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business of life sciences

  • sam patrick posted an article
    Predictive platform expansion into immunotherapy testing a boon for pharma see more

    KIYATEC, Inc. today announced that research published in the March 2021 Cancer Immunology, Immunotherapy journal solidifies the foundation to characterize predictive accuracy in immune-oncology. By using a patient’s own tumor cells and infiltrating immune cells to model patient-specific biological complexity, KIYATEC’s platform achieves a fundamental requirement bridging drug discovery through post-approval clinical use. The future ability to accurately predict which patients respond to immunotherapy agents, prior to treatment, will spare non-responders from financial toxicity and drug-induced side effects.

    Immune checkpoint inhibitors that target programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) have only shown modest activity as monotherapies for the treatment of ovarian cancer. Approval for a patient’s use of these immunotherapies is based on the current paradigm of cancer drug selection, spanning genetic sequencing, gene expression and biomarkers. For many checkpoint inhibitor indications, only 10-30% of patients treated with these premium-cost drugs respond. The importance of checkpoint inhibitors meeting key clinical endpoints has recently been brought into focus in more than one cancer indication.

    Tessa DesRochers, PhD, KIYATEC Chief Scientific Officer said, “Our research highlights the significant steps that we have defined and those we have met to ultimately validate immune-oncology response prediction. While clinical prediction is still in progress pharmaceutical companies can today utilize our technology to make meaningful decisions during their drug development process.”

    The company has defined the four critical steps necessary to successfully predict immunotherapy response in the clinic. The latest research from KIYATEC demonstrates achievement of the first three: 1) development of a live cell co-culture test with patient-matched cells, 2) demonstration of sustained functionality of key infiltrating immune cells, and 3) characterization of dose-dependent and patient-specific cellular responses to immunotherapies. These three steps deliver what drug developers need today, strengthening KIYATEC’s basis for high value-added preclinical services. The fourth step will be to correlate the test results with patient immunotherapy endpoints in the clinic, enabling the prediction of patient-specific response to immunotherapies prior to treatment.

    KIYATEC’s platform is already predictive for chemotherapy and targeted agents. In December 2020, the company announced that unblinded use of KIYATEC’s test results to inform drug selection for recurrent brain cancer patients approximately doubled the expected clinical outcome. An earlier blinded clinical study, published in 2019, demonstrated that progression-free survival doubled for newly diagnosed ovarian cancer patients if they had received a drug treatment to which KIYATEC’s test results had predicted a response.

    “We are optimistic about the growing need for more effective pairing of immunotherapies and patients, particularly given recent developments in this multi-billion-dollar market,” said Matthew Gevaert, PhD, CEO and Founder of KIYATEC. “The expansion of our predictive platform beyond chemotherapy and targeted agents has the potential to change how patients are selected for life-saving treatments.”

    Appleton, K.M., Elrod, A.K., Lassahn, K.A. et al. PD-1/PD-L1 checkpoint inhibitors in combination with olaparib display antitumor activity in ovarian cancer patient-derived three-dimensional spheroid cultures. Cancer Immunol Immunother 70, 843–856 (2021). https://doi.org/10.1007/s00262-021-02849-z

     

    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, United Community Bank to sponsor development program see more

    Furman University’s Women’s Leadership Institute (WLI) will be presented virtually this year with two statewide community partners supporting the effort. United Community Bank will be the program’s presenting sponsor and SCBIO has signed on to be a presenting partner.

    The WLI is a seven-week leadership development program open to emerging and established women leaders in South Carolina, with past participants from every corner and many industries of the Palmetto State. It is led by distinguished Furman faculty and expert facilitators from civic and corporate organizations who cover core competencies from team leadership and design thinking to negotiating and developing networks.

    The program this year will comprise live, virtual sessions on Tuesdays and Thursdays, from 11:30  a.m. to 1:00 p.m. EST, beginning April 15 and ending June 1. The cost is $1,499 and registration is open now. For more information, or to nominate someone for participation, visit the WLI website.

    “The Women’s Leadership Institute at Furman is a wonderful opportunity to network with other female leaders in the community, learn more about my own natural strengths and abilities, and discover how I can use my voice to be an advocate for change in our local community,” says Jessica McCoy, a 2020 WLI graduate.

    “I would recommend this program to anyone who is actively seeking to make a difference in every area of their life. I promise you won’t regret a single second of it,” said McCoy, the business development manager for Brasfield and Gorrie, one of the country’s largest privately held construction companies.

