coronavirus

  • sam patrick posted an article
    Zverse steps up for South Carolina see more

    Compliments of Charleston Business Magazine

    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.”

  • sam patrick posted an article
    Greenville's Humimic Medical pivots to meet pandemic needs see more

    Compliments of Greenville Business Magazine

    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.   

  • sam patrick posted an article
    Nephron employees achieve Lean Six Sigma green belt certification see more

    Courtesy of Columbia Business Report

    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.

    Read entire article here.

  • sam patrick posted an article
    Zverse honored in national competition see more

    Compliments of GSA Business Report

    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.”

  • sam patrick posted an article
    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... 

  • sam patrick posted an article
    Belimed 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).

     

    About Belimed

    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.

  • sam patrick posted an article
    MUSC Shawn Jenkins Children’s Hospital in Charleston on leading edge of treatment see more

    When 4-year-old K.J. Griffin arrived at MUSC Shawn Jenkins Children’s Hospital in Charleston, South Carolina, the normally bubbly boy who loves to ride his bike and play outside with his friends was frighteningly limp.

    His mother was stunned and exhausted. The little boy she’d worried about for days as his fever spiked had already been to a hospital near their home in rural Smoaks. But the condition K.J. was suffering from was so new and rare that it went unrecognized.

    So Talaiyah Stephens watched over her son at home, doing what she could to ease his symptoms but feeling helpless as he got sicker and sicker. “He didn’t want to talk. All he would do was sleep. He’d wake up, throw up, go to the bathroom, then lay back down and go to sleep. He would look at you like he was staring right through you.”

    When K.J.’s fever rose to 105 degrees and wouldn’t come down, Stephens came to a decision. She would drive him to MUSC Shawn Jenkins Children’s Hospital, about an hour and 15 minutes away. It was a choice that saved his life. 

    Read the full, incredible story right here.

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    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

  • sam patrick posted an article
    Dr. David Cole chronicled many MUSC achievements during the 2020 fiscal year see more

    CHARLESTON, S.C. (Aug. 14, 2020) – Recently, the Medical University of South Carolina (MUSC) and Medical University Hospital Authority (MUHA) Board of Trustees held their regularly scheduled combined committee sessions and board meeting. With its fiscal year-end closing on June 30, MUSC administrators focused on the multilayered impacts of the novel coronavirus on the operations of all three missions of the institution – education, research and patient care – along with MUSC’s leadership role across the community and state during this pandemic. To support established social distancing guidelines in the COVID-19 era, the MUSC trustees and administrators met via teleconference.

    “The ripple effects of the pandemic continue to reach every area of our institution,” said MUSC President David J. Cole, M.D., FACS. “We are committed to battling this virus at every turn and continue to find innovative ways to deliver safe, top-quality education and patient care in the face of this challenge. In addition, we are engaged in ongoing research projects, many which, in collaboration with national networks, are designed to help define how to best treat and mitigate the impact of this virus.”

    “Throughout the pandemic, MUSC Health has been recognized and called upon as an essential health care resource, having performed nearly 138,000 diagnostic screening tests, primarily through mobile testing sites in communities across the state,” said Patrick J. Cawley, M.D., CEO of MUSC Health and vice president for Health Affairs, University. “In partnership with the state legislature, MUSC set up mobile screening and collection sites in rural and underserved areas in an intentional bid to reach those who are most vulnerable and too often underserved when it comes to health care. Reliable diagnostic and antibody testing remain key elements of managing this unprecedented statewide health challenge.”

