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COVID-19

  • sam patrick posted an article
    Reshoring accelerates in life sciences, other industries see more

    Compliments of GSA Business Report

    Some South Carolina-based suppliers are feeling a burst of demand as domestic content percentages for materials used in public projects are set to go into effect in October. 

    The Buy American Act – not to be confused with the Reagan-era Buy America Act – was first created in 1933 to give preference to domestic manufacturers. 

    The bill has evolved over the years, but in January 2021, the Biden Administration passed an executive order sparking “the most robust changes to the implementation of the Buy American Act in almost 70 years,” according to a White House news release.

    The order raised the percentage of domestic content required in public projects from today’s 55% to 60% starting Oct. 22, according to a document published by Federal Register. 

    By 2024, the required percentage will climb to 65%, and in 2029, to 75%. The initial increase to 60% will occur several months from publication of the final rule, according to the Defense Department, General Services Administration and National Aeronautics and Space Administration document.

    Andrew McAllister, partner with Washington D.C-based Holland & Knight, shared in a webinar that materials “manufactured in the United States” is not defined in the law, but that it implies a step beyond assembly.

    “Then the second piece of that test is that the cost of the components from the U.S. must exceed a certain threshold of the cost of all components,” McAllister said, adding that iron and steel products undergo more strict standards. 

    Under the new ruling, foreign iron and steel must make up less than 5% of the total cost of components purchased.

    “It doesn’t mean you can never offer a foreign product,” he said. “It’s more so you’re going to be penalized for providing that foreign product.”

    Bringing it all home

    The Buy American Act may often come up in conversations about building materials and construction products, but it also dictates procurement for other forms of federal infrastructure as well – for example, procedure trays used in tax-funded operating rooms.
    COVID-19 wreaked havoc on medical product supply chains Greenville’s CPT Medical depended on for their company’s specimen collection supplies in 2020. 

    “A lot of it was not just made in China, but one of the largest specimen collection manufacturers COPAN is in Italy, and BD is in Germany,” said Austin Shirley, vice president of commercial operations at CBT Medical’s holding company Diversified Medical Healthcare. “So there was very little U.S. production.”

    So, out of necessity, Diversified Medical Healthcare certified its viral transport medium for distribution and launched production. Being one of few domestic manufacturers, Shirley said they couldn’t fill orders fast enough.

    An ongoing shortage of polypropylene wrap used to sterilize surgical instruments later prompted Diversified Medical Healthcare to seek out U.S. partners Hanes Fabrics.

    So, when a federal customer came to CBT Medical with a request for medical supplies and the Buy American Act requirements in hand nine month ago, the OEM supplier was poised for action.

    Now, about 67% of CBT products go toward facilities used by this federal customer, he said. 

    It hasn’t always been easy to find domestic suppliers – especially for plastics, textiles and nitrile rubber components– but Shirley said they’ve uncovered many U.S.-based suppliers able to supply CBT’s custom surgical trays.

    Teasing out impacts 

    Jarrett Martin, president of Mar-Mac Industries, an industrial wire supplier for concrete reinforcement in McBee, said he has witnessed a positive uptick in U.S. suppliers used by the Florida Department of Transportation.

    But, at this time, he said it is hard to pinpoint the booming demand for Mar-Mac products to the Buy American Act alone. More than 90% of his business comes from outside the Palmetto State.

    “It has been difficult to tease out impacts to our business just with all the other noise going on in the supply chain disruptions, and before that, the pandemic, and before that, the steel tariffs from Section 232 by the Trump administration,” Martin told SC Biz News. “We expect a positive impact.”
    Section 232 placed a 25% ad valorem tariff on steel imports from all countries except Canada and Mexico as a national security measure, according to the Executive Office proclamation. 

    Turmoil in the ocean freight market, along with ongoing lockdown in China due to COVID-19, forced many contractors to reassess of their suppliers before the Oct. 22 requirements come into place.

    “Essentially, we saw demand snap back much more quickly than we expected after the spring of 2020, and nobody was ready for it,” Martin said. “Everybody in the supply chain had done the same thing. They had moved to conserve cash and take inventory down, expecting a big recession.”
    The rise in ocean freight prices and the uncertainty of import times has proved kind to Mar-Mac Industries so far.

    “As a domestic manufacturer, I’ve been well positioned to take advantage of that,” Martin said.

