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biopharmaceuticals

  • sam patrick posted an article
    Hundreds of nation’s industry leaders to gather for strategic partnership development, insights see more

    With the biggest story of 2021 – the global COVID-19 pandemic – serving as a backdrop, the largest life sciences conference in Palmetto State history will convene both in-person and virtually February 22-24 to address how South Carolina and America are accepting the challenge of  achieving health and prosperity for all, South Carolina life sciences industry officials have announced.

    Themed “Challenge Accepted,” the 2-day SCBIO 2022 event will feature national speaker sessions on Transformational Technologies, Next Generation Patient Care, Ensuring Opportunity for All, and Embracing Collaboration & Innovation – fundamental forces driving the state’s fastest growing industry: life sciences.

    Currently listed as a $12 billion industry, national economist Dr. Joseph Von Nessen of University of South Carolina’s Moore School of Business will report findings of a just-completed economic impact study of the state’s life sciences cluster, last analyzed in 2017.

    FDA Associate Director of the CDER Drug Shortage Staff Valerie Jensen is the first announced featured major speaker for the 2-day conference, addressing the gathering in a Program “Challenge Accepted:  Delivering Next Generation Care to Patients Now.”  A trained clinical pharmacist, Captain Jensen was one of the initial developers of FDA’s Drug Shortage Program and was named Associate Director in 2012. She continues to manage the Drug Shortage Staff at FDA. Joined by MUSC Health CEO Dr. Pat Cawley, Velocity Clinical Research executive Steve Clemons, and USC Provost Dr. Stephen Cutler, the panel will focus on the industry’s success in to expediting development of medicine, devices, technologies and vaccines in record time and with startling efficacy – and what it means for care around the world going forward.

    Captain Jensen will be joined by more than 25 additional presenters and honorees at SCBIO 2022, which brings together leaders and executives from life science organizations across the nation to South Carolina. In deference to the pandemic, FDA protocols on safety are being rigorously adhered to and events are also being presented and distributed virtually, organizers revealed.

    The conference will feature a significantly expanded exhibit hall showcasing scores of life sciences industry businesses, institutions of higher learning and essential support industry partners from across America, as well as presentation of the prestigious Pinnacle Awards by South Carolina Life Sciences to the outstanding 2021 Organization of the Year and Individual of the Year. Also to be honored with Pinnacle Awards will be an inductee into the SC Life Sciences Hall of Fame, and an award for an industry Rising Star under 40 years of age.  

    New SCBIO CEO James Chappell will deliver a highly anticipated “State of South Carolina’s Life Sciences Industry” address, while hundreds of in-person and virtual attendees will take advantage of meetings and connection sessions through the conference’s Partnering Portal. Additional speakers will be announced shortly, as well as posted online.

    Registration to attend the 2-day conference is now open online.  For more details, visit the 2022 Annual Conference section at www.scbio.org. Registration and exhibiting are free to many SCBIO investors. Early bird general admission pricing provides significant discounts to interested companies, industry supporters, students interested in life sciences, faculty and teachers. Limited Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

    The 2-day conference annually draws attendees from across America for networking, innovation updates, opportunity discovery, partnership making and strategic discussion. Already committed attendees include officials across a broad spectrum of life sciences industries including medical devices, bio manufacturing, drug discovery, R&D, pharmaceuticals, diagnostics and testing, digital health and health IT, bio-ag and more.

    SCBIO is South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has more than 700 firms directly involved and over 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental, and agricultural biotechnology products.  In early 2021, Governor Henry McMaster issued an Executive Order making it a state priority to continue to grow and expand the life sciences industry in the Palmetto State.

    “Life sciences is a major driver of South Carolina’s economy, and this conference’s growth is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and region,” noted SCBIO President and CEO James Chappell. “Already accounting for thousands of highly-skilled jobs in the Palmetto State, this sector has tremendous growth potential, and we’re excited to showcase top companies, research universities and leaders from across our state and country at SCBIO 2022.” 

    Among leading biotech and med-tech industry brands participating in the conference are Nephron Pharmaceuticals, BIO, Johnson & Johnson, AVX, PhRMA, Medpoint, AdvaMed, Poly-Med, VWR, Rhythmlink, SoftBox Systems, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami and more. All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, and economic development entities including the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include academic institutions, biotech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products that transform how we heal, fuel and feed the world.

