to last beyond the pandemic.
Some restaurants called for the face shields Zverse was delivering to hospitals.
“I looked at them and said if I walked into a restaurant and saw someone wearing this, I wouldn’t want to eat there. That’s going to be bad for business,” he said.
Instead, Zverse designed ZShield Plex —something that would be a comfortable and effective barrier from transferring droplets from your mouth. The shield attaches at the neck and can flip down when on break or away from where needed.
“That one captured everyone’s attention,” he said.
Zverse started taking pre-orders for the shield in May from businesses, schools and others, and has since shipped millions.
Carrington said Zverse was able to make its huge pivot to meet the demands of the pandemic moment with “brute force and an incredible team.”
“The core group that’s been here since March has been averaging like 16-hour days since March, including weekends,” he said. “Everyone is driven by the fact that we’re able to produce something that is able to solve problems.
“Right now the world needs a lot of problems solved,” Carrington said.
“I don’t think there’s been a time in history when the world has needed as much innovation in one moment as it does right now.”
Greenville's Humimic Medical pivots to meet pandemic needs see more
When the coronavirus pandemic left businesses around the nation struggling with dwindling orders and growing bills, some took a chance on something new.
Among them was Greenville-based Humimic Medical.
The 10-year-old company produces synthetic gels that mimic human tissue used in medical applications. Almost overnight, it switched to producing personal protective equipment (PPE), illustrating that there are opportunities everywhere for people with innovative ideas.
But it wasn’t all smooth sailing and the path was punctuated by a couple of Hail Mary passes, said Humimic founder and CEO Joel Edwards.
“None of our (products) had any ties with PPE or any Covid-related things … and everything was going pretty well,” he said. “We thought we were bulletproof.”
Then the phones stopped ringing, he said. There were no orders for three months.
Edwards spoke at the first of a series of webinars called “Leading Beyond the Crisis” that examines companies that responded to the pandemic. The webinars are hosted by InnoVision Awards, a grass roots non-profit dedicated to innovation and technology across the state.
Originally a defense industry company, Humimic began to focus on the medical side about four years ago, he said.
And in the face of the virus, it started looking at what else it could do, he said.
Since the company had a plastics supplier in Mount Pleasant and had just bought some new equipment, it turned to face shields when the virus exposed the desperate need for PPE, he said.
“We thought raw product (plastic, foam) was easy to come by, but when we started looking around, none were easy to secure,” he said. “And I’m running numbers in my head and thinking what did I get myself into.”
His contact in Mount Pleasant was his “only saving grace.” Then the elastic supply dried up.
“So we said, heck, Velcro is readily available,” he said. “And we started to get as much as we could get our hands on.”
The first shield the company made had straps that weren’t long enough to fit most men’s heads, he said. But once that problem was solved, it did an initial run of 500, he said.
Company officials thought they’d sell their shields for $4 to $4.50, he said. But with the Chinese selling theirs for $2 to $3, he wondered how the company could potentially make a profit and keep everyone employed.
“It was a hard thing for us to get people to understand. We were not looking to gouge the market and get rich,” Edwards said. “But our cost for the plastic was two to three times what Chinese were charging.”
In the end, he said, with no assembly line experience, the company had to produce 1,500 a day to make about $1 profit per shield.
“We knew price was going to be a hard thing,” he said. “The only way we were able to do it was to scoop up the plastic.”
As other suppliers ran out of stock, Humimic found markets at veterans’ centers, VA hospitals, dentist offices, nursing homes and mortuaries.
In the end, the company was able to produce some 80,000 shields sold around the country on Amazon and Walmart websites, Edwards said.
He said Humimic still has several thousand shields in stock, but it came out OK even though orders for PPE are slowing down.
If Covid flares up this winter, he said, the need might grow again.
This week's South Carolina life sciences newsletter is hot off the press! see more
Enjoy this week's newsletter from SCBIO featuring updates on South Carolina's inaugural Women in Life Sciences initiatives... a report on MUSC's growing economic impact statewide... details on more Palmetto State organizations stepping up for the greater good... an update from EVP Erin Ford and much, much more... click here to read complete details!
