South Carolina life Sciences

  • sam patrick posted an article
    Greenwood Genetic Center project receives grant to expand access for genetics services see more

    The Greenwood Genetic Center (GGC), through the Self Regional Healthcare Foundation, has been awarded a grant of $899,000 from The Duke Endowment for 'Genetics Access for All,' a project to expand access to genetics services for patients and providers.

    "In this current era of genomic medicine, there is an increasing demand for clinical genetics services, but our workforce is insufficient to meet this demand, and our current work flows are inefficient," said Mike Lyons, MD, Director of Clinical Services at GGC and lead on the funded project. "This leads to families facing long waits to be evaluated and tested, and subsequent delays in managing and treating their child's condition."

    GGC has provided clinical genetics services since 1974; however, with the increase in demand for services, and inability of genetics training programs to keep up with the ensuing workforce demand, patients often wait for six months or longer to be seen.

    "This is not just a GGC issue. Genetics clinics around the country are facing wait times that are as long or longer than ours," said Steve Skinner, MD, GGC Director. "And we have found that as genomic technology has been evolving at such a rapid pace, many non-genetics providers do not feel comfortable ordering and interpreting genetic tests on their own."

    'Genetics Access for All' proposes a new standard of genetics care by optimizing access for patients and employing a new system of communication to transform how non-genetics providers engage with genetics providers in order to better manage their patients.

    In 2019, GGC and the Medical University of South Carolina (MUSC) signed an affiliation agreement with the goal of improving access to genetic services for patients across SC.

    One initiative that has grown out of this affiliation is a pilot project with the MUSC Center for Telehealth to develop an electronic consult (e-consult) system for genetics referrals. The project initially offered the option only to a limited number of referring providers in the MUSC system. Funding from The Duke Endowment will allow that project to expand on a much larger scale.

    During the first year of the funded project, GGC will implement e-consults through an online platform to allow non-genetics providers to upload patient information, and receive clinical impressions and testing recommendations within two business days. E-consults will help avoid unnecessary referrals, improve communication with non-genetic providers, and enhance efficiency by decreasing the amount of time needed for in-person and telemedicine visits.

    In year two, GGC plans to expand the concept to provide electronic patient visits (e-visits) allowing patients to upload their information electronically and quickly receive clinical feedback and recommendations. The goal of e-visits is not to replace in-person or telegenetics visits, but to provide another care option that improves communication with and access for patients.

    Lyons says that the ultimate goal of this project is to change the model of genetics care from a long diagnostic odyssey to a more efficient system that decreases unnecessary referrals, expedites diagnoses, and decreases wait times for appointments.

    "Through e-consults, we'll be able to more quickly identify patients who need genetic testing and facilitate the appropriate testing," he said. "A rapid diagnosis will allow for more timely and precise management and treatment for all patients impacted by a genetic disorder."

    GGC expects to see significant improvements in patient care as the project expands. "Our goals are to complete 50 outpatient and 25 inpatient e-consults and 25 e-visits per month by the end of the grant cycle," said Lyons. "We anticipate this project to dramatically improve wait times for all types of visits, and hope that our success can be translated into a new model for genetics care in clinics nationwide."

     

    About Greenwood Genetic Center

    The Greenwood Genetic Center (GGC), founded in 1974, is a nonprofit organization advancing the field of medical genetics and caring for families impacted by genetic disease and birth defects.  At its home campus in Greenwood, South Carolina, a talented team of physicians and scientists provides clinical genetic services, diagnostic laboratory testing, educational programs and resources, and research in the field of medical genetics.  GGC’s faculty and staff are committed to the goal of developing preventive and curative therapies for the individuals and families they serve.  GGC extends its reach as a resource to all residents of South Carolina with satellite offices in Charleston, Columbia, Florence and Greenville. For more information about GGC please visit www.ggc.org.

     

    About The Duke Endowment

    Based in Charlotte and established in 1924 by industrialist and philanthropist James B. Duke, The Duke Endowment is a private foundation that strengthens communities in North Carolina and South Carolina by nurturing children, promoting health, educating minds and enriching spirits. Since its founding, it has distributed more than $4 billion in grants. The Endowment shares a name with Duke University and Duke Energy, but all are separate organizations.