    For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.

  • sam patrick posted an article
    South Carolina's fastest-growing industry stars in new SCBIZ Magazine features see more

    The story on life sciences in South Carolina just took a big step forward to becoming even better known as SCBIZ Magazine featured the booming industry as its Summer 2021 cover story -- out now.

    The 14-page feature spanned four stories, from the trends driving the rapid growth of life sciences in South Carolina, to major advances in life science research happening here at home. A fabulous story on how SCBIO and life sciences organizations are working to close the workforce gap is also included, as well as an industry salute for our role in helping America emerge from COVID.  It's a tremendous section.

    Over 20 organizations are featured in stories, and nearly as many industry leaders from across SC are quoted in articles, enriched with photos, industry data on segments and market penetration, and more.

    More than two years in the making by the SCBIO team who worked with SCBIZ to bring this first-ever magazine feature on the industry to life, SCBIZ intends to build on this year's momentum and do another life sciences feature next Summer.  READ THE ENTIRE SECTION HERE!

  • sam patrick posted an article
    Nephron Pharmaceuticals continues on rapid growth curve... see more

    Compliments of the Post and Courier

    Nephron Pharmaceuticals’ expansion is progressing as production gets underway on a spate of new business ventures — from at-home COVID-19 test kits to chemotherapy drugs.

    Since 2020, the West Columbia drug maker has invested $215 million to build out its campus in Lexington County’s Saxe Gotha Industrial Park. In the past month, the company hired 1,500 new part-time workers as it ramps up production of new product lines, CEO Lou Kennedy said, bringing it to 1,200 full-time employees and 2,500 part-timers.

    The hiring spree comes as Nephron produced 30 million doses of reagent for Abbott Laboratories’ at-home COVID-19 test kits last month and assembled about 1 million kits. Kennedy hopes to increase kit production to 2 million per month in January as demand for them has skyrocketed amid new variants of the deadly virus. 

    CONTINUE READING FULL STORY HERE...

  • sam patrick posted an article
    The life sciences cluster in Charleston, SC -- and across the state -- is booming see more

    Compliments of CRDA and Investment Monitor

    Aligned by a shared vision for a healthier world, a united life sciences sector is a powerful thing. In the Charleston, South Carolina, market, strong synergies between new and established businesses, academic institutions and state-led initiatives provide prime opportunities for scientific innovation and business success. A growing cluster of life science companies prove testament to the power of the region’s networks.

    When considering possible locations for a new office, laboratory or manufacturing site, life science businesses will have a long checklist. This includes a provision of talent, access to markets, ease of transport and connectivity, quality of life and support from local government. When these elements come together an additional benefit is created: a thriving scientific ecosystem that generates a virtuous circle of advantages for businesses and their employees.

    The Charleston region’s ecosystem helps companies solve business challenges and mitigate risks. As a result, an increasing number of biotech and medtech manufacturers, research laboratories and service companies are calling the area home, giving birth to a burgeoning life sciences community and all the network effects that come with it. For companies seeking to enter or expand in the US, the professional economic development organization, Charleston Regional Development Alliance, exists to guide you through the process. The Alliance provides multiple services at no cost to the company.

    Click here to continue reading the entire article.

  • sam patrick posted an article
    Pall expects to hire even more associates in 2022 see more

    Compliments of Upstate Business Journal

    Pall Corporation announced Nov. 8 it will hire 300 people to staff its new 220,000-square-foot manufacturing facility at 816 Berry Shoals Road in Duncan.

    The facility manufactures products such as its Allegro platform, which may be used in the creation, purification and packaging processes for biotechnology and pharmaceutical products such as antibiotics, antibodies and vaccines, including COVID-19 vaccines.

    “We’re excited to join the Duncan community and welcome new associates to our growing team,” said Joseph Repp, president, Pall Life Sciences. “Pall has a proud, 75-year history of supporting development of life-saving vaccines and therapeutics. The important products we make here in South Carolina are used by customers around the world and critical to Pall’s global expansion plans as we increase production globally.”

    The company also expects to hire for additional positions in 2022.

    To apply for open positions, visit jobs.danaher.com/global/en and search for ‘South Carolina’ as the role location.

  • sam patrick posted an article
    South Carolina life sciences is surging across the state, experts say see more

    As Published in Greenville, Columbia and Charleston Business Magazines

    When describing today’s South Carolina’s life sciences industry, words like "surging" and “booming” are often mentioned.

