Rutgers University and Premier Medical Laboratory Services Conduct Studies Showing TAG-NGPM+™ Inactivates SARS CoV-2 Virus, Increases StabilityTogether, Rutgers and Premier are publishing a scientific article demonstrating their findings see more
Public Health Research Institute at Rutgers New Jersey Medical School and Premier Medical Laboratory Services (PMLS) have conducted studies on the stability and viral inactivation properties of the Truckee Applied Genomics (TAG) TAG-NGPM+ virus inactivating media. The studies show that the non-flammable solution contains a chemical make-up which may increase both room temperature stability and freeze-thaw integrity. This means that the specimen is better preserved during transit to a testing laboratory, and as a result, could increase the accuracy of testing results while decreasing the number of samples ruined by temperature changes. Rutgers’ data also shows that the patented TAG-NGPM+ inactivates SARS-CoV-2 in the specimen, making it safer for transport and handling by laboratory staff.
“PMLS is proud to participate in this collaborative effort with such great institutions as Rutgers and Truckee Applied Genomics,” said Austin Shirley, Director of Operations for Premier Medical Laboratory Services. “Effectively inactivating the SARS-CoV-2 virus and other pathogens before transporting them to labs, while also making the testing more accurate and the handling of the media safer, is a tremendous innovation in specimen collection.”
The TAG-NGPM+ media was developed based on the patented TAG-1™ Class 1 General Reagent. TAG-1 is a formaldehyde-free tissue fixative that was designed to improve molecular tests while requiring no changes to pathology workflows. The TAG-NGPM+ formulation adds sufficient and complementary anti-viral and anti-bacterial components. These components improve the safety of viral sample handling and provide safer and less costly media handling compared to other virus inactivating media since TAG-NGPM+ contains no guanidinium salts.
The studies conducted by PMLS show that the TAG-NGPM+ solution can also be used as an optimal transport media for COVID-19 sample testing. There was a 5 log10 reduction in the viral titer after treatment of SARS-CoV-2 virus with TAG-NGPM+ buffer within 30 minutes while the integrity of the viral RNA remained intact. This might potentially help centralized core laboratories and Point of Care (POC) laboratories safely process patient samples when access to BSL II facilities is limited. Another major advantage the buffer offers is in safe disposal in any disinfectant including 10% bleach solution, since the media is free of hazardous reactive chemicals like guanidinium isothiocyanate (GITC).
Drs. Padmapriya Banada and Sukalyani Banik conducted the studies in the Alland laboratory at Rutgers NJMS. According to Dr. Banada, “the TAG-NGPM+ transport media can potentially reduce the biohazard risk associated with COVID-19 testing, as practice that could otherwise expose laboratory personnel to live SARS-CoV-2, the virus that causes COVID-19. The study showed that the transport media inactivated SARS-CoV-2 at both room temperature and under refrigeration conditions at the tested concentrations. Studies by PMLS also showed that the transport media prolonged sample stability. By improving the safety and stability of COVID-19 test samples, the transport buffer should greatly simplify on-site or point of care testing in settings such as doctor's offices, workplaces or schools”
Dr. Tian Yu, TAG VP of Product Development commented, “TAG-NGPM+ virus inactivation media was designed to increase lab staff safety, while eliminating the need for a cold chain and protecting RNA integrity for weeks at ambient temperature. Because TAG-NGPM+ is designed to better stabilize viral RNA fragments and preserve protein structures, it will enable additional testing formats on top of molecular testing which are known to show high specificity in COVID19 diagnosis.“
The article by Rutgers NJMS and PMLS demonstrating their research findings is soon to be published. For more information, please call 866-405-2199 or visit www.PreMedInc.com.