  • sam patrick posted an article
    Softbox Systems the partner of choice for Pfizer vaccine see more

    Compliments of GSA Business Report and SCBIZ News

    Frontline workers at Prisma Health received the first shipment of Pfizer’s COVID-19 vaccine last week, but to some extent, the shipment was simply returning home to the Upstate.

    Greenville is the North American headquarters for Softbox, the British manufacturer of the insulated containers critical to the stability of the Pfizer vaccine.

    “I consider this the start to the finish as we move into this process of trying to get enough immunity into the community,” Dr. Steve Shelton said as the dry ice-laden Softbox made a triumphant arrival at Prisma Health-Midlands, complete with pom-poms and cheering health care workers. Shelton is an emergency room physician with Prisma Health who spearheaded COVID-19 treatment efforts in the Midlands.

    “I know there is a lot of anxiety about this, but I am confident in the FDA in making sure that they have approved an effective vaccine,” he said. “I feel like I am honored to be here to receive this and am doing my part to combat this disease.”

    To remain effective, the vaccine must be shipped at temperatures colder than most of Antarctica, in a box with more layers than a Russian doll. The Softbox includes a top layer or “pod” of dry ice housed on top of five trays of the vaccine, which in turn, nests in a carrying box with a foam lid and temperature gauge. All this is fitted in a cardboard shipping container, according to a Dec. 3 manual from Pfizer.

    Read the entire story here...

  • sam patrick posted an article
    First release of 3D-PREDICT clinical study data fuels momentum of company’s glioblastoma program see more

    GREENVILLE, SC – December 17, 2020 – KIYATEC, Inc. today announced the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients. Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.

    Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.

    “In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center,” said Dr. Lipinski. “Our results show that we are far along in the paradigm shift toward individualized medicine.”

    Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.

    KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.

    “Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this.” 

    This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.
     

    About KIYATEC, Inc.
    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

     

    Citation:

    Lindsay Lipinski, et al., INNV-16. Clinical applicability of individualized drug response profiling utilizing ex-vivo tissue-derived 3D cell culture assays in high-grade glioma: a single institution case series using 3D-PREDICT results, Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Pages ii119–ii120, https://doi.org/10.1093/neuonc/noaa215.499.

     

  • sam patrick posted an article
    South Carolina's Rhythmlink acquires California-based med device manufacturer see more

    COLUMBIA, SOUTH CAROLINA – Rhythmlink International, LLC is pleased to announce an exciting new investment, the acquisition of Chalgren Enterprises, a California-based medical device manufacturer that will add to their already extensive portfolio of products for brain and nervous system monitoring.  

    As a market leading designer and manufacturer of disposable neurodiagnostic devices and consumables, Rhythmlink has been quickly growing, even during an otherwise challenging year. Chalgren Enterprises provided another growth opportunity with a close alignment of culture, values, and product manufacturing expertise. The acquisition was completed on December 11, 2020. 

    “Chalgren is a good fit for our first acquisition both because of their experience in our industry and the way our cultures and missions align,” said Shawn Regan, CEO and Co-Founder of Rhythmlink. “Even with minimal changes we believe within the first year we’ll be able to take the Chalgren line of products and apply our manufacturing and sales best practices to see extensive growth.” 

    Chalgren Enterprises has been manufacturing electrodes for neurodiagnostics, specializing in EMG electrodes, for over 50 years. For the last 30 years Chalgren has been run by the father and son team of Richard and Michael Kaiser, who have seen the industry evolve from reusable to disposable products, product innovations, and a host of market and regulatory changes that have defined neurodiagnostic medical devices. Their reputation in the EMG market especially made them an appealing partner for Rhythmlink. 

    “Chalgren’s extensive experience is a good match for our innovation and steady growth,” said Regan. “Taking on their EMG products and legacy knowledge of EEG is a natural fit for our existing product lines and helps us encompass the full need of products that connect patients to machines.”