    Life sciences is diverse, with seven sectors: drugs and pharmaceuticals; medical devices and equipment; digital health solutions; research, medical and testing laboratories; bioscience distribution; bio-agriculture and ecosystem support. 

    Surprisingly, life sciences are South Carolina’s fastest-growing industry -- not more expected industries like automotive, tires, or aerospace, notes Erin Ford, Interim CEO of SCBIO -- a nonprofit dedicated to building, advancing and growing life sciences here. 

    “A 2017 study by USC's Moore School of Business showed 402 life science companies in South Carolina –  that’s grown to over 700 today.  It employed over 43,000 South Carolinians and generated $12 billion in impact,” said Ms. Ford. 

    To read the complete story, please click here...

  • sam patrick posted an article
    Nephron went looking for a way to automate syringe-filling for small batch manufacturing, found more see more

    Compliments of Pharma Manufacturing

    t’s no secret that working long hours in a cleanroom environment can be grueling. The bunny suits can get sweltering and the hours doing monotonous tasks can drag. On top of that, staffing cleanroom techs for an around-the-clock operation can be a major challenge for pharma companies.

    With the hope of overcoming these issues, South Carolina-based Nephron Pharmaceuticals recently went looking for a way to automate syringe-filling for small batch manufacturing and turned to the brainpower nearby.

    Within the University of South Carolina, the Office of Innovation, Partnerships, and Economic Engagement (OIPEE) provides a way for companies to engage with students and faculty to solve vexing industry problems. 

    “The university can bring a client in, and we’ll create a solution for that client with advanced manufacturing,” Bill Kirkland, executive director of OIPEE, explains.

    For Nephron, that solution was robotics. After striking up a partnership, students and researchers from UofSC eventually innovated a new automated syringe-filling system that utilizes flexible, high-speed robots provided by Yaskawa Motoman and processing power developed by Siemens. According to Kirkland, the system’s robotic arm that works under a single hood is part of what makes it unique. It was also designed specifically for small-batch operations, and importantly for Nephron, the new technology will help eliminate manufacturing downtime.

    “We have a workforce issue in that we have lots of trained sterile pharma techs, but expecting them to show up every shift 24/7 is challenging,” Lou Kennedy, CEO of Nephron, says. “So, for example, if someone calls in sick, this allows us to do many steps using robotics, and it keeps us from having to shut down.”

    Although there are other robotic syringe-filling solutions on the market, Kennedy says she has never seen a system as small and nimble as the one built by UofSC.

    “It operates underneath a flow hood in a cleanroom and that’s important because we are working with injectables,” Kennedy says. “And it’s compact and can move from one cleanroom to another.”

    After the technology was developed, the system was installed in a Nephron facility earlier this year, where Kennedy says the company is perfecting the tech and it is being commercially validated. Once they find the manufacturing “sweet spot” and it wins regulatory approval, the companies plan to license and commercialize the technology. Ultimately, the plan is to target biopharma facilities and hospitals in need of small-batch manufacturing solutions. 

    “By virtue of its previous relationships with Yaskawa and Siemens, UofSC faculty and OIPEE pitched this solution to Nephron, who agreed to bear some of the initial cost of setting up the research facility in the McNAIR [Aerospace] Center,” Kirkland said in a statement this spring. “All three companies, as well as the university, will benefit greatly from the introduction of this system into the commercial space.”

    In addition to being a boon for the Nephron, the collaboration also showcased how industry partnerships can be a stepping stone for engineering and manufacturing students — including those who were not considering a career in pharma before. According to Kirkland, one of the students involved in the collaboration went on to score a job at Siemens, and another did the same at Nephron.

    “Partnerships like this one are a win for patients, employees and students, not to mention for companies like ours, that continue to grow and expand our capacity to help others,” Kennedy said in a statement this spring. 

     September 26, 2021
  • sam patrick posted an article
    Two life sciences companies make list for SCRA support see more

    Compliments of Midlands Biz

    Advent Innovations, LLC and DPX Technologies, LLC have been accepted as South Carolina Research Authority (SCRA) Member Companies and awarded grant funding. Parimer Scientific, LLC and Prewrite, Inc. have been accepted as Member Companies. As Member Companies, they will receive coaching, access to experts in SCRA’s Resource Partner Network, eligibility to apply for grant funding, and the potential to be considered for an investment from SCRA’s affiliate, SC Launch, Inc.

