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.”
Charleston, Vikor Scientific featured in national media see more
Empty hotel rooms, half-full offices, and shuttered retail. The coronavirus has wreaked havoc on the most established commercial real estate asset classes, creating short-term financial crunches and raising long-term secular concerns as remote work is tested and e-commerce rates rise.
Other asset classes, once alternatives, have become institutional investing gold standard. Logistics assets such as warehouses are providing a punch to the portfolio of the world’s largest landlord, Blackstone.
As industrial real estate investing becomes more crowded, and many of the other large asset classes slump, attention is turning to life sciences real estate — or space that’s used by pharmaceutical and biotech companies for research, development, and even manufacturing of new diagnostics, therapies, and vaccines.
The life science industry had been growing rapidly before the pandemic, attracting $17.4 billion in venture capital funding in 2019, up 370% from $3.7 billion in 2008, according to a Cushman & Wakefield report. Funding has continued to pour into the sector, even as coronavirus has slowed down venture funding overall, creating demand for more lab space.
Nephron employees achieve Lean Six Sigma green belt certification see more
If there were ever a time for improved efficiency to help a fast-moving company, it would be now for Nephron Pharmaceuticals Corp.
With the West Columbia-based manufacturer of sterile respiratory medication churning out product at a record pace during the COVID-19 health crisis, owner and CEO Lou Kennedy is in search of every competitive advantage available.
“In spite of my Southern accent, I do move like a New Yorker, and this company goes at that pace,” she said. “It’s a testament to the team here that everybody’s running on high-test, premium unleaded, and keeping up.”
The most recent example came when nine Nephron employees achieved Lean Six Sigma green belt certification after completing courses at the University of South Carolina’s Darla Moore School of Business. Six Sigma or lean manufacturing, pioneered by the likes of Henry Ford and famously implemented by Toyota in the years following World War II, is a systematic method aimed at reducing waste and variation to improve production quality and efficiency.
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!
Zverse honored in national competition see more
Columbia-based digital manufacturing company ZVerse has won a national design award for its ZShield Flex.
The ZShield, designed and manufactured by Columbia-based ZVerse, has won a national design award for innovation. (Photo/Provided)
The face shield, designed and produced by ZVerse, has been named an Innovation by Design Awards winner by business magazine Fast Company. The awards, in their ninth year, recognize creative, problem-solving innovations and have included winners such as Spotify, Google and Disney+.
The shields feature lightweight visors that clip around the wearer’s neck, making the shield comfortable for all-day wear. ZVerse’s computer assisted design platform creates custom, manufacturable 3D files that are returned to clients for production, enabling an invention to quicky go from idea to reality.
“We need innovative design more than ever, and the 2020 honorees have brought creativity, inventiveness, and humanity to address some of the world's most pressing problems, including the global pandemic, racial injustice, and economic inequality,” Stephanie Mehta, editor-in-chief of Fast Company, said in a news release. “Together these entries offer a glimpse into a future that is more inclusive, more accessible, and more just.”
The ZShield Flex won in the Workplace category and also received an honorable mention in the Best Design of North America category alongside companies such as Microsoft, Google and Logitech. A complete list of winners, finalists, and honorable mentions are featured online and in the October-November issue of Fast Company, on newsstands Oct. 20.
In March, ZVerse founder and CEO John Carrington adapted the company’s business model to accelerate the mass production of face shields in response to a health care community struggling to deal with the COVID-19 health crisis. The company tested more than a dozen designs before settling on the ZShield, focused initially on the needs of health care workers before being adapted in partnership with industrial designer Scott Henderson for everyday use.
“At the onset of the pandemic, we recognized our unique role in the world as great enablers of digital manufacturing, and we pivoted to become one of the largest producers of face shields to serve our country’s urgent need for PPE,” Carrington said in the release. “After launching with ZShield Health, we brought on Scott Henderson to reimagine the traditional face shield design and create a product that would be comfortable for a variety of work environments as well as everyday life. Going to market with such a novel design and seeing it in use by so many people and industries has been a humbling experience. We’re honored to be recognized by Fast Company for our work; it’s truly been a labor of love.”
To date, ZVerse has produced more than four million shields, nearly tripling its workforce. Notable users include television and film production companies, Disney, Chick-fil-A, Four Seasons Hotels and Resorts, and Walgreens, according to the release.