    “The Women’s Leadership Institute has a long history of helping women succeed in their chosen careers and in life,” said Elizabeth Davis, Furman University president. “We are excited to have two cornerstone organizations join us this year to help extend our leadership training and advance equality, equity and diversity in the workplace.”

    Furman’s WLI began in 1998, and has helped more than 600 women from diverse sectors develop their leadership skills that are essential to advancing within their organizations.

    “Having United Community Bank and SCBIO join as presenting sponsor and presenting partner, respectively, increases the breadth and depth of the program into South Carolina’s business community,” says Anthony Herrera, executive director of Furman’s Institute for Innovation and Entrepreneurship.

    “United Community Bank is committed to making a difference in our community and we believe that is achieved through sponsoring programs that support the development of those who serve others,” said Moryah Jackson, vice president of community development and engagement for United Community Bank. “We are excited to be this year’s presenting sponsor and provide women with a professional development opportunity that will help them go out and make the world a better place.”

    “Furman’s Women’s Leadership Institute is among the premier programs in the Southeast devoted to promoting talent development, fostering invaluable connections and expanding new opportunities for current and emerging women leaders across the business ecosystem,” said Erin Ford, executive vice president and chief operating officer for SCBIO. “We are honored and enthusiastic supporters of the WLI program and mission, and look forward to being actively involved in this fantastic program.”

    Ford and Sam Konduros, chief executive officer and president of SCBIO, will present during one session, and a panel from United Community Bank will close the program on June 1.

  • sam patrick posted an article
    $30.2 million investment will create 425 new jobs see more

    Pall Corporation (Pall), a global leader in filtration, separation and purification, today announced plans to establish operations in Spartanburg County. The company is creating 425 new jobs and investing $30.2 million into a new facility that will support the rapid development and production of vaccines and therapeutics, including a COVID-19 vaccine.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies.

    Located at 816 Berry Shoals Road in Duncan, Pall's new facility will focus primarily on single-use technology such as the Allegro™single-use platform.

    The facility is expected to be operational in May 2021. Individuals interested in joining the Pall team should visit the company's careers webpage.

    The Coordinating Council for Economic Development has approved job development credits related to the project.

    QUOTES

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county." -Pall Life Sciences President Joseph Repp

    "Pall Corporation's decision to invest into South Carolina comes at a time when our life sciences sector has evolved into one of our fastest-growing industries. The continued development of life sciences will create high-paying jobs that will ensure wellness and prosperity in South Carolina for years to come." -Gov. Henry McMaster

    "We could not be happier with Pall Corporation's decision to invest in Spartanburg County. We welcome this globally recognized company to South Carolina, and we look forward to partnering with them going forward." -Secretary of Commerce Bobby Hitt

    "The decision by Pall Corporation to come to Spartanburg is a win for our county, and a win for our budding life sciences sector. The variety of investments coming into our county, and the diversity of the industries that now call Spartanburg home, is a sign that our future is bright in the years to come." -Spartanburg County Councilman and Chairman of the Economic Development Committee David Britt

  • sam patrick posted an article
    Vikor Scientific and Quantgene announce major advance in precision genomics see more

    Courtesy of GSA Business

    Starting this March, a South Carolina lab will become ground zero for a preventative test that can detect cancer-causing mutations, risks or tumors in advance through a quick blood sample taken at home or a physician’s office.

    S.C. life science organization SCBio and the Charleston Regional Development Alliance linked together Charleston’s Vikor Scientific and California’s Quantgene Inc. when the West Coast company was on the hunt for a lab that could commercialize its AI and genomic-powered preventative care program, Serenity.

    Serenity puts to task a deep genomic sequence process that covers 20,000 genes in combination with the disease, medication and lifestyle risks that could contribute to multiple variations of cancer. Along with the blood test, or “liquid biopsy,” it can detect cancerous mutations in the blood, according to Vikor Scientific co-founder Shea Harrelson.

    “What this means is that we can detect cancer early enough so that patients don’t have to resort to chemotherapy,” she said during SCBio’s Virtual Meeting Wednesday morning. “They may have options for immunotherapy or aggressive preventative strategies or even excisional therapy.”

    Patient-specific health profiles covering personal and family history, as well as lifestyle choices, will brief analysts on how additional risks may contribute to a patient’s likelihood of developing early-stage cancer, thus prompting preventative care.

    “With Serenity, we are first-to-market in combining liquid biopsy cancer detection with whole exome sequencing and advanced medical intelligence,” Johannes Bhakdi, founder and CEO of Quantgene, said in a news release. “We hope to unlock a new era in medicine in which trained physicians can detect multiple cancers at early stages in the blood with single molecule precision. Serenity brings genomic technologies to patients within an innovative system of preventative care that we believe will set a new standard in patient-centered personalized medicine. We are excited to take this important step with our partners at Vikor Scientific.”

