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  • 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
    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.”

  • sam patrick posted an article
    Nephron's Lou Kennedy on building a career while building up people see more

    Compliments of Columbia Regional Business Report

    The executive who strides into her expansive office may have come a long way from the Fulton County government building where she once stood in line to get her water service turned back on, but Lou Kennedy remains the same Lexington County product, rooted in hard work and family, that other S.C. businesses leaders say they have known for decades.

    The national spotlight has recently shone on Kennedy, owner and CEO of West Columbia-based Nephron Pharmaceuticals Corp., as a program she created to help teachers earn extra cash was featured on NBC News while her on-premise lab has churned out respiratory drugs during the COVID-19 pandemic and processed tests for the community. But those who have known her the longest say that, along a career path that wound through Georgia and Florida before circling back to her hometown, Kennedy has never changed who she is.

    “Lou has always been a dynamo,” said Sam Konduros, the former CEO of SCBIO who recently became president and CEO of a new health innovation division at Charleston-based Vikor Scientific. “Her mother taught me first grade. We actually met when we were six years old at Seven Oaks Elementary School in Columbia and have known each other ever since.”

    With a July birthday three days before Kennedy’s, Konduros shares both her Zodiac sign of Cancer and her love for the water.

    “She says Cancers are water babies and that’s why we both love swimming, boating and being at the lake all the time,” Konduros said. “I’ve said there is not one passive bone in Lou’s body, and that’s the truth. She is very action-oriented, and very results-driven.

    “I love that about her, but the fact is, she is so much fun to be around, too, just a great personality and zest for life.”

    Kim Wilkerson, president of South Carolina for Bank of America, grew up “caddywampus backdoor neighbors” with Kennedy in the Cayce subdivision of Edenwood, home to many families with members employed by Eastman Chemical Co., where Kennedy’s father worked for 44 years.

    “Our daddies worked together at Eastman back when we were little girls,” said Wilkerson, who is five years Kennedy’s senior. “I’ve known Lou literally just about her whole life. … She is just a very genuine person. What you see with Lou is absolutely what you get.”

    Although Kennedy has led Nephron since 2007, there are still those who are surprised by what they see when she walks into a room, ever-present high heels clicking.

    “If they haven’t seen a picture of me — now it’s better, because you have social media — they’re going to assume Lou’s a man,” Kennedy said. “You call always tell: ‘Oh, we’re waiting on Lou Kennedy.’ ‘Hi, I’m Lou Kennedy.’ ”

    Kennedy has also encountered those who know who she is but have a faulty perception of how she came to be where she is. She said she still deals with folks who think her success is from her husband, Bill Kennedy, a fellow University of South Carolina graduate who in 1997 founded Nephron, a producer and manufacturer of generic respiratory medication that relocated from Orlando, Fla., to Lexington County in 2017.

    “That happens to this day,” she said. “If you spend about half a day around here, you’ll see that that’s not the case. My husband and I are 20 years difference in age. He has a pharmacy degree. I have a journalism degree. So one would think that I got a kind of free ride onto his coattails. But what you have to know is he doesn’t like daily execution. He likes business, five and 10 years (out) and what’s going to be the goal for this profitability or the pricing mechanism. He doesn’t want to know what goes on to make the sausage. He wants to talk about who’s the buyer of the sausage, what’s the contractual price, those kinds of things.

    “Once you spend some time around us, which has happened with our bankers, which has happened with the lawyers — they know now that they’re going to face Bill for this kind of question, and they’re going to face me for what goes on around here.”

    Long road home

    Kennedy left Lexington County after college in search of bigger things on a journey that took her to Atlanta and Houston, among other places, and through difficult life experiences that proved invaluable.

    “I had two failed marriages. The father of my child, the second ex-husband, was an addict, and it was a really, really tough life,” Kennedy said. “He did a lot to ruin my credit, a lot to make life hard for me, but I’m forever grateful, because when you have to live with an addict, you learn a lot about the field of psychology. How not to set them off, how not to cause this to happen, how not to have the house come tumbling down, how to keep the creditors from evicting you. These are skills in my little middle-class wonderful upbringing that I never thought I’d have to have. But I swear I benefit. I can see bull---- from 40 miles off. I can spot a con artist, a liar.

    “I got my daughter from that. I’m never regretful, because many of the skills that serve me well today came out of those rough eight to 10 years.”

