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translational research

  • sam patrick posted an article
    MUSC sets new research record with 15% jump over 2019 see more

    The Medical University of South Carolina has broken its own record as the state’s leader in garnering extramural funding for biomedical research. MUSC set a new high-water mark in FY2021, bringing in more than $328 million. The previous MUSC record for annual biomedical research funding was more than $284 million, set in FY2019.  

    “Being the state’s leader in biomedical research funding year after year is a significant accomplishment, and we applaud the passion and expertise of our dedicated scientists and their teams,” said David J. Cole, M.D., FACS, MUSC president. “Even so, reaching another record-breaking number is not an end in itself. The true impact of MUSC research is reflected in how we translate discoveries into new modalities of care and life-changing therapeutics. Research is a dynamic force that fuels how we fulfill our mission to lead health innovation for the lives we touch,” he added. 

    Lori McMahon Ph.D., vice president for Research, called the accomplishment outstanding, especially during a period when being awarded research grant funding has become more intensely competitive than ever before. No other publicly assisted academic institution in South Carolina consistently garners near $250 million in research funding year after year. 

    MUSC research focuses on a wide variety of areas including cancer, community health, drug discovery, health disparities, inflammation and fibrosis, neuroscience, oral health, stroke and addiction.

  • sam patrick posted an article
    Charles River is first CDMO in North America to gain approval see more

    Charles River Laboratories, International Inc. (NYSE: CRL) announced it has received regulatory approval, in the form of Good Manufacturing Practice (GMP) certification, to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European Medicines Agency (EMA).

    Charles River also has a major research and production facility located in Charleston, South Carolina.

    The approval follows an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on the EMA’s behalf. The GMP certification of Charles River’s Memphis contract development and manufacturing (CDMO) facility complements an existing GMP license for Investigational Medicinal Product (IMP) production. The Memphis site can manufacture and ship drug products intended for European Union distribution. The approval recognizes Charles River’s industry-leading expertise, multidisciplinary team, regulatory know-how, and quality standards.

    Charles River’s Memphis CGMP CDMO facility is suitable to manufacture clinical (early- and late-phase) as well as commercial cell and gene-modified cell therapies. With the 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences, Charles River significantly expanded its cell and gene therapy portfolio to include end-to-end CDMO capabilities (plasmid DNA, viral vector, and cellular therapies). These capabilities have been integrated with Charles River’s legacy services resulting in a “concept-to-cure” cell and gene therapy portfolio.

    Approved Quotes

    • “We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy. We are looking forward to continuing close partnerships with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.” – Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River
    • “Our team in Memphis has worked extremely hard to successfully complete the EMA inspection and authorization process. We are excited to be the first CDMO in North America to reach this milestone.” –Will Isom, Site Director, Memphis, Charles River

    About Charles River
    Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

  • sam patrick posted an article
    Clemson researchers seek solutions to Alzheimer's mysteries see more

    Clemson University is seeking healthy older adults to volunteer for a study called Preventing Alzheimer’s with Cognitive Training. This study examines whether computerized brain training exercises can reduce the risk of cognitive impairment and dementia such as Alzheimer’s disease.

    Additional funding of $3.2 million was awarded to further investigate if Alzheimer’s disease can be detected early through simple blood tests, according to a university news release. The grant from the National Institute on Aging, part of the National Institutes of Health, expands Clemson’s PACT study. The PACT study will now work with the National Centralized Repository for Alzheimer’s Disease and Related Dementias to analyze blood specimens collected from study participants.

    The PACT study is recruiting volunteers aged 65 and older with no signs of cognitive impairment or dementia, the release said. Those interested in the study may participate in initial testing at the Clemson University’s Institute for Engaged Aging at Prisma Health Oconee Memorial Hospital in Seneca. Participants may also join the study at the University of Florida, University of North Florida, University of South Florida, or Duke University. PACT participants may now volunteer to provide blood samples that will be used to develop tests for early detection of Alzheimer’s disease.

