CRO sells to Singapore company see more
A Charleston-based medical firm that conducts clinical research for the biopharmaceutical industry is being acquired by a Singapore company that’s looking to expand its reach in the U.S. market.
Novotech, which has an office in Boston but has primarily provided contract-based clinical services in the Asia-Pacific region, will take on NCGS’ roughly 300 employee and a client base that has been built over the past 38 years. Financial terms of the sale were not disclosed.
The Charlotte Street company said on its website that it has conducted research for 80 approved drug, biologic, diagnostic and device products for the medical industry.
“We have a similar cultural fit and focus on excellence, so joining Novotech will be seamless for both ours and Novotech’s clients,” NCGS founder Nancy C.G. Snowden said in a written statement.
Snowden, a onetime owner of Carolina’s restaurant on Exchange Street in downtown Charleston, said the two companies have previously collaborated on research.
“NCGS focuses on complex areas of clinical development, oncology, hematology, infectious disease and CNS (central nervous system) in both adult and pediatric populations,” Snowden said. “Our lean organizational structure and nimble operational model with highly tenured staff have been specifically designed to overcome the challenges inhibiting our industry today. We have the ability to pivot in real time as the needs of the trial evolve.”
Novotech CEO John Moller said called the acquisition “a strategic move to provide U.S.-based expertise and infrastructure for our U.S. clients wanting trials” in both the Asia-Pacific and domestic markets, as well as for Asia-Pacific clients wanting to U.S. clinical programs.
“Clients will receive seamless service, with a unified approach to systems and standard operating procedures well developed,” he said.
Privately held NCGS is headquartered at 16 Charlotte St. on the peninsula’s historic Wraggsborough neighborhood. It bought the building for $4.95 million in July 2016, when the business was based on Broad Street, and spent $10 million on renovations before the site became operational in the spring of 2017.
NCGS is the third major acquisition for Novotech in recent years. The company in 2018 bought out the Clinical Network Services research group, which gave it a customer base in the U.S., New Zealand and Australia, according to a report by Endpoints News. In 2020, the company raised $59 million in venture capital to purchase London-based ASLA Venture, which had backed oncology-based companies Epsilogen and Oxford Biotherapeutics, according to Endpoints.
Prior to founding NCGS, Snowden was the senior nursing lead for a National Institutes of Health and National Cancer Institute grant at the Medical College of Georgia/University Hospital. She also established a community clinical oncology program at the hospital, and oncology trials were an early focus for her company.
MUSC ranked #30 among public institutions see more
The Medical University of South Carolina College of Medicine has been ranked No. 56 in Best Medical Schools: Research by U.S. News & World Report’s latest survey. The school tied with Georgetown University.
When ranked solely among other public institutions, MUSC came in at No. 30.
The U.S. News research rankings are based on federal expenditures, survey assessments completed by deans and senior faculty members at peer institutions, and entering class data, MUSC said. The magazine surveyed 192 accredited medical and osteopathic schools in the U.S. for this year’s rankings.
“This ranking is truly a testament to the dedication of our faculty, their leadership and their desire to make discoveries that can change the lives of patients,” said Lisa Saladin, MUSC executive vice president for Academic Affairs and provost. “Research is at the core of what we do as an academic health sciences center, and we believe it is an important component of medical education. Our faculty, students, trainees and staff are inspired to reach for the impossible every day, which is vitally important in a time where we’re more committed than ever to improving the health of all.”
MUSC was additionally recognized by U.S. News & World Report as nationally ranked in several adult specialties, including No. 17 in gynecology, No. 14 in ear, nose and throat and No. 39 in cancer. The institution also was ranked No. 6 in most graduates practicing in medically underserved areas.
In the most recent Best Children’s Hospitals Honor Roll, MUSC also ranked in pediatric specialties, including No. 12 in cardiology and heart surgery, No. 30 in pediatric nephrology, No. 42 in pediatric gastroenterology and gastrointestinal surgery and No. 44 in cancer.
Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more
South Carolina’s Integrated Micro-Chromatography Systems, Inc. (IMCS), a leader in recombinant enzymes and micro-chromatography technologies, was awarded $1.8 million for Phase II of its Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health/ National Institute of General Medical Sciences (NIH/NIGMS).
Combined with earlier SBIR funding, the grant will provide scientists access to affordable gangliosides that aid in developing therapeutics and diagnostics for neurological diseases including Huntington's Disease, Parkinson's Disease, and Alzheimer's Disease.
The NIH/NIGMS previously awarded IMCS a 4-year, $2.56 million Fast-Track Small Business Technology Transfer (STTR) grant to expand the glycan toolkit and build an extensive array of sialoglycans that advance glycobiology-related research. The combined Fast-Track grants for the projects now exceeds $5.25 million. These projects will provide the scientific community access to affordable, easy-to-use reaction kits to facilitate synthesis of various glycans to advance research into potential diagnostics and therapeutics for neurodegenerative diseases.
The SBIR project is headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS, along with Xi Chen, Ph.D., Professor of Chemistry at the University of California, Davis. The STTR project is in collaboration with Hai Yu, Ph.D., Project Scientist at the UC-Davis.
Glycobiology, the study of the biological impact of sugars, has gained momentum in recent years. The surfaces of viruses, bacteria, and cells of our bodies are decorated with unique sugars or glycans. Some viruses and bacteria can exploit glycans to wreak havoc on our bodies, while a lack of glycans can result in disease progression. Studies suggest that modifications to certain glycans in molecules related to the brain are implicated in the onset and progression of neurodegenerative diseases.
To date, the high cost of reagents and materials needed for glycobiology research have contributed to few tools to study glycans. Glycan-modified cell membranes (glycolipids) and gangliosides (a component of brain matter critical to research) must be harvested from pigs, sheep, and cows as there is currently no cost-effective manufacturing process. The biosynthetic manufacturing technology used for these projects will result in animal-free gangliosides.
Matthew Macauley, Ph.D., Assistant Professor of Chemistry at the University of Alberta, is eager to access significant quantities of gangliosides. "Some experiments with glycolipids are cost-prohibitive, but scalable and facile access to glycolipids would make such experiments financially feasible,” he noted.
While not involved in the grant, Dr. Macauley’s lab studies glycan-binding proteins called Siglecs and their impact on disease states such as Alzheimer’s. Noting that commercially available glycolipids do not capture the diversity needed in research, he notes that reaction kits funded by the grant could be “a tremendous help for a lab that doesn't have expertise with glycan synthesis and doesn’t want to invest in getting all these enzymes expressed.”
Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Numbers R44GM139441 and R42GM143998. 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 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 Government agencies, and health science companies around the world.
Heartbeat Technologies, Integrated Micro-Chromatography Systems, and Victory Exofibres were accepted see more
Heartbeat Technologies, Integrated Micro-Chromatography Systems, and Victory Exofibres were accepted as South Carolina Research Authority (SCRA) Member Companies. All SCRA Member Companies receive coaching, access to experts in SCRA’s Resource Partner Network, eligibility to apply for grant funding, and the potential to be considered for an investment from SCRA’s investment affiliate, SC Launch Inc.
Heartbeat Technologies LLC has been accepted as an SCRA Member Company. The Charleston-based startup is dedicated to improving cardiac arrest outcomes and developed a device called ‘The SAVER,’ to better perfuse the heart and brain during emergency events.
Integrated Micro-Chromatography Systems Inc has been accepted as an SCRA Member Company. The Irmo-based startup creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology organizations, academic research facilities, federal government agencies, and health science companies.
Victory Exofibres LLC has been accepted as an SCRA Member Company. The Greenville-based startup company produces super-efficient viral particle isolation kits that enable more efficient medical diagnostic testing.
SCRA welcomes these new Member Companies.
