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.
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.
Diversified Medical Healthcare Celebrates One Year Since FGDA Validation of State's First COVID-19 Testing LabCompany has processed over one million COVID tests see more
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical, has provided leading-edge solutions to combat COVID-19 nationally, addressing supply chain gaps and infrastructure restrictions caused by the virus. Their molecular diagnostics laboratory, PMLS, became the first lab in South Carolina validated as an independent COVID-19 testing lab one year ago. Just as PMLS achieved this validation for testing shortly after the first case was reported in the US, they continue to meet demands caused by COVID-19 as they arise with their laboratory staff of over 360 employees and in-house research and development team of Ph.D. scientists. Along with large scale testing via state of the art automated lab equipment, DMH companies developed advanced software for most efficient data management, distributed customized PPE supply kits, and manufactured COVID-19 testing kits as well as viral transport medium that properly preserves specimens during transit.
“Since COVID-19 became a threat to our nation, we quickly streamlined our workflow, hired employees, validated various coronavirus assays, and purchased the equipment needed to test a large volume of specimens with the highest quality standards,” said Kevin Murdock founder of Diversified Medical Healthcare. “With our laboratory having one of the highest testing capacities in the nation, an in-house medical manufacturing firm, a lab equipment company, and data management software company, we feel that it’s imperative to do our part to help keep the country open and our citizens safe.”
At this one year mark, PMLS has processed over one million (1,000,000) tests to determine COVID-19 results for patients nationwide. With their highly advanced laboratory information management system (LIMS) created by OnGen, data is communicated directly from high throughput laboratory equipment for fast, accurate storage and delivery of data to healthcare providers and patients. Many of PMLS’ lab processes are automated to allow them a testing capacity of 300,000 tests per day. With this scalability, PMLS has enabled other laboratories and testing sites to increase their testing capacity and turnaround of results with Virtual Lab. An innovative COVID-19 testing solution to overcome laboratory infrastructure restrictions, Virtual Lab allows these facilities to utilize PMLS’ fully-automated robotic workflow and team of 360 employees to largely increase their testing capacity and efficiency while bypassing the need to purchase new equipment or endure waiting time of weeks or more for shipping, installation, and validation. Along with helping other labs, hospital systems and large organizations to test more patients, Diversified Medical Healthcare has 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.
As another means to aid laboratories, healthcare systems, and large organizations in the expansion of their COVID-19 testing, Vessel Medical offers Lab in a Box, turnkey lab equipment 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. Developed by leading scientists and technicians in partnership with Hamilton Company, Thermo Fisher, and Grenova, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. With precision robotic instruments, lab in a box includes high throughput liquid handling along with automated, custom-programmable pipetting that decreases human error and result turnaround time.
Another DMH company, CPT Medical, shifted their production of surgical supplies to include manufacturing of COVID-19 testing kits since the beginning of the pandemic. CPT Medical is now capable of manufacturing 60,000 test kits per day and works in conjunction with PMLS to offer customizable testing to large organizations. Some of the large organizations that PMLS has partnered with as the official COVID-19 testing lab are 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. PMLS is also the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina and is the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina. Through all of these partnerships, PMLS has continued in their reputation of delivering the most advanced testing with rapid, reliable results, and diligent customer care.
Now, as vaccines are administered and restrictions on social distancing are being lifted, PMLS is conducting a critical large scale genomic sequencing for the surveillance of new COVID-19 variants, taking proactive measures so that a future surge of a mutated Sars CoV-2 strain is less likely to occur. The data collected from genomic sequencing can help pharmaceutical companies to stay ahead of the variants and make any changes needed to the current vaccines and treatments for higher efficacy and best patient outcomes. With PMLS’ high throughput genomic sequencers and library prep instruments that automate the library prep and sequencing process, a much higher capacity for genomic sequencing is achieved and margins of human error are drastically reduced. By sequencing an exponentially higher amount of specimens, PMLS is better equipped to provide meaningful analysis with larger amounts of data and faster turnaround times for the effective surveillance of SARS-CoV-2. PMLS is in discussions with the CDC and multiple states across the nation to provide COVID sequencing services at ports of entry and local and regional hotspots. Along with this and their previous accomplishments, more groundbreaking COVID-19 solutions by Diversified Medical Healthcare are soon to be announced.
For more information, please visit www.divmedinc.com or call 866-521-7541.
Orangeburg, SC bio-ag facility included as part of acquisition see more
Syngenta Group has announced the acquisition of Valagro, a leading Biologicals company, by its business unit Syngenta Crop Protection. The investment positions Syngenta Crop Protection as one of the key global companies poised to shape the rapidly growing Biologicals market, which is set to nearly double in size over the next five years. Valagro will continue to operate as an independent brand in the market within the Syngenta Crop Protection business.