  • sam patrick posted an article
    National magazine does cover story on Greenville's Precision Genetics see more

    The February 2022 issue of Healthcare Business Review magazine features Greenville, South Carolina-based Precision Genetics in a fabulous story entitled "Where Precision Healthcare Meets Genetics".  The cover story addresses such topics as the role of genetics in mental health... the pandemic's impact on mental health... a look ahead at the future of healthcare.  Click here to enjoy the complete article.

  • sam patrick posted an article
    Part of a $10 million funding round recently closed by company see more

    Compliments of The Business Narrative

    South Carolina Research Authority (SCRA’s) investment affiliate, SC Launch Inc., has invested in Elastrin Therapeutics Inc.

    The $300,000 investment will help the company advance the development of therapeutics that reverse damaged tissue making it supple again, SCRA officials said.

    The Simpsonville-based biotech startup developed this technology, which restores hardened or damaged arteries and tissues by targeting the elastic fiber and removing the calcification that causes stiffening. Initial applications include reducing hardened arteries, de-calcifying heart valves, and treating diabetes and COPD.

    Elastrin became an SCRA Member Company in 2018 and received a $25,000 Academic Startup Grant. It also received a $50,000 Federal Matching Grant in 2019.

    Elastrin became an SC Launch Inc. Portfolio Company in 2022 when it received this first investment of $300,000. It also received a $50,000 grant during SCRA’s pandemic funding round for startups providing Covid-19 solutions.

    Elastrin recently closed a $10 million funding round, which included this investment.

    It also recently announced the formation of its scientific advisory board, comprised of leading industry and university experts in cardiovascular research and clinical development.

  • sam patrick posted an article
    Rebuttal to a factually inaccurate and decidedly slanted article about a member of SC life sciences see more

    South Carolina is blessed with over 1,000 life sciences organizations, engaged in biotechnology and pharmaceuticals to medical devices and health IT. Never was this more important than during the pandemic, when millions were hospitalized and too many lives lost.

    As neighbors fell ill, our industry -- including Charles River Laboratories professionals -- stepped up. Over 100 organizations produced PPE, tested for COVID-19, conducted vaccine clinical trials, and expedited health solutions. Gov. McMaster expressed appreciation by declaring Life Sciences Week in South Carolina.

    As our state’s voice of life sciences, SCBIO wishes your “Monkeys & Blood” article had highlighted Charles River’s globally celebrated work that helps save millions of lives and improves patient safety.

    Carefully obtained from Atlantic horseshoe crabs by Charles River professionals, Limulus amebocyte lysate (LAL) is critical to saving lives of patients everywhere. The unique, natural substance is used to test every injectable pharmaceutical, implantable medical device, and approved COVID-19 vaccine against contamination. Without it, endotoxins could enter the body and produce life-threatening sepsis.

    For decades, Charles River has protected and nurtured our crab population. Its microbial testing is considered best-in-class by scientists globally. And with synthetic LAL neither readily available nor FDA-licensed, industry experts decline its sole use because the safety of IVs, vaccines and more would not be assured as with natural LAL.

    Charles River and our life sciences ecosystem make tremendous contributions to our state and the health of mankind. Their lifesaving medical innovations should be celebrated.

    James Chappell, CEO of SCBIO

  • sam patrick posted an article
    Talented students honored at SCBIO 2022 life sciences conference see more

    Two Clemson University students placed in SCBIO’s Challenge Accepted video competition for their videos presenting research from the lab of Ramakrishna Podila, an associate professor  in the Department of Physics and Astronomy, on inexpensive COVID-19 and tuberculosis sensors using smartphones.

    Alan Rowland, a first-year graduate student in physics from Easley, South Carolina, and Dylan Carroll, a first-year genetics major from Knoxville, Tennessee, won second and third place, respectively.

    Highlighting innovation

    Participating students created videos no longer than three minutes highlighting life science innovation or research in South Carolina. The videos were judged on the content, production quality and creativity, and potential impact of their work on the industry.

    The competition was part of SCBIO’s annual conference held February 22-24 in Charleston. SCBIO is a member-driven organization formed to advance South Carolina’s life science industry through collaboration, advocacy and resource support. It provided students a creative way to engage with the state’s life sciences ecosystem, said Zach Hargett, SCBIO’s programming and special projects director.