ABOUT PREMIER MEDICAL LABORATORY
Premier Medical Laboratory Services (PMLS) is a CLIA and COLA regulated laboratory based in Greenville, South Carolina focused on providing clinically meaningful results to medical practitioners. Premier Medical Laboratory Services offers a variety of highly specialized tests including: the only Type II Diabetes molecular predisposition test available in the U.S., advanced cardiovascular testing, hereditary cancer screening, carrier screening, women’s health panels, pharmacogenomics, serum allergy testing, blood wellness, Hepatitis C genotyping, respiratory pathogens, gastrointestinal pathogens, and more. In addition to its specialty programs, Premier Medical Laboratory offers a comprehensive testing menu of general chemistry, immunoassay, and hematology tests. The company also is proud to offer a patient friendly billing policy. For more information, please visit www.PreMedInc.com or call 866-405-2199.
KIYATEC Announces Investment from Seae Ventures and Names Managing Partner Jason Robart to KIYATEC Board of DirectorsCancer testing innovator KIYATEC fits investor’s focus in disruptive healthcare technology see more
KIYATEC, Inc. announced today that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures. The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.
Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.
“We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers,” said Matthew Gevaert, CEO and co-founder of KIYATEC.
The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.
Robart said, “KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors.”
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.
SCBIO innovation partner GCMI names new CEO see more
Sherry Farrugia has been selected by the Global Center for Medical Innovation (GCMI) board of directors as the organization’s permanent CEO, effective April 1, 2021. Farrugia had been serving as interim CEO for GCMI, a Georgia Tech affiliate, since September 2020.
“We are so pleased to congratulate Sherry as she joins GCMI in this permanent capacity,” said Chaouki T. Abdallah, Georgia Tech’s executive vice president for Research. “She was a steadfast advocate, innovator, and leader in her time at Tech and I know she will bring that same dedication to the important, transformational work of GCMI.”
Farrugia came to GCMI from the Children’s Healthcare of Atlanta Pediatric Technology Center at Georgia Tech, where she served as chief operating and strategy officer for 10 years, focusing on accelerating innovation for pediatrics. During that time, Farrugia worked with GCMI on numerous projects. Recently, she played a key part in GCMI’s success supplying frontline healthcare workers with personal protective equipment during the pandemic.
“Sherry Farrugia is nationally recognized for her work in advancing translational medical research, and we are excited that she will continue with GCMI as permanent CEO,” said Bob Crutchfield, chair of the GCMI board of directors and CEO of TeleHealth Solution. “Her visionary leadership, strong community ties, and knowledge of the commercialization ecosystem and medical device strategy and development have been great assets to GCMI thus far and will be instrumental in our path forward.”
Recently, Farrugia was named to the board of directors for the Medical University of South Carolina Foundation for Research Development. She is currently an advisory board member of Atlanta Ronald McDonald House Charities, on the board of directors of the International Society of Pediatric Innovation, and a member of the Southeast Life Sciences Women@SLS advisory board.
“Sherry brings over 30 years’ experience in the healthcare innovation industry,” said Devesh Ranjan, Georgia Tech’s interim vice president for Interdisciplinary Research and Ring Family Chair and professor in the George W. Woodruff School of Mechanical Engineering. “Her knowledge and experience are invaluable, and I know she will serve the role well.”
In 2018, Farrugia received the Women in Technology Woman of the Year Award, and she was honored by Georgia Bio for three consecutive years for her work in supporting the life sciences.
“GCMI’s mission and history of working with startups, clinicians, and universities to bring innovative medical products to the world is perfectly aligned with my passion for supporting translational research in the healthcare space,” Farrugia said. “I am so pleased to accept the position as GCMI’s permanent CEO and to continue the important work to accelerate the development, testing, training, and commercialization of life-changing technologies.”
Senator views progress one year later see more
Senator Tim Scott’s senior staff visited Diversified Medical Healthcare (DMH) headquarters, touring the Greenville, SC facility which houses four healthcare companies making a national impact. Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical serve as a large-scale molecular diagnostics lab, clinical test kit manufacturer, surgical kit manufacturer, medical data management software firm, laboratory equipment supplier, and PPE kit supplier.