“When ZVerse originally contacted me about collaborating, I immediately realized how historic this moment was and felt an urgent need to help with the project,” Henderson said. “Prior to COVID-19, face shields weren't considered an essential accessory outside of the healthcare and medical science industry. After a century of little innovation in regard to face shield design, I am so proud of our team for applying out-of-the-box critical thinking to create this new option for PPE.”
Enjoy good news for a change, compliments of SCBIO... see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 4 minutes or less. This week, enjoy an uplifting reminder from Clemson University's Angie Leidinger... plus lots more uplifting news... enjoy today's edition right here...
DPX Technologies introduces new product line see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, announces the development of a new product line for size exclusion chromatography. The technology is patent-pending and utilizes a novel INTip swelling method that supports a hands-off approach for size exclusion chromatography workflows. The automated INTip swelling process allows the gel resin bed to be prepped and ready for sample application in less than 20 minutes.
Size exclusion chromatography (SEC), also known as gel filtration, is a method by which molecules pass through SEC resin media and are separated by their size. The DPX methodology uses a group separation technique for desalting and buffer exchange where small molecules such as salts are separated from a group of larger molecules such as proteins. Desalting and buffer exchange are commonly used prior to affinity chromatography for antibody purification or polymerase chain reaction (PCR) cleanup. The new product line includes SEC pipette tips and automation accessories, offering a highly reproducible, automated solution for proteomics applications.
Antibody testing and PCR cleanup are highly conversed topics due to the COVID- 19 pandemic, and DPX is committed to developing products that simplify and automate complex sample preparation for biological matrices. “This new product, along with INTip filtration products for Tip-on-Tip solid phase extraction, will help laboratories that need high throughput methods for processing thousands of samples daily, ” said Dr. Matthew Fitts, lead molecular biologist at DPX Technologies.
DPX has been manufacturing pipette tips for sample preparation since 2007 and specializes in developing custom workflows for a diverse client base.
# # #
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
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.
McDermott Will & Emery expand life sciences team see more
McDermott Will & Emery, the nation's leading health law firm, announced Brian Malkin has joined as partner in the FDA practice of its Health Industry Advisory group based in Washington, DC. Brian's practice complements McDermott's broader life sciences and healthcare capabilities with decades of experience and perspective on critical regulatory and strategic business issues that life sciences, pharmaceutical and biologic companies seek in bringing new products to market and managing product life cycles.
The firm also announced that Michael Siekman and Jenny Chen have joined the Intellectual Property (IP) practice as partners based in the Boston office. The duo builds upon Boston’s active and diverse IP practice and will complement the Firm’s robust legal service offering to the life sciences and health industries.
"Aligning FDA regulatory and intellectual property strategy for drug development is more critical than ever and Brian's unique background will give our clients a strategic advantage," said Eric Zimmerman, head of McDermott's Health Industry Advisory practice group and a Washington, DC-based partner. "Incorporating Brian's practice into our existing FDA practice further strengthens our ability to assist innovators through all stages of approval."
"As the market and regulatory landscape evolves to focus on novel therapies, including orphan drugs and biosimilars, our team needs to deftly navigate the complex regulatory, policy and strategic business considerations for this space. Brian is a thought-leader on these issues and has helped several companies successfully bring life-saving products to market. We're thrilled to join forces," added Vernessa Pollard, head of McDermott's FDA practice and a Washington, DC-based partner.
Brian counsels pharmaceutical and biologic clients on FDA regulatory matters and intellectual property law, with an emphasis on patent strategy and litigation. His position at the intersection of FDA regulated products and patent law makes him an invaluable partner to drug developers, biotechnology clients, medical device companies and cannabis companies as they protect their innovations, bring their products to market and pursue transactional opportunities.
He is a key advisor regarding FDA regulated drugs development strategies and patent strategies, including: New Drug Applications (NDAs) and orphan/specialty drugs; 505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products; biologics and biosimilars; and cannabis-derived products. Additionally, he is an experienced litigator of Hatch-Waxman Act cases for both pharmaceutical and biotechnology clients and a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space.
Brian holds a JD from The George Washington University Law School and a BA also from The George Washington University. While practicing law, Brian earned a BS in Biochemistry from the University of Maryland.