Grant funding is made possible, in part, by the Industry Partnership Fund (IPF) contributions that fuel the state’s innovation economy. Contributors to the IPF receive a dollar-for-dollar state tax credit, making it an easy and effective way to help one of the fastest growing segments of the South Carolina economy. Grant funding for Member Companies creates a direct, positive economic effect and job creation.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
SCRA continues successful run building state economy see more
South Carolina Research Authority (SCRA) marked a strong year in 2021. The impact on South Carolina’s innovation economy was over a billion dollars. The total amount includes jobs supported, the salaries of Member and Portfolio Companies, grant funding to companies and academic institutions, and investments made by its affiliate, SC Launch Inc. SCRA’s economic impact was recently published in its annual report, ScaleUP SC.
Included in the $1.003 billion impact are:
- 5,429 South Carolina-based jobs supported by SCRA programs and operations.
- $73,811 average salary of SCRA-supported companies, 53% higher than the state’s average of $48,097.
- $4.6 million in grants to advance research capabilities, commercialize technology, expand product offerings, and fund the costs for businesses relocating to the state.
- $2.2 billion in additional funding from venture capitalists, etc. to SC Launch companies since the inception of the program in 2006, with over $722 million received in 2021 alone.
“SCRA again has proven how important it is to our state’s economy. The funding and other support they provide to tech startups and academic institutions produce higher-paying jobs. This has a direct impact on our state’s economy. South Carolina is becoming a state known for its growing knowledge-based economy and SCRA is a major catalyst for this growth,” said Joey Von Nessen, PhD, University of South Carolina Research Economist who prepared the economic impact analysis.
Other 2021 highlights include several SCRA Member Companies and SC Launch Inc. Portfolio Companies scaling up after pauses due to the pandemic. Many increased staff, affecting job growth, and others expanded their physical operations. Some even moved their operations to South Carolina from other states.
“I often talk about how exciting it is to see innovation develop and grow in our state. We not only have a front row seat, but we also have the honor and responsibility to help it grow. Our team shares my passion and it’s evident in our daily activities. We may be funding a relocation to bring a technology-based company to South Carolina, providing a grant to a startup at one of our colleges or universities, or connecting an early-stage startup to a large industry leader to solve a technology problem, which creates significant growth for the startup or establishes a technology platform at the university. It’s all in a day’s work here at SCRA,” said SCRA Executive Director Bob Quinn. “With a vibrant entrepreneurial ecosystem, world-class universities, and thriving industry, we’re off to a great start this year as well.”
The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?Long term impacts of COVID-19 across the health care spectrum are still to be determined see more
Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.
The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.
The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.
Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.
COVID-19 Resulted in an Acceleration of the Clinical Research Process
When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future.”
As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.
A New Focus on the Clinical Research Participant
Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial.
Use of More Decentralized Clinical Research
A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by increasing both access to clinical trials and the overall diversity of trial participants. Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective.
Increased use of Digital Technology
The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies.
Is there a silver lining from COVID-19 when it comes to clinical trials?
The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.
For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.
Clinical laboratory investing over $3 million, creating 54 new positions see more
Luxor Scientific, LLC (Luxor), a full-service clinical laboratory serving customers nationwide, today announced plans to expand operations in Greenville County, South Carolina. The more than $3.2 million investment will create 54 new jobs.
Luxor is a CLIA and CAP-accredited, and DEA registered full-service clinical laboratory that specializes in infectious disease, immunology, integrated oncology and genetics, chemistry and hematology research. The company is comprised of recognized experts in providing cutting-edge scientific solutions to better serve the health care community.
“We are excited to continue Luxor Scientific’s growth and investment in Greenville. Our team has established itself as one of the best serving our community, and we are glad to be adding to our capability and to our numbers,” said Luxor Scientific, LLC Chief Strategy Officer Jay Flanagan. “We are ever thankful to Greenville County and the S.C. Department of Commerce for helping us make this expansion a reality.”
Located at 1327 Miller Road in Greenville, Luxor’s expansion will increase the company’s research and development capacity to better serve its clientele.
“Luxor’s expansion highlights the tremendous success life science companies are seeing throughout South Carolina,” stated South Carolina Governor Henry McMaster. “This investment will bring enhanced care and innovation to South Carolina’s health care community while also creating high-quality jobs in Greenville County.”