Valagro, a leader in the development, production and marketing of biostimulant and advanced nutrient solutions for cash and row crops, began construction of its Orangeburg, South Carolina plant in October 2019 with a groundbreaking ceremony, which was attended by members of the local community, esteemed guests, state representatives, as well as members of federal government. Consistent with Valagro’s commitment to innovation, the now-operational plant has introduced cutting-edge technologies for the production of plant biostimulants and chelated micronutrients in the United States. The opening of the production site also created nearly 50 new advanced manufacturing jobs.
Valagro is a market-leading producer of innovative Biologicals, with a ~10% CAGR from 2009-2019 and an approximate revenue of $175m in 2019. The company has excelled by harnessing the power of nature to provide innovative and effective solutions for plant nutrition and care. With 40 years of experience, it offers its customers a comprehensive crop portfolio in Biologicals with a market-leading position in biostimulants and speciality nutrients. Headquartered in Atessa, Italy, Valagro serves customers around the world with a strong presence in Europe and North America, as well as a growing footprint in Asia, including China, and LATAM. Valagro has over 700 employees, 13 subsidiaries and 8 production sites around the world, with a portfolio backed by best-in-class biological R&D, production and commercialization capabilities.
This strategic acquisition enables Syngenta Crop Protection to build a world-leading Biologicals business. Valagro has a strong commercial and production standing, as well as an industry-leading technology and research capacity. Valagro's well-established portfolio in biostimulants and specialty nutrients will complement both Syngenta Crop Protection's current range of biostimulants and biocontrols, as well as its future pipeline of biological solutions. Biocontrols and biostimulants, natural solutions for pest, disease control and crop improvement, are increasingly important for farmers worldwide in their efforts for sustainable agricultural production. This acquisition is fully in-line with Syngenta Crop Protection’s strategy to provide growers with additional complementary choices of products and technologies in order to effectively and sustainably care for their crops by managing resistance, enhancing soil health, reducing residues in crops, and addressing consumer demands.
Erik Fyrwald, CEO of Syngenta Group stated: “We are looking forward to welcoming the Valagro team to Syngenta Group. This acquisition underlines our growth ambitions in this area and positions us as one of the strongest players in the global biologicals market. The investment also forms part of our $2 billion commitment to help farmers address the effects of climate change and improve agricultural sustainability as part of our Good Growth Plan.”
Giuseppe Natale, CEO Valagro said: “For 40 years our mission at Valagro has been to harness nature in order to help farmers achieve higher yields and grow better quality crops. This agreement will open up new, previously unimaginable growth prospects for the Valagro group worldwide. Now that we are part of a company with the resources and ambition of Syngenta Crop Protection, we have exciting new opportunities for our innovation to better deliver even more options for farmers and to invest even more effectively in the sustainable future of agriculture.”
Jon Parr, President Global Crop Protection at Syngenta noted: “Significant levels of investment in innovations such as Biologicals are necessary in order to deliver a sustainable future and help farmers deliver a food system working in harmony with nature. Syngenta Crop Protection and Valagro have a foundation in science-based innovation and are eager to collaborate, share knowledge and build on each other’s capabilities. By fostering the entrepreneurial spirit and culture of Valagro, powered by our global scale and capability, together we will shape the future of the agricultural Biologicals market.”
The financial terms of the transaction are not disclosed.
About Syngenta Group
Syngenta Group is one of the world’s leading agriculture innovation companies, with roots going back more than 250 years. Its 48,000 people across more than 100 countries strive to transform agriculture through breakthrough products and technologies that play a vital role in enabling the food chain to feed the world safely, sustainably and with respect for our planet. Swiss headquartered and Chinese-owned, the Group draws strength from its four business units – Syngenta Crop Protection headquartered in Switzerland, Syngenta Seeds headquartered in the United States, ADAMA headquartered in Israel, and Syngenta Group China – that provide industry-leading ways to serve customers everywhere.
$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.
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 email@example.com.
For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.
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.”
SCBIO, industry honored by Governor during record-setting virtual annual conference see more
South Carolina Gov. Henry McMaster
Proclamation – Feb. 15, 2021
WHEREAS, South Carolina has cultivated a cutting-edge life sciences sector with an annual economic impact of more than $12 billion dollars; and
WHEREAS, more than 800 firms and over 43,000 professionals are directly involved in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products; and
WHEREAS, since 2017, the life sciences sector has become South Carolina's fastest- growing industry, with employment growing at double the rate of South Carolina's economy as a whole; and
WHEREAS, SCBIO is the organization exclusively focused on attracting new life science sector jobs and investment to South Carolina; and
WHEREAS, during the COVID-19 pandemic, more than 100 life sciences organizations across South Carolina worked together to support and promote the procurement and distribution of personal protective equipment, support and implement COVID-19 testing and expedite health solutions for our citizens; and
WHEREAS, in collaboration with the South Carolina Department of Commerce and SCBIO, South Carolina's economic development recruitment efforts shall include an enhanced emphasis and focus on attracting, building, advancing, innovating and growing existing and new life sciences businesses in the state.