    Advent Innovations Limited Company has been accepted as an SCRA Member Company and awarded a $50,000 Federal Matching Grant. The University of South Carolina-affiliated startup provides services in modeling, analysis, design, and product development using cutting-edge research with novel sensors, big data analytics, and other smart technology such as robotics. Their customers include private corporations and government entities in aerospace, automotive, civil infrastructure, and energy.

    DPX Technologies, LLC has been accepted as an SCRA Member Company and awarded a $50,000 Federal Matching Grant. The University of South Carolina-affiliated company manufactures sample lab preparation products and develops custom methods for a diverse client base. Their proprietary and patented INTip™ technologies provide efficient, automated solutions for laboratories that are easy to customize and implement with any workflow or method.

    Parimer Scientific, LLC has been accepted as an SCRA Member Company. The Easley-based company provides turn-key laboratory services at competitive rates to biotech and pharmaceutical companies with no upfront capital or long-term commitment needed. In 2020 alone, more than 10,000 units of pharmaceutical products were made at Parimer and shipped directly to the end-users at hospitals, doctor’s offices, and nursing homes.

    Prewrite, Inc. has been accepted as an SCRA Member Company. The Greenville-based startup offers a story development platform for writers, producers, and content creators of all types. Their powerful tool ensures the writer is using good story fundamentals. Stories of any complexity are easily built, piece-by-piece. Originally designed for screenplays, Prewrite is used around the world by professionals and amateurs alike.

    SCRA welcomes these new Member Companies!

    Grant funding is made possible, in part, by Industry Partnership Fund (IPF) contributions that fuel the state’s innovation economy. Contributors to the IPF receive a dollar-for-dollar state tax credit, making it an easy and effective way to help one of the fastest growing segments of the South Carolina economy. Grant funding for Member Companies creates a direct, positive economic effect and job creation.

    About SCRA
    https://scra.org/
    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.

     September 08, 2021
  • sam patrick posted an article
    Life sciences expands career opportunities for SC graduates see more

    Compliments of Lowcountry Graduate Press

    COVID caused pain and heartache and death across the world and here in the Lowcountry, but it also revealed some bright spots. One of those is the life sciences industry, which was responsible for diagnosing COVID, providing responses, and ultimately developing effective vaccines.

    Coincidentally, the life sciences industry in South Carolina is itself on a growth spurt that was accelerated by the pandemic. The number of firms in the industry had doubled in the last four years, making it the fastest-growing industry sector in the state. The Darla Moore School of Business estimated its annual economic impact at $12 billion before the most recent spike.

    Life sciences produce next-generation pharmaceuticals and vaccines; advanced medical devices, diagnostics, and testing; digital health; bioscience distribution; bio-agriculture and biomaterials; and biological solutions for advanced manufacturing.

    Life sciences also encompass two areas of focus for the Lowcountry Graduate Center – advanced manufacturing and healthcare management. While the connection with healthcare is obvious, many people don’t realize that life science research and advanced manufacturing work symbiotically. Many life science innovations, like medical devices, require advanced manufacturing to produce, while life science innovations can power the process of advanced manufacturing itself.

    Career Opportunities in Life Sciences

    That means jobs, and not just for M.D.s and Ph.D.’s, but for technical college graduates and university biology and chemistry majors as well. The average life sciences position pays $79,000, according to the official state affiliate of the U.S. Biotechnology Innovation Organization, also referred to as SCBIO, the nonprofit organization dedicated to promoting the life sciences industry in S.C. Because workforce development is the primary challenge facing the industry, SCBIO is engaged in an initiative to promote the industry as a career path for students, guidance counselors, and parents at the K-12 level and in two- and four-year college.

    Indeed, SCBIO is in the process of developing an industry-advocated life sciences curriculum for technical colleges that can prepare graduates for jobs in the field. Courses would cover manufacturing processes; safety and technical protocols like measurements and ISO standards; soft skills required for all workplaces; and the connections between the various life science components and the life-saving innovations they support.

    “We want to get to students even sooner so we’re partnering with organizations that are already in schools to add more of the ‘S’ in STEM,” said Erin Ford, interim CEO at SCBIO. “If someone takes a course at Trident Tech, they can get a job paying $50,000 or more with health insurance while working on a product that helps people live better lives.”