    With the acquisition of Chalgren, Rhythmlink International will now offer products for epilepsy monitoring, electroencephalography, electromyography, evoked potentials, polysomnography, intraoperative monitoring and more, better serving the needs of neurologists and critical care providers through one company. 

    Regan concluded, “The culture we have built at Rhythmlink and our reputation in the marketplace are incredibly important to us, and Chalgren comes to us with more similarities than differences. We wanted growth that would ensure this dynamic would stay intact, and we’re excited about the future of these products and our company.”

    About Rhythmlink
    Rhythmlink International is a medical device manufacturing company specializing in devices that help connect patients to machines to record or elicit physiologic information. Rhythmlink designs, manufactures and distributes a variety of medical devices for intraoperative neuromonitoring, electroencephalography, evoked potentials, polysomnography, long-term monitoring epilepsy and critical care units. Founded by neurodiagnostic technologists and engineers in 2002, Rhythmlink enhances patient care worldwide by transforming medical device technology that links patients to equipment. Rhythmlink also offers custom packaging, custom products, private labeling and contract manufacturing services.

  • sam patrick posted an article
    NIH recognizes outstanding performance bySouth Carolina organization see more

    Pensievision, the Charleston based company that develops AI-based, 3D medical imaging technologies, earned a rare perfect score from the National Institutes of Health (NIH) on its grant application for developing a low-cost, handheld, 3D imaging system for improved screening of cervical neoplasia, to help prevent cervical cancer. The grant funds awarded by the National Cancer Institute (NCI) will be used for a clinical study, in collaboration with the University of California, San Diego (UCSD).

    The proposal submission, led by Pensievision’s CTO, Dr. Joe Carson, who is also an Associate Professor in the Department of Physics & Astronomy at College of Charleston, received a perfect score of 10, ranking in the top one percentile of all grants submitted to the NIH.

    The NIH review board indicated that “the proposal was perceived as exciting, highly innovative, extremely significant, with an exceptional investigative team, and outstanding environment”. 

    “We knew that we wrote a strong grant proposal, but we were still surprised by the rare perfect score” says Tal Almog, Pensievision’s Co-founder and President. “We are honored and very excited with the opportunity to enhance screening and diagnostic technologies that could save lives”  

    Earlier this year, Pensievision completed development of CervImage™, the world’s first portable colposcope capable of producing high-resolution 3D images to assist in early-stage detection and analysis of pre-cancer cervical lesions. The team decided to focus on cervical cancer (the third most common cancer worldwide and the leading cause of cancer death in women in developing economies) where screening efforts in low resource communities have only achieved limited success due to lack of laboratory infrastructure, shortage of trained personnel, and high costs, leading to high mortality rates. CervImage™ could improve existing screening methods by offering a point of care screening & diagnostics solution to enable single-visit screen-and–treat without the need for return visits or lab results.

    ###

    Experienced Team and Advisory Board

    Pensievision was founded by a unique team of four interdisciplinary professionals: Dr. Joe Carson, a professor of Astrophysics, Dr. YT Liu, a medical doctor, Tal Almog, a technology entrepreneur/executive, and Ben Carson, a business attorney. They are assisted by a seasoned advisory board, including Dr. Dennis Carson, a renowned cancer researcher and the former Director of the UCSD Moores Cancer Center, and Raymond McDaniel, CEO and President of Moody’s Corporation, a $50B financial services company. 

    Novel Imaging Technology 

    The company develops medical-grade 3D imaging technologies using Dr. Carson’s untraditional approach of borrowing imaging techniques used in astronomy, such as for NASA’s space telescopes. He used his own experience in extraterrestrial imaging, including his direct-imaging discovery of a ‘super-Jupiter’, and his discovery of the coldest imaged companion of a sun-like star (which was recognized as ‘TIME magazine top 10 science discoveries of 2009’).

    Product Pipeline

    Pensievision is working to miniaturize its devices and is developing a fiber-optic based endoscope to achieve precise 3D imaging of pre-cancerous lesions inside the body, including within the cervical canal, the ovaries, and the esophagus.