    “We need another 400 healthy older adults to volunteer for the PACT study,” said principal investigator Lesley Ross, SmartLIFE Endowed Chair in Aging and Cognition in the College of Behavioral, Social and Health Sciences and director of the Clemson University Institute for Engaged Aging and associate professor of psychology at Clemson University.

    “We are very grateful for the 250 volunteers who have already joined our fight against Alzheimer’s disease by enrolling in PACT,” she said in the release. “The additional funds will enable us to further our goal of understanding and ending Alzheimer’s disease and dementia in the future. I am excited to bring this study to the Seneca and surrounding communities and further the Clemson University Institute of Engaged Aging’s mission of conducting groundbreaking research and providing opportunities to the community.”

    More information is available at the PACT study website, pactstudy.org.

    The Clemson University PACT study concentrates on the effectiveness of computerized programs, or brain games, for preventing dementia such as Alzheimer’s disease, the release said. At the end of the PACT trial, the scientists will examine the blood samples from willing participants and determine which specific blood-based biomarkers predict Alzheimer’s disease, the severity of the disease, or responsiveness to treatment.

  • sam patrick posted an article
    GlycoPath joins other life science organizations in SCRA portfolio of companies see more

    Compliments of Charleston Regional Business Journal

    Glycopath has become the latest S.C. Research Authority member company.

    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.

    Glycopath Inc. received a $50,000 federal matching grant, the release said. The Charleston-based startup is working to improve biomarker research by streamlining methods with proven clinical impact and simplifying assays to improve patient care and treatment.

    Grant funding is made possible in part by the Industry Partnership Fund contributions. Contributors to the IPF receive a dollar-for-dollar state tax credit.

    Chartered in 1983 by the state as a public, nonprofit corporation, S.C. Research Authority is intended to fuel 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.

  • sam patrick posted an article
    Xequel, formerly First String Research, adds top executives see more

    Xequel Bio, Inc. (formerly FirstString Research, Inc.), a clinical stage biopharmaceutical company developing dermatologic and ophthalmic therapeutics utilizing its patented new chemical entity aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide), announced today the appointments of Jerry St. Peter as Chief Executive Officer and Wes Brazell as Chief Financial Officer.

    “As we embark on a new corporate phase focused on clinical development and approval of novel treatments, we have brought in two seasoned executives, Jerry St. Peter, and Wes Brazell, to lead these efforts,” said Tony Bartsh, Chairman of Xequel’s Board of Directors and partner at Park West Asset Management. “Jerry’s proven track record in building successful, fully integrated biopharmaceutical companies, partnered with Wes’ financial management and operations expertise, provide the right combination to design and execute our strategic transformation. Both Jerry and Wes bring extensive corporate leadership, business development execution and entrepreneurial acumen to Xequel. With these exciting leadership appointments, we have also rebranded the organization from FirstString Research to emphasize our emergence as a growing biopharmaceutical company in late-stage clinical development.”

    “It is a pleasure to join Xequel at such a pivotal moment in its evolution,” said Jerry St. Peter, Chief Executive Officer and Board Member. “Our talented team of scientists and clinical development professionals have established a cutting-edge technology platform culminating in a robust pipeline of product candidates backed by strong preclinical and clinical research. We have also created a strong corporate identity under the Xequel Bio name, reflecting our strategic move into the Company’s next chapter.”

    “Our proprietary aCT1 technology platform provides tremendous opportunity to address unmet needs for patients in dermatologic and ophthalmic treatments. We have multiple, novel late-stage programs with near-term inflection points as well as preclinical research in other valuable target disease states. Wes and I look forward to working with our dedicated team to implement our growth plan, advance our pipeline, deliver meaningful patient outcomes and successful business results,” concluded Mr. St. Peter.

    The Company is in the process of developing a new corporate website and updated social media accounts reflecting the Xequel Bio name.