Just one year ago, Diversified Medical Healthcare’s laboratory, PMLS, became the first lab validated for COVID-19 testing in South Carolina alongside their other advanced clinical diagnostics offerings. Providing an inside look at their 40,000 sqft faciltiy for the US Senator’s staff, DMH founder, Kevin Murdock introduced them to the company’s research and development team of Ph.D. scientists and over 450 employees as well as showcased the cutting edge laboratory automation equipment which has allowed them one of the highest laboratory testing capacities in the nation.
“From leading research and innovation to generously donating PPE for our front line workers, Diversified Medical Healthcare has been a valuable partner for South Carolina as we’ve worked to get through the pandemic,” said Senator Scott. “Their efforts highlight the life-saving impact of American innovation, and I am proud of the work they have done.”
The senator’s staff toured the laboratory where over 1,000,000 COVID-19 tests were processed during the last year and data has been managed by their laboratory information management software developed in-house. They viewed CPT Medical where over 6,000,000 COVID-19 testing kits and viral transport media have been manufactured and saw the Vessel Medical facility where hundreds of thousands of customized PPE supply kits were assembled and distributed.
In the laboratory, PhD Scientist, Vidhya Narayanan spoke with them about a large scale genomic sequencing that Premier Medical Laboratory Services is conducting for the surveillance of new variants of the Sars CoV-2 virus. As the only laboratory in the US fully automated for Next Generation Sequencing, PMLS expects to sequence up to 84,000 specimens per week. This will be a critical contribution in preventing a future surge of new COVID-19 variants.
“It was a high honor to have Senator Tim Scott’s team here and to show them all that we’re doing right here in South Carolina to improve healthcare across the US,” said Kevin Murdock, founder of Diversified Medical Healthcare. “Senator Tim Scott has done much to improve healthcare and create jobs, and those are two of the driving forces behind what we do here as well.”
The visit of Senator Tim Scott’s staff, comes just two weeks after SC State Representatives, Bobby Cox and Bruce Bannister visited the facility to view all that DMH is doing to contribute to healthcare in the state of South Carolina and the nation.
Over the past year, Diversified Medical Healthcare companies have also:
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster delivery of data to healthcare providers and patients
- Developed Virtual Lab, an innovative solution to laboratory infrastructure limitations which allows other labs to utilize PMLS’ testing capacity, 450 employees including a research and development team of PhD scientists, and top of the line lab equipment
- Developed Lab in a Box, turnkey lab equipment for other labs, hospital systems, and large organizations that comes with everything needed for professional laboratory level diagnostics for COVID-19, Flu A and B, upper respiratory, STD/UTI, cancer risk screening, pharmacogenomics, and antibiotic resistance testing
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Achieved the capacity to produce 60,000 COVID-19 testing kits per day
- Become the official COVID-19 testing lab for the United Soccer League (USL) and Division I/Division II teams in 7 collegiate conferences as well as large schools and business organizations across the US
- Become the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina
- Become the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.divmedinc.com or call 866-521-7541.
ABOUT DIVERSIFIED MEDICAL HEALTHCARE
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical. PMLS is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including Clinical Laboratory Improvement Amendments (CLIA) and COLA. PMLS testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women’s Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict. CPT Medical, Inc. has manufactured surgical custom and standard procedure trays, packs, and kits assembled to fit specific needs and requirements for over 15 years. Now, CPT Medical also manufactures and distributes COVID-19 testing kits with the FDA recommended viral transport medium as well as nuclease free water for laboratories. OnGen is an advanced Laboratory Information System that automates laboratory processes for higher efficiency, accuracy, and profitability. Vessel Medical, since its inception in 1991, has been committed to providing physician’s offices, hospitals, laboratories and their employees with the right workflow solutions, medical supplies, and medical equipment for their needs. Included in their medical equipment offerings is ‘Lab in a Box,’ turnkey laboratory equipment that can turn a 600 sq. ft. room into a COVID-19 testing facility with the capacity to process up to 12,000 tests per day within 24 hours. For more information, please visit www.divmedinc.com or call 866-521-7541.