    Dylan carroll Dylan Carroll

    “Connecting students with companies in South Carolina is a critical part of developing our state’s workforce. The SCBIO student video competition is a unique way to highlight several of South Carolina’s best and brightest minds in front of hundreds of industry leaders throughout the state and country,” Hargett said. “We believe programs like this, our student membership program and student-industry engagement sessions are giving both students and companies a unique platform to get the most out of South Carolina’s life sciences ecosystem.”

    The COVID-19 pandemic illustrated the need for access to convenient, inexpensive testing that facilitates rapid diagnosis to help stop the spread of diseases, Carroll said.

    Carroll’s video focused on how Analtye-induced disruption in luminance quenching (AIDLuQ) technology is used as a sensor. AIDLuQ uses regular printer paper coated with graphene particles that a smartphone could read to detect disease.

    Access to testing

    “As we’ve seen during the COVID-19 pandemic, there’s been lots of problems with access to testing and how long it takes to get results,” Carroll said. “With Dr. Podila’s research, you could get test results in under 15 minutes at home using your smartphone. That would solve a lot of problems with access to testing.”

    Rowland’s video focused on research that turns a smartphone into a spectrogram to detect tuberculosis, a bacterial infection that attacks the lungs. Tuberculosis is the leading infectious disease killer in the world.

    Headshot of Ramakrishna Podila Ramakrishna Podila

    “Often, tests have to be done by trained medical professionals. That can be a problem,” Rowland said.

    While some people would think lack of access to medical tests would be a problem in the developing world, it also affects countries like the U.S., Podila said.

    “While the COVID test is free, if there is any other test, you pay a minimum of 100 bucks. You have to go to the doctor, and that’s another 100 bucks for the copay. You have to make an appointment, which can take time,” Podila said. “The whole idea behind this research is to take existing technology, in this case a smartphone, to allow for accessible health care.”

    The sensors are ready for human clinical trials, Podila said. Bharat Biotech, a COVID-19 vaccine manufacturer in India, has inquired about using the sensors developed by Podila’s lab to check antibody levels of people in their clinical trials.

    Explaining the science

    Rowland said the most significant challenge he faced when producing his video was to explain the technology so non-scientists could understand.

    “Often, the biggest issue in science is explaining research in a way that’s not science,” he said. “Time was the biggest challenge in making the video because you have to take this research that has taken months, or even sometimes years, to do and condense it down into a marketable video that somebody could watch and say, ‘I can help on that project.’”

    Alan Rowland Alan Rowland

    Carroll said he wanted his video to grab attention, so he bought a $20 animation software program.

    “Whenever I’ve needed to watch science videos in the past, it was always some sort of animated video that grabbed my attention,” he said. “I wanted to make it anecdotal, something that could relate to everyone. I wanted it to grab the attention of anyone who’s ever traveled and needed medical care. Once I grabbed their attention, I wanted to bring in the science aspect of it and how the device could benefit them and society.”

    SCBIO CEO James Chappell said, “The SCBIO student video competition is a unique way to cultivate relationships between life science industry leaders and some of our most talented students. This relationship leads to career opportunities for the individual students and establishes comfort and familiarity between the companies and schools, leading to a more long-term talent pipeline.”

    One of Podila’s main goals is to train students to communicate.“Knowledge is its own reward,” Podila said. “We not only teach them physics, we not only teach them science, but we also teach them how to communicate effectively,” he said. “I’m happy Dylan and Alan put in the effort and won the contest. But for me, they already won when they made the video because they learned something. That was the real prize.”

  • sam patrick posted an article
    Portal sees surge in traffic see more

    In early March, Thornton Kirby, president and CEO of the S.C. Hospital Association, raised an alarm that South Carolina may face a shortage of personal protective equipment.

    The message circulated through a number of economic development groups, along with surveys probing retooling capabilities in response to the Trump administration’s invocation of the Defense Production Act.

    As manufacturers geared up across the state to meet critical needs, the S.C. Hospital Association, SCBio, the S.C. Department of Commerce and the S.C. Manufacturing Extension Partnership joined forces to connect healthcare providers and other industries with critical needs equipment through the S.C. Emergency Supply Collaborative portal announced April 13.

    Kirby said the portal will help streamline the product’s trip from the manufacturer to the hospital. He hopes other sectors, such as auto assembly, construction and education, will be able to make use of the portal to replenish their equipment stores, too.