NOW, THEREFORE, I, Henry McMaster, Governor of the great State of South Carolina, do hereby proclaim February 15-19, 2021, as
SCBIO LIFE SCIENCE WEEK
throughout the state and encourage all South Carolinians to recognize and appreciate the many contributions of the life sciences industry to South Carolina's health and economic prosperity.
Governor McMaster Issues Proclamation Recognizing South Carolina Life Sciences Week to Celebrate State’s Fastest-Growing IndustryGovernor salutes industry during record-setting SC Life Sciences Conference see more
SOUTH CAROLINA – February 16, 2021 – In recognition of the importance of the life sciences industry in South Carolina, Governor Henry McMaster today issued a proclamation recognizing February 15-19, 2021 as South Carolina Life Sciences Week in the Palmetto State.
Governor McMaster made the announcement just steps from where SCBIO organizers were putting the finishing touches on Day 1 of the largest-ever life sciences gathering held – virtually of course -- in the state. A record 600 registrants from across America and around the globe are attending the virtual SCBIO gathering of South Carolina’s life sciences community – and celebrating the contributions of its 800+ organizations in helping America and the world overcome the challenging COVID-19 pandemic.
“South Carolina has developed a strong reputation as an emerging leader in the life sciences,” said Governor McMaster. “Our innovative companies and exceptional workforce are key drivers in strengthening our economy and creating new opportunities for South Carolinians. With an incredible pace of growth in the industry here, we know that the life sciences will continue to play a critically important role in our state’s economic success for generations to come.”
Governor McMaster made the proclamation in downtown Greenville, in the heart of the county which possesses the state’s largest concentration of life sciences companies, although the industry boasts life sciences organizations in 42 of South Carolina’s 46 counties currently. Governor McMaster was flanked by leadership and Board members of SCBIO, South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, innovating and growing the life sciences industry in the state.
Life sciences has a $12 billion economic impact in the Palmetto State, with more than 800 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 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.
“Life sciences is a major driver of South Carolina’s economy today, and this conference is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and country,” noted SCBIO President and CEO Sam Konduros. “We’re honored by Governor McMaster’s recognition, and appreciate his personal support for the contributions that life sciences are making to improve quality of life, care and economic standing for South Carolina citizens.”
For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.
Producing and shipping 10,000 Rapid COVID-19 antigen test kits for King of Hammers racing event see more
Vigilent Labs, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has completed and shipped its first major order of Alfa Scientific Instant-View COVID-19 Antigen Test Kits for use in the King of Hammers racing event.
”We have worked diligently for months to progressively and proactively execute the safest off-road racing event possible, and we could not have held this event without the help of Vigilent Labs,” said Dave Cole, Lead for the King of Hammers Race and President of Hammerking Productions. "Our innovative partnership with Vigilent Labs enabled us to navigate public health requirements and deploy a comprehensive digital COVID monitoring solution for pre-screening our racing event attendees to ensure their health and safety."
This project marks an important milestone for Vigilent Labs and the South Carolina life science sector as the company recently announced that it is investing more than $104.6 million and will create over 400 new jobs at its state-of-the-art COVID-19 test manufacturing facility in the Charleston Navy Yard.
"Our Vigilent Labs Medical Systems technology platform is the first digital health credential connecting a real person to a rapid COVID test, taking health surveillance to the Next Level,” said John Falk, President of Vigilent Labs. “With the outstanding support from the entire FedEx organization, we were able to quickly get these important COVID-19 test kits into the hands of the King of Hammers organizers, enabling their public event to go forward in California."
The cost-effective rapid antigen tests, which produce fast and accurate results in seven to 10 minutes, are CE-marked and pursuant to CDC guidance, useful for COVID-19 screening and surveillance. The kits will be immediately put to use by the King of Hammers Racing event, which is being held from January 28 to February 6, 2021, in San Bernardino County, California, to pre-screen attendees for COVID-19. This event is the first widely attended event to deploy the Vigilent Labs’ v.PASS digital credential, the company’s state-of-the-art health monitoring solution, to ensure adherence to increased federal, state and local safety guidelines.
“We take pride in our dependable, fast and efficient transportation mechanisms, which enabled us to help Vigilent Labs to deliver these COVID-19 antigen tests,” said Elizabeth Tonelis, FedEx Sales Executive.