    As she got back on her feet, Kennedy, with a background in marketing, worked three jobs, including a stint as a house painter with daughter Xanna often in tow.

    “She’d sit, on the weekends, underneath me on a ladder,” Kennedy said. “I had all these Little Golden Books for her to try and read to keep her occupied so I could make enough to keep our lights on. I had this little blond mouth to feed. You just figure it out.”

    Visting South Carolina for a girlfriend’s shower, Kennedy was talked into meeting someone, a friend of her friend’s brother-in-law, who had also gone through a divorce. The girlfriend’s selling point to her? “ ‘We think you might at least finally have somebody who could afford to pay for the date,’ ” Kennedy said.

    After spilling a glass of wine on her, Bill Kennedy told her what he did for a living. Xanna took one of the respiratory drugs, albuterol, manufactured by Nephron, and Kennedy’s interest was piqued. She peppered her new acquaintance with questions about his business, learning he had three customers.

    “I met him 10 minutes before this, and I said, ‘Don’t you think you ought to diversify? Three customers. Aren’t you a little concerned?’ ” Kennedy said. “And that’s how this whole thing started.”

    The personal partnership became professional when Kennedy joined Nephron in 2001. As the Kennedys were contemplating a Nephron expansion in Florida, Lou Kennedy reached out to an old friend with economic development connections at the S.C. Department of Commerce.

    “She called on a day that she was a little frustrated and said, ‘You know, I really think it’s time for us to look at South Carolina to diversify where our company is going,’ ” Konduros said. “I ended up looping her in with the Department of Commerce leadership, and the rest is kind of history. Not only did they diversify to South Carolina, they ended up bringing the entire company, and here we are, several years later, with over 2,000 employees and a huge expansion.”

    Work on Nephron’s $215.8 million expansion of its Saxe-Gotha Industrial Park campus, announced last July and projected to increase its workforce by 380 workers, is nearing completion. The project was the fourth-most lucrative capital investment secured by the state in 2020 and the latest in a line of Nephron initiatives that have boosted the state and area economy.

    The Kennedy Pharmacy Innovation Center in the University of South Carolina’s College of Pharmacy was established by a $30 million gift announced in 2010, the biggest splash in a long-time partnership between the Kennedys and their alma mater that has also included a donation to the Pastides Alumni Center. During the height of the COVID-19 pandemic, the company also donated more than 100,000 bottles of company-made hand sanitizer to the university.

    “There’s a reason that people call her Cockadoodle Lou,” said Wes Hickman, CEO of the University of South Carolina Alumni Association. “She is one of the biggest fans and supporters of our institution, and the generosity she and Bill have shown the university and the alumni association in particular have made a real difference. … Beyond the financial support, it’s her engagement and her willingness to share ideas, to participate in events, and to help drive innovation.”

    Nephron has also donated its hand sanitizer to the Dorn Veterans Affairs Medical Center, partnered with Clemson University to develop rapid robotic drug processing and has donated welding equipment to programs at Orangeburg-Calhoun Technical College. The company also partnered with Dominion Energy to transform Dominion-owned land off Interstate 77 near Nephron’s campus into a drive-through COVID vaccination site that was inoculating up to 150 people per day in February.

    Wilkerson pointed to that initiative as an example of how Kennedy gets things done — and fast.

    “She is a real difference-maker,” Wilkerson said. “She’s a dot connector, an outside-the-box thinker, (and) because she is such an outside-the-box thinker, she is able to make things happen so quickly. She looks for ways to collaborate with others to make a difference for the greater good. … Her Lexington County roots really have paid off for us here in the Midlands.”

    ‘Lift as you climb’

    For Meghan Hickman, like many Midlands professionals, Kennedy’s reputation proceeded her. 

    “I remember hearing stories of Lou before I actually got to meet her,” said Hickman, executive director of nonprofit economic development organization EngenuitySC who has worked with Kennedy on initiatives to improve the Midlands’ competitiveness and livability. “The story I kept hearing was that she was boundless energy and would take these men on tours of this facility in high heels and outwalk all of them. I was like, ‘I don’t know who this woman is, but I want to meet her.’ ”

    The reality exceeded the expectation.

    “She’s one of those personalities that has a way of magnifying any room she’s in,” Hickman said. “When she’s around, you know it. When she’s participating, she wants to be relevant. She wants to play a role. She doesn’t give anything just half of who she is. … One of the things that I love the most about Lou is her unabashed candor. She is honest to a fault, and I love watching the way that she will say what’s on her mind and on her heart in a room without any fear of how it will land or without fear of repercussion. I love that bravery.”