MUSC has multi-billion-dollar impact on South Carolina... see more
A new report shows the Medical University of South Carolina has an annual economic impact on the state of about $5.6 billion. MUSC Health CEO Patrick Cawley, M.D., knows where a big part of the credit lies. “MUSC Health has grown significantly in the past 18 months and this report details the growing economic impact across the entire state of South Carolina.”
In early 2019, MUSC bought four hospitals in Lancaster, Florence, Marion and Chester, creating a regional hospital network and establishing itself as a health care organization that reaches well beyond Charleston.
Joseph Von Nessen, Ph.D., a research economist at the Darla Moore School of Business at the University of South Carolina in Columbia, led the six-month economic impact study. “MUSC maintains a unique and sizeable statewide economic footprint. Its impact in Charleston may already be well known, but it’s also important to recognize that MUSC’s economic benefits extend well beyond the borders of the Tri-county region.”
For example: “About 38,000 people in South Carolina can attribute their jobs either directly or indirectly to the activities that are going on at MUSC every day. It really shows how significant MUSC’s impact is,” Von Nessen said.
Belimed Steam Sterilizers now announced compatible for crisis strategy decontamination of specific single-use N95 respiratorsBelimed collaborating with 3M manufacturing see more
Courtesy of Lowcountry Biz SC
Can N95 respirators be decontaminated in a steam sterilization cycle for reuse in situations of severe personal protective equipment (PPE) shortage? That question has been explored through collaboration between a world-leading respirator manufacturer, 3M, and a global leader in sterilization solutions, Belimed.
“The expert team at 3M was open-minded and very supportive in evaluating this question,” says Markus Auly, Head of Scientific Affairs at Belimed. “After two rounds of testing six different respirator models steam-treated by Belimed, and a thorough technical analysis of the data, 3M felt confident in the compatibility of the process with certain respirator models.”
3M’s latest version of the Technical Bulletin confirms that one standard 250° F sterilization cycle in Belimed Medical Steam Sterilizer models MST-H or MST-V does not compromise the form, fit, and function of their flat-fold respirators.
The benefit of evaluating and confirming compatibility with this standard steam sterilization process is that it is the gold standard among decontamination technologies because of its high microbiocidal efficacy, even in the presence of residual soils. From a resource standpoint, it is safe to use due to freedom from toxic residues, easy to administer, and has low processing costs, using only water and electricity.
Steam decontamination of N95 respirators will double the availability of 3M flat-fold respirators during a supply crisis in any healthcare center that has a Belimed Steam Sterilizer MST-H or MST-V.
During the global shortage in the last months, the supply of N95 respirators in all regions of the world, including healthcare leaders like the USA, Germany, or the Netherlands, has been tight. It soon became clear that disposing of single-use respirators after one use (standard protocol) could leave health care workers exposed due to lack of supply.
Hospitals around the world are seeking options to provide respirators to their employees to help reduce their risk of exposure when working with confirmed or suspected COVID-19 patients. The solutions include extended use and/or contingency reprocessing methods, both of which have their challenges.
Previously, Belimed had published a white paper explaining these reprocessing options that various countries were adopting to alleviate the scarcity of disposable personal protective equipment (PPE) like N95 respirators, surgical gowns, or face shields. The goal was to share this information with healthcare facilities across the globe. The whitepaper can be downloaded on the Belimed website.
Now, with the evaluation by 3M of steam decontamination of N95 respirators, specific programmed cycles of the Belimed Steam Sterilizer MST-H or MST-V were determined to be compatible with specific 3M respirator models.
“Belimed’s number one priority has always been to protect the health and safety of hospital staff and their patients. With our expertise in sterile processing we want to contribute our part and create certainty in uncertain times,” says Dominik Arnold, CEO of Belimed. “Now our customers and the healthcare community can be confident to have a more reliable fall-back solution in times of short supply of N95 respirators.”
For more information please check 3M’s technical bulletin “Decontamination of 3M Filtering Facepiece Respirators, such as N95 Respirators, in the United States – Considerations” and Belimed’s website (www.belimed.com).