    The vector of life science development is different depending on the area of the state, with the Lowcountry showing strength in biotechnology, pharmaceutical, and manufacturing, says Ford.

    Life Science Companies Need Space to Grow

    Besides workforce development, the next big challenge constraining growth is space. Lab space at the new WestEdge development in downtown Charleston was fully subscribed when it opened and now developers are seeking new space. Clean labs are more complex and costly to retrofit and build than ordinary office or warehouse space.

    Nonetheless, the firms keep coming – or starting – and the state has gotten behind the industry. As a critical step, it authorized and funded SCBIO as the state’s lead life sciences industry economic development organization.

    Life science provides more than just more job growth: it provides diversification of an economy that 30 years ago relied heavily on a Navy base that packed up and left. Life sciences are more recession-resistant than automotive and aeronautics, two areas of manufacturing strength in the Lowcountry that respond to retail market demand. People never cease needing health innovations.

    Recognizing that, the Charleston Regional Development Alliance (CRDA) and South Carolina Research Authority have backed the industry. CRDA was the first development authority in the state to build map out a strategic plan to attract and retain life science businesses.

    Headwinds for Life Sciences in South Carolina

    Sam Konduros of KOR Medical, a clinical cannabis firm launched by the Charleston-based diagnostic and testing company Vikor Scientific, says South Carolina and SCBIO have created a business climate conducive to the industry, and the health care and advanced manufacturing infrastructure have added tailwinds to its development. Citing Vikor’s growth from 45 employees to 450 during COVID, he says recruiting a talented workforce has not been a significant challenge so far. He notes the usual Charleston quality-of-life benefits – weather, beaches, history, and food, in addition to the growing vibrancy of the industry – as recruiting tools have contributed to the success.

    Ford and Konduros see possible headwinds elsewhere for the industry. Roadways and other transportation infrastructure could use improvement, and housing availability and affordability are statewide issues. For example, the state’s franchise tax, now eliminated by 36 states, penalizes early-stage companies successfully raising venture capital before going to market. In an industry that often spends millions to earn FDA approval prior to commercialization, the tax is a burden, they say.

     September 02, 2021
  • sam patrick posted an article
    Greenville company enters MOU with global player see more

     Xcelerate, Inc. (OTC pink sheets: "XCRT") today announced that it has signed a Definitive Memorandum of Understanding with HS Pharmaceuticals, LLC of Greenville, SC defining the terms under which Xcelerate, Inc. will acquire 100% of the membership interests in HS Pharmaceuticals, LLC as well as a 51% interest in HS Cosmetics, Inc.

    The DMOU calls for the drafting and signing of an Acquisition Agreement with a pre-determined valuation of HS Pharmaceuticals as well as the raising of capital sufficient to progress the development of HS Pharmaceuticals IP and to fulfill the expansion of the current HS Cosmetics marketing plan launched in April of 2021.

    "Since the announcement of a letter of intent with HS Pharmaceuticals in May, the teams at Xcelerate and HS have been working to define the terms that have resulted in this DMOU and were able to agreement with the assistance of our advisors at Network1 Financial who will be working with us going forward in our capital raising efforts" said Michael O'Shea, Xcelerate CEO."

    "Xcelerate remains focused on joining early-stage medical technology companies in a setting of controlled clinical care where these new developments can be trialed, tested and applied," said O'Shea. 

    For more information, please visit www.xcelerate.global.

  • sam patrick posted an article
    South Carolina-based firm names new head of pharma and medtech see more

    DUNCAN, SC - Stäubli announced today that Olivier Cremoux has been appointed Deputy Head of Pharma and Medical Device for Stäubli Robotics North America.

    Cremoux joined Stäubli Group in 2015 before transferring to Stäubli Corporation as the North American Business Development Manager for Robotics in 2018. Most recently, he became Key Account Manager – Pharma and will maintain this role throughout the transition period.  Cremoux will use his experience to help build the Medical Robotics team while focusing on the Pharma and Medical Device specific markets.

    Cremoux graduated from the National Institute of Science Applied of Lyon (France) with a bachelor degree in Electrical Engineering.