    That freedom stems from success in putting principals into practice. Nephron, a certified woman-owned business as recognized by the National Women Business Owner Corp., employees a workforce that is 44% female and is offering a diversity internship program this summer.

    Kennedy believes in such efforts because she has seen what they produce. At the height of the pandemic in March 2020, Nephron’s monthly production of inhalation solutions increased 141% from 80 million doses shipped to 193 million. And while demand has since subsided, Nephron is still operating all 12 of its production lines while adding new packaging lines.

    The company is also in talks with two potential vaccine partners to help produce pre-filled sterile syringes and are part of the company’s booming 503B Outsourcing Facility arm that supplies hospitals nationwide and is newly supported by the 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that is part of its expansion.

    Such results give Kennedy confidence in her methods.  

    “After this many years as the lone female in the room, I feel like it’s really the right person for the job,” Kennedy said. “It’s not my problem to get you to accept that I’m the right person for the job. That’s your problem. If I’m putting numbers on paper and we’re productive and we do the things that we promise patients we’re going to do, then haven’t I already proven that I’m the right person for the job? You can respect me or not. That’s not my problem anymore. That’s yours.”

    These days, respect for Kennedy is not in short supply. Elected to the National Association of Manufacturers board of directors in March, Kennedy is chair of the SCBIO board, a position she has also held for the S.C. Chamber of Commerce. Awards line the shelves of her office, and she’s particularly proud of a recent honor: In March, Lou and Bill Kennedy were recognized with the 2021 Townes Award from the S.C. Governor’s School for Science and Mathematics.

    The award is named for S.C. native Dr. Charles Townes, whose pioneering research into lasers earned him both the Nobel and Templeton prizes. Kennedy especially appreciates the honor’s focus on encouraging STEM education.

    “Much as I love my journalism degree, I really wish I’d have stepped out on a limb, taken an extra three hours of some sort of science other than a geology class,” she said. “I do regret not taking high school chemistry. I’m always telling kids, even if you make a C, learn it. Just go learn it.”

    Journalism did afford Kennedy one of her first mentors: Mary Caldwell, a journalism professor of Kennedy’s for whom the University of South Carolina’s School of Journalism and Mass Communications’ excellence in teaching award is named.

    “She had a snappy briefcase, and in the 80s, you still carried briefcases,” Kennedy said. “She whisked in there and she, just like me, loved to wear heels. She’d come into class and she had a blazer, she had a snappy briefcase and some heels, and she had worked in Atlanta in a giant PR firm, and that to me seemed like an episode of Mad Men from my little seat in Lexington County. Atlanta, New York, Madison Avenue — it all seemed like big potatoes to me. She would look at me and say, ‘’You can do anything you want to do. You just have to work hard enough.’ ”

    And Kennedy believes hard work has given her a different kind of knowledge.

    “I definitely think there is a value to a female in a leadership role with the focus on emotional intelligence,” she said. “Forget the academic IQ of it. I mean emotional intelligence. Are the people ready for a bold statement? Do you need to couch something? I just believe the communication skills that most women utilize when they’re working on any project serve us well.”

    Some of those professional skills were borne out of personal hardships, Kennedy said.

    “When you have to struggle as a single mom to put food on the table, pay for gas, pay the rent, pay the light bill — forget having cable; that was too much of a luxury — all of that makes you cognizant of how to look toward a leaner operation,” she said.  “And when you live with a spouse that has a lot of issues, it teaches you about reading people. … I’m telling you. I feel like it’s a life experience Ph.D. in psychology is what I’ve obtained, based on my experiences.

    “It’s not an academic Ph.D.; it’s a lifetime wear and tear.”

    A product of those life lessons is a phrase that Wilkerson, Hickman and other women who’ve worked with Kennedy use: Lift as you climb.

    “We get into a place and we send the elevator back down to pick others up and bring them with us,” Wilkerson said. “This idea of lifting as you climb, for Lou and for me, is very, very real. It’s just a part of how we think.

    “We are both in unique positions of being able to help young women see what’s possible.”

    Echoed Hickman: “Particularly with females, for a long time, opportunities that came along to lead were so few and far between that you fiercely protected those opportunities. It’s almost like, for women in leadership, there was a scarcity mindset that defined what it meant to be a leader, as opposed to this abundance mindset. … With Lou, there’s such an abundance mindset.