Belimed AG is a leading provider of product and service solutions for the sterilization, disinfection, and cleaning of medical and surgical instruments. The company, with its headquarters in Zug (Switzerland), can look back on more than 50 years of history. We are continuously developing our technology-based portfolio and are always looking for innovative solutions to improve reliability, efficiency and sustainability in sterile supply departments.
We are engineers of confidence: we listen to our customers and find the right solutions for their challenges. We create optimal conditions for a better working environment. Our comprehensive range of sterile workflow solutions ranges from planning and conception to industry-leading systems and consumables to professional services and data connection options. In addition, we offer our customers training and further education opportunities.
The focus of our work is the unlimited trust of our customers. Together we make an important contribution to medical progress and ensure the safety and health of patients and medical personnel.
South Carolina life sciences is booming, with new organizations growing and moving here see more
Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. It’s a powerful force in today’s Palmetto State economy.
The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.
Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag. Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.
What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare. An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.
To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point. Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.
Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.
SCBIO has become a catalyst for and voice of South Carolina life sciences. From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.
And innovation is the lifeblood of progress. For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.
Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.
From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.
Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level. Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis. Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.
A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields. ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.
The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association — is an important step in helping organizations share best practices and stimulate innovation.
Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital.
Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:
- Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them;
- Accelerate best solutions through development and into commercialization; and
- Scale startups and networks to drive investment and job creation across South Carolina and Georgia.
With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.
As American poet Robert Frost penned:
“The woods are lovely, dark and deep, but I have promises to keep,
And miles to go before I sleep.”
Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources. With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter.
Over twenty experts to speak on major business issues see more
Subject matter leaders from across state, nation to cover what business needs to know to thrive despite pandemic, how to leverage state’s fastest-growing knowledge economy segment
SOUTH CAROLINA – September 2, 2020 – SCBIO will host a half-day virtual program September 23 -- Life Sciences Boot Camp: Building Your Brand & Business In a Pandemic – to inform and connect businesses, educators and professionals from across the state on leveraging opportunities, identifying trends and overcoming challenges that face organizations interested in tapping into South Carolina’s fastest-growing industry segment.
To be held completely online, the program will run from 8:15 a.m. until 12:15 p.m. on Wednesday, September 23rd. The program is delivered free to all SCBIO Members and Investors, and for a nominal fee of $50 to all non-Members. Students and media may also attend free of charge. Six sessions featuring over 20 noted presenters will precede a closing Virtual Networking Session for all attendees. Confirmed topics and speakers include:
- Search for a Cure: A National Update on the Global Pandemic – featuring a live national report from PhRMA executive Sharon Lamberton on success in battling the COVID-19 pandemic, and what lies ahead for America
- Marketing in a Pandemic: Building Your Brand & Your Topline – despite the economic turndown, some businesses are enjoying even great success – and are positioning themselves for an even better future. Learn the secrets to thriving, not surviving, during and after the pandemic from Henry Pellerin of Vantage Point, Heather Hoopes-Matthews of NP Strategy and Jessica Cokins of Thorne Research
- Best Practices in Talent Recruiting, Retention & Development – Nephron's Lou Kennedy, Arthrex's Jimmy Dascani and ERG's Matt Vaadi share how the state’s life sciences leaders are attracting, training and retaining top talent – and offer ideas your organization can deploy right now
- Partnering Effectively with Higher Education & Research Universities – tap into the wealth of resources, knowledge and experience prevalent in the state’s research universities to enhance innovation and success. Enjoy insights from Chad Hardaway of USC’s Office of Economic Engagement, Michael Rusnak of MUSC’s Foundation for Research Development, and Angela Lockman of Clemson
- Leading Virtual Teams Effectively – the pandemic has showed us that working virtually is here to stay. Find out how to make your organization collaborate seamlessly, efficiently and effectively -- wherever your colleagues are located -- from Annie McCoy of ChartSpan, Andrew Collins of Alcami and Jenni Dunlap of Parker Poe
- Pivoting with a Partner: Collaborating to Grow Your Business – learn how to successfully identify and partner with other organizations to expand and enhance product/service offerings. Hear incredible stories from the teams at Zverse/Phoenix Specialty and Rhythmlink, ZIAN and MUSC as they share their stories -- and how you can find your next great opportunity.