IMCS growing into new space, adding positions see more
An Irmo-based biotechnology company is investing $4.1 million to expand its Richland County operations in a move expected to create 31 jobs during the next five years.
Integrated Micro-Chromatography Systems Inc. creates, manufactures and distributes products and services for clients including clinical and forensic toxicology labs, academic research facilities, federal government agencies and health science companies. In January, the National Institutes of Health awarded the company a $900,000 Small Business Innovation Research Fast-Track grant.
“Over the past several years, IMCS has experienced considerable success as a part of the Richland County business community,” Andrew Lee, IMCS CEO, said in a news release. “The tax incentives provided by the county will allow us to continue investing in people, capital equipment and facilities to expand our company and increase economic development in the county.”
Richland County Council approved a special source revenue credit to reduce property taxes for IMCS by 35% over a 10-year period.
“County Council is always eager to support growing businesses in Richland County, and it is especially exciting to watch a company like IMCS get its start here and achieve so much,” Paul Livingston, county council chair, said. “The investment and new jobs IMCS is bringing to our community will benefit our residents and are evidence of the type of success businesses can achieve here.”
IMCS’ enzymes are used in drug-testing labs, and drug discovery labs use the company’s micro separations products to discover antibodies that can be used to fight diseases such as COVID-19. IMCS is using the federal grant to scale up production of new enzymes that will be used to make therapeutic drugs for treating neurodegenerative diseases such as Parkinson’s and Alzheimer’s.
The grant is funding research into the production of affordable gangliosides, biomolecules that contain sugars and a type of lipid called ceramides and play critical roles in various biological processes.
In addition to its headquarters in Richland County, IMCS bought a second nearby facility in 2019 and anticipates purchasing a larger building in the county in the future, according to the release from Richland County. IMCS is combining the existing facilities to ramp up production and delivery of its products to pharmaceutical companies worldwide.
“We were a USC IdeaLabs incubator company and have continued to grow in the county over the past seven years,” Lee said. “As we look to expand our operation to a third facility, it is only natural that we would want to do so here.”
The new investment and jobs will be split between IMCS’ Irmo headquarters and the new facility.
Founded in 2013 by three Ph.D. scientists from the University of South Carolina, IMCS now has 40 full-time employees, with 600 clients in every U.S. state and in 15 countries.
SCBIO CEO Konduros Accepts New Leadership Position, COO Erin Ford Appointed Interim CEO by SCBIO Board of DirectorsErin Ford named SCBIO Interim CEO as Konduros accepts private sector position see more
Exiting CEO credited with reinvigorating organization, building team and investor base to “take South Carolina life sciences to an entirely new level”; SCBIO to conduct national search for new CEO
SOUTH CAROLINA – April 7, 2021 – SCBIO Chief Executive Officer Sam Konduros – who has led the rejuvenation of South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, innovating and growing the life sciences industry in the Palmetto State for four years – is stepping down from his current role in May to pursue “an extraordinary private sector opportunity in the life sciences and healthcare space,” the organization’s Board of Directors has announced.
Konduros is departing SCBIO to serve on the Board of Directors of Charleston-headquartered Vikor Scientific, and as Chief Executive Officer of a new health innovation company focused on delivering a novel blueprint to the healthcare marketplace, powered by AI and blockchain technologies and focused on science-based personalized medicine strategies to solve some of the nation’s most pressing healthcare challenges. The soon-to-be identified organization will be revealed in May 2021 and will be part of the Vikor Scientific growing portfolio of companies. Vikor Scientific, led by co-Founders Scotty Branch and Shea Harrelson, is a prominent national brand among SCBIO’s Board and 140+ investors and organizational members, that has experienced explosive growth over the past 3 years.