    Despite the hurdles posed by COVID-19, Cole chronicled many MUSC achievements during the 2020 fiscal year, including:

    • The MUSC Shawn Jenkins Children’s Hospital and Pearl Tourville Women’s Pavilion opened in February.
    • MUSC became the only institution in the country to house both a Digestive Disease Research Core Center and a Center for Biomedical Research Excellence in Digestive and Liver Disease.
    • MUSC Health West Ashley Medical Pavilion opened as scheduled in December and served 10,418 patients in the first month, with 214 operative procedures.
    • The South Carolina Clinical & Translational Research Institute, one of about 60 Clinical and Translational Science Award hubs nationwide, was awarded a $24M five-year renewal.
    • Safely held a series of virtual graduation celebrations, including a drive-through diploma pick-up event for its 660 graduates.
    • Transitioned more than 3,000 students to online education in response to the novel coronavirus within 24 hours’ notice. 
    • MUSC was first in the nation to combine drive-through testing with a virtual screening platform for potential COVID-19 patients.
    • MUSC and Clemson collaborated to launch the Healthy Me – Healthy SC program to increase health access and fight health disparities statewide. The program began expanding in early 2020 after successful pilots in Anderson, Barnwell and Williamsburg counties.
    • MUSC, Clemson and Siemens Healthineers co-hosted a summit in Columbia about artificial intelligence (AI) to bring together faculty, clinicians and engineers. They shared information about current work, new opportunities and discussed the future of AI in health care. The pilot effort funded three joint AI projects with Clemson.
    • U.S. News & World Report named MUSC the state’s best hospital for the fifth consecutive year.
    • The inaugural 2019 Lowvelo Bike Ride for Cancer Research engaged more than 709 cyclists and 300 volunteers, raising some $650,000 to support MUSC Hollings Cancer Center.
    • The U.S. Patent Office granted the MUSC Foundation for Research Development 18 patents.
    • MUSC received $25 million from the General Assembly to partner with the South Carolina Department of Health and Environmental Control and the South Carolina Hospital Association to develop and deploy a statewide testing plan. The focus of the plan is on rural and underserved areas of the state. More than 200 testing events/sites have been implemented.
    • MUSC Health continues to support the reopening plan and testing strategy for the University of SC, College of Charleston, The Citadel and Clemson University.

    The 16-member MUSC/MUHA board voted unanimously to elect James Lemon, DMD, as chairman and Charles W. Schulze, CPA, as vice chairman. Each will serve a two-year term. Lemon is an oral and maxillofacial surgeon by training. A native of Barnwell, he has lived in Columbia for more than three decades. Elected to the MUSC board in 2014, he serves as the medical professional representative from the 2nd Congressional District. Schulze, a Greenwood native, began his first term as an MUSC trustee in 2002 as the lay representative from the 3rd Congressional District. A retired shareholder of a regional accounting and consulting firm, Schulze currently practices and is an expert in financial forensics.

    In other business, the board voted to approve:

    • The fiscal year 2021 budgets for MUSC (University), the MUSC Health system and MUSC Physicians. 
    • Moving the spring commencement and graduation date from its originally scheduled date of May 22 to May 15, 2021.
    • A seven-year lease to provide new clinical care space for the MUSC Neuro Rehabilitation Institute in Charleston.
    • A supplemental HVAC system for the MUSC Hollings Cancer Center Compounding Pharmacy.
    • A lease renewal to provide 140 parking spaces at the intersection of Line Street and Hagood Avenue.  

     

    The MUSC/MUHA Board of Trustees serves as separate bodies to govern the university and hospital, normally holding two days of committee and board meetings six times a year. For more information about the MUSC Board of Trustees, visit http://academicdepartments.musc.edu/leadership/board/index.html.

     

    About The Medical University of South Carolina

    Founded in 1824 in Charleston, MUSC is the oldest medical school in the South as well as the state’s only integrated academic health sciences center with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. The state’s leader in obtaining biomedical research funds, in fiscal year 2019, MUSC set a new high, bringing in more than $284 million. For information on academic programs, visit musc.edu.

    As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality patient care available, while training generations of competent, compassionate health care providers to serve the people of South Carolina and beyond. Comprising some 1,600 beds, more than 100 outreach sites, the MUSC College of Medicine, the physicians’ practice plan, and nearly 275 telehealth locations, MUSC Health owns and operates eight hospitals situated in Charleston, Chester, Florence, Lancaster and Marion counties. In 2020, for the sixth consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

    MUSC and its affiliates have collective annual budgets of $3.2 billion. The more than 17,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.