Luxor was founded in 2016 by brothers Ryan and Jay Flanagan, and has grown to more than 140 employees, including world-class PhD science officers on its staff. Among their clients are S.C. Department of Health and Environmental Control (DHEC), the S.C. Department of Agriculture, the US Drug Enforcement Administration, private sector employers, hospitals, universities, clinics, and others.
“When companies like Luxor Scientific operate in South Carolina and find success, it highlights the diversity of our state’s economy. We congratulate Luxor on this expansion in Greenville County and look forward to watching their continued work in South Carolina,” added Secretary of Commerce Harry M. Lightsey III.
The latest expansion is expected to be completed by April 2022. Individuals interested in joining the Luxor team should visit the company’s contact webpage.
“We are always pleased when a homegrown company like Luxor chooses to expand here in Greenville County, commented Greenville County Council Chairman and Greenville Area Development Corporation Board Member Willis Meadows. “Luxor’s leading-edge expertise in life sciences has made them a strong resource to our state and to communities across the country already, and we are delighted that they have chosen to continue that growth from right here in Greenville County.”
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The Greenville Area Development Corporation is a non-profit organization established by Greenville County Council to promote and enhance the economic growth and development of Greenville County. Since its founding in 2001, GADC efforts have resulted in the creation of over 30,000 new jobs, nearly $6 billion in capital investment, and a cumulative economic impact of over $55 billion in Greenville County, SC -- including an economic impact of more than $6 billion annually. To learn more, please visit www.goGADC.com or call (864) 235-2008. To learn more about workforce opportunities, visit www.jobsingreenvillesc.com.
Researchers awarded $120,000 grant see more
SC INBRE is pleased to announce that a team of South Carolina biomedical researchers has received an NIH NIGMS collaboration award. This goal of this one-year funding opportunity is to encourage collaborations between IDeA programs investigators while providing students a broad continuum of research opportunities. The team of Dr. Austin Shull from Presbyterian College and Dr. Antonis Kourtidis from the Medical University of South Carolina were awarded approx. $120,000 for their project. Dr. Shull is a current recipient of an SC INBRE Developmental Research Project Program (DRP) award; Dr. Kourtidis is a member of CDLD [Center for Biomedical Research Excellence (COBRE) in Digestive and Liver Disease]. This is the third consecutive year NIH NIGMS has offered collaborative awards and the third consecutive team from South Carolina to have received one.
As described in the project proposal, “Loss of epithelial integrity is common in cancer. However, mechanistic understanding of how compromised epithelial architecture promotes aberrant cell behavior, is still incomplete.” The collaboration team will be investigating a novel functional interaction between the adherens junctions, which are guardians of epithelial integrity, with ribonucleoprotein complexes, which has the potential to significantly advance their knowledge in the field. “Collectively, the experimental approach will aide in making considerable strides for understanding the downstream intracellular consequences that induce a mesenchymal-like cancer cell state when disrupting the adherens complex via PLEKHA7 suppression.”
Said the collaborators, “Since meeting at an SC INBRE Symposium in Columbia, SC in 2020, we have been in communication about initiating a collaborative research project between our labs which will advance our mutual interests in investigating the molecular consequences in disrupting cell-cell junction in epithelial cells that contribute to cancer progression. This collaborative project will support the long-term trajectory of our labs by leveraging our different research backgrounds and combining our technical expertise to address fundamental gaps in the field’s current knowledge about the molecular changes that take place during disruption of cell junctions. In addition, the findings from this project will serve as critical pilot data for a larger follow-up proposal to support this collaborative work.”