Konduros is working closely with SCBIO’s board leadership on a carefully designed transition strategy. SCBIO’s world class board – comprised of top executives from industry, economic development, healthcare, research, government and higher education – will begin the search for Konduros’ successor immediately with SCBIO Executive Vice President and Chief Operating Officer Erin Ford assuming day-to-day responsibilities and reporting to the board once Konduros officially departs in early May.
“Sam Konduros has been a force – for economic development, for life sciences and for the long-term prosperity of South Carolina,” said SCBIO Board of Directors Chair Lou Kennedy, also the CEO of Nephron Pharmaceuticals. “It has been an honor to work with him, he has made a remarkable impact on this organization, and he leaves it better than he found it, as one of the most influential associations in the state. We thank Sam for the service and sacrifice he has given to SCBIO, and we wish him all the best.”
As Executive Vice President and Chief Operating Officer, Ms. Ford has served as primary lead for SCBIO’s business operations and finances, championing investor relations and existing industry strategies, and spearheading integrated marketing initiatives. She has managed the majority of the organization’s day-to-day requirements since joining SCBIO in 2017. She will assume the role of Interim CEO of SCBIO effective May 1st.
“Serving as President and CEO of SCBIO has been a true honor, and one of the great highlights of my career to date. It is bittersweet to depart in the midst of such incredible progress, but the organization has never been on more solid footing with strong finances, an amazing team, and a world-class Board of Directors to lead it forward. I will remain committed to its success for years to come in my new role, as I directly join the beloved industry that I have striven to serve and support in recent years. I am beyond grateful to SCBIO’s Board and to my new employer, Vikor Scientific, for the extraordinary opportunities that I’ve received,” said Konduros.
During Konduros’ tenure, SCBIO has more than doubled membership and quadrupled revenues, implemented a strong economic development focus, and launched a new innovation platform. It also 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. In a recent proclamation followed by an executive order issued last week, Governor Henry McMaster has formally authorized SCBIO and the state’s Commerce Department to work together to accelerate the onshoring and repatriation of the pharmaceutical industry and vital PPE products and technologies to South Carolina.
“SCBIO has worked diligently to help 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. Sam has been an incredible contributor to this effort, and we intend to build on our Board’s, team’s and his vision to build, advance and grow life sciences in our state.”
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 also represents a significant economic development focus for the state, with strong life science recruiting initiatives led by the South Carolina Department of Commerce and other regional economic development teams.
South Carolina life sciences has seen a near-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.
For additional information on SCBIO, please visit www.SCBIO.org.
DPX earns SBIR grant see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.
RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.
DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.
The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*
* Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
Life sciences company establishes diversity internship program see more
The ISPE Foundation and Nephron Pharmaceuticals Corporation announced a partnership on the ISPE Foundation Diversity Internship Program's newest cycle to provide world-class opportunities to groups that are typically underrepresented in the pharmaceutical industry.
Established December 2020, the pilot ISPE Foundation Diversity Internship Program received a strong response from applicants. This series with Nephron will be a 12-week experience that offers graduate and undergraduate students in their junior or senior year the opportunity to spend the summer working on priority projects for one of the fastest-growing pharmaceutical companies in the country.
“I am delighted and honored to announce the partnership of Nephron Pharmaceuticals with the ISPE Foundation on its Diversity Internship Program,” said Antonio Moreira, PhD, ISPE Foundation Board Chair, Vice Provost, Academic Affairs, University of Maryland Baltimore County. “Over the coming years, a diverse pool of very talented students will be engaged in a variety of technologically stimulating projects under the guidance and mentorship of Nephron Pharmaceuticals scientists and engineers. These life changing experiences will inspire the interns to continue pursuing the many career opportunities that the pharmaceutical industry offers to these future leaders.”