    “There are some who are on a two-, three-, four-day supply but generally, we’re better than we were a couple weeks ago. The problem is that assumes the current number of COVID patients. If you fill up a hospital with 50 or 60 more like they do in New York City, the so-called ‘burn rate’ for every patient goes up a lot,” Kirby said on April 13.

    He hopes the mobilization of manufacturers across the state will also contribute to a state stockpile for future emergencies.

    “The national stockpile has been largely distributed, at least to the best of my understanding. South Carolina did get our share, that’s 1% based on population, but the volume of personal protective equipment is just so great, it quickly outstripped the national stockpile,” he said.

    Chuck Spangler, CEO and president of the S.C. Manufacturing Extension Partnership, said he was awake until midnight after the announcement of the portal, responding to S.C. manufacturers who want to sell their critical needs goods through the portal.

    “It’s been a thrill to see all of these companies step up, rise to the challenge and meet the critical needs in our state,” Spangler said.

    By Tuesday morning, Spangler said about 80 companies had joined the portal to sell critical needs goods after careful vetting from portal organizers to bar price-gougers. Several offered donations.

    “Last week, we saw an incredible response,” he said.

    About 15 health care providers had already begun scouting out the portal for PPE and other equipment along with several manufacturers.

    As many of the state’s manufacturers return to normal operations — Spangler thinks by May 4 — he hopes South Carolina will support each other by buying and selling PPE through the portal and is encouraging manufacturers to consider using other three-layer mask alternatives to preserve the stores of N95 masks for health care workers and food providers.

    Courtesy: GSA Business Report

  • sam patrick posted an article
    Life sciences was key for the state during COVID see more

    Compliments of Upstate Business Journal & Jennifer Oladipo

    Here’s what I was imagining at the end of January: You, now, breathing easier as omicron retreats into the realm of memory, no worrisome COVID variant in sight. We’re looking at each other going, “Wow, two years, can you believe it’s over?”

    And, we’re thinking about all the folks who helped get us through. With SCBIO’s annual conference scheduled for February 22-24, I started thinking again about all the homegrown life science organizations making a direct impact on the pandemic and our experiences of it. SCBIO, the state’s life science trade organization, has an impressive list of these at https://www.scbio.org/cpages/schelps.

    South Carolina has shown up in everything from testing (Abbott, Clemson University, Hoowaki) to treatment (Alcami) to remote care (ChartSpan) and protection (Humimic Medical, ZVerse). And then some. Years of background efforts were suddenly big news.

    Seeing life sciences become consistent headline fodder has been a real trip. It reminds me of how business news leaped from back sections to front pages in the early 2000s, when mega-scandals rocked Enron, Tyco, WorldCom and others. Biz news got sexy. It was a permanent change. 

    I hope the boosted attention to life sciences is permanent, too. Yes, to celebrate, but also to stay educated about how the world works. I wonder how the past two years would have looked if we’d started out with a broader, realistic understanding of all the parts and pieces it would take to get to the other side.

  • sam patrick posted an article
    Assay designed for RapidRona at home tests see more

    Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19 response. They have also implemented one of the largest variant surveillance initiatives in the country with the capability to sequence up to 42,000 specimens per day. Now, they have been granted Emergency Use Authorization (EUA) from the Food and Drug Administration to process results for at-home COVID-19 tests.

    The RT-PCR-based SARS-CoV-2 assay now authorized by the FDA is designed for RapidRona at home tests which can be ordered online at www.rapidrona.com. RapidRona enables those who would like to test for COVID-19 to collect their own sample at home by a minimally invasive nares swab and then send the specimen with prepaid shipping to the lab for processing of results. Polymerase Chain Reaction (PCR) tests have been known throughout the pandemic as the gold standard of testing methods due to the highly accurate results that they provide.  

    “Our scientists have worked diligently to take the steps necessary in receiving the EUA for this test,” said Kevin Murdock, Founder and CEO of Premier Medical Laboratory Services. “We did this because we know how important it is to enable the population to more easily access reliable COVID-19 tests with fast turnaround times from home. We’re proud that this is another way we can provide effective solutions for COVID-19 management.”

    At-home COVID-19 tests have been reported as difficult to find during the Omicron surge. The EUA attained by PMLS will allow more people the ability to test and mitigate the spread of the virus. Because some countries around the world only accept incoming travelers who have taken a RT-PCR test with a negative result, RapidRona is the choice for at-home testing among travelers. Returning schools and businesses can also reduce viral transmission rates utilizing RapidRona’s sample collection method designed for improved comfortability, keeping infected employees, students, and staff to a minimum. 