Presbyterian College undergrads will perform the vast majority of experiments and data analysis. Dr. Shull has a strong track record of mentoring undergrads with many students being leading presenters of their personal work at national meetings (ex: American Association for Cancer Research). Shull is fully committed to continuing his mentorship of undergrads and advancing their exposure to novel techniques, growing research areas, and quality experts within their respective fields through this collaborative project. For the first Aim of this project (COBRE Investigator-led efforts – Examine increased mRNA translation activity in PLEKHA7-depleted epithelial cells), Presbyterian College undergrads (along with Shull) will travel to MUSC to perform experiments under the training and guidance of Dr. Kourtidis. The students will be able to leverage the expertise of the MUSC Cell Models Core in developing gene-edited cell lines pertinent for the proposal. For the second Aim (INBRE investigator-led efforts – Determine the DNA methylation changes caused by translocation of PIWIL2 from the adherens junctions to the nucleus), Presbyterian College undergrads will perform experiments at Presbyterian College under the guidance of Shull with samples received from MUSC.
Arthrex, Clemson work to resolve workforce pipeline needs see more
As the biomedical industry continues to expand in South Carolina, so does Arthrex’s need for a specialized workforce.
Arthrex, a company engaged in the research, design and manufacture of minimally invasive surgical technology, announced in 2017 plans for its new $69 million facility and the creation of 1,000 new jobs in Sandy Springs. Kevin Grieff, Arthrex senior vice president of operations, said he expects to reach 1,000 employees by 2024.
A pair of programs with Clemson University helps bridge a divide between science and sales for the company’s future workforce.
Students like T.J. Biondolillo are also recognizing the need for more specialized education, especially when it comes to blending science and business.
“Both of the programs have helped my education immensely,” Biondolillo, a senior majoring in biological sciences, said in a news release. “As a biology student, who for the first two years of college had the goal of one day attending dental school, until I shadowed a neighbor who does medical device sales, I had pretty much no selling experience.”
Soon after the expansion announcement, Arthrex approached Clemson University with an educational partnership opportunity to help students develop the interdisciplinary skills to position them for success in the fast-growing orthopedic medical device field. The result was an educational pilot program designed with the needs of the global medical device industry in mind.
Arthrex has since expanded its partnership with Clemson, which is just 10 miles from the Sandy Springs location.
Working with the academic leaders and the Clemson University Office of Corporate Partnerships and Strategic Initiatives, the company has created scholarships and two certificate programs.
“Arthrex takes great pride in its commitment to education and we are pleased to help develop the next generation of highly skilled professionals like Arthrex technology consultants who work with orthopedic surgeons to provide trustworthy technical product support,” Arthrex President and founder Reinhold Schmieding said in the release.
The Sales Innovation Certificate Program and Orthopedic Medical Device Product Specialist certificate programs are designed to enable students from any major to explore medical device technology consulting. Through the programs, students gain knowledge of medical devices and techniques, and gain an introduction to the sales and marketing aspects of medical products. The programs are intended to create a strong pipeline to help support Arthrex’s growing needs in this area, according to the release.
More than 10 students in the Sales Innovation Certificate Program have been hired by Arthrex in the last two years.
“Through the strategic partnership with Arthrex, we have worked together to develop one-of-a-kind workforce development programs to support an integral partner need,” Angie Leidinger, vice president of external affairs for Clemson, said in the release. “The success of the pilot programs has showcased the talent of our faculty and students, and we’re excited about the opportunity to continue engaging with Arthrex in mutually beneficial ways that will strengthen educational outcomes while providing them with top-tier talent.”
After learning about the certificate program, Biondolillo said he jumped at the opportunity to gain the targeted knowledge in medical device sales.
“The Sales Innovation Program has improved my selling skills and taught me the principles of being a great salesperson and the Orthopedic Device Product Specialist Program has improved my product knowledge from materials used in devices to diagnosing issues and being able to properly convey product benefits,” he said in the release.
The Sales Innovation Program coursework is tailored to develop students’ business acumen, selling frameworks and presentation ability in order to equip them for roles in health care and medical device sales or related positions. Through the program, students also take part in real-world challenges, foundational role-play exercises and leadership opportunities, the release said.
The Orthopedic Medical Device Product Specialist Certificate provides students with core competencies in the orthopedic medical device industry with a focus on managing a product throughout its life cycle, including product development and performance relevant to clinical use, and communication of its commercial value.