    “It doesn’t matter whether she’s working in her business or she’s working in the community. There is no such thing as scarcity. There is abundant opportunity.”

    Contributing to her hometown, in an office “which, as the crow flies, is right through the woods” from Eastman Park, where her family picnicked in facilities maintained by her father, makes extending those opportunities all the more meaningful for Kennedy.

    “You walk around here and there are people that actually worked with my daddy in the first part of their career, so that feels really good,” Kennedy said. “It feels good to do that in South Carolina. I had said I was never coming back. I left for 35 years, and to come home and provide jobs is way more meaningful than doing it in Orlando, Florida.”

    With a lineage from the Tennessee mountains that includes a Baptist preacher grandfather and tobacco-farming relatives, Kennedy saw that attitude exemplified by her parents, Nancy and Jerry Wood. Kennedy’s mother signed her up for gymnastics classes so she could be better prepared for cheerleading tryouts and “expected perfection in all things,” Kennedy said. “She would probably argue that she didn’t, but she did … My dad’s the greatest man ever. He can just do anything, fix anything. He could patch a cheerleader uniform. He could sew. He can do all these things. So I guess maybe I’ve always aspired to try and be half as useful.”

    Kennedy is proud of what she’s been able to give back to her community and pleased when employees, especially women, chose science careers after working at Nephron. And while she’s quick to show off pictures of new grandson Lincoln, Kennedy laughs at the idea of contemplating her legacy right now.

    “Are you kidding me?” she said. “I’m more focused on what isn’t right than that.”

  • sam patrick posted an article
    Multi-year plan designed to help drive growth of industry across Palmetto State see more

    SCBIO CEO Erin Ford only has to look at recent history to understand the opportunity in front of South Carolina life sciences.

    Life sciences has a $12+ billion economic impact in the Palmetto State, with more than 700 firms involved and over 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental, and agricultural biotechnology products. 

    It represents a significant economic development focus for the state, with strong life science recruiting initiatives led by the South Carolina Department of Commerce and regional economic development teams – so much so that  Governor McMaster recently issued an Executive Order to emphasize the industry in domestic and international recruiting efforts.

    Now armed with the industry’s third multi-year Strategic Plan to build, advance, innovate and grow the industry, Ms. Ford sees an opportunity to “take South Carolina life sciences to an entirely new level” over the next handful of years, she said as SCBIO published the 2021-2022 Life Sciences Strategic Plan recently.

    Ms. Ford is no stranger to leading the industry.  Since taking over as interim CEO for the departed Sam Konduros just weeks ago, she has expanded emphasis on investor relations and existing industry support strategies, the spearheading of integrated marketing initiatives, implementation of the new SCBIO innovation platform, and a strong emphasis on economic development initiatives – from an industrywide presence at this week’s PGA Tournament at Kiawah to next month’s BIO Global conference and the Fall MEDICA event in Germany.

    Guided by the new Strategic Plan, which spans 24 months and continues the vision of the last two editions, SCBIO and SC life sciences are clearly focused on doing “the right things to continue to build, advance, innovate and grow” the multifaceted industry.

    SC Life Sciences 2021-2022 Strategic Plan is shaped by input from SCBIO’s Board of Directors and dozens of contributors from industry, higher education, economic development, government and supporting organizations and authored by the SCBIO team.  The 70-page document includes detailed sections on the COVID Effect on the industry, 2020 Highlights, documentation of the breadth and depth of the Industry Segments in the state, Priority Initiatives, and specific Objectives, Plans and Budgets to advance life sciences.

    A shorter summarized version is available to media and business leaders interested in learning more about the fastest-growing industry in South Carolina, as documented recently by Dr. Joseph Von Nessen, economist with the Moore School of Business at the University of South Carolina.  To request a copy, interested persons should email info@scbio.org.

    South Carolina life sciences has seen a near-doubling of firms and 40% increase in life sciences’ direct employment since 2017 alone, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Von Nessen, state research economist and a noted economic development expert.  It also has companies in 42 of 46 counties – a far greater penetration than most major industries possess.