    Pensievision’s 3D imaging software could further be adapted to applications in consumer electronics, smartphones, and digital health. The company is currently working with market-leading strategic partners to license its technology.

  • sam patrick posted an article
    South Carolina life sciences company adding 148 new jobs to booming industry see more

    Vikor Scientific, LLC, a molecular diagnostics company, today announced plans to expand operations in Charleston County. The $1 million investment will create 148 new jobs.

    Founded in 2018, Vikor Scientific, LLC specializes in antibiotic stewardship and tangible solutions for the practice of value-based medicine in the treatment of infectious disease. The company provides clinicians with advanced molecular methodology for pathogen detection, quantification and resistance gene identification.

    Located at 22 Westedge Street in Charleston, Vikor Scientific, LLC's expansion will increase the company's capacity to assemble and distribute both COVID-19 and full molecular panel testing kits across the country.

    The expansion is expected to be completed by January 2021. Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.

    QUOTES

    "The prior backorder of testing supplies was crippling for the U.S. during the beginning of the pandemic, and no one wants to experience that again. This expansion will help us to continue to stay ahead and increase the production of our testing kits for both COVID and our other infectious disease molecular panels by the hundreds of thousands, which is vital as we enter the sick season." -Vikor Scientific Co-Founder Shea Harrelson

    "Vikor Scientific, LLC's expansion and the 148 new jobs it will create will have a huge impact in Charleston County and across the state. We couldn't be more excited to continue this partnership and watch them succeed here for years to come." -Gov. Henry McMaster

    "Team South Carolina works hard to offer businesses a strong foundation to foster growth and be successful. Vikor Scientific, LLC's decision to expand in Charleston County is an indication that we are doing it right, and we look forward to supporting this great company every step of the way." -Secretary of Commerce Bobby Hitt

    "Charleston County offers an environment supportive of innovation, which is a catalyst for our growth in the life sciences industry. We welcome Vikor Scientific's expansion, as it will have a positive impact on our economy with the creation of 148 new jobs." -Charleston County Council Chairman Elliott Summey

    "As we continue to respond to the effects of the coronavirus pandemic, the remarkable work of companies like Vikor Scientific has proven critical to keeping our citizens healthy and safe. Not only will this expansion create 148 new jobs in Charleston, but it will increase our ability to provide COVID-19 tests to those who need them throughout the state and across the country. On behalf of the citizens of Charleston, I'd like to thank Vikor Scientific for the lifesaving work they do in our community and wish them Godspeed as they continue to expand operations." -Charleston Mayor John J. Tecklenburg

    "Vikor Scientific is a young company making a monumental impact within the life sciences industry, and we are grateful this important work is happening in our backyard. Congratulations to Vikor Scientific on this significant expansion and we look forward to our continued partnership." -Charleston County Economic Development Executive Director Steve Dykes

    FIVE FAST FACTS

    • Vikor Scientific, LLC is expanding operations in Charleston County.
    • The $1 million investment will create 148 new jobs.
    • Vikor Scientific, LLC is a molecular diagnostics company.
    • Located at 22 Westedge Street in Charleston, S.C.
    • Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.

  • sam patrick posted an article
    Furman cited for excellence by global organization see more

    Furman University’s Institute for Innovation and Entrepreneurship has been named an Outstanding Emerging Entrepreneurship Center by the Global Consortium of Entrepreneurship Centers, a group of more than 250 universities.

    Other recipients of the 2020 award were Boston University, Eastern Washington University and Smith College. The centers, which had to have been nominated for the award within five years of launching, were judged on early success, engagement with stakeholders on and off campus, an established management team, novel or unique approaches and clearly established goals and objectives. Winners in recent years include Dartmouth College, Brown University, Vanderbilt University, Virginia Tech and Babson College.

    “This recognition is a testament to Furman’s commitment to innovation and entrepreneurship and the unparalleled support by the campus community, alumni, parents, community members, administration and Board of Trustees,” said Anthony Herrera, executive director of Furman Innovation and Entrepreneurship. “In just two short years, we have built a globally recognized institute and paved a way for Furman to lead nationally among liberal arts and sciences universities in the space of innovation and entrepreneurship.”