    Vikor Scientific, a hub for medical testing, will process test results in collaboration with Serenity’s proprietary cloud for both individual end-users and health care professionals.

    The South Carolina company will launch its public awareness and physician education campaigns alongside the concierge-product release on March 1, according to Scotty Branch, co-founder of Vikor Scientific, and will soon build out its current location in Charleston.

    “Our number one goal is to educate physicians throughout the country, which is what we do best,” Branch told GSA Business Report, adding that the team is working to get insurance companies on board with the treatment program now.

    “Until then, the liquid biopsy, or the early detection portion, will be on a concierge or cash-paid basis,” he said.

    Vikor Scientific will conduct whole exome sequencing and send that information to the Serenity cloud for both physicians and individual consumers, potentially for a variety of uses.

    While existing genetic tests on the market like those sold by 23 and Me may be able to offer a surface level detection of certain cancer-causing genetic variations in a patient, Serenity takes genomic testing to the next step of preventative treatment, the company said.

    “Genetic mutations only play a role in about 5% to 10% of cancer,” Harrelson said. “So, there’s about 90-95% of cancers that don’t have genetic mutations, and without that, you still have a lot of familial cancers. And most people die from cancer than heart disease or automobile accidents, so this liquid biopsy test will be very important, because if patients have put stress on their body or smoke or other risk factors that can increase their chance for cancer, this liquid biopsy test is pretty painless and a great screening tool for this and other cancers that … like pancreatic cancer. We often don’t find out about pancreatic cancer until stage three or four.”

    Taking into account detected at-risk genetic variations, the Vikor-Quantgene team will analyze additional risks for early stages of cancer through the liquid biopsy test, in lieu of more invasive measures, which can detect whether nascent tumors are forming in the body.

    “It’s a great continuum of care,” he added. The test analysis could then be used, in tandem with additional data, to launch preventative treatment and care.

    “We need to use liquid biopsy as part of an annual or bi-annual screening,” Branch said.

    After a Monday Vikor Scientific Board meeting, Branch said 99% of the plans for the facility buildout have been nailed down. The full announcement will come when the company approves the final portion of its development strategy.

    “This is an amazing announcement for South Carolina and for economic development, where we are going to build out at our location at 22 West Edge, where Vikor’s location is currently,” he said. The company will start small with 10 to 20 new employees and scale up from there. “That is exciting news that a corporate hub would be located here in Charleston’s West Edge Medical Innovation District."

  • sam patrick posted an article
    Executive Partnering, Virtual Exhibit Hall Add Draw for Power of Us Conference Feb. 16-17 see more

    With conference registration surging more than 20% past prior record levels and the addition of a “singularly significant innovation announcement focused on cancer treatments and precision medicine advancement”, SCBIO's “The Power of Us”  virtual conference Feb. 16-17 is preparing for its largest gathering ever next week... delivered virtually to registrants from across the Palmetto State plus 25 states and 8 countries.

    Adding to the excitement is a just-scheduled “major innovation announcement” by a South Carolina company, in tandem with West Coast and German allies, that has significant implications for cancer diagnosis and treatment on a global level, organizers say.

    Already in excess of 500 registrants from across America and around the globe, the acclaimed SCBIO conference – the annual gathering of South Carolina’s life sciences community – will also celebrate the rapid growth of the industry and the contributions of its 800+ organizations in helping America and the world overcome the brutal COVID-19 pandemic.

    South Carolina life sciences has seen a doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Joseph Von Nessen, the state's research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.

    “Dr. Von Nessen’s data validates that the life sciences industry in South Carolina is experiencing stunning growth, thanks to the combined efforts of our state’s economic development teams, industry partners, research universities, elected officials and other partners,” said SCBIO CEO Sam Konduros.  “It’s an exciting time to be a part of an industry that is saving lives and improving quality of care.”

    The industry has a $12+ billion economic impact in the Palmetto State, with more than 800 firms located in 42 of 46 counties across the state and over 43,000 professionals employed directly or indirectly in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.

    Organizers are tight-lipped about the Innovation Announcement details, which will be unveiled at 8:30 a.m. on the second day of the conference—February 17. 

    “We will say that the implications of the announcement include a new technology that has the ability to detect cancers at the earliest time ever, to further lifespans, and to unlock a new era of precision medicine, ” said Mr. Konduros.