    The 2021-2022 plan seeks to continue the growth strategies of the industry evident over the last four years during which Ms. Ford served as EVP/COO prior to assuming the interim role of CEO.  During those four years, SCBIO has more than doubled membership and quadrupled revenues, implemented a strong economic development focus, and launched a new innovation platform.  It expanded its role as the voice of the life sciences industry, implemented a surging workforce development initiative and created ongoing programs to encourage participation by women in life sciences, to support diversity-equity-inclusion initiatives and to encourage student participation in the industry.  The organization also successfully led industry and organizational pivots during the COVID pandemic.

    “Prior SC life sciences plans have  performed admirably in helping South Carolina raise its profile as an emerging leader in the life sciences,” said Ms. Ford. “Our innovative companies and exceptional workforce are drivers in strengthening this industry, and we know that the life sciences will continue to play a critically important role in our state’s economic success.  We intend to build on our Board’s and team’s vision to continue this momentum and to build, advance and grow life sciences in our state.”

  • sam patrick posted an article
    South Carolina featured in JD Supra article see more

    South Carolina has long been known for its colorful history, beautiful beaches and vibrant tourist industry.  In recent decades, it has also come to be well known for its high-tech manufacturing with the likes of BMW, Boeing, Honda, Michelin, Samsung and Volvo, all locating large manufacturing facilities throughout the State. What you might not know is that South Carolina is also home to another rapidly growing high-tech industry—the Life Sciences industry.

    The term Life Sciences is generally used to include companies in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, and biomedical devices. The Life Sciences industry also includes organizations and institutions that devote the majority of their efforts in the various stages of research, development, technology transfer and commercialization, as well as the companies who support these entities.

    According to SCBIO, the trade association which represents the Life Sciences industry in South Carolina, there are over 700 companies and businesses actively engaged in the Life Sciences industry in South Carolina and at least one Life Sciences organization is located in 42 of the State’s 46 counties. The economic impact of the Life Sciences industry is approaching $12 billion per year and is continuing to increase, according to a recent study. It is also estimated that the Life Sciences industry has created over 40,000 high paying jobs in South Carolina over the last several years, with an average annual salary of over $70,000.

    The Life Sciences industry in South Carolina is very diverse.  It includes companies ranging from small startups focusing on developing new technology like Okra Medical, to a unique genetic clinical and research institution like Greenwood Genetic Center, which has been serving the State for decades, to large established companies like Nephron Pharmaceuticals. Nephron is a pharmaceutical manufacturer and cGMP compliant 503(B) Outsourcing facility, and a global leader in the manufacture of generic respiratory medication that has rapidly expanded its manufacturing capacity and services over the last seven years. Nephron is owned and led by Lou Kennedy, whose vision and leadership have spurred the Company’s growth and success and have also made her one of the State’s most important business leaders, as well as an important thought leader in the Life Sciences industry.

    South Carolina is a pro-business state that has worked diligently to attract large companies looking for a friendlier business climate from a tax and regulatory perspective. An additional driver for the growth of the Life Sciences industry is the existing ecosystem for Life Sciences, which is supported by the State’s three major research universities: University of South Carolina, Medical University of South Carolina and Clemson University as well as over ten additional universities and colleges in the State - from Furman University with its innovation program and nationally recognized chemistry department, to Newberry College launching new curriculum and a degree focused on pharmaceutical manufacturing. These universities and colleges further validate the increasing depth of the existing ecosystem and the positive impact it will have on strengthening the talent pool available to the Life Sciences industry. Other factors contributing towards this growth are the efforts of the South Carolina Department of Commerce and the South Carolina Research Authority, the strong system of hospitals and health care systems within the State, the support of various economic development alliances, the State’s expanding technical college system, the support of elected officials and the growth and leadership of SCBIO over the last several years.

    SCBIO has spearheaded a series of joint private / public initiatives to promote the growth of the Life Sciences industry in South Carolina. These efforts include promoting statewide economic development strategies to attract Life Sciences companies to locate or relocate in South Carolina and consistently promoting and strengthening the existing ecosystem which allows established South Carolina Life Sciences organizations to collaborate, grow and flourish. In addition to its economic development efforts, SCBIO has integrated its efforts with the broader mission to transform and positively impact healthcare as evidenced by its unique alliances forged with the South Carolina Hospital Association, several large health systems and large payers like Blue Cross Blue Shield of South Carolina.  For the past four years, SCBIO has been led by its CEO, Sam Konduros. Konduros has experience with economic development, operations of Life Sciences companies, developing start-up companies and most importantly—developing and implementing an ambitious strategic plan for the Life Sciences industry. During his time at SCBIO, Konduros has assembled a talented team.  His vision and energy have fueled a rapid growth in membership and engagement and an increased in awareness and support for the Life Sciences industry across the State. Under his leadership, SCBIO significantly expanded its membership and quadrupled its revenues, while at the same time establishing itself as a powerful force for economic development and creating a new platform for Life Sciences companies to collaborate on innovations and research. Earlier this month, Konduros announced his departure from SCBIO to serve on the Board of Vikor Scientific, another successful company within the Life Sciences space in South Carolina that is rapidly expanding. He will also serve as CEO of a new health innovation company powered by artificial intelligence (AI) and blockchain technologies focusing on science personalized medicine strategies that will be a part of Vikor Scientific’s expanding portfolio of companies. SCBIO is conducting a national search for Konduros’ replacement and there is no doubt that the association and its members will continue to benefit from the momentum created over the last four years as it continues to push the Life Sciences industry forward.