    PMLS is part of a house of brands under Diversified Medical Healthcare which manufacture testing supplies, develops medical data management software, and provides PPE to seamlessly meet the needs of organizations without delay or disruption.

    During the pandemic, PMLS has:

    • Processed millions of COVID-19 tests with a turnaround time of 24 hours or less
    • Served as the choice processing lab for Health and Human Services testing sites
    • Been the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments spanning from coast to coast

    To order a test, please visit www.rapidrona.com. For more information on Premier Medical Laboratory Services, please visit www.PreMedInc.com.  

    ###

    ABOUT PREMIER MEDICAL LABORATORY SERVICES: Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS), easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry and patient-friendly billing. Their expansive testing menu includes advanced Cardiovascular Testing, Diabetes panels, Pharmacogenomics, COVID-19 testing, Women’s Wellness panels, Allergen Specific Ige Blood Testing, and Toxicology. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.

  • sam patrick posted an article
    When it came to vaccine distribution, Softbox saved the day. see more

    When a pneumonia and meningitis immunization program needed to be rolled out worldwide, the safe transportation of vaccines was a crucial component in the process.

    The global bio-pharmaceutical company leading this initiative required a totally reliable, cost-effective Temperature Control Packaging solution to support its drive – and one that was ideal for air transportation.

    The award-winning Softbox Silverpod® range was tailor-made for just this kind of activity. Not only was the entire global distribution program completed, but it was done so without any product excursions whatsoever.

    Download the complimentary case study today, courtesy of Softbox.

  • sam patrick posted an article
    Premier Medical, Clemson detect latest variant in Upstate region see more

    December 20, 2021 – Today, Premier Medical Laboratory Services (PMLS), headquartered in Greenville, SC, reports their findings that the Omicron variant is now confirmed to be present in the Upstate. The laboratory has been surveilling for Omicron and other novel variants through Next Generation Sequencing (NGS) in partnership with the Clemson University Bioengineering Department. Clemson University REDDI Lab has collected samples for COVID-19 testing from throughout the upstate community and was funded through the National Institutes of Health (NIH) to then have the COVID-19 positive specimens undergo NGS at PMLS. NGS is the process of decoding the genetic make-up of the virus to track how it is mutating and spreading throughout the population.

    “As a proactive and solutions-driven company, we implemented Next Generation Sequencing to meet the needs of our population with preparedness for novel variants like Omicron,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “Through partnerships like ours with Clemson University, we are happy to increase the amount of data for South Carolina and the entire nation which is vital for vaccine efficacy and our understanding of the virus.”

    Knowing the importance of accumulating data in the continued fight against the pandemic, PMLS implemented one of the largest sequencing initiatives among any lab in the nation – with the capability to sequence up to 42,000 samples per week. Many labs that are conducting COVID-19 testing have not developed the capabilities to conduct sequencing, and new variants cannot be fully identified via COVID-19 diagnostic testing methods alone. PMLS will continue working to uncover any further novel variants and mutations that COVID-19 presents and notify health officials.

    Other ways PMLS has helped to meet demands during the pandemic:

    • Processing lab for Human Health Services surge sites and several state health departments 
    • Blue Cross Blue Shield preferred COVID-19 testing lab in several states
    • Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
    • Developed medical data management software that communicates directly from laboratory equipment for faster HIPAA compliant delivery of data to healthcare providers and patients
    • Shifted production to add in-house manufacturing of COVID-19 testing kits
    • Donated thousands of COVID-19 tests to children's diabetes summer camps throughout the nation
    • Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic

    For more information, please visit www.premedinc.com or call 1.866.800.5470. 

    ABOUT PREMIER MEDICAL LABORATORY SERVICES
    Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and highly advanced diabetes test, MDDiabeticPro. For more information, please visit www.PreMedInc.com

  • sam patrick posted an article
    SCRA makes third investment in Zylo Therapeutics see more

    South Carolina Research Authority (SCRA’s) investment affiliate, SC Launch, Inc. has made its third investment into Zylö Therapeutics, Inc. This $300,000 investment will help the company continue providing therapeutic topical solutions.