    Jerry St. Peter, Chief Executive Officer and Board Director

    Jerry St. Peter brings over 30 years of specialty biopharma executive leadership implementing strategic planning, commercial operations, financial management, fundraising, business development, and overall general management. Prior to joining Xequel, Mr. St. Peter was the Chief Executive Officer and President of Eyevance Pharmaceuticals (a Santen Company), a global ophthalmic company focused on serious, unmet treatment needs by developing innovative solutions that protect and restore vision. Mr. St. Peter was Co-founder, Chief Executive Officer, and Board Member of Eyevance Pharmaceuticals prior to its acquisition by Santen for $225 million in 2020. Established in 2017, Eyevance was a private equity backed venture solely focused on ophthalmic diseases that affect millions of patients every day. Prior to co-founding Eyevance, Mr. St. Peter was the Senior Vice President and Head of Sun Pharmaceuticals’ newly formed Ophthalmics division. Before Sun, he was the Executive Vice President and General Manager for Nicox’s Ophthalmic business in the United States and formerly served as the Senior Vice President and Head of the Ophthalmic division at Inspire Pharmaceuticals before Merck acquired Inspire for $450 million in 2011.

    Wes Brazell, Chief Financial Officer

    Wes Brazell brings three decades of leadership and expertise in pharmaceuticals and medical devices with broad experiences in operations management, financial management, business development, portfolio management, corporate finance, international operations and corporate strategy. Prior to joining Xequel, Mr. Brazell was Chief Financial Officer for Eyevance Pharmaceuticals, a private equity backed pharmaceutical company which was acquired by Santen for $225 million in 2020. Prior to Eyevance, Mr. Brazell was the Chief Financial Officer of TearLab, a NASDAQ-traded company focused on the marketing and development of tear related diagnostic products. Mr. Brazell previously spent 21 years in multiple financial management positions with Alcon, a multi-billion-dollar ophthalmology focused pharmaceutical and medical device company, including Vice-President of Finance for Alcon’s business in the United States, Vice-President of Finance for Alcon’s Europe, Middle East and Africa business as well as Vice-President of Corporate Financial Planning and Analysis.

    About Xequel’s aCT1 Technology Platform

    Xequel Bio’s aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform is designed to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity, based on the C-terminal sequence of Connexin43, designed to selectively and reversibly inhibit protein binding of endogenous Connexin43 to key binding partners. Connexin43 plays critical roles in multiple aspects of the injury response, including spread of injury signals, extravasation of immune cells, granulation tissue formation and fibrosis. aCT1’s unique, targeted mechanism of action has been demonstrated to restore the coordination of cellular communication, reinforce junctional integrity and temper excessive inflammatory responses in injured tissues for optimal injury response and tissue repair. aCT1 is currently in clinical development for multiple indications across dermatology and ophthalmology, as well as in ongoing preclinical research in pulmonology.

    About Xequel Bio, Inc. (formerly FirstString Research)

    Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. The Company also has ongoing preclinical research in pulmonology. For more information, please visit www.xequel.com.

    Source: Xequel Bio, Inc.

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    Improvements may one day improve the effectiveness and safety of chemotherapy see more

    For patients with cancer, the tumor-killing power of chemotherapeutic drugs is a double-edged sword. While many cancer drugs kill tumor cells, they can also harm healthy cells as they travel throughout the bloodstream.

    “A major limitation of chemotherapy agents is that only a tiny fraction goes to their targeted tumor,” said Dieter Haemmerich, Ph.D., D.Sc., professor at the Darby Children’s Research Institute within the Department of Pediatrics at the Medical University of South Carolina (MUSC). “As a result, there are side effects that include damage to the heart.”

    But what if you could “cleanse” the blood of chemotherapeutic drugs to reduce their harmful side effects? 

    In an article published in March 2022 in the journal Cancers, an MUSC research team led by Haemmerich reported that it had developed a device to remove excess chemotherapeutic drugs from circulation after cancer treatment. Using this device, the team removed 30% of the administered drug by one hour after treatment. Seed funding to develop the device was provided by a High Innovation - High Reward grant from the South Carolina Clinical & Translational Research Institute’s pilot project program.