  • sam patrick posted an article
    Milliken leveraging textile expertise in COVID fight see more

    Compliments of Spartanburg CEO

    Milliken & Company, a global diversified manufacturer with more than 150 years of textile expertise, has invested significant resources to increase domestic production of its Milliken PerimeterTM advanced medical fabrics. Since March, the company has distributed more than 10 million yards of reusable medical fabrics in response to the global shortage of personal protective equipment (PPE). This recent inventory increase signals Milliken’s continued commitment to ensuring a sustainable, U.S.-based PPE supply chain.

    Reusable medical textiles are ideal when cost is a driving factor and when single-use PPE supply is limited or unreliable. Garments made with Perimeter fabric can be laundered for safe reuse at least 25 times. The current demand for protective medical garments and the potential for shortages in the fall and winter prompted Milliken to prioritize production of the advanced material.

    “Scaling up U.S. manufacturing of reusable protective fabrics protects the country’s PPE pipeline, which in turn protects more medical professionals,” said Chad McAllister, president of Milliken’s Textile Division and EVP, Milliken & Co. “These brave people have continued to care for us tirelessly, and we are committed to doing all we can to help keep them safe.”

    Milliken’s durable Perimeter fabric is not only engineered for manufacturing Level 1 and 2 gowns for critical medical environments such as trauma centers but also provides a smart solution for other industries such as dental, educational and hospitality environments where advanced PPE is now important. The material’s ability to be used multiple times while maintaining a demonstrated protective barrier makes it a cost-effective, made-in-USA alternative to single-use PPE.

    “An increasing number of industries and service providers are looking for American-made PPE solutions to protect their employees and customers. This demand highlights the critical need we noted earlier this year, specifically for the U.S. to have a stable PPE supply chain,” McAllister said. “Our goal at Milliken is to be part of the solution, so we’re proactively taking steps to help avoid another shortage of critical PPE.”

    Milliken is collaborating with industry partners to ensure protective garments made with Milliken Perimeter fabric are available immediately across the country.

  • sam patrick posted an article
    SCBIO webinar generates stance from SC Senator Lindsey Graham on repatriation see more

    Compliments of South Carolina CEO

    South Carolina's senior Sen. Lindsey Graham introduced legislation last week that he cited as important during a recent SCBIO webinar, saying it will make sure that essential medical personal protective equipment is made in America.

    With support from other senators, Sen. Graham introduced the U.S. Made Act of 2020 to “decrease U.S. dependence on countries like China for personal protective equipment for our health care providers." 

    “With the spread of coronavirus, the inability of the United States to be self-sufficient with our supply of PPE has shown itself to be a national security issue,” he stated. “Just as the United States does not rely on China to supply military uniforms or equipment, we must not rely on them to supply PPE.”

    Items declared national priorities include testing swabs, surgical and respirator masks, face shields, surgical and isolation gowns, sanitizing and disinfecting wipes, gauzes and bandages, and privacy curtains, beds and bedding.

    The bill also outlines personal protective equipment acquisition requirements for the Strategic National Stockpile, and establishes an investment credit for qualifying personal protective equipment manufacturing projects.

    “Coronavirus has been a painful wake-up call that we are too reliant on nations like China for critical medical supplies,” Sen. Graham noted. “Without changes, China remains set to dominate the PPE market for years to come. We have seen firsthand the problems not having a reliable source of PPE places on our health care system. The Chinese grip on this critical supply chain must come to an end, and this legislation accomplishes that goal.”

  • sam patrick posted an article
    SC life sciences news of note fro your reading pleasure is now live! see more

    This edition of SCBIO's semi-monthly newsletter is chock full of great information, including next week's eagerly anticipated webinar featuring top elected officials on SC's path forward from COVID, the "Slow the Spread" PSA campaign from BCBSSC and SCHA, highlights on companies stepping up in tough times, late-breaking news and more.  Read the entire thing by clicking here!