    Zylö Therapeutics became an SCRA Member Company in 2018 and received a $21,500 Project Development Fund Grant. They also received a $41,000 SBIR/STTR Matching Grant in 2020. Zylö also became an SC Launch, Inc. Portfolio Company in 2019 when they received their first investment of $200,000. They also received a $182,500 investment as part of SC Launch, Inc.’s pandemic funding round to startups providing COVID-19 solutions.

    Zylö developed a sustained-release drug delivery system that uses patented xerogel-derived particles, called Z-pods™, to topically deliver Nitric Oxide and other notoriously hard-to-deliver therapeutic agents. The technology enables a product concept called the Patchless Patch™, an innovative, competitive response to a lidocaine patch.

    SCRA Investment Manager Steve Johnson said, “Technology applied to health care challenges is a powerful tool and the Zylö Z-pod® delivery system is creating value not only in health care but in a wide range of applications, from medicine to agriculture. These solutions have the potential to benefit us all.”

    Founder and CEO Scott Pancoast said, “We knew we discovered something special with our breakthrough delivery technology. The highly engineered silica-derived Z-pods enable us to improve performance of a wide range of payloads. Our success is changing the way treatments can be delivered via the skin, providing sustained release with fewer systemic side effects. The teams at SCRA and SC Launch, Inc. continue to be trusted partners, and we’re glad they are on this journey with us.”

    Scott Pancoast was a recent guest in our CEO Podcast Series. Listen to learn more about Zylö’s progress with silica particles, Nitric Oxide, and other developments for medical treatment solutions.

    “The list of health care conditions to be treated by Zylö’s developments continues to grow. They are pursuing solutions to help patients with lupus, hair loss, joint pain, and even burns, just to name a few. Their commitment to innovative treatment discoveries have set them on a path of continued growth and success. We’d excited to have them in our portfolio of companies,” said Bob Quinn, SCRA Executive Director.

     

    About SC Launch Inc.

    Established in 2006, SC Launch, Inc. is the investment affiliate of the South Carolina Research Authority. The independent nonprofit corporation provides loans and investments to selected South Carolina-based companies participating in the SC Launch program.

    About SCRA

    Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.

  • sam patrick posted an article
    Long term impacts of COVID-19 across the health care spectrum are still to be determined see more

    12.02.2021

    Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.

    The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.

    The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19[1]. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites[2]. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.

    Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.

    COVID-19 Resulted in an Acceleration of the Clinical Research Process

    When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s[3]. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV[4]. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine[5]. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future[6].”

    As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.

    A New Focus on the Clinical Research Participant

    Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial[7].

    Use of More Decentralized Clinical Research

    A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site[8]. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site[9]. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by  increasing both access to clinical trials and the overall diversity of trial participants[10].  Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective[11].

    Increased use of Digital Technology

    The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased[12]. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE[13]. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies[14].

    Is there a silver lining from COVID-19 when it comes to clinical trials?

    The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.

    For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.

  • sam patrick posted an article
    Dr. Delphine Dean of Clemson honored see more

    The Governor’s School for Science + Mathematics (GSSM) was pleased to award the Fall 2021 Randall M. La Cross Distinguished Leadership Award to Dr. Delphine Dean of Clemson University at the 33rd Annual Research Colloquium. 

    Dr. Delphine Dean is the Rob and Jane Lindsay Family Innovation Professor of Bioengineering at Clemson University. Dr. Dean earned her B.S., M.Eng., and Ph.D. in Electrical Engineering and Computer Science from the Massachusetts Institute of Technology. She joined the Clemson University faculty in 2007. She is a member of the American Chemical Society, American Physical Society, Materials Research Society, Biomedical Engineering Society, Society for Biomaterials, American Society for Engineering Education, the Orthopaedics Research Society, and is one of the newest members of the American Institute for Medical and Biological Engineering’s College of Fellows. Dr. Dean is a recipient of the Class of ’39 Award for Excellence from Clemson University. 

    Dr. Dean’s Multiscale Bioelectromechanics Lab at Clemson University studies the mechanics and interactions of biological systems at the nano-to micro-scale using techniques like atomic force microscopy and mathematical modeling. Her research focus includes the nanostructure of cardiovascular cells and tissues, the effects of ionizing radiation, and the development of novel medical devices. These innovations include saliva-based blood glucose strips that can be read by a smartphone application and a biodegradable marker for tumor localization that reduces the cost of breast cancer surgery. 