    Haemmerich and his colleagues, including Katherine Twombley, M.D., a professor in the MUSC Department of Pediatrics, Division of Pediatric Nephrology, focused on doxorubicin (DOX), which is one of the most widely used chemotherapy drugs in adults and children. 

    DOX is also known to be toxic to the heart. This toxicity is particularly detrimental in pediatric patients, since any resulting heart failure will have negative health effects for the rest of the child’s life. In a 2006 clinical trial, DOX reduced cardiac function in children with leukemia, and steroid therapy was required to reduce its damaging effects.

    Despite its toxicity to the heart, DOX is a popular chemotherapy drug because it is highly effective at stopping cancer cells from dividing.

    “Doxorubicin works by basically damaging DNA,” said Yuri Peterson, Ph.D., an associate professor in the Department of Drug Discovery and Biomedical Sciences in the MUSC College of Pharmacy and an author of the article. “That is useful for treating cancer, but it can also cause off-target side effects like hair and bone marrow loss.” 

    Recent efforts to target DOX more precisely to the tumor site have included encapsulating it inside temperature-sensitive nanoparticles. These tiny particles are intact at normal body temperature and carry the drug through the bloodstream to the tumor. There, they can be heated with a probe to around 105 degrees Fahrenheit to release their DOX cargo.

    However, the technique has its own limitations. Only a fraction of the administered nanoparticles release their cargo when the heat is applied at the tumor site. Once the nanoparticles break down in the body, which can take as little as an hour, the remaining drug enters the bloodstream and can then cause side effects. 

    The MUSC research team wanted to improve outcomes with this technique by developing a device that would remove the leftover DOX after treatment.

    Using a rodent model of cancer, the researchers injected the heat-sensitive DOX nanoparticles and applied heat at the tumor site to release DOX. After treatment, they cleansed the blood of leftover DOX by first passing it through a heating element to get the nanoparticles to release the drug and then through an activated carbon filter to remove the drug from the blood before it was returned to the rodents’ circulation.

    Krishna Ramajayam, Ph.D., a postdoctoral fellow in Haemmerich’s laboratory in the Division of Pediatric Cardiology at MUSC, designed the heating element in the filtration device and supported the imaging studies for monitoring drug release and filtration.

    “Since the device is computer controlled, you can have very precise heating to ensure that the drug is released,” said Ramajayam. “The most exciting part for me is addressing both delivery and removal of the drug, which will improve patients’ quality of life immensely.”

    Importantly, the team also developed a method for detecting drug levels in the blood in real time to ensure that the drug is effectively removed.

    “By imaging the blood before and after filtration, we can actually predict how much drug is being removed in real time in the clinic,” said Anjan Motamarry, Ph.D., who completed work on the study while a doctoral student in Haemmerich’s lab before transitioning to a job in industry. “This would be very useful information for a clinician who needed to make a decision about when to stop filtration.

    ”Reducing the exposure of patients to leftover chemotherapy drugs could allow them to recover faster, with fewer side effects. It could also enable them to receive more chemotherapy cycles in the future in case additional treatment is necessary to kill the cancer cells.

    “Every drug has a maximum tolerated dose that you cannot go beyond,” said Motamarry. “Since we are removing the leftover drug after treatment, you can actually give an additional dose if the first cycle is not sufficient, which would not be possible if the drug was not removed.”

    Filtering the blood through the device also led to nearly three times less DOX in the heart, as measured using mass spectrometry at the MUSC Drug Discovery Core. Peterson and Thomas Benton, Ph.D., who was a doctoral student at MUSC at the time of the study, performed the measurements.

    These promising results suggest that the new device could reduce side effects in the heart that can be caused by chemotherapy, but more studies will be needed to confirm that promise.

    “If you deliver less drug to the heart, you will probably have fewer side effects,” said Haemmerich. “Our next step is to test the function of the heart directly after using this method in long-term animal tumor studies.”

    Further improvements to their device may one day improve the effectiveness and safety of chemotherapy in children and adults.