“We pride ourselves on two things: first, we do everything we can to make sure that everyone has a chance to achieve their dreams, and second, we utilize interns and apprentices in everything we do – they are playing key roles in our expansion and growth,” said Lou Kennedy, CEO, Nephron. “This is why I am so excited to partner with the ISPE Foundation to rollout these new internship opportunities. They represent a win-win – for participants and for our company. We are proud to invest in talented young people, and we are excited they want to invest in us. We cannot wait to get started.”
There are currently multiple internship opportunities through the ISPE Foundation-Nephron partnership, including in the following departments:
- Analytical Services and Formulation
- Molecular Biology
The individuals participating in these internships will play key roles in Nephron’s ongoing projects. They will work directly with the entire Nephron team. And they will make a difference for patients across America.
The deadline to submit is 6 May 2021. To learn more, please visit ISPEFoundation.org/Diversity-Internship-Program.
About ISPE and ISPE Foundation
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its 18,000+ Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. Founded in 2017 as the philanthropic arm of ISPE, the ISPE Foundation supports education, training, and research for the advancement of innovative technologies and provides solutions to global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world. To aide in this endeavor, the Foundation focuses on initiatives related to increasing the technical knowledge of the incoming workforce, fostering diversity within the industry, and supporting efforts to bring quality pharmaceutical manufacturing to new markets. Visit ISPEFoundation.org for more information.
About Nephron Pharmaceuticals Corporation
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs.
Inquiries related to the program may be directed to Foundation@ISPE.org.
USC adds accolades for its medical school see more
The University of South Carolina School of Medicine Columbia is the top medical program in the country for graduates who are practicing in areas where there is a shortage of health care professionals, according to the latest U.S. News & World Report’s Best Graduate School rankings.
The medical school’s distinction is part of the U.S. News rankings released March 30; the rankings show that UofSC is now home to more than 60 nationally ranked programs.
Among those is the International MBA program in the Darla Moore School of Business, which retained its No. 1 ranking for the eighth consecutive year.
“From meeting the health care needs of South Carolina’s underserved communities to preparing graduates to excel in careers in all corners of the world, these rankings demonstrate the work our faculty, staff and students do each day to improve the lives of people across the state, nation and world,” says William Tate, the university’s provost and executive vice president of academic affairs.
The School of Medicine’s No. 1 ranking fulfills the university’s mission by providing doctors for underserved areas, sometimes referred to as “medical deserts.”
The Columbia med school also ranks No. 45 for the number of doctors practicing in primary care specialties and No. 54 for graduates practicing direct patient care in rural areas. The School of Medicine is ranked No. 76 nationally in primary care, improving 14 spots from last year’s U.S. News rankings.
“We are proud to be producing graduates who are committed to providing exceptional patient care to underserved communities,” says Dr. Les Hall, dean of the UofSC School of Medicine Columbia. “Our school was established to create a pipeline of quality health care professionals for South Carolina. These rankings are a clear illustration that we are achieving that mission and more.”
The Moore School continued its reign as the highest ranked international business master’s program in the country. The International MBA has been ranked in the top three for 32 straight years.
The university’s ranked graduate and professional programs include diverse areas of study in the sciences, humanities, technology, engineering, health sciences, law and business.
Other highlights from the new rankings include:
- No. 7 for school library media.
- No. 9 for services for children and youth.
- No. 17 for library and information studies.
- No. 23 for criminology program.
- No. 25 for part-time MBA.
- No. 25 for nuclear engineering.
- No. 25 for speech language pathology.
Gov. Henry McMaster Announces New Economic Development Initiative to Expand Recruitment of Pharmaceutical Companies, Shore Up Emergency Supply ChainsGovernor provides strong support for growing life sciences in state see more
In front of several dozen business leaders, executives and media members at Bausch and Lomb in Greenville today, Governor Henry McMaster today issued Executive Order 2021-17, which directs the Department of Commerce to enhance recruitment efforts of pharmaceutical and medical supply manufacturers in South Carolina and directs state agencies to focus procurement efforts of medicines, medical devices, and medical supplies on those made in South Carolina. The new initiative will safeguard South Carolina from supply chain disruptions experienced during the COVID-19 pandemic by working to manufacture even more essential, life-saving products in South Carolina.