In addition to the certificate programs that provide students a pathway to learning about medical device sales, the Arthrex Scholars program provides scholarships to those same students, according to the release.
Arthrex Scholars was announced in 2019 as a two-year pilot program, with the first scholarships awarded in 2020. Fifteen students pursuing medical device sales careers will receive $5,000 scholarships and a potential summer internship.
“Under the direction of Ryan Mullins, our Sales Innovation Program has shown an ability to connect students with companies like Arthrex that can potentially lead to sales careers with those organizations,” Jennifer Siemens, department of marketing chair, said in the release. “Arthrex’s investment as an innovation partner in our Sales Innovation Program helps students financially and potentially creates a pipeline to our best and brightest as their next generation of employees.”
Managed by the Department of Marketing and the Sales Innovation Program team, applications open during the fall semester and are awarded the following spring semester.
Arthrex also works with Clemson on several research projects, including a NanoScopeTM Surgical Imaging System reprocessing assessment with bioengineering associate professor Melinda Harma, according to the release.
Matt Bell named to head SC Launch see more
The South Carolina Research Authority (SCRA) has announced that Matt Bell was recently named Director of SC Launch and Executive Director of SC Launch, Inc. Bell replaces Russell Cook who resigned to focus on his recovery from a medical issue.
A member of SCRA’s leadership team, Matt Bell is responsible for leading the strategic direction of the SC Launch program, which provides mentoring, networking, and grant funding to eligible companies that are employing new technologies within the advanced materials and manufacturing, information technology, and life science sectors. He also serves as the liaison to the SC Launch, Inc. board of directors, which makes capital investments in SCRA Member Companies that successfully complete the due diligence process. Established in 2006, SC Launch, Inc., is an independent, nonprofit corporate affiliate of SCRA.
“Matt brings a broad background in startup creation from managing intellectual property and launching startups in academia to early-stage investing and venture capital experience. He is also an expert convener who understands how to bring the right people and resources to the table for economic development through innovation,” said Bob Quinn, SCRA Executive Director. “The SC Launch team has been accelerating the growth and success of Member Companies for many years, and Matt brings the right background and experience to lead this team as they guide our companies to becoming highly investible. We sincerely thank Russell Cook for his service to SCRA and the state, and we wish him a speedy and full recovery.”
Prior to coming to the SCRA, Bell was managing director for Discovery Partners Institute, a University of Illinois-led initiative that leverages the state of Illinois’ university resources to drive economic development through workforce training, student immersion, and research programs. He was also a managing director and a principal with Cultivian Sandbox Venture Fund where he raised capital, managed strategic investor relationships, and managed fund activities.
Matt Bell is a board member and advisor for Michigan State University’s state-wide, agriculture-focused translational fund, a former board member of Abcelex Technologies, and a U.S. Department of Agriculture Small Business Innovation Research grant reviewer. He earned a Master of Business Administration and a Bachelor of Science from the University of Illinois. He will be based in SCRA’s Greenville office.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance multi-institutional, translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
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.
South Carolina’s $90-million research pipeline creates jobs and improves healthcare, researchers sayResearch pipeline adds jobs and improves healthcare in South Carolina see more
The $41.8 million that has flowed into Clemson University for three separate research centers could be the beginning of a larger enterprise that brings South Carolina new business, improved patient care and lower healthcare costs.
But success will hinge on how well some of the state’s largest institutions can work together, researchers said.
The funding comes from a National Institutes of Health program that is aimed at helping South Carolina, 22 other states and Puerto Rico establish Centers of Biomedical Research Excellence. Each has a specific research theme and can receive as much as $30 million distributed in three phases over 15 years. SC BioCRAFT, launched in 2009, has received two phases of funding totaling $20.3 million. Clemson officials announced Oct. 18 that SC-TRIMH received $11 million in its first phase of funding. EPIC started in 2015 with $10.5 million.