    “It’s really hard for anyone to go through chemotherapy,” said Motamarry. “This is the least that we can do to make it easier for them.”

  • sam patrick posted an article
    Long-standing partnership between Clemson University and MUSC paying off see more

    South Carolina is strengthening its position as a hub for high-impact biomedical research with a new multi-million-dollar project that undergirds the long-standing partnership between Clemson University and the Medical University of South Carolina (MUSC) and loops in crucial support from the National Institute of Dental and Craniofacial Research (NIDCR) at the National Institutes of Health (NIH).

    Researchers will study temporomandibular joint (TMJ) function, how the TMJ functions in different craniofacial developmental disorders that seem to put the joint at risk for degeneration and how the joint responds to surgical correction of these disorders, researchers said.

    The TMJ makes it possible to move the lower jaw to eat and talk. Understanding the stresses on the TMJ before temporomandibular joint disease (TMD) occurs will unlock the mechanisms that put certain individuals at risk for TMD.

    The focus of the research aligns with the recommendations made by an ad hoc committee on temporomandibular disorders that was formed under the auspices of the National Academies of Sciences, Engineering, and Medicine’s Health and Medicine Division.

    Four of the researchers involved in the new project are connected to the Clemson-MUSC Bioengineering Program. As part of the program, Clemson bioengineering faculty and students are based at MUSC’s Charleston campus where they collaborate closely with MUSC researchers and clinicians.

    The new project, funded by a $3.18-million U01 grant from NIDCR, has two principal investigators. Hai Yao, serves as the Ernest R. Norville Endowed Chair and professor of bioengineering at Clemson, professor of oral health sciences at MUSC, the associate department chair for the Clemson-MUSC Bioengineering Program and a member of the national temporomandibular disorder ad hoc committee. Janice Lee is the clinical director of the NIDCR and chief of the Craniofacial Anomalies and Regeneration Section within the NIH intramural research program.

    Yao said the project is possible only because of the synergy and complementary strengths of Clemson, MUSC and NIDCR.

    “Clemson and MUSC work together so seamlessly it’s as if we are one university, and we both collaborate closely with NIDCR,” he said. “This project is the latest example of how these strategic partnerships are making South Carolina a hub of biomedical research that is recognized globally. Through these partnerships, we are well positioned to address urgent healthcare needs identified by the NIDCR and the National Academy of Medicine.”

    Lee said the researchers are uniquely positioned for success.

    “The U01 is an extremely competitive grant that requires intra- and extra- mural collaboration utilizing the world-renown resources at the NIH Clinical Center,” Lee said. “It is extra special as this is a first for NIDCR intramural as well. Temporomandibular joint disorders are debilitating conditions, and I am thrilled to be working with Hai Yao and his team to truly move the research forward. His team brings outstanding bioengineering technology to examine craniofacial musculoskeletal function to the Clinical Center; our discoveries will be translated and, ideally, will initiate first-in-human therapies for TMD at the NIH.”

    Lee continued: “NIDCR is committed to working with world-class partners such as Clemson and MUSC to advance translational research into temporomandibular disorders. This project will help improve understanding of these disorders, thereby improving outcomes for patients.”

    This is particularly important to Lee as she is the oral and maxillofacial surgeon who will be providing the surgical treatments and is acutely aware of the impact that surgery can have on TMD, she said.

    Özlem Yilmaz, chair of the Department of Oral Health Sciences at MUSC, said the new project presents an important venue to help patients debilitated with TMJ disorders and underpins South Carolina’s leading position in temporomandibular disorders research.

    “New measurement tools and computational models will be tested on patients at the NIH Dental Clinic,” Yilmaz said. “These novel technologies, stemming from more than a decade of teamwork bringing together bioengineers, oral surgeons, and oral biologists at MUSC and Clemson, will push the boundary of the current temporomandibular disorders research.”

    Sarandeep Huja, dean of the College of Dental Medicine at MUSC, said the new project further solidifies MUSC’s partnership with Clemson and NIDCR.