    Adding to the draw of the conference are scores of organizations from across America showcasing their capabilities in a virtual exhibit hall, direct 1-to-1 executive meetings on demand via a Partnering Portal, major industry awards and – naturally – top speakers.

    Committed presenters include BIO Global CEO Dr. Michelle McMurry-Heath; Microsoft Vice President Jamie Harper, who leads the global team supporting higher education and K-12 initiatives; and Bill Stadtlander, Commercial Leader of Verily, the Google subsidiary focused on life sciences and use of health data and AI to improve lives.

    Also speaking at SCBIO 2021 are Courtney Christian, Senior Director of Policy and Research at PhRMA and former leader of the Black Women's Health Imperative; Dr. Harris Pastides, former USC President and outgoing chair of the SC Institute of Medicine and Public Health; Dr. Pat Cawley, CEO of MUSC Health; and Dr. Marjorie Jenkins, Dean of the USC School of Medicine - Upstate and Chief Academic Officer of Prisma Health Upstate, among others.

    Themed “The Power of Us,” the 2-day SCBIO 2021 virtual event will feature sessions on The Power of Innovation, The Power of Partnership, and The Power of People – each a fundamental force which drives the state’s surging $12 billion industry that is a key contributor to South Carolina’s expanding knowledge economy.

    The conference will also feature SCBIO CEO Sam Konduros delivering the “State of South Carolina’s Life Sciences Industry” address, and release of SCBIO’s 2020 annual report

    Leaders already registered to attend include executives from Presenting Sponsor Vikor Scientific, Champion Sponsor Nephron Pharmaceuticals, Keynote Sponsor Medpoint, Pinnacle Awards Sponsor Softbox and others.  Leading biotech and med-tech industry brands participating include BIO, Johnson & Johnson, AVX, PhRMA, AdvaMed, Poly-Med, VWR, Ritedose Corporation, Rhythmlink, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami, SSOE – Stevens & Wilkinson, and more.  All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    Registration is open online at the 2021 Virtual Conference section of www.scbio.org.  Registration is free to employees of most SCBIO investors and supporters as well as to students interested in life sciences careers, while faculty and teachers can attend the entire conference for $25.  General admission tickets are available for as little as $75.  Virtual Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

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

  • sam patrick posted an article
    Founders take virtual stage at South Carolina life sciences conference to introduce technology see more

    Founders take virtual stage at South Carolina life sciences conference to introduce revolutionary ability for early detection of cancer mutations

     

    Santa Monica, CA and Charleston, SC -- Feb. 17, 2021Vikor Scientific, a South Carolina-based leading, molecular diagnostics company with a rapidly expanding nationwide footprint, has announced a strategic investment in California-based Quantgene Inc. to accelerate the commercialization of Quantgene’s flagship product, SerenityTM. Serenity provides world-leading accuracy in precision genomics and AI-enabled personalized preventative care.

    Quantgene’s Serenity combines advanced next-generation sequencing with proprietary cloud and AI technology to uncover deeper and more meaningful health insights earlier. Serenity will launch with four core components of health protection:

    • Liquid biopsy to detect cancer-related mutations in the blood to support early detection
    • Deep genomic sequencing across all 20,000 genes for a more complete picture of disease, medication and lifestyle risks
    • In-depth patient health profiles including health history, family history and lifestyle to bring more context to test results
    • An expert clinical team to provide analysis and connect patients to a network of world-leading medical experts

     

    The combination of these components allow the system to detect, flag and monitor disease and disease risk at earlier stages. Early intervention for potentially fatal conditions like cancer is critical to ensuring better treatment response and long-term outcomes. This is a critical advancement in marrying medicine and technology to ensure the company realizes their mission of extending the average lifespan of members by a decade within a decade.

    South Carolina-based Vikor Scientific is a market leader in providing targeted, molecular diagnostics that can improve clinical and economic outcomes.  Headquartered in Charleston, S.C., Vikor anchors the WestEdge Life Sciences Campus adjacent to the Medical University of South Carolina and is approaching 400 employees nationwide.  The announcement was made at SCBIO 2021, the acclaimed national conference of South Carolina’s life sciences industry which draws industry leaders from around the globe.

    In addition to ensuring the successful launch of Serenity commercially, the new partners have plans to launch several downstream liquid biopsy-based clinical oncology products including minimum residual disease detection (“MRD”), recurrence monitoring and companion diagnostics over the next several months. Vikor Scientific will leverage their proven commercialization engine for innovative molecular diagnostics technologies and leverage their growing national salesforce in service of the new product roll outs.