Those centers could be just the start of a continuous funding stream– a big one that transforms the South Carolina healthcare industry. Clemson officials are preparing to apply for a fourth center and have set a goal of continuously maintaining three centers. The plan would create a pipeline worth up to $90 million at any given time constantly flowing into South Carolina for biomedical research.
Clemson bioengineers lead two of the centers, SC BioCRAFT and SC-TRIMH. They said they rely on clinicians from Greenville Health System and the Medical University of South Carolina to guide their research, ensuring it remains relevant to what happens in real-world hospitals and clinics.
“Team effort is what is required,” said Naren Vyavahare, the director of SC BioCRAFT. “A lot of institutions are required for these big grants.”
One of the gems of the centers is that junior faculty members are mentored so that they can compete for their own federal funding. SC BioCRAFT is credited with mentoring 23 faculty members and generating $35 million in addition to the $20.3 million that funds the center itself. The center is also bearing fruit off campus. Research done at SC BioCRAFT has led to 16 patents, four spin-off companies and better care for patients suffering from ailments ranging from diabetes to traumatic brain injury.
The success of SC BioCRAFT could be a harbinger for the newest center, SC-TRIMH, which is led by Hai Yao, theErnest R. Norville Endowed Chair in Biomedical Engineering at Clemson.
A key part of SC-TRIMH’s mission is developing virtual human trials that would allow researchers to test new devices with computational models before trying them on humans. The idea is to close the gap between animal and human trials, allowing new devices to move from the lab to patients’ bedsides more quickly and less expensively. It’s an approach that has been used for drugs, but SC-TRIMH will be the first to try to apply it to medical devices, a step that could attract device manufacturers to the state, Yao said.
“The companies are going to come to us,” Yao said. “Why? Because we have the technology, and we have clinical partners here. So, we can test their products– not just test their products but use our technology to totally redesign their products.”
Initial research could apply to bad discs in the back, hip replacements and disorders of the temporomandibular joint, Yao said.
Martine LaBerge, chair of the Department of Bioengineering at Clemson, said SC-TRIMH could improve patient care for South Carolinians by staking a claim as a national leader in musculoskeletal health, the center’s primary focus.
“If we’re the leader, why would a patient need to fly to another state for treatment?” she asked. “We’ll become the leading health provider. Patients from other states may have to fly to South Carolina. This is our goal, and collaboration among institutions will be crucial to making it happen.”
Tanju Karanfil, vice president for research at Clemson, said officials are preparing to apply for a fourth center but will have to wait until 2020, because NIH rules limit each institution to three centers in the first two phases. He said that he is hopeful that SC BioCRAFT will receive Phase III funding.
“This is excellent for a university without a medical school,” Karanfil said. “Of course, with all credit, we are working with GHS, MUSC and USC. Their clinical expertise is indispensable.”
Vyavahare, the Hunter Endowed Chair at Clemson, took the lead in organizing the university’s first center, SC BioCRAFT, starting in 2006. The first proposal was rejected, and then a federal funding shortfall in 2008 put the program on hold for a year, he said. SC BioCRAFT received its first $10 million in 2009, and funding was renewed for the second phase five years later. Vyvahare said he is most proud of the center’s junior faculty.
SC BioCRAFT provided mentors who helped guide them through the research funding process, he said. The center also helped pay for new research equipment that is crucial to generating the data needed for a successful research proposal, Vyavahare said.
“It’s a good way to start your career quickly,” Vyavahare said. “A lot of people started getting good data, and everybody started getting funding.”
SC BioCRAFT is an acronym for the South Carolina Bioengineering Center for Regeneration and Formation of Tissues. SC-TRIMH stands for the South Carolina Center for Translational Research Improving Musculoskeletal Health. EPIC stands for Eukaryotic Pathogens Innovation Center.
Researchers said one of the key ingredients in the success of SC BioCRAFT and SC-TRIMH is Clemson’s deep integration with GHS and MUSC.
Both centers are based at the Clemson University Biomedical Engineering Innovation Campus, or CUBEInC, which is on the GHS Patewood Medical Campus in Greenville. Research is also conducted at MUSC, where Clemson has space in the medical university’s Bioengineering Building.