    “This partnership will help us innovate the future of oral health and wellness,” Huja said. “We will not only be advancing knowledge of temporomandibular disorders but also expanding knowledge for the next generation of oral health providers and researchers. As a practicing clinician and orthodontist, I frequently encounter patients with temporomandibular disorders, in the very type of patients that will be recruited in this study. It is critical we find evidence based treatments for these patients.”

    The vice presidents of research at Clemson and MUSC are crucial to the institutions’ partnership, Yao said. Tanju Karanfil is vice president of research at Clemson, and Lori L. McMahon is vice president for research at MUSC.

    “We look forward to solidifying the strong foundation that Clemson and MUSC have built,” Karanfil and McMahon said in a joint statement. “These large, high-impact projects are advancing knowledge and creating a new generation of talent, while strengthening the state’s national and international reputation for biomedical research and education.”

    Researchers are calling their project “Assessment of Temporomandibular Joint Morphology, Mechanics, and Mechanobiology in Class II and III Target and Surgical Phenotypes.”

    Part of what makes the project unique is the collaboration that maximizes the expertise of the investigators.


    “Dr. Lee and her craniofacial team at NIDCR will recruit the large number of patients that will be required for the research, characterize the patients, and support their travel and treatment costs,” Yao said.

    Clemson and MUSC will perform analysis of temporomandibular joint biomechanics and mechanobiology and put that information into context to better understand patients’ health status and the potential for future problems

    Martine LaBerge, chair of Department of Bioengineering at Clemson, said the U01 grant that funds the new project is the first of its kind at Clemson.

    “This grant is a testament to the strength of the biomedical research enterprise that Clemson and MUSC are building in partnership with federal collaborators, especially the National Institutes of Health,” she said. “Dr. Yao’s leadership has been crucial to the partnership’s success, and it remains in good hands with him at the helm.”

    The project is the latest major NIH grant led by Yao. He is also principal investigator on South Carolina Translational Research Improving Musculoskeletal Health (SC TRIMH), a Center for Biomedical Research Excellence that was founded with an $11-million NIH grant in 2018. Researchers associated with the center have accounted for $8 million in NIDCR awards over the past year.

    Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, said the success underscores the high quality of research that has come out of interdisciplinary partnerships such as the Clemson-MUSC Bioengineering Program.

    “Working together in collaboration with federal partners is elevating South Carolina’s position as a place for top-tier biomedical research and predoctoral and postdoctoral education,” he said. “Dr. Yao and his team have built a high-impact program and are continuing to climb. I offer them my whole-hearted congratulations.”

  • sam patrick posted an article
    Investment from large investors attracted into SMO industry see more

    Velocity Clinical Research ("Velocity") today announces it has acquired two multi-site companies, VitaLink Research ("VitaLink") and the National Research Institute ("NRI"), for an undisclosed amount. The double acquisition adds 11 sites to Velocity's existing 18, making it the largest fully integrated site management organization in the world and signaling the next phase in the evolution of the industry.

    South Carolina-based VitaLink Research operates a network of six (6) sites in the central and western part of the state, including the Greenville/Spartanburg corridor. California-based National Research Institute has five (5) facilities in the greater Los Angeles area. The combination of VitaLink and NRI will further boost Velocity's therapeutic reach and recruiting power. Velocity's goal to reach more minority populations is particularly enhanced through NRI's Los Angeles-area locations and bilingual staff.

    Dr G. Paul Evans, Chief Executive and President of Velocity Clinical Research, said: "Velocity has moved into the next phase of its development. We have accelerated the pace of site acquisitions this year, bringing VitaLink and NRI's experience into our fully integrated site network.

    "When consolidators start buying up the consolidators, it signals a maturing market. The clinical trials site landscape is going to look very different a year from now. We anticipate most of the large site organisations will change ownership in the coming months, as large investors take an increased interest in the sector."