    The global COVID-19 pandemic presented a profound challenge to the Life Sciences industry as it disrupted the way business was conducted. The Life Sciences industry in South Carolina stepped up to these challenges and turned them into opportunities. Many Life Sciences companies pivoted from their existing strategic plans to address the needs of the State and Nation by providing assistance in key areas that became critical during the pandemic. Companies like Nephron Pharmaceuticals, Vikor Scientific, KIYATEC, Premier Medical Lab Services and others offered much needed expanded COVID-19 testing services inside and outside South Carolina. Others such as ZVerse, a digital manufacturing company, modified its business model to become one of the largest producers of reusable face shields for use during the pandemic and beyond. Over the last 12 months, they have produced millions of these reusable facemasks and have been recognized throughout the country for their efforts. Rhythmlink International, a medical device leader, donated thousands of masks and personal protective equipment (PPE) to hospitals and other healthcare providers across South Carolina.  In addition, Milliken & Company boosted its production of biosmart fabrics used in scrubs and lab coats, which uses chlorine bleach-activated technology and molecular engineering to kill up to 99.9% of the bacteria and viruses it touches. Headquartered in Greenville, Vitalink Research was selected by Moderna to run its Phase III vaccine clinical trial, demonstrating national confidence in Life Sciences research operations in South Carolina. These are just a few examples of how South Carolina Life Sciences companies responded to the challenges of the COVID-19 pandemic and highlight why the Life Sciences industry is one of the fastest growing segments of South Carolina’s economy.

    The future of the Life Sciences industry is bright in South Carolina.  South Carolina has become an attractive place to develop and expand Life Sciences companies and there is great leadership within these companies. The rapid growth of Life Sciences is becoming more apparent to the public and media. In February 2021, Governor McMaster proclaimed February 15-19 as South Carolina Life Sciences Week in the Palmetto State.  Our Life Sciences companies are leading the discussions of how to bring more Life Sciences manufacturing back to the U.S, including to South Carolina, and how to develop a domestic source of PPE and other parts of the supply chain. There is also increased collaboration on leveraging increased use of technology like telehealth and digital health to deliver health care services to rural and less developed areas using technology developed and perfected in South Carolina. SCBIO is also leading an effort to expand and improve the workforce to support Life Sciences companies.  All signs point to a very bright future for the Life Sciences industry and South Carolina is just beginning to see the benefits of this growth and development.

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  • sam patrick posted an article
    New Jersey firm expands into South Carolina see more

    Courtesy of Charleston Regional Business Journal

    A biopharmaceutical company has opened a Goose Creek facility as part of its goal to establish 10 or more collection centers around the country by 2024, the company said in a news release..

    New Jersey-based ADMA Biologics Inc. is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics.

    Adam Grossman, president and CEO, said South Carolina and Gov. Henry McMaster expressed strong support for opening the new facility.

     “The state’s impressive infrastructure and skilled workforce create a terrific foundation for ADMA to safely collect and process plasma, and we look forward to continuing to grow our operations in the state now and in the coming years,” he said in a statement.

    McMaster was on hand April 23 for a ribbon cutting ceremony, which Grossman said helped create an even stronger beginning for the company.

    Beneath the corporate umbrella, ADMA has seven plasma collection facilities at various stages of approval and development. The Lowcountry plasma center, located at 214 Saint James Ave., is the newest and is projected to need up to 50 health care workers at full capacity.

    “Securing raw material plasma supply has never been more important than it is today, and we believe the series of recent acquisitions of plasma collection facilities validates this scarcity value,” Grossman said.