In commenting on the addition of Mr. Siekman and Ms.Chen, the Firm's Head of Strategy Michael Poulos noted, “We are laser-focused on smart expansion, and virtually every McDermott practice group and geography is focused on legal representation for the life sciences sector. Our new partners reflect our continuing strategic commitment to growing the pre-eminent life sciences practice in our industry.”
“The last few years have shown an increasing need for breakthrough innovations in the life sciences market. Patent protection is essential for bringing necessary technology to market, and Michael and Jenny truly understand what it takes to be a fearless client advocate during every stage of the IP lifecycle,” Bill Gaede, leader of the Firm’s Global Intellectual Property practice, said. “Michael’s and Jenny’s addition in Boston bolsters our IP capabilities in this leading region for life sciences innovators and research institutions as well as across our international platform.”
“This IP team is a natural part of our planned Boston expansion given the significance of the life sciences industry to our region,” Tony Bongiorno, litigation partner and Boston office managing partner, added. “We look forward to collaborating with Michael and Jenny on exciting opportunities across all of our practices in Boston.”
Michael focuses his practice on a broad range of intellectual property matters, including architecting patent prosecution strategies, life sciences partnering and transactions, licensing, post-grant proceedings and litigation. Leveraging more than 25 years of experience, Michael has built in-depth patent portfolios, advising clients in the biotechnology and pharmaceutical industries.
Jenny counsels both US and international clients in a variety of patent-related matters in the biotech and life sciences space, including prosecution, due diligence and post-grant proceedings. Her practice focuses on matters including cell and gene therapies, antibodies, diagnosis and pharmaceutical formulations. She is particularly experienced in strategic counseling on life cycle management of both biological and small molecule products.
Michael received his BS at Bates College and his JD at Boston University School of Law. Jenny received her BS from Fudan University, her PhD in pharmacology from Baylor College of Medicine and her JD from Northeastern University School of Law.
Webinar features inside details on beating back the COVID pandemic see more
Top executives from five of the Palmetto State’s leading life sciences organizations shared 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 took place August 25th and featured 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 -- moderated. Enjoy the whole program here.
MUSC partners with AstraZeneca, IQVIA in chase for vaccine for COVID see more
As researchers from across the globe race to find a vaccine for the coronavirus, the Medical University of South Carolina has entered as a key player in that fight. Along with AstraZeneca and IQVIA, MUSC was selected to be part of a Phase III trial of a vaccine that has shown promise in battling COVID-19.
“The science behind it looks good,” said MUSC emergency medicine physician Gary Headden, M.D., who will be leading the trial. “So, I’d say I’m optimistic.”
MUSC and Charleston will be part of the first wave of locations across the United States to test the vaccine. In total, manufacturers and researchers hope to enroll and collect data on 30,000 people across 20 cities in the U.S., with as many as 1,500 of those being from right here in Charleston.
For context: Once a pharmaceutical company thinks it has a promising vaccine on its hands, it begins clinical trials. According to the U.S. Food and Drug Administration, these trials consist of three phases:
- Phase 1, also referred to as initial human studies, is performed on small groups and focused on safety and the recipient’s immune response to the vaccine.
- Phase 2, which are usually administered on hundreds of people, are still focused on safety and fine-tuning the dosage and treatment regimen required.
- Phase 3 typically enrolls thousands of individuals and focuses on the safety and efficacy (how well it works) in a population.
If successful, the manufacturer can then submit an application to the FDA for approval.
Because of the unique world we’re living in, the U.S. government has implemented “Operation Warp Speed,” which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. In other words, a process that often takes years is being compressed into mere months. To facilitate this process, the government is speeding up all aspects that can safely be sped up and is pumping billions of dollars into the pharmaceutical industry. AstraZeneca, the company that has manufactured the vaccine being tested at MUSC, received $1.2 billion alone.
According to Amanda Cameron, Trial Innovation Network manager at MUSC and a key figure in bringing the trial to the university, even with Operation Warp Speed in play, this is one of few Phase III vaccine trials out there.
“For us to get to bring a trial here to MUSC is incredible, but the fact that it’s one that researchers are optimistic about is even more exciting,” she said.
Recently, Russia claimed to have a vaccine ready. U.S. researchers believe it has effectively only cleared Phase I, so to roll it out so quickly could prove to be reckless, Headden said.