The value of collaboration was a consistent theme when researchers from the three institutions gathered to announce the creation of SC-TRIMH.
Scott Sasser, chief clinical officer for the GHS western region, said that Clemson was the health system’s primary research partner.
“That was by design, and it is unique,” he said. “We are so thankful for your investment in the medical school. The successful medical education of every student who walks through our doors is inextricably tied to your commitment to research that this project exemplifies.
“The novel methodology that will be used in this program will lead to new innovations and new devices that will not only change health outcomes but will help us all address the rising cost of healthcare in this country.”
Michael Kern, a professor in the Department of Regenerative Medicine and Cell Biology at MUSC, said what excites him most about SC-TRIMH is the chance to continue working with Yao.
“My research and Hai’s research before the COBRE grant have dovetailed nicely,” he said, using the acronym for the NIH funding program. “We’ve worked quite closely together for the previous 12 years. With the COBRE, we will be able to continue our work together to benefit young investigators and help them mature in their science.”
Kathleen Brady, associate provost for clinical and translational science at MUSC, said collaboration is part of a growing trend in research because it leads to success.
“When groups get together, studying a similar problem, you’re much more likely to come up with innovative solutions,” she said. “They are usually innovative solutions that neither group could have come up with on their own. SC-TRIMH is a perfect example of that– people with very different expertise coming together to do something unique and innovative.”
Spence Taylor, president of GHS, said in a written statement that working together can lead to significantly improved health care and health outcomes in South Carolina and the nation.
“These innovative partnerships between Clemson faculty and GHS clinicians allow us to solve clinical challenges by leveraging medical insights with the extraordinary research depth of Clemson,” he said. “What we do today can pave the way for transformational improvements to health care for generations to come.”
Vincent Pellegrini, chair of the Department of Orthopedics at MUSC, said much of the SC-TRIMH research will focus on musculoskeletal conditions that result from normal aging, including arthritis at the base of the thumb, hip replacement prostheses and tendon degeneration.
“The really exciting thing about the COBRE is that it juxtaposes the engineering, science and clinical medicine with the appropriate individuals in those disciplines on the same campus under the same roof to come up with real, clinically relevant devices and products that benefit patients,” he said.
Michael Kissenberth, a GHS orthopedic surgeon, said the collaboration will allow the institutions to complement each other
“We at GHS will be able to advise on the clinical needs that Clemson can then use to develop the technology that improves health outcomes,” he said. “In some cases, the technology may exist, and we can help show how it can be applied.”
Kyle Jeray, a GHS orthopedic surgeon, said SC-TRIMH will strengthen the collaborative spirit in South Carolina’s research community.
“Through SC-TRIMH, we will enhance the research infrastructure at Clemson and GHS by developing essential core facilities, fostering research collaborations and increasing scientific expertise of junior and senior faculty members,” he said.
Windsor Sherrill, associate vice president for Health Research at Clemson and chief science officer at GHS, said she wanted to recognize Tommy Gallien, the manager/coordinator for SC-TRIMH. She also wanted to acknowledge the Clemson University School of Health Research, or CUSHR.
“CUSHR is the interdisciplinary health research entity at Clemson that connects health researchers across colleges and departments with clinical researchers at health care systems such as GHS and MUSC,” she said. “The junior investigators for the SC-TRIMH initiative are from several different departments, ensuring that we have multidisciplinary focus to solve complex health care problems. The big challenges in health care do not fit neatly within one discipline or even in one university. SC-TRIMH is the kind of program we envision with CUSHR– one that leverages talents across Clemson health research faculty with the input of clinicians research at our partner institutions.”
Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, congratulated Yao and his team on the SC-TRIMH grant.
“Through this grant, Dr. Yao and his team from Clemson, GHS and MUSC are strengthening the biomedical research capacity for South Carolina,” he said. “The award is a testament to the scholarship that Dr. Yao brings to Clemson and the power of collaboration to achieve the most innovative results.”