    Commenting on the announcement, North American Robotics Division Manager, Sebastien Schmitt stated, “We are pleased to announce Mr. Cremoux as Stäubli Robotics North American Deputy Head of Pharma and Medical Device. We believe Mr. Cremoux is the right leader for Pharma and Medical Device as we continue to expand our growing team.  This is an important step in setting up an organization fully dedicated to the pharmaceutical industry to build on our existing expertise in a number of high‑tech markets.”

    Olivier Cremoux: “I am honored by such an opportunity within Stäubli Robotics.  The Pharma and Medical Device is a strategic and growing market in which Stäubli has provided, for over 20 years, significant technological innovations.  High throughput screening, aseptic fill/finish, orthopedic surgery, bio-printing and cell culturing are examples of processes where Stäubli Robotics started as a pioneer and became a reference. With COVID-19 pandemic, robotics became even more essential to our customers, from drug production to Covid test manufacturing.  In North America, we will continue the development of our organization to ensure all current and future needs of our customers.”

    About Stäubli Robotics

    Stäubli Robotics is a leading global player in robotics, consistently delivering engineering as effective and reliable as our service and support. A complete solutions provider for digitally networked production, Stäubli offers a broad range of 4- and 6-axis robots including robotic arms designed specifically for sensitive environments, autonomous mobile robots, driver-less transport systems (AGVs) and cobots for human-robot collaboration.  www.Stäubli.com/robotics 

    About Stäubli North America

    Stäubli North America has more than 200 employees supporting Connectors, Robotics and Textiles customers. The company’s North American headquarters is in Duncan, South Carolina. Stäubli provides customer support through its locations in Duncan, Queretaro, Mexico, and the newest Stäubli North American facility, which opened in 2018 in Novi, Michigan. In addition to 24/7 customer support, each of these facilities offers training and has dedicated on-site technical experts who can be deployed whenever needed. Stäubli’s North American sales force is located strategically on the West and East coasts, and also serves Canada and Puerto Rico.

    Worldwide, Stäubli is a leading manufacturer of quick release couplings, robotics systems and textile machinery. With a workforce of more than 5,500 employees, Stäubli is present in 29 countries supported by a comprehensive distribution network in 50 countries worldwide.

  • sam patrick posted an article
    Another SC start-up is making good see more

    Compliments of the Post and Courier

    During a procedure with a young patient, Cephus Simmons noticed something wasn’t working as well as it could. Part of the child’s small intestine had slid into the large intestine, causing an obstruction that can be life threatening for small children.

    But the catheter used to keep the bladder flowing wasn’t staying firmly in place.

    “It became frustrating to me, and it was something that medically I knew wasn’t correct, and something that needed to be fixed,” said Simmons, a Ph.D. and radiology assistant at the Medical University of South Carolina.

    The catheter the MUSC team was using, called a Foley catheter, features a balloon to hold it in place internally. After the procedure, Simmons drew up his idea for a different kind of catheter that would have two balloons, one to be placed on the inside and one on the outside of the body. He founded SealCath in 2013.

    While Simmons says it solves the problems that were at hand during that procedure, the catheter he developed can be used for colonoscopies and more. It’s also made to work for both pediatric and adult patients.

    But it took several years after founding of the company for the catheter to become available on the market. Simmons worked on the effort from his home in Mount Pleasant in between his clinical time at MUSC, getting little sleep.

    The company quickly began to take off in 2018. Simmons was awarded a research grant that year from the National Institutes of Health

    The S.C. Research Authority, a tech accelerator program that receives state funding, also enrolled SealCath in its SC Launch program for startups in 2018. The program gives companies mentorship and capital in order to grow. 

    SealCath went to market in the summer of 2019. Then, Simmons secured a patent in Canada in 2020. 

    When COVID-19 shut hospitals’ doors to many patients, visitors and vendors, SealCath also had to shut down temporarily. Business picked back up by the end of 2020, and now Simmons plans to bring to market a silicon version of his catheter this fall — it’s available in latex for now, and some buyers are concerned about allergies to the material. 

    Innovations in the life sciences are some of the most promising in Charleston’s burgeoning technology industry.

    Health care technology, along with biotech and pharmaceuticals, make up two of the state’s top three startup industries, according to an annual analysis by BIP Capital. Still, in terms of the amount of outside funding coming in, South Carolina’s startups can’t match the size of Georgia’s, North Carolina’s, Florida’s or Tennessee’s in the Southeast. 

    SealCath is one of a number of successful spin-offs to come from researchers and clinicians at MUSC. 