This week, MUSC will go live with a webpage, officially opening the trial to applicants. The hopes are that soon thereafter, the study's first patients will be seen at the Clinical Sciences Building on MUSC’s downtown campus. Several hundred have already expressed interest in participation, and MUSC clinical research manager Ashley Warden said the team would love to get as many people involved as possible.
“This is a really important research opportunity,” Warden said. “We need to have a therapy that can bring this pandemic into control. It would be best that those that participate in this trial are representative of our region.”
The trial – which will be double-blind, randomized and placebo-controlled in a 2:1 ratio, meaning that for every two people who get the active vaccine, one will get the placebo – will require the participants to come in at Day 1 and Day 29 to receive their vaccines or the placebo.
Researchers and doctors hope each of these two visits will last about 90 minutes, during which time the participants will undergo a physical examination that includes having their medical histories reviewed, blood drawn for testing and a nasal swab test for COVID-19. The vaccine will then be administered.
All subjects will be monitored over a period of two years. During this time, those who show any signs of illness that could be due to COVID-19 will undergo additional testing. Compensation will be provided for participants’ time.
“This is a big study with an aggressive time frame, which is expected of a trial of this importance,” Headden said. “As for the science behind it, it’s totally solid. Put it this way: I would let my family take this vaccine.”
To learn more about the trial or to enroll, visit https://research.musc.edu/clinical-trials/coronavirus-clinical-trials.
Nephron CEO and SCBIO Board Chair Lou Kennedy speaks out see more
The team at Nephron Pharmaceuticals Corp. in West Columbia has been honored to answer the call to serve during the unprecedented COVID-19 pandemic.
We have shipped hundreds of millions of doses of life-saving respiratory medications to patients nationwide. We have provided tens of thousands of gallons of Nephron-made, FDA-approved hand sanitizer to students, businesses, families and those in need. And we recently announced a $216 million expansion that includes factory production space where we will fill COVID-19 vaccines.
Every Nephron employee has a sense of pride. Of patriotism. But I would be remiss if I failed to mention that we also share a sense of concern.
China is one of the world’s largest suppliers of the precursor chemicals used to make active pharmaceutical ingredients and personal protective equipment. What we have come to recognize firsthand are the perils of dependence on foreign counties, such as China, for medicine and medical supplies.
As trade tensions between China and the United States grew last year, I was afraid China could intentionally disrupt the drug supply chain to the United States, exacerbating the drug shortage crisis, increasing the cost of drugs and potentially killing American patients.
The recurring question I had was: What can America do to break this dangerous dependence?
Now, as the world considers how to deal with China in the aftermath of this pandemic, the picture of a potential supply chain disruption is grimmer, serving as a vivid reminder that we are talking about matters of life and death.
I have been vocal about this issue for quite some time. In fact, I discussed America’s dependence on China for drug ingredients last year with federal officials, including President Donald Trump, Vice President Mike Pence and Health and Human Services Secretary Alex Azar. When U.S. Sen. Lindsey Graham visited our plant a few weeks ago, we agreed: Something must be done to find American solutions to this American public health crisis.
So, it should be no surprise that I am excited about the executive order President Trump signed last week to shore up the domestic supply chain for life-saving medicines, reduce dependence on foreign sources of drugs and medical supplies and expand domestic production of both.
When the president signed this new executive order, he said: “As we’ve seen in this pandemic, the United States must produce essential equipment, supplies and pharmaceuticals for ourselves. We cannot rely on China and other nations across the globe that could one day deny us products in a time of need. We can’t do it. We can’t do it. We have to be smart.”
I could not agree more.
This is a no-brainer. The pandemic has taught us an important lesson. The best way to protect American patients, families and businesses is onshoring production of the things we need to keep them healthy and safe.
Over the past five months, the American people have endured hardships no one could have foreseen. We grieve with those who have lost loved ones to this unrelenting silent enemy. We support business owners small and large who want to slow the spread of this virus so we can reopen the world’s greatest economy. And we share the frustrations many people feel with politicians who are focused on winning the next election, rather than preparing for the next public health crisis.
We are grateful for these first steps President Trump is taking to make sure we never end up in this place again.
At Nephron, we have the technology, resources and people it takes to successfully partner with the federal government to make the public health preparedness infrastructure of this nation stronger than ever. South Carolina can and will be a leader in the effort to find American solutions for American public health.
This new executive order is the right way to do it.
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/.