    According to Herrera, three strengths set Furman apart from other universities. 

    “Our engaged faculty and students from across disciplines; strong ties with the community, including city and state government organizations as well as local venture capital groups; and a core group of alumni and parents who provide financial support, make the effort self-sustaining,” he noted.

    “This award signals that a liberal arts and sciences education can be a catalyst for innovation, that students who come to Furman can have a profoundly impactful experience as innovators and entrepreneurs regardless of their choice of major,” said Furman President Elizabeth Davis. “We are grateful that the Global Consortium of Entrepreneurship Centers recognized Furman’s role in creating an ecosystem of entrepreneurship for our students, faculty and the community.”

    “The heart of innovation and entrepreneurship is creativity, in identifying opportunities and solving problems,” said Kem Wilson III ’98, a Furman trustee and alumnus, principal of Kemmons Wilson Companies and supporter of Furman Innovation and Entrepreneurship. “The entrepreneurial experience Furman students can experience will benefit them regardless of their career path.” Wilson’s grandfather founded Holiday Inn. The company that bears his name now manages a diverse portfolio of companies spanning a myriad of industries, from hospitality to green technology to consumer brands.

    Furman Innovation and Entrepreneurship sprang from The Furman Advantage and its focus on self-discovery, engaging the community and experiential education. It launched in August 2018 with Herrera’s hiring and has become “a perfect vehicle to encourage cross-disciplinary thinking and provide students, faculty and community members a place to participate in engaged learning experiences,” Herrera said.

    Early successes include:

    • pitch competition that attracted more than 80 student competitors and culminated in the most-attended pitch competition in South Carolina’s history; 530 people attending the final round between six students, where $30,000 in startup grants were awarded.
    • The Summer Business & Innovation virtual boot camp that has attracted 42 students from 10 universities across the Southeast. Following the boot camp, the City of Greenville funded 10 student internships with local startup ventures.
    • A virtual academy for high school students that led 62 teens from 11 states and 11 countries through a capstone project to pitch a venture in innovation and entrepreneurship, sustainability or community health.
    • The “Class E Podcast,” produced in partnership with the Furman Department of Communication Studies, which presents biweekly talks and interviews with entrepreneurs, innovators and disruptors from the Furman network. Fourteen episodes have drawn more than 1,000 listeners.
    • Leading in Times of Crisis,” a series of six virtual workshops for corporate, entrepreneurial and nonprofit leaders that attracted more than 1,000 registrants.
    • Collaborations, partnerships and ongoing relationships with organizations, including the City of Greenville, SCBIO, Upstate SC Alliance, Greenville Area Development Corporation,  Build Carolina, Village Launch, NEXT, 6AM and VentureSouth.

    In addition to continuing and expanding its programs, Furman Innovation and Entrepreneurship has extensive plans to become more engaged and integrated with Greenville, the Upstate and South Carolina. Herrera expects to make several announcements over the coming months about partnerships with corporate and community stakeholders.

    For information about Furman Innovation and Entrepreneurship, or to contribute financially, contact Anthony Herrera at anthony.herrera@furman.edu.

  • sam patrick posted an article
    Nephron expanding again in Columbia, SC see more

    Courtesy of SCBIZ News

    With promising news about a COVID-19 vaccine making headlines, Lou Kennedy had reason for optimism during a beam-raising ceremony marking a milestone for a $215.8 million expansion at Nephron Pharmaceutical Corp.’s Saxe-Gotha Industrial Park campus.

    Part of the expansion is a 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that Kennedy, Nephron owner and CEO, expects to be operational around March 2021. She said Nephron is actively looking for a vaccine production partner to provide the ammunition for the pre-filled sterile syringes that make up the booming 503B Outsourcing Facility arm of the company.

    “It’s a Chamber of Commerce day,” Kennedy said after signing the final beam of the 240,000-square-foot Kennedy Innovation Center’s steel skeleton on Tuesday morning. “This marks a milestone in 2020. This is good news. This is giving us the space to continue to grow.”