    Shea Harrelson, co-founder of Vikor Scientific, said: “In Quantgene, Vikor saw a compelling opportunity to support the commercialization of advanced genomics in the service of preventative care and positively impacting the course of many chronic diseases, starting with cancer. This partnership aligns perfectly with our mission as a company - to improve patient outcomes and prevent unnecessary healthcare costs and delays in treatment by improving diagnostic accuracy, reducing turnaround time and personalizing treatment options.”

    Scotty Branch, co-founder of Vikor Scientific added: “Changing the paradigm of healthcare has always been the vision for Vikor Scientific. The platform built by the Quantgene team is revolutionary and certain to accelerate the speed at which we diagnose and treat patients for cancer. Vikor is excited to lead the commercialization and expand on our mission of driving clinical outcomes. And we are particularly excited to do so here in Charleston, where we envision a dynamic future for innovation, growth and expansion of the booming life sciences hub here in South Carolina.”

    “With Serenity, we are first-to-market in combining liquid biopsy cancer detection with whole exome sequencing and advanced medical intelligence. We hope to unlock a new era in medicine in which trained physicians can detect multiple cancers at early stages in the blood with single molecule precision.” added Jo Bhakdi, founder and CEO of Quantgene. “Serenity brings genomic technologies to patients within an innovative system of preventative care that we believe will set a new standard in patient-centered personalized medicine. We are excited to take this important step with our partners at Vikor Scientific.”

    Alluding to Serenity as a new frontier in science that “promises earlier detection than ever and promises to unlock a new era of medicine,” Branch saluted the role of SCBIO and the Charleston Regional Development Authority in making the announcement a reality.

    “I can envision the day when this collaboration leads to a new corporate hub here with new labs and bright new talent from South Carolina medical schools advancing this revolutionary technology,” Branch added.  “We credit the efforts of SCBIO and this state in bringing our organization and Quantgene together, and we intend to identify new collaborations and partnerships that advance the future of medicine, and promise a healthier future for our state, country and world.”

  • sam patrick posted an article
    Robotics usage expands at Nephron see more

    Two years ago, Nephron Pharmaceuticals brought a problem to the engineering and pharmacy colleges at the University of South Carolina.

    When employees operating machinery at Nephron called in sick or otherwise couldn’t come to work, production is halted. Nephron CEO Lou Kennedy hoped the company and the two colleges could find a solution.

    Kennedy is no stranger to the university, having graduated from USC. She and her husband Bill also established the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.

    However, she had not been a part of a collaboration with the university that actually shifted the way the West Columbia drug manufacturer operates.

    After several classes of mechanical engineering students and pharmacy students worked to fix the problem, the project was finally completed this year— a robot named Smithers after The Simpsons character. The robot improves productivity by cutting out most of the human involvement in pre-filling sterile syringes with injectable medicines.

    While Nephron has faster robots than Smithers, they require more human intervention.

    “It just continues to make drugs without, frankly, a bathroom break or other things. So a steady machine, even if it’s slower, is better than people who haven’t shown up for the night and we have orders to fill,” Kennedy said.

    Despite increased automation, Kennedy said employment will not be hurt. Nephron is currently in a hiring surge, trying to fill 380 positions including sterile pharmacy technicians and automation engineers. This year, Nephron will open its state-of-the-art vaccine production facility as part of a $215 million expansion.

    “I can’t hire enough sterile pharmacy techs for what I need fast enough because of our growth, so this is just augmenting what we’re already doing— not to replace humans,” Kennedy said.

    The robot consists of four pieces of equipment, all designed by students, that work together to mimic the actions of a human pre-filling sterile syringes, according to Nephron’s chief of engineering and USC mechanical engineering professor Ramy Harik. Separate pieces pick up the syringes, complete the filling process and cap the syringes to seal them.

    Harik led three different teams of senior engineering students over two years to create the robot, while pharmacy students made sure the medical and sterilization aspects of the robot was safe for future human injection. The teams tested nearly ten different designs before finding one that worked.

    The machine, which was installed last week, is being validated for commercial use and should be up and running in a couple of weeks, said Kennedy. She has already ordered the parts to make another one to put into production and hopes to have several of them going at the same time one day.

    “My dream for the university is that we could commercially market these robots for hospitals around the world,” said Kennedy. “If we had the ultimate dream, it would be to sell these and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”

    From the partnership, Harik created a pharmaceutical manufacturing class at USC for the next semester, and Nephron donated the equipment needed for students in the form of a glass cleanroom. The room allows students to work in a sterile environment for pharmacy manufacturing.

    “Usually an entry-level engineer wouldn’t be given the opportunity to build an entire system from the ground up and it’s just been a great opportunity,” said John Diamond, one of the engineering students who started the project and now works at Nephron.