The program will end with a Virtual Networking session offering attendees to chat with leading economic development professionals including Stephanie Few of Womble Bond Dickinson, Tushar Chikhliker of Nexsen Pruet, and John Osborne of Good Growth Capital for conversations on Onshoring, Incentives, Accessing Capital and more.
To register or for more details, visit the Events page. Interested students and media members are invited to attend, with advance registration, at no cost.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.
For additional information on SCBIO, visit www.SCBIO.org.
PPE available through national exchange see more
The spring 2020 collaboration between SCMEP, the SC Hospital Association, the SC Department of Commerce and SCBIO which launched the online South Carolina Emergency Supply Collaborative portal to provide critical personal protective equipment (PPE) to healthcare providers, hospitals and businesses across the Palmetto State has taken a giant leap forward.
The SC Emergency Supply Collaborative has joined forces with the national team at PPE Exchange to provide a dramatically expanded and fully automated resource for accessing PPE and supplies for all South Carolina businesses.
PPE Exchange is an online marketplace of regional and national suppliers of PPE, similar in concept to an Amazon but dedicated to the provision of PPE and essential supplies. Via PPE Exchange, hospitals, health care providers and businesses seeking supplies are virtually connected to a marketplace of already-verified suppliers to securely search for items, schedule orders, compare prices and complete transactions.
Among the enhanced benefits of sourcing supplies via PPE Exchange is its support technology built on blockchain, allowing buyers: to track transactions from order placement to delivery; access to over 200 regional and national suppliers; easy ability to source from SC-based suppliers; price comparison capabilities; ability to order in small volumes; and a “request a quote” feature.
“The demand for PPE continues to be critical to our state and its diverse businesses and healthcare providers,” said Chuck Spangler, President of the South Carolina Manufacturing Extension Partnership and a spokesperson for the Emergency Supply Collaborative. “After creating and operating the South Carolina COVID-19 Emergency Supply portal with our partners these past several months, we identified PPE Exchange as an organization with the secure technology platform, expanded mix of vendors and products, and service-driven operations approach to provide the secure digital marketplace that Palmetto State organizations seeking PPE deserve.”
Much as with the prior Collaborative portal, PPE Exchange connects parties in need of essential supplies and equipment with those that can provide it quickly and efficiently. It allows industry providers of critical medical supplies (such as face shields, gowns, ventilators and masks) from South Carolina and across the U.S. to directly connect with the healthcare providers and members of industry in search of essential supplies in one easy step. South Carolina suppliers of goods are clearly marked to ensure that Palmetto State organizations can “Shop SC” as desired.
To begin accessing the marketplace on PPE Exchange, visit https://www.ppe.exchange/ and request access. Upon entering a contact email and basic information, an email will be automatically sent prompting a password reset and allowing login to the PPE Exchange website.
“Whether from a South Carolina or a South Dakota supplier, organizations and individuals can go online 24/7 via PPE Exchange to identify and select the critical need items they need from the expanded menu of providers and offerings,” said Sam Konduros, CEO of SCBIO. “We encourage every member of our state’s industry, if you have a need for PPE products, or want to add your products to the growing registry of vendors, to visit PPE Exchange now.”
Visit PPE Exchange at https://ppe.exchange/.
Aug. 25 webinar highlights SC businesses stepping up during COVID see more
Top executives from five of the Palmetto State’s leading life sciences organizations will share how they have found opportunity by pivoting, product adjustment, service expansion and partnering to overcome the global COVID pandemic and find accelerating opportunity and growth. The SCBIO webinar, free and open to the public with advance registration, will take place Tuesday, August 25 at 10 a.m. EST.
Entitled “Beating Back COVID: 5 SC Companies Leading the Way”, the program will feature Shea Harrelson and Scotty Branch, co-Founders of Vikor Scientific; John Carrington, CEO of Zverse; Jen Thorson, COO of Modjoul; Steve Clemons, CEO of VitaLink Research; and Lou Kennedy, CEO of Nephron Pharmaceuticals. Erin Ford EVP of SCBIO – South Carolina’s official life sciences industry organization -- will moderate the discussion.