    The Goose Creek center includes automated registration, high-tech collection equipment designed to shorten the donation process, free WiFi and individual flat-screen TVs at each donor station and trained, certified staff.

    The company is on track to achieve its 2024 goal and Grossman said the expansion will support ADMA’s goal of producing “quarter-over-quarter revenue growth throughout 2021 and beyond.” The Goose Creek operations also will help ADAM create a fully integrated and self-sufficient plasma supply chain, ensure continuity of product supply and generate asset value for shareholders, the company said.

    ADMA plans to file an application for a biologics license and anticipates a standard 12-month BLA review period by the Food and Drug Administration.

    Until then, ADMA is allowed to collect plasma donations on site. Following the FDA’s approval, the company can then use the collections for further use in the manufacturing of life-saving therapies.  

  • sam patrick posted an article
    SCBIO, 3 life sciences companies highlighted in media reports see more

    Courtesy Greenville News/Gannett

    As the distribution of COVID-19 vaccines have ramped up in recent weeks, life science firms in South Carolina have pivoted to play a role in the vaccination campaign.

    After weeks of only 60,000 dose allocations in January, that figure has doubled with over 130,000 first doses expected to arrive in South Carolina this week.

    The brands are well known — Pfizer, Moderna, Johnson & Johnson — but lesser known companies have played a role in the clinical trials and ancillary supplies critical to the rollout of the vaccine and some are found in the Palmetto State.

    Gov. Henry McMaster celebrated SCBIO, a life sciences non-profit, and the industry in February for their great year. Part of that success was in response to COVID-19.

    "While 2020 will forever be remembered as the year of an unmerciful global pandemic, our stakeholders heroically rose to the challenge," Sam Konduros, SCBIO's president and CEO, wrote in the non-profit's 2020 report.

    SCBIO and over 100 industry firms supported pandemic efforts such as distribution of personal protective equipment — which includes creating an online PPE exchange portal — creation of a jobs portal, testing and promoted proper mask use on social media.

    That list now includes COVID-19 vaccines research and packaging, and potentially its production.

     

    Clinical trials vital to vaccine development

    The Moderna vaccine was authorized for emergency use on Dec. 18 after clinical trials proved its effectiveness and safety. VitaLink, a Greenville based research company, played an important role in Moderna's phase 3 trials.

    South Carolina had four Moderna phase 3 clinical trial locations out of the nearly 100 locations around the country. Three trial locations — Anderson, Greenville and Spartanburg — were conducted by VitaLink Research, a South Carolina based research company which specializes in respiratory medicine.

    "It really was just a natural fit for us," Steve Clemons, VitaLink's CEO and president, said.

    Clemons expected roughly 400 participants through the three sites but the Upstate had roughly 1,200 of the 30,000 enrolled participants nationwide.

    "There should be an awful lot of pride to the Upstate because, frankly, we as VitaLink couldn't have done this without the volunteers," Clemons said.

    Participants were enrolled in the summer and either received the drug or a placebo.

    One of these participants was George Acker who has learned since talking with The News in November that he got the placebo — to his surprise.

    The studies were unblinded in January and those who received the placebo were able to get the real vaccine.

    Acker has received both shots since then.

    VitaLink continues to conduct monthly follow-ups with participants for two years to track side effects, safety and efficacy of the vaccine.

    Nearly 400,000 doses of the Moderna COVID-19 vaccine have been administered in South Carolina in the last three months.

    The Moderna product has played a vital role in vaccinating long-term care facility residents and staff as initial allocations were given to these populations.

    Clemons is proud that VitaLink has played a part in the solution to the pandemic but also in their work in general.

    "I get to treat people every day using, kind of, tomorrow's therapies," Clemons said. "And I get paid to do it and patients never get billed."

     

    Packaging of Pfizer vaccines

    The Pfizer-BioNTech vaccine requires ultra cold storage, around minus 70 degrees Celsius. This makes shipment a little more challenging but a local packaging company had the solution.

    Softbox Systems, a British company with North America headquarters in Greenville, has over two decades of thermal shipping experience.

    They supply ultra-cold temperature shippers which keep vaccines between minus 90 and minus 60 degrees Celsius for at least ten days unopened with the use of dry ice and insulation. If managed well, these reusable containers can store vaccines for about a month by re-icing the dry ice.

    "[Softbox] immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine," Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, said in a March 10 press release. "And quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.”