    Simmons didn’t imagine becoming the CEO of a startup company when he decided to go into medicine. 

    “Innovation does the same thing as what I’ve been doing my whole career, which is helping patients,” he said. “If you find the right product that’s going to improve health care, then innovation is actually just as good or better than what I’ve been doing the whole time as far as taking care of my patients.”

    Simmons plans to retire from MUSC, which he now counts among his customers, this year and take his catheter on the road to market it to other hospitals. His long-term goal is to export the device to Canada. 

    Simmons graduated from Walterboro High School. He is married with four children. 

  • sam patrick posted an article
    Workforce efforts paying off for life sciences in SC see more

    Compliments of GSA Business and SCBIZ News

    South Carolina’s life science sector creates twice as many jobs as the average of all other sectors in the state economy, according to a recent study, but whether it can fill those positions is another matter — especially in the manufacturing and logistics side of the house.

    “It has historically been the majority of the time that you find a qualified person, they already have a job in M&L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company that serves the manufacturing sector. Turner is also a former staffing professional.

    He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field.

    “All I’ve heard since the pandemic is [that] it has been hard to even find available people, much less available and qualified people,” he said.

    This gap is even more prominent in a life science field that sometimes requires more than the standard specialization or training. And to add insult to injury, few in-school training programs target this unique brand of manufacturing and logistics, said SCBIO interim CEO Erin Ford.

    “The life sciences encompasses so many aspects from medical devices to pharmaceutical research and development to logistics in getting the drugs or pharmaceuticals or medical devices to where they need to be,” she said. “There's just so many aspects to the life sciences. And we really, as a state, have not focused on having any specific curriculum or programs that are specialized in this area.”

    She argued that while the traditional medical careers such as nursing fall under the Life Science umbrella, industrial aspects of the sector often get overlooked in the classroom.

    “It’s just not even a part of the discussion as to what career you want to have,” Ford said.

    Since the economic development organization formed its Workforce Development Taskforce a few years ago, its more than 300 members have aimed to do something about that.

    She hopes that 2021 (or early 2022) will be the year she can see their work come to fruition through a curriculum pilot geared toward two-year students in South Carolina’s technical college network.

    Students upon learning about the field may often feel intimidated by the math or science components attached to a traditional science, technology, engineering and math field, she said, but really it’s the requirements of working in a clean room in the medical device field that can prove to be the most challenging.

    And that is the gap Ford hopes the program will fill.

    So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, she said, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field.

    “We don't want to reinvent the wheel,” Ford said. “That's why we're working with a lot of the partners to add in more substance for life sciences. So if we see that there is more for us to do, we will definitely take that on.”

    Life science companies in each region have already offered up some input to their needs and will continue to do so once the program launches: Trident Technical College has its ear to the ground for workforce demands of AlcamiCharles River Labs and Vikor Scientific while Tri-County Technical College is partnering with ArthrexAbbott Laboratories and Poly-MedMidlands Tech has an open channel to the demands of medical device companies Rhythmlink and Nephron Pharmaceuticals.

    “You’ve seen the map, right? Of the 700 life science companies? The kids just don’t know,” she told GSA Business Report, adding that it’s the job of SCBIO and its partners to share the story of the state’s abundance of life science firms and manufacturers.

    Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise Tri-County Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation.

    “And really surprisingly, it's not really geared toward the sciences as much as it's geared toward control, like how to control processes and design, and also there's a lot of statistics involved with showing proof that you're adhering to specific specifications that you've set,” Shalaby said. “So basically the course outline that we set up with Tri-County is to give them exposure to those sorts of things.”

    Tri-County instructors will teach company and industry requirements, he said, and help create a workforce pipeline to Poly-med, Arthrex and Abbott.

    “Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.”

    The course would help prime students for employment at partnering industries like Poly-med, and Ford foresees a potential apprenticeship route on a case-by-case basis. SCBIO has been in conversation with Apprenticeship Carolina’s Carla Whitlock on those possibilities.

    In the meantime, Ford encouraged other industry voices interested in contributing to the program through input or partnership to get in touch and jump on board.

    “Reach out to us,” she said. “Reach out to me and SCBIO, because the more industry that we can have involved in these programs, the more successful it will be.”