The program is presented by Medpoint, a leading specialty consulting firm, with experts providing domestic and international consulting for the medical device, biotechnology, and pharmaceutical industries in over 90 countries.
The group will discuss such topics as:
- With more than 70 South Carolina companies pivoting or expanding product and service offerings to meet needs during the COVID crisis, how have these organizations leveraged their strengths to create new, long-lasting opportunities for their organizations?
- How businesses found willing and capable partners in the state’s universities, colleges, healthcare systems and advanced manufacturing industry to advance their capabilities and rapidly create new product offerings – expanding their market opportunities despite the economic downturn
- Industry perspective on the approach taken to reopen South Carolina’s economy, and what must be done to ensure safety for workers and limit litigation against businesses which employ them
- The importance of developing policy improvements around the re-shoring and repatriation of producing essential healthcare equipment, pharmaceuticals and ingredients, personal protective equipment and other medical products and devices back to the US and South Carolina from abroad.
Participation in the webinar is free to all interested parties. Those wishing to participate can register while space remains at https://www.scbio.org/events/scbio-webinar-beating-back-covid-sc-companies-leading-the-way.
The 60-minute program will provide attendees with insights on the pandemic’s impact on businesses and their employees in South Carolina to date, and insights and strategies to help organizations recover and grow in the coming months. The panelists will also offer reasons to be optimistic as South Carolina works to return to normalcy while still navigating a virus with no clear endpoint.
“Our goal is to bring the diverse perspectives of top business leaders from across the spectrum of life sciences together in one forum to share the opportunities they’ve found and the ideas and partnerships they’ve pursued which have resulted in business growth and success – despite the negative impact of COVID on our state and America,” said SCBIO CEO Sam Konduros.
“The panelists will also share their insights on lessons learned, reasons to be optimistic going forward, and ways for all South Carolinians to come together to solve health, social and economic challenges and improve quality of life for our citizens,” he added.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 600 firms directly involved and 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
For additional information on SCBIO, visit www.SCBIO.org
Market is currently valued at $770 million see more
Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).
Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.
“We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”
Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.
As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.
AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.
SC invention provides a solution for reducing accidental needle sticks see more
Medical University of South Carolina neurophysiologist Jessica Barley, Ph.D., and neurologist Jonathan C. Edwards, M.D., noticed a clinical problem and decided to do something about it. The needle electrodes used to monitor a patient’s nervous system function during surgery can also pose a safety risk. Stranded uncapped needles can find their way into health care workers or even patients. Working with the Zucker Institute for Applied Neurosciences (ZIAN), an MUSC technology accelerator, and Rhythmlink International LLC, a medical device manufacturer headquartered in Columbia, South Carolina, the team created a novel safety electrode that has the potential to reduce needle sticks.
The electrode, known as the Guardian Needle, was recently approved by the U.S. Food and Drug Administration for intraoperative monitoring (IOM). The technology has been licensed to Rhythmlink, which is ramping up production for a rollout to hospitals nationwide this autumn.
“We thought it was unacceptable and unfair that the team providing the care to the patient should be put in harm's way by equipment that was meant to do the opposite and ensure patient safety,” said Barley, who runs the intraoperative neurophysiology program at MUSC Health and is co-inventor of the Guardian Needle. “This is how we first came up with the design.”
During high-risk surgical cases, the neurophysiology team uses IOM to monitor a patient’s nervous system. The process involves inserting approximately 40 needles throughout the patient’s body and connecting them with long wires to the IOM machine.
“IOM serves as a vital early warning system,” explained Barley. “It preserves neurologic function in real time.”
However, the setup increases the risk of needle dislocation. Currently available needles can become uncapped when dislodged from the patient’s skin. This results in a danger of needles sticking the staff while in the operating room (OR).
“We don't have to accept that a certain number of our staff are going to get stuck by an IOM needle,” said Edwards, chief of the Integrated Centers of Clinical Excellence in Neuroscience at MUSC Health and co-inventor of the Guardian Needle. “That's a problem, and it's our responsibility as people in the field to solve it.”