    Velocity will provide additive business development effort and streamlined service delivery to VitaLink and NRI, which have already demonstrated they can perform well in high volume studies. Combined, the companies will multiply their strengths with enhanced therapeutic expertise and shared operational functions. Prior to acquisition, Velocity, VitaLink, and NRI independently enrolled over 10% of the COVID vaccine volunteers in the U.S.

    Evans added: "Patient recruitment is a key factor in speeding up drug development. The site management industry attempted to consolidate back in the 90s but this time, it's different. The focus now is on site integration rather than affiliation, allowing for greater control and leading to more efficient data collection and delivery.

    "The race to find a COVID vaccine provided impetus to speed up clinical research and demonstrated the benefit it has in getting drugs to market faster. Our goal is to offer big pharma companies access to a range of integrated sites that have a range of therapeutic capabilities through one single contact point, making site selection easier. This will ultimately change the way pharmaceutical companies approach global drug development and the reason why we believe more capital is flowing into the sector now."

    Management from both companies will occupy key roles within Velocity, strengthening its senior management bench. Steve Clemons, CEO of VitaLink, is Velocity's new SVP of Client Delivery. Samira Moran, CEO of NRI, is Velocity's new SVP of Specialist Care Delivery.

    All of Velocity's sites are fully integrated via a centralized infrastructure and common technology backbone, allowing for superior patient enrollment and consistent, high quality data delivery.

    Notes to editors:

    • A full list of Velocity's sites can be found on its website.
    • Velocity has extensive experience in vaccines, general medicine, neurology, dermatology, endocrinology, gastroenterology, and women's health.

    About Velocity Clinical Research

    Velocity Clinical Research, headquartered in Durham, NC, is the leading integrated site organization for clinical trials, offering dedicated site capabilities to help biopharmaceutical and contract research organization customers find the right patients for their studies. Velocity supports global drug development in primarily conducting phase II and phase III clinical trials. The company has 30 U.S. locations across 14 states.

    We place the care of the patient at the heart of everything we do. With over 35 years of experience running sites and more than 7000 studies completed, Velocity has refined its patient recruitment strategies while maintaining a focus on delivering timely and reliable data quality. For more information visit our website at https://velocityclinical.com.

    About VitaLink Research

    Founded in 2004, VitaLink has six dedicated sites in South Carolina: Greenville, Spartanburg, Union, Gaffney, Anderson, and Columbia. They specialize in vaccines, dermatology, respiratory and pulmonary diseases, women's health, and internal medicine, with over 31,000 volunteers in their database. https://vitalinkresearch.com

     September 24, 2021
  • sam patrick posted an article
    MUSC, Cumberland Emerging Technologies collaborate to develop biomedical products see more

    The technology transfer organization for the Medical University of South Carolina, the MUSC Foundation for Research Development, and Cumberland Emerging Technologies Inc. have entered into a collaboration agreement to develop new biomedical products.

    Consistent with their longstanding commitment to biomedical innovation and translational research, CET and the MUSC Foundation for Research Development have agreed to collaborate on future co-development programs that combine the strengths of each institution with the goal of advancing new technology to clinical practice.  Under the agreement, CET will evaluate MUSC discoveries, license intellectual property rights to promising technologies, and partner with MUSC research scientists to advance product development toward commercialization.  CET will pursue new sources of funding for these projects through the Small Business Technology Transfer and Small Business Innovation Research and other grant programs. New development programs are expected to span a variety of therapeutic areas including oncology, inflammatory diseases, and cardiovascular disease. 

    "Our office receives over 100 product ideas a year, most of which require an industry partner to be further developed," said Michael Rusnak, the executive director of the MUSC Foundation for Research Development. "We are very enthusiastic about having Cumberland as a collaborator to aid in getting technologies to market and ultimately to the patient."

    "We are very pleased to have the opportunity to partner with the MUSC Foundation for Research Development to develop technologies invented at MUSC, a nationally-recognized biomedical research institution," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals and CET. "We are excited to facilitate the introduction of promising new products by combining our expertise in drug development and commercialization with the MUSC's research initiatives."