“This last year has made it very clear that relying on China for life-saving medical supplies is a risk we can no longer afford, and South Carolina can lead the way when it comes to bringing the manufacturing of those products back home to the United States," said Gov. Henry McMaster. “By successfully recruiting pharmaceutical and medical manufacturing companies to invest and locate here, we will bring good, high-paying jobs for our people and reliable access to the critical supplies we may need in an emergency.”
The Department of Commerce will work directly with SCBIO on the new initiative. SC BIO is a statewide, not-for-profit life sciences and economic development organization formed to promote and expand South Carolina’s life sciences industry.
“As a major driver and diversification of South Carolina’s growing economy, the surging impact, reach and significance of the multi-billion dollar life sciences industry in our state certainly warrants the strategic emphasis being placed on it by Governor McMaster,” noted SCBIO President and CEO Sam Konduros. “We’re honored by the Governor‘s profound support, and this bold Executive Order further demonstrates his ongoing commitment to empower our statewide mission to build, advance and grow the life sciences and pharmaceutical industry in the Palmetto State like never before.”
To further investment and job creation from businesses in the pharmaceutical industry, the governor’s Order directs the South Carolina Department of Commerce to:
- Prioritize and enhance ongoing economic development and recruitment efforts by identifying, encouraging, and incentivizing pharmaceutical and medical supply manufacturers, both international and domestic, to locate research, development, and production facilities within the State of South Carolina.
- Develop and execute international and domestic marketing campaigns that promote the State of South Carolina as a global leader in this Sector.
- Facilitate, assist, and incentivize growth, expansion, investment, and employment opportunities at existing businesses and industries in the Sector located within the State of South Carolina.
- Identify and advocate for statutory or regulatory changes or enhancements to the state’s existing economic development mechanisms for new business and industry investment or expansion in the Sector.
The Order also directs the Department of Commerce to review its existing operations and organizational structure to determine whether any changes would assist with the recruitment of pharmaceutical companies and to recommend any needed modifications to the General Assembly, if statutory authority is required to make them.
To further ensure supply chain security, the governor’s Order calls upon state agencies to prioritize South Carolina-made products in the procurement of medicines, medical devices, and medical supplies. The move will benefit existing businesses and will give Commerce another resource to attract additional life science investment into South Carolina.
Ahead of Spring Break, Makers of ZShield Product Line Offer Easy Way to Stay Safe, Avoid Coronavirus see more
Digital manufacturing company ZVerse, Inc., makers of the award winning ZShield line of face shield and face mask products, has launched a public service campaign aimed at promoting the best way to stay protected against the COVID-19 virus.
As Spring Break approaches and coronavirus cases remain high across the U.S., ZVerse is recommending a "Good-Better-Best" model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
ZVerse is recommending a “Good-Better-Best” model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
The simple model recommends wearing a face mask as a minimum, or good level of protection, followed by a face mask and a face shield combined for better protection. The best protection comes with wearing a filtered face mask combined with a face shield, according to the ZVerse model.
"Experts are warning of a new pandemic wave if people let down their guard during the upcoming Easter and Spring Break holidays and fail to protect themselves and their loved ones," said ZVerse Founder & CEO John Carrington. "At ZVerse, we have learned so much from our own customers and our own product development journey about how to stay safe. So, we created what we hope is a simple and easy guide for COVID-19 protection."
In addition to raising public awareness, ZVerse is recommending its model to city and state officials looking for an easy way to keep citizens safe.
"ZVerse has been a valuable member of South Carolina's business community for many years, and they really stepped up when they received the call to help combat the COVID-19 pandemic," said Columbia Mayor Steve Benjamin. "Their "Good-Better-Best" model is exactly what we need to not only further the decline of COVID-19 cases, but also build toward a return to normalcy where we work, learn and play in our local communities."