  • sam patrick posted an article
    Registrations Surge, Partnering and Virtual Exhibit Hall Draw Strong Interest see more

    A newly announced group of national and state leaders will join Biotechnology Innovation Organization (BIO) President and CEO Dr. Michelle McMurry-Heath in headlining SCBIO's “The Power of Us”  virtual conference slated for broadcast Feb. 16-17.

    Newly announced additions include Microsoft Vice President Jamie Harper, who leads the global corporation's team supporting both higher education and K-12 initiatives across America, and Bill Stadtlander, Commercial Leader of Verily, the Google subsidiary focused on life sciences and use of health data and AI to improve lives.

    At Microsoft, Mr. Harper leads a team that supports higher education and K-12 initiatives impacting students, teachers, and leaders both public and private.  He previously has led Microsoft's US Education team and served as the General Manager of ten countries in Asia and South Africa.  Prior to Microsoft, Jamie worked for The Coca-Cola Company and Westinghouse Power Generation.  He holds an MBA from Emory University, and a degree in Industrial Engineering with a minor in Economics from Clemson University.

    Mr. Stadtlander is the Commercial Lead at Verily for Baseline, its end-to-end digital platform solution to transform clinical research by increasing participation, driving efficiency and incorporating novel data. Bill has over 15 years of commercial healthcare experience with prior roles at Ceribell, Element Science, Boston Scientific and McKinsey & Co.'s healthcare practice. He holds an MBA from Wharton, a Master of Biotechnology from University of Pennsylvania, and Mechanical and Biomedical Engineering degrees from MIT.

    Also named to speak at SCBIO 2021 are Courtney Christian, Senior Director of Policy and Research at PhRMA and former leader of the Black Women's Health Imperative; Dr. Harris Pastides, former USC President and outgoing chair of the SC Institute of Medicine and Public Health; Dr. Pat Cawley, CEO of MUSC Health; and Dr. Marjorie Jenkins, Dean of the USC School of Medicine - Upstate and Chief Academic Officer of Prisma Health Upstate, among other speakers.

    Themed “The Power of Us,” the 2-day SCBIO 2021 virtual event will feature sessions on The Power of Innovation, The Power of Partnership, and The Power of People – each a fundamental force which drives the state’s surging $12 billion industry that is a key contributor to South Carolina’s expanding knowledge economy.

    The conference will feature a virtual exhibit hall showcasing scores of life sciences industry organizations from across the country, and presentation of the prestigious Pinnacle Awards by South Carolina Life Sciences to the outstanding 2020 Organization of the Year and Individual of the Year.  SCBIO CEO Sam Konduros will deliver the “State of South Carolina’s Life Sciences Industry” address, while attendees can schedule 1-to-1 meetings with top executives through the conference’s Partnering Portal

    Hundreds of life sciences leaders from across the nation are already registered to attend with hundreds more expected.  SCBIO's virtual conference is supported by Presenting Sponsor Vikor Scientific, Champion Sponsor Nephron Pharmaceuticals, Keynote Sponsor Medpoint and others.  Among leading biotech and med-tech industry brands participating are Nephron, Vikor, BIO, Johnson & Johnson, AVX, PhRMA, Medpoint, AdvaMed, Poly-Med, VWR, Ritedose Corporation, 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 entities including the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    Registration is open online at the 2021 Virtual Conference section of www.scbio.org.  Registration is free to employees of most SCBIO investors and supporters as well as to students interested in life sciences careers, while faculty and teachers can attend the entire conference for $25.  General admission tickets are available for as little as $75.  Virtual Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

    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 a $12 billion economic impact in the Palmetto State, with more than 750 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.

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

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

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

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

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

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

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

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

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

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

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

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

    Click to read...

  • sam patrick posted an article
    Charleston, Vikor Scientific featured in national media see more

    Compliments of Charleston Regional Development Alliance and Business Insider

    Empty hotel rooms, half-full offices, and shuttered retail. The coronavirus has wreaked havoc on the most established commercial real estate asset classes, creating short-term financial crunches and raising long-term secular concerns as remote work is tested and e-commerce rates rise.

    Other asset classes, once alternatives, have become institutional investing gold standard. Logistics assets such as warehouses are providing a punch to the portfolio of the world’s largest landlord, Blackstone.

    As industrial real estate investing becomes more crowded, and many of the other large asset classes slump, attention is turning to life sciences real estate — or space that’s used by pharmaceutical and biotech companies for research, development, and even manufacturing of new diagnostics, therapies, and vaccines.