    Read the full article here, courtesy of Columbia Business Report

  • sam patrick posted an article
    Moderna vaccine results looking very good early see more

    The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.

    Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.

    Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.

    Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.

    Read the entire story here.

  • sam patrick posted an article
    Newly elected President's plans have major bearing on the medtech industry see more

    While former Vice President Joe Biden and the team he builds won't take office for another two months, the campaign’s plans for COVID-19healthcare and other policy areas offer clues to how changing tides in Washington may impact the medtech industry.

    In approaching the top task at hand — getting the pandemic under control — the Democrat's plan includes proposals with implications for the industry, from how diagnostic testing is covered to access to telemedicine services.

    In some ways, the act of swapping out administrations, regardless of who's in power, means device makers can anticipate shifts at key government agencies like the FDA.

    Read on for the full article from Medtech Dive.

  • sam patrick posted an article
    MUSC FRD honors innovators, patent recipients at virtual gala... see more

    Congratulations to all of the honorees from the recent John N. Vournakis NAI Induction Ceremony and Annual Adm. Albert J. Baciocco Innovator of the Year Reception.  Learn about teh honorees and this highly anticipated annual event right here!

    Click to read...

  • sam patrick posted an article
    News you can use about SC life sciences see more

    Catch up on all the important reading around South Carolina life sciences -- and the national and global issues impacting it.  It's all here, easy to read in just a few minutes, with dozens of helpful links.  Enjoy!  

    Click to read...

  • sam patrick posted an article
    SE Color initiates “We Are In” Campaign to encourage minority participation in Clinical Trials see more

    On September 9, Southeast Life Sciences announced the formation of SE Color, an organization dedicated to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities.

    The founding advisory board members are Jayne Morgan MD, Clinical Director, Covid Task Force at Piedmont Healthcare, Kornelius Bankston, Managing Partner with techPLUG, and John Newby, Chief Executive Officer for Virginia BIO. As executive director of Southeast Life Sciences, Jason Rupp will staff the organization.

    SE Color’s initial effort will focus on increasing the number of minorities in clinical trials. In an article published in Healthcare Tech Outlook, Dr. Morgan notes that, “African Americans make up 13.4 percent of the US population, yet only 5 – 7 percent of clinical trial participants nationally.”

    Dr. Morgan further states, “Nearly every advance in medicine today was first evaluated in a clinical trial. Clinical trials offer our best and most forward thinking and can be the gateway to provide earlier access to life saving medicines and therapies years ahead of FDA approval. Equitable participation in clinical trials is therefore a critical call to action in ensuring that medicines, devices, and vaccines that are developed are relevant to all populations.”

    Although there are many aspects to facilitate minority recruitment in clinical trials, SE Color will initially focus on education through the “We Are In” campaign. The initial priority will be to share information on clinical trials available throughout the southeast. SE Color will partner with state associations in the region to ensure we have updated information and extend the network.

    Southeast Life Sciences recognizes the great need for effort in these areas and though we will only be one part of the solution, we will be part of it. In closing, Bankston adds “I believe the greatest social injustice in modern history is health inequalities which disproportionately impact people of color. We can create more effective therapeutics, applications and medicines for all populations- by addressing the systemic issues in clinical research.”

  • sam patrick posted an article
    Vigilent Labs to call Charleston, South Carolina home see more

    Compliments of Charleston Post and Courier

    Congratulations to our colleagues in Charleston County for this excellent announcement, advancing the growth of life sciences in South Carolina.  Read the full story here.

     

    A technology firm with ties to the U.S. defense industry said Thursday it will invest nearly $105 million in a facility on the former Navy base in North Charleston that the company says will manufacture COVID-19 test kits.

    Vigilent Labs said it will hire 400 workers to produce FDA-approved test kits that can detect COVID-19 antibodies and antigens in 10 minutes or less.

    Manufacturing will begin in December and the company said it also will move its headquarters to the site at 1105 Truxton Ave. Vigilent is currently based in Alexandria, Va., near the nation’s capital, and it was incorporated in Wyoming.   Read on for full details.

  • 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.”