  • sam patrick posted an article
    Validated platform with clinically actionable results creates real possibilities to improve care see more

    Validated platform with clinically actionable results creates real possibilities to improve care for glioblastoma (GBM) and other high-grade glioma patients

     

    GREENVILLE, S.C. – June 17, 2021 – KIYATEC, Inc. announced today the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients. The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

    A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict™ Glioma assay.

    The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

    KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

    Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

    “Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment,” said Matthew Gevaert, PhD, CEO of KIYATEC.

    Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

    About KIYATEC
    KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection. 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.

  • sam patrick posted an article
    SCBIO, business community shaping curriculato grow life sciences careers see more

    Compliments of GSA Business and SCBIZ

    South Carolina’s life science sector creates twice as many jobs as the average of all other sectors in the state economy, according to a recent study, but whether it can fill those positions is another matter — especially in the manufacturing and logistics side of the house.

    The life science fields are struggling to fill positions in the fast-growing sector. (Photo/Provided)

    “It has historically been the majority of the time that you find a qualified person, they already have a job in M&L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company that serves the manufacturing sector. Turner is also a former staffing professional.

     He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field.

    “All I’ve heard since the pandemic is [that] it has been hard to even find available people, much less available and qualified people,” he said.

    This gap is even more prominent in a life science field that sometimes requires more than the standard specialization or training. And to add insult to injury, few in-school training programs target this unique brand of manufacturing and logistics, said SCBIO interim CEO Erin Ford.

    “The life sciences encompasses so many aspects from medical devices to pharmaceutical research and development to logistics in getting the drugs or pharmaceuticals or medical devices to where they need to be,” she said. “There's just so many aspects to the life sciences. And we really, as a state, have not focused on having any specific curriculum or programs that are specialized in this area.”

    She argued that while the traditional medical careers such as nursing fall under the Life Science umbrella, industrial aspects of the sector often get overlooked in the classroom.

    “It’s just not even a part of the discussion as to what career you want to have,” Ford said.

    Arthrex and Tri-County Tech have had an existing apprenticeship partnership since 2020. (Photo/Provided)

    Since the economic development organization formed its Workforce Development Taskforce a few years ago, its more than 300 members have aimed to do something about that.

    She hopes that 2021 (or early 2022) will be the year she can see their work come to fruition through a curriculum pilot geared toward two-year students in South Carolina’s technical college network.

    Students upon learning about the field may often feel intimidated by the math or science components attached to a traditional science, technology, engineering and math field, she said, but really it’s the requirements of working in a clean room in the medical device field that can prove to be the most challenging.

    And that is the gap Ford hopes the program will fill.

    So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, she said, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field.

    “We don't want to reinvent the wheel,” Ford said. “That's why we're working with a lot of the partners to add in more substance for life sciences. So if we see that there is more for us to do, we will definitely take that on.”

    Life science companies in each region have already offered up some input to their needs and will continue to do so once the program launches: Trident Technical College has its ear to the ground for workforce demands of AlcamiCharles River Labs and Vikor Scientific while Tri-County Technical College is partnering with ArthrexAbbott Laboratories and Poly-MedMidlands Tech has an open channel to the demands of medical device companies Rhythmlink and Nephron Pharmaceuticals.

    “You’ve seen the map, right? Of the 700 life science companies? The kids just don’t know,” she told GSA Business Report, adding that it’s the job of SCBIO and its partners to share the story of the state’s abundance of life science firms and manufacturers.

    Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise Tri-County Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation.

    “And really surprisingly, it's not really geared toward the sciences as much as it's geared toward control, like how to control processes and design, and also there's a lot of statistics involved with showing proof that you're adhering to specific specifications that you've set,” Shalaby said. “So basically the course outline that we set up with Tri-County is to give them exposure to those sorts of things.”

    Tri-County instructors will teach company and industry requirements, he said, and help create a workforce pipeline to Poly-med, Arthrex and Abbott.

    “Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.”

    The course would help prime students for employment at partnering industries like Poly-med, and Ford foresees a potential apprenticeship route on a case-by-case basis. SCBIO has been in conversation with Apprenticeship Carolina’s Carla Whitlock on those possibilities.

    In the meantime, Ford encouraged other industry voices interested in contributing to the program through input or partnership to get in touch and jump on board.

    “Reach out to us,” she said. “Reach out to me and SCBIO, because the more industry that we can have involved in these programs, the more successful it will be.”