The Guardian Needle should protect the surgical team from harm because it is never uncapped. It was designed to deploy the electrode safely only when inserted in the patient. If the needle is dislodged from the skin, it automatically resheathes into its protective casing.
“The key thing is that you don't have to cap and uncap the needle, and it automatically retracts when it's not in the patient,” said Paul Asper, vice president of commercialization at ZIAN.
The design also includes adhesive bandages around the needles. The adhesives enable the team to secure needles to the patient without manually taping them, thus decreasing OR time and cost. The bandage, like the needle electrode, is sterile, which reduces the risk of infection from nonsterile tape.
“We did timed trials,” said Barley. “Just trying the full setup the very first time using the new design, we were all faster,” she said, comparing the new needles with the needles they had used before.
Not only does the Guardian Needle protect the surgical team and decrease OR time, but it also enables better patient care by reducing the risk of needle sticks to patients and helping to maintain a sterile environment.
The adhesives on the needle also secure it in place despite shifts in patient positioning. The adhesives thus ensure signal integrity as the electrodes monitor nervous system function during surgery.
The clinician-innovators were able to come up with the clever design because they were personally familiar with the clinical problem they were trying to address.
“Clinicians have great ideas all the time,” said Edwards. “But 99% of those ideas die, mostly because we don’t have time.”
Enter ZIAN, with the expertise, knowledge and resources to turn an idea into a product. In the case of the Guardian Needle, the ZIAN team developed a business plan and patent strategy, raised funding for research and development, engineered the prototype and forged a licensing agreement with a world-class medical device company, saving valuable time for the busy clinicians.
“The expertise on the ZIAN team aligns perfectly with the clinical expertise of the inventors, enabling both parties to execute on their strengths,” explained Mark Semler, CEO of ZIAN. The core mission of ZIAN is to develop and bring to market technologies that solve unmet clinical needs.
“We have that clinical perspective to create a pipeline of ideas,” said Edwards. “ZIAN provides the practical implementation of those ideas, and neither of those two would be successful without the other.”
Rhythmlink, a South Carolina-based company specializing in medical devices that record or elicit neurophysiologic biopotentials, has licensed the technology and has begun to ramp up production of the Guardian Needle. Their unique position in the industry allowed them to recognize the importance of this invention. That, combined with their contribution to the intellectual property, design enhancements for manufacturing and expertise in regulatory guidelines, helped the product become a reality.
“This is a great example of South Carolina organizations collaborating in the health care space and an illustration of South Carolina’s prowess in innovation, entrepreneurship, life sciences and manufacturing,” said Shawn Regan, co-founder and chief executive officer of Rhythmlink. “Creating a safer work environment for health care professionals absolutely aligns with our mission to improve patient care. Working with ZIAN and MUSC to develop the Guardian Needle and bring this creation to life was a no-brainer from a collaboration standpoint.”
Successful commercialization of the product and the widespread distribution that Rhythmlink can provide are key to realizing a potentially industry-changing standard of care. As the novel electrode is rolled out in hospitals across the country, researchers will collect needle-stick data to determine whether it is safer than the current standard of care. If it is safer, as its inventors believe, it would likely become the new standard of care, given federal workplace safety rules.
“Being at the forefront of an innovative and potentially industry-changing movement is exciting and exactly where we strive to be,” said Regan.
To the inventors, the Guardian Needle provided a way to make a difference not only for their MUSC Health colleagues but also for surgical team members across the globe.
“In health care, we gladly and eagerly place ourselves at risk every day when we're caring for others. But it does have an element of stress and anxiety,” said Barley. “This invention is particularly special because we're not only caring for our patients in a safer, higher-quality way, we're also protecting our colleagues and teammates. It feels like a way of giving back to them and keeping them safe.”
Edwards explained that it is this type of innovation that has enabled him to help patients and health care providers he will never meet. This he considers a benefit of practicing academic medicine.
“We always think of clinical practice, teaching and research as the three pillars of medicine,” he explained. “There's a fourth pillar, and that fourth pillar is innovation.”
Innovation has led this MUSC team to create a solution for a once-tolerated problem. They encourage other clinicians to do the same.
“Take obstacles as an opportunity to find the solution yourself,” encouraged Barley.