    Many of the projects led by Dr. Dean address needs in under-resourced communities around the world – a commitment aligned with that of GSSM’s mission to develop “ethical leaders” prepared to take on “the world’s most significant issues.” These efforts include a breast pump with a filter to inactivate HIV in breast milk, basket-woven braces for neck injuries that can be produced and sold by local women in Tanzania, and a low-cost patient monitor that a hand crank can power. 

    In response to the COVID-19 pandemic, Dr. Dean led the establishment of the certified clinical diagnostic Research and Education in Disease Diagnosis and Intervention lab at Clemson, which is key to Clemson’s COVID-19 testing strategy, as well as providing testing for their surrounding community. She also led the Clemson COVID Challenge, an undergraduate research, and design challenge to address issues related to the pandemic. 

    A core element of Dr. Dean’s work has been to engage students below the graduate school level with challenging and meaningful projects. Dr. Dean has provided mentored research & inquiry experience to over a dozen GSSM students since 2008 and over 150 Clemson undergraduates through Clemson’s Creative Inquiry program. Current student projects include designing medical devices for the developing world, collaborating on biomedical engineering innovation with students in Tanzania, testing radiation for biomedical applications, using magnetic nanoparticles to reduce the need for arterial stent implants, and applying human factors engineering to medical device design. 

    The Randall M. La Cross Distinguished Research Leadership Award is presented to Dr. Dean by Dr. Tyler Harvey. Dr. Harvey is a GSSM Class of 2011 graduate. As a rising senior at GSSM, he conducted his mentored research & inquiry experience at Clemson University under Dr. Dean. He returned to Clemson, earning his B.S., M.S., and Ph.D. while continuing research with Dr. Dean. Dr. Harvey is currently a Lecturer in Bioengineering at Clemson University and has contributed to the development of GSSM Outreach & STEM Foundations programs.

  • sam patrick posted an article
    Biotech startup receives top honors in category see more

    Elastrin Therapeutics of Simpsonville, SC has been named winner of the 2021 InnoVision Award for Technology Development, organizers have announced.

    Elastrin Therapeutics is a biotech startup with technologies to restore hardened and damaged arteries and tissue by targeting the elastic fiber that makes them work.

    Founded by Mr.Douglas Mulhall, Dr.Naren Vyavahare, Dr.Charles D. Rice, and Dr. Mirko Stange, the SCRA Client Company has demonstrated proof-of-concept for a patented therapeutic compound that may provide needed repair and restorative function to lungs that have been damaged by the COVID-19 virus. According to Vyavahare, “Elastin is present in lung alveoli that are being degraded by enzymes such as neutrophil elastases and MMPs released by inflammatory cells in COVID-19 infection of lungs. Our elastin targeting nanoparticle can also target drugs to the lungs and prevent lung injury.

    Click here to view the winner's video.

  • sam patrick posted an article
    Nephron steps up to help state's most vulnerable see more

    As children ages 5 to 11 become eligible for COVID-19 vaccines, Nephron Pharmaceuticals Corporation has announced the opening of a pediatric COVID-19 vaccine clinic at its vaccination drive-thru in West Columbia. The clinic is open Monday – Friday from 12:00 PM – 5:30 PM.

    Nephron, in partnership with Dominion Energy South Carolina, launched a convenient drive-thru COVID-19 vaccination site earlier this year. The drive-thru is located on Dominion Energy property off of I-77 at Exit 2. In addition to providing the space for a drive-thru, Dominion Energy is also generously contributing power and logistics support.

    As a part of its ongoing efforts to help respond to the COVID-19 pandemic, Nephron offers Pfizer and Moderna vaccinations to citizens, including those ages 5 to 11, who are eligible. This includes regular doses and boosters for adults, during regular hours, which remain Monday – Friday from 10:00 AM – 4:00 PM.

    Nephron registered nurses and pharmacists are administering vaccinations, with assistance from Nephron CLIA-certified diagnostics lab employees.

    COVID-19 tests are also available as a part of the drive-thru. Nephron established a diagnostics lab last year in order to conduct COVID-19 tests. Since opening the lab, Nephron has tested thousands of people across the state for COVID-19 – including employees, students, educators, athletes and families – as the company does its part to keep South Carolina healthy and safe during the public health crisis. The Nephron CLIA-certified lab procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing. Results are delivered within 24-48 hours.