    The life science industry had been growing rapidly before the pandemic, attracting $17.4 billion in venture capital funding in 2019, up 370% from $3.7 billion in 2008, according to a Cushman & Wakefield report. Funding has continued to pour into the sector, even as coronavirus has slowed down venture funding overall, creating demand for more lab space.

    Read the entire story here...

  • sam patrick posted an article
    This week's South Carolina life sciences newsletter is hot off the press! see more

    Enjoy this week's newsletter from SCBIO featuring updates on South Carolina's inaugural Women in Life Sciences initiatives... a report on MUSC's growing economic impact statewide... details on more Palmetto State organizations stepping up for the greater good...  an update from EVP Erin Ford and much, much more...  click here to read complete details!

  • sam patrick posted an article
    MUSC has multi-billion-dollar impact on South Carolina... see more

    A new report shows the Medical University of South Carolina has an annual economic impact on the state of about $5.6 billion. MUSC Health CEO Patrick Cawley, M.D., knows where a big part of the credit lies. “MUSC Health has grown significantly in the past 18 months and this report details the growing economic impact across the entire state of South Carolina.”

    In early 2019, MUSC bought four hospitals in Lancaster, Florence, Marion and Chester, creating a regional hospital network and establishing itself as a health care organization that reaches well beyond Charleston. 

    Joseph Von Nessen, Ph.D., a research economist at the Darla Moore School of Business at the University of South Carolina in Columbia, led the six-month economic impact study. “MUSC maintains a unique and sizeable statewide economic footprint. Its impact in Charleston may already be well known, but it’s also important to recognize that MUSC’s economic benefits extend well beyond the borders of the Tri-county region.”

    For example: “About 38,000 people in South Carolina can attribute their jobs either directly or indirectly to the activities that are going on at MUSC every day. It really shows how significant MUSC’s impact is,” Von Nessen said.

    Read the entire story here...

  • sam patrick posted an article
    South Carolina life sciences is booming, with new organizations growing and moving here see more

    Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  It’s a powerful force in today’s Palmetto State economy.  

    The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.  

    Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag.  Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.

    What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare.  An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.

    To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point.  Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.  

    Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.  

    SCBIO has become a catalyst for and voice of South Carolina life sciences.  From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.

    Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.

    And innovation is the lifeblood of progress.  For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.

    Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.  

    From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.

    Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level.  Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis.  Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.

    A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields.  ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.

    The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association —  is an important step in helping organizations share best practices and stimulate innovation.  

    Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital. 

    Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:

    • Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them; 
    • Accelerate best solutions through development and into commercialization; and 
    • Scale startups and networks to drive investment and job creation across South Carolina and Georgia. 

    With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.

    As American poet Robert Frost penned:

      “The woods are lovely, dark and deep, but I have promises to keep, 

       And miles to go before I sleep.”

    Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources.  With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter

  • sam patrick posted an article
    SC invention provides a solution for reducing accidental needle sticks see more

    Medical University of South Carolina neurophysiologist Jessica Barley, Ph.D., and neurologist Jonathan C. Edwards, M.D., noticed a clinical problem and decided to do something about it.  The needle electrodes used to monitor a patient’s nervous system function during surgery can also pose a safety risk. Stranded uncapped needles can find their way into health care workers or even patients. Working with the Zucker Institute for Applied Neurosciences (ZIAN), an MUSC technology accelerator, and Rhythmlink International LLC, a medical device manufacturer headquartered in Columbia, South Carolina, the team created a novel safety electrode that has the potential to reduce needle sticks. 

     The electrode, known as the Guardian Needle, was recently approved by the U.S. Food and Drug Administration for intraoperative monitoring (IOM). The technology has been licensed to Rhythmlink, which is ramping up production for a rollout to hospitals nationwide this autumn. 

    “We thought it was unacceptable and unfair that the team providing the care to the patient should be put in harm's way by equipment that was meant to do the opposite and ensure patient safety,” said Barley, who runs the intraoperative neurophysiology program at MUSC Health and is co-inventor of the Guardian Needle. “This is how we first came up with the design.”

    During high-risk surgical cases, the neurophysiology team uses IOM to monitor a patient’s nervous system. The process involves inserting approximately 40 needles throughout the patient’s body and connecting them with long wires to the IOM machine.

    “IOM serves as a vital early warning system,” explained Barley. “It preserves neurologic function in real time.”

    However, the setup increases the risk of needle dislocation. Currently available needles can become uncapped when dislodged from the patient’s skin. This results in a danger of needles sticking the staff while in the operating room (OR).