To learn more about Vigilent Labs’ solutions for COVID-19 testing and monitoring, visit www.vigilentlabs.com.
About Vigilent Labs
Vigilent Labs is an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats. The company provides point-of-care (POC) medical testing devices, initially centered on the COVID-19 pandemic, paired with a comprehensive digital health and credentialing platform that offers near real-time tracking of disease. Founded in 2019, Vigilent Labs is headquartered in Charleston, South Carolina, with additional manufacturing and production facilities in Laramie, Wyoming and throughout the United States. For more information, visit https://vigilentlabs.com/.
Nephron, Lexington County businesses step up again see more
WEST COLUMBIA — Nephron Pharmaceuticals CEO Lou Kennedy watched proudly from her office window as a company security guard rushed out to help a woman with a hot pink walker from her vehicle into the West Columbia drug company’s headquarters.
Having found the location on the state Department of Health and Environmental Control’s website, the woman was there to receive a COVID-19 vaccine.
Nephron, along with Cayce-based Dominion Energy and two Lexington County road sign companies, Stay Alert Safety Services and Optec Displays, are donating time and services to put on a free drive-thru vaccine clinic. Eligible participants, age 65 or older, must have an appointment to receive a shot.
“I’m so proud we can do this,” Kennedy said.
While the vaccine itself is free, providers are legally able to bill people or their insurance for the doctor or pharmacy visit. Nephron is not charging.
With about 30 nurses on staff and almost as many doctors of pharmacy, the West Columbia drug maker applied for the certification needed to give the shots and administered its first 500 doses to Lexington County seniors inside its building over the week of Feb. 1.
It has 1,000 more doses to start giving out on Feb. 8, this time without people having to get out of their vehicles in an effort to make recipients more comfortable, Kennedy said.
When she first had the idea, she called Keller Kissam, president of electric operations at Dominion Energy South Carolina, to ask if they could use the power company’s vehicle turnaround area. Dominion’s headquarters a 10-minute drive from Nephron.
“Keller didn’t even hesitate,” Kennedy said. “It was ‘What can we do? How do we help?’ You talk about community spirit.”
In addition to the drive-thru space, Dominion is providing power to the site to power the computers needed to make appointments for recipients’ second doses. Stay Alert, Optec, as well as the town and county of Lexington are providing signage.
Those wishing to receive a vaccine from Nephron can go online to DHEC’s website in order to sign up for an appointment.
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.
Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more
IRMO, S.C. -- January 26, 2021 -- Integrated Micro-Chromatography Systems, Inc. (IMCS), known for their expertise in developing recombinant proteins and enzymes, has been awarded a $900,000 Small Business Innovation Research (SBIR) Fast-Track grant from the National Institutes of Health (Developing Chemoenzymatic Strategies, Enzymes, and Kits for Accessible and Affordable Gangliosides).
Under this grant, IMCS expands enzymes, reagents, and methods for animal component-free manufacturing of various gangliosides. This award funds research into the production of affordable gangliosides and kits that will enable researchers to establish the potential of ganglioside-based diagnostics and therapeutic interventions. The grant will be headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS in conjunction with Xi Chen, Ph.D., Professor at the Department of Chemistry, University of California, Davis.
Gangliosides are biomolecules that contain sugars and a particular type of lipids, or ceramides. Analogous to biological antennae in cells, gangliosides are involved in critical roles across multiple biological processes, making them ideal for therapeutic applications. With this research grant, IMCS will provide the broader scientific community access to affordable reagents and tools to synthesize and modify various gangliosides, thereby enabling researchers to understand how these biomolecules affect neurological functions.
Ronald Schnaar, Ph.D., Professor of Pharmacology at the Johns Hopkins University School of Medicine likened the grant’s approach to building Legos. Schnaar, who is not involved in the grant, said that the technology presented features a very flexible system that would allow scientists to use molecular building blocks called glycans, to create a library of various gangliosides that could be used for a wide variety of research applications. “If you give us the pieces to build the Lego [structure], we can generate the tools to study anything from cell activity to testing potential therapeutics. You can use this to build anything. You can build a mimetic library.”
In addition to its portfolio of enzymes, IMCS provides technologies to pharmaceutical companies, academic medical centers, and contract research organizations to develop next-generation antibody and gene therapy technologies, such as those used to fight the COVID-19 pandemic.
Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R44GM139441. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Integrated Micro-Chromatography Systems, Inc (IMCS) is a privately held biotechnology company that strives to address the growing needs of clinical and research laboratories through innovative technologies and custom solutions designed to increase testing efficiency. IMCS creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology, academic research facilities, US Federal Government agencies, and health science companies in North America, Europe, and the Asia Pacific Region.