ZVerse designs, manufactures and sells a complete line of acclaimed PPE products popular with consumers, schools, employers and government entities - and often seen covering famous faces across Hollywood
For information about ZShield products and pricing, visit: https://zshield.com/collections/available-products.
ZVerse was founded in 2013 by John Carrington in Columbia SC. ZVerse, a digital manufacturing ecosystem, currently provides the only CAD as a Service (CADaaS) platform and designer marketplace. ZVerse recently launched the next generation of its Digital Manufacturing Enablement (DME) platform, an AI drive workflow solution - a category defining technology for digital manufacturing and OEMs. In 2020, in response to the COVID-19 pandemic, ZVerse adapted its business model to quickly produce and distribute its new personal protective equipment product, ZShield, to hundreds of thousands of citizens. To learn more visit zverse.com and zshield.com.
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.
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.
$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.
"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
Study shows diagnostic test effective for providing conclusive genetic results see more
GREENWOOD, SC – The Greenwood Genetic Center (GGC), working with collaborators at Lawson Health Research Institute in Canada and the University of Amsterdam, published a study this month that provides clinical validation of EpiSign, a molecular genomics test that diagnoses rare, heritable neurodevelopmental conditions. GGC has been the sole US laboratory provider of this novel diagnostic test since 2019.
EpiSign analyzes changes that affect gene expression rather than the gene sequence. Researchers have found that certain genetic disorders display unique genomic patterns, or epigenetic signatures, allowing for a diagnosis through EpiSign when traditional genetic testing has been uninformative.
The laboratory testing in the US is performed at GGC while the analysis of the results is performed using machine learning at Lawson where the EpiSign Knowledge Database was developed. This database compiles information on rare genetic diseases using laboratory analyses of the epigenetic signature from patients with suspected genetic abnormalities.
The current study analyzed data from early EpiSign testing to validate the ability of the novel test to make a diagnosis. Epigenetic signatures have been identified for over 40 genetic disorders.
The analysis studied EpiSign test performance and diagnostic yield in 207 subjects from two different cohorts. A targeted group included patients with previous genetic findings that were ambiguous or inconclusive. The second screening group was those with clinical findings consistent with hereditary neurodevelopment syndromes but with no previous genetic findings.
“Of the 207 subjects tested, 57 were positive for a diagnostic episignature including 48 in the targeted cohort, and 9 in the screening cohort. Only four remained inconclusive after EpiSign analysis,” says Dr. Bekim Sadikovic, lead researcher at Lawson and Scientific and Clinical Director of the Verspeeten Clinical Genome Centre at London Health Sciences Centre (LHSC). “This gives us strong evidence for the clinical use of EpiSign, as well as the ability to provide conclusive findings in the majority of subjects tested.”
While currently there are limited treatment options associated with many of these conditions, providing a diagnosis can help physicians better predict the course of the disease, and allows for better planning and support for the patient. EpiSign is the only test in the world that has been clinically validated for epigenetic testing for these types of genetic disorders, and in the US, is only available through GGC.
“Patients with rare diseases often wait years and undergo numerous exams and tests before receiving a correct diagnosis, if one is found at all,” says Matthew Tedder, PhD, staff scientist at the Greenwood Genetic Center, who was involved in the study. “EpiSign provides an additional high-yield diagnostic tool for clinicians to include in their evaluation of patients with undiagnosed diseases, providing better medical management for patients and hope for their families.”
The study, “Clinical epigenomics: genome-wide DNA methylation analysis for the diagnosis of Mendelian disorders", is published in February’s Genetics in Medicine.
For more information about EpiSign, visit, www.ggc.org/EpiSign.
Vikor Scientific and Quantgene Partner to Launch SerenityTM -- Ground-Breaking Advancement in Precision Genomics, Personalized MedicineFounders 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, 2021 – Vikor 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.”