    “We don't have to accept that a certain number of our staff are going to get stuck by an IOM needle,” said Edwards, chief of the Integrated Centers of Clinical Excellence in Neuroscience at MUSC Health and co-inventor of the Guardian Needle. “That's a problem, and it's our responsibility as people in the field to solve it.”

    The Guardian Needle should protect the surgical team from harm because it is never uncapped. It was designed to deploy the electrode safely only when inserted in the patient. If the needle is dislodged from the skin, it automatically resheathes into its protective casing.  

     “The key thing is that you don't have to cap and uncap the needle, and it automatically retracts when it's not in the patient,” said Paul Asper, vice president of commercialization at ZIAN.

    The design also includes adhesive bandages around the needles. The adhesives enable the team to secure needles to the patient without manually taping them, thus decreasing OR time and cost. The bandage, like the needle electrode, is sterile, which reduces the risk of infection from nonsterile tape. 

    “We did timed trials,” said Barley. “Just trying the full setup the very first time using the new design, we were all faster,” she said, comparing the new needles with the needles they had used before. 

    Not only does the Guardian Needle protect the surgical team and decrease OR time, but it also enables better patient care by reducing the risk of needle sticks to patients and helping to maintain a sterile environment. 

    The adhesives on the needle also secure it in place despite shifts in patient positioning. The adhesives thus ensure signal integrity as the electrodes monitor nervous system function during surgery. 

    The clinician-innovators were able to come up with the clever design because they were personally familiar with the clinical problem they were trying to address. 

    “Clinicians have great ideas all the time,” said Edwards. “But 99% of those ideas die, mostly because we don’t have time.”

    Enter ZIAN, with the expertise, knowledge and resources to turn an idea into a product. In the case of the Guardian Needle, the ZIAN team developed a business plan and patent strategy, raised funding for research and development, engineered the prototype and forged a licensing agreement with a world-class medical device company, saving valuable time for the busy clinicians. 

    “The expertise on the ZIAN team aligns perfectly with the clinical expertise of the inventors, enabling both parties to execute on their strengths,” explained Mark Semler, CEO of ZIAN. The core mission of ZIAN is to develop and bring to market technologies that solve unmet clinical needs.

    “We have that clinical perspective to create a pipeline of ideas,” said Edwards. “ZIAN provides the practical implementation of those ideas, and neither of those two would be successful without the other.”

    Rhythmlink, a South Carolina-based company specializing in medical devices that record or elicit neurophysiologic biopotentials, has licensed the technology and has begun to ramp up production of the Guardian Needle. Their unique position in the industry allowed them to recognize the importance of this invention. That, combined with their contribution to the intellectual property, design enhancements for manufacturing and expertise in regulatory guidelines, helped the product become a reality. 

    “This is a great example of South Carolina organizations collaborating in the health care space and an illustration of South Carolina’s prowess in innovation, entrepreneurship, life sciences and manufacturing,” said Shawn Regan, co-founder and chief executive officer of Rhythmlink. “Creating a safer work environment for health care professionals absolutely aligns with our mission to improve patient care. Working with ZIAN and MUSC to develop the Guardian Needle and bring this creation to life was a no-brainer from a collaboration standpoint.” 

    Successful commercialization of the product and the widespread distribution that Rhythmlink can provide are key to realizing a potentially industry-changing standard of care. As the novel electrode is rolled out in hospitals across the country, researchers will collect needle-stick data to determine whether it is safer than the current standard of care. If it is safer, as its inventors believe, it would likely become the new standard of care, given federal workplace safety rules. 

    “Being at the forefront of an innovative and potentially industry-changing movement is exciting and exactly where we strive to be,” said Regan. 

    To the inventors, the Guardian Needle provided a way to make a difference not only for their MUSC Health colleagues but also for surgical team members across the globe. 

    “In health care, we gladly and eagerly place ourselves at risk every day when we're caring for others. But it does have an element of stress and anxiety,” said Barley. “This invention is particularly special because we're not only caring for our patients in a safer, higher-quality way, we're also protecting our colleagues and teammates. It feels like a way of giving back to them and keeping them safe.”

    Edwards explained that it is this type of innovation that has enabled him to help patients and health care providers he will never meet. This he considers a benefit of practicing academic medicine. 

    “We always think of clinical practice, teaching and research as the three pillars of medicine,” he explained. “There's a fourth pillar, and that fourth pillar is innovation.” 

    Innovation has led this MUSC team to create a solution for a once-tolerated problem. They encourage other clinicians to do the same.

    “Take obstacles as an opportunity to find the solution yourself,” encouraged Barley.