    One of two manufacturing centers supporting the vaccine distribution is located in Greenville, the other is in the Netherlands.

    "Our Americas headquarters in Greenville features a full qualification testing lab, product engineering capabilities, and a world-class team," John Hammes, Softbox's general manager of the Americas, said. "All of which helped us support Pfizer in the fight against COVID and develop a way to successfully distribute a vaccine to support the global community."

     

    Vaccines could soon be filled in the Lowcountry

    Lou Kennedy didn't expect on her company would be filling vaccines, but she also didn't plan on the pandemic — no one did.

    In addition to helping with COVID-19 testing efforts, she thought Nephron Pharmaceuticals could take it a step further and help with the vaccinations.

    "We have the type of equipment already in our possession, we will have it retooled," Kennedy said. "We'll build a wing and it is our sincere desire to find a vaccine partner — like Moderna, Pfizer or Johnson & Johnson — and say, let us fill some of the capacity that the American patient needs."

    The Lexington County-based company is currently undergoing a $215 million expansions which includes a 110,000 square foot vaccine production space. Kennedy expects at least 380 new jobs with the expansion.

    About 300 of those could be centered around the vaccine production and she hopes to partner with a COVID-19 vaccine manufacturer to fill vaccines and help ramp up vaccine supply.

    Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson, or it could be another brand who could receive authorization in the U.S., Kennedy said.

    "Between now and the time we move in there, there could be 10 new ones, so we're keeping our eyes and ears open," Kennedy said.

    They've already hired about half the people they need. The building is still being worked on but once it's completed, Kennedy believes the production lines could be operational by the summer.

    The expansion, originally announced in July, will also include a new office, a new warehouse, expanded secondary packaging operations and a 20,000 square foot machine shop.

    In the meantime, Nephron Pharmaceuticals already partnered with Dominion Energy to set up a drive-thru vaccination site in Lexington County in February.

    "I had this idea that why can't we help the vaccination," Kennedy said. "We have nurses on staff and we have [doctors of pharmacy]."

    Dominion Energy provided the space and set up a temporary power pole for Nephron's nurses and staff. They also enlisted the help of Rick Lee, a Department of Environmental Control board member from Rock Hill, on how to best setup a drive-thru clinic.

    Like health systems across the state, Nephron is running this clinic out of their own pocket. Vaccines and ancillary supplies are supplied by the government, but staff and other costs are not.

    "We're not getting reimbursed for any of this," Kennedy said. "We're doing this out of the bottom of our heart."

    The drive-thru site has ramped up from about 30 vaccinations per day when it first opened to about 150 vaccinations per day by March. Kennedy hopes to get this up to 300 per day.

  • sam patrick posted an article
    Rockwell to lead growth strategy at PAI see more

    Pharmaceutical Associates, Inc. (PAI) today announced the appointment of Brandon Rockwell as Chief Operating Officer, bringing 15 years of business development experience to the company. In his new role, Rockwell will oversee PAI’s growth strategy, further solidifying the company’s position as the number one manufacturer of quality liquid pharmaceuticals in the US.

    Rockwell has led teams in business development and strategy, portfolio management, and project management for nearly 15 years, most recently as Senior Vice President of Business Development and Strategy for Endo, where he was responsible for the generic, hospital, and branded divisions. Prior to that, he worked for Par Pharmaceutical where he led the Business Development and Licensing function. In this role, he helped shape the strategic direction of the company through its acquisitions of Edict, Anchen, JHP and the integration between Qualitest and Par.

    Under Rockwell’s tutelage, PAI will implement more advanced strategies and continue to revolutionize the space of unit dose medicine and liquid pharmaceuticals so they can meet the ever-growing number of healthcare facilities that PAI serves.

    For more information about Pharmaceutical Associates Inc., please visit www.paipharma.com.

     

    About Pharmaceutical Associates, Inc.

    Among North America’s leaders in quality, safety, and productivity, Pharmaceutical Associates Inc. (PAI) manufactures and markets generic liquid pharmaceuticals. PAI has been at the forefront of producing better-targeted suspensions, oral solutions, elixirs, syrups, and liquids for nearly 50 years. To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities, and government agencies, PAI offers standard bottle packaging and ready-to-dispense packaging. In fact, PAI was the first independent manufacturer to develop vertically integrated unit-dose (UD) packaging and the first to offer complete lines of hard-to-find liquid products in both out-patient and UD packaging.