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South Caroilina clinical trials

  • 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
    Infectious disease physician calls for vaccinations see more

    Compliments of the Los Angeles Times

    My patient sat at the edge of his bed gasping for air while he tried to tell me his story, pausing to catch his breath after each word. The plastic tubes delivering oxygen through his nose hardly seemed adequate to stop his chest from heaving. He looked exhausted.

    He had tested positive for the coronavirus 10 days ago. He was under 50, mildly hypertensive but otherwise in good health. Eight days earlier he started coughing and having severe fatigue. His doctor started him on antibiotics. It did not work.

    Fearing his symptoms were worsening, he started taking some hydroxychloroquine he had found on the internet. It did not work.

    He was now experiencing shortness of breath while doing routine daily activities such as walking from his bedroom to the bathroom or putting on his shoes. He was a shell of his former self. He eventually made his way to a facility where he could receive monoclonal antibodies, a lab-produced transfusion that substitutes for the body’s own antibodies. It did not work.

    He finally ended up in the ER with dangerously low oxygen levels, exceedingly high inflammatory markers and patchy areas of infection all over his lungs. Nothing had helped. He was getting worse. He could not breathe. His wife and two young children were at home, all infected with the virus. He and his wife had decided not to get vaccinated.

    Last year, a case like this would have flattened me. I would have wrestled with the sadness and how unfair life was. Battled with the angst of how unlucky he was. This year, I struggled to find sympathy. It was August 2021, not 2020. The vaccine had been widely available for months in the U.S., free to anyone who wanted it, even offered in drugstores and supermarkets. Cutting-edge, revolutionary, mind-blowing, lifesaving vaccines were available where people shopped for groceries, and they still didn’t want them.

    Outside his hospital door, I took a deep breath — battening down my anger and frustration — and went in. I had been working the COVID-19 units for 17 months straight, all day, every day. I had cared for hundreds of COVID patients. We all had, without being able to take breaks long enough to help us recover from this unending ordeal. Compassion fatigue was setting in. For those of us who hadn’t left after the hardest year of our professional lives, even hope was now in short supply.

    Shouting through my N95 mask and the noise of the HEPA filter, I introduced myself. I calmly asked him why he decided not to get vaccinated.

    “Well, I’m not an anti-vaxxer or anything. I was just waiting for the FDA to approve the vaccine first. I didn’t want to take anything experimental. I didn’t want to be the government’s guinea pig, and I don’t trust that it’s safe,” he said.

    “Well,” I said, “I can pretty much guarantee we would have never met had you gotten vaccinated, because you would have never been hospitalized. All of our COVID units are full and every single patient in them is unvaccinated. Numbers don’t lie. The vaccines work.”

    This was a common excuse people gave for not getting vaccinated, fearing the vaccine because the Food and Drug Administration had granted it only emergency use authorization so far, not permanent approval. Yet the treatments he had turned to — antibiotics, monoclonal antibodies and hydroxychloroquine — were considered experimental, with mixed evidence to support their use.

    The only proven lifesaver we’ve had in this pandemic is a vaccine that many people don’t want. A vaccine we give away to other countries because supply overwhelms demand in the U.S. A vaccine people in other countries stand in line for hours to receive, if they can get it at all.

    “Well,” I said, “I am going to treat you with remdesivir, which only recently received FDA approval.” I explained that it had been under an EUA for most of last year and had not been studied or administered as widely as COVID-19 vaccines. That more than 353 million doses of COVID-19 vaccine had been administered in the U.S. along with more than 4.7 billion doses worldwide without any overwhelming, catastrophic side effects. “Not nearly as many doses of remdesivir have been given or studied in people and its long-term side effects are still unknown,” I said. “Do you still want me to give it to you?”

    “Yes” he responded, “Whatever it takes to save my life.”

    It did not work.

    My patient died nine days later of a stroke. We, the care team, reconciled this loss by telling ourselves: He made a personal choice not to get vaccinated, not to protect himself or his family. We did everything we could with what we had to save him. This year, this tragedy, this unnecessary, entirely preventable loss, was on him.

    The burden of this pandemic now rests on the shoulders of the unvaccinated. On those who are eligible to get vaccinated but choose not to, a decision they defend by declaring, “Vaccination is a deeply personal choice.” But perhaps never in history has anyone’s personal choice affected the world as a whole as it does right now. When hundreds and thousands of people continue to die — when the most vulnerable members of society, our children, cannot be vaccinated — the luxury of choice ceases to exist.

    If you believe the pandemic is almost over and I can ride it out, without getting vaccinated, you could not be more wrong. This virus will find you.

    If you believe I’ll just wait until the FDA approves the vaccine first, you may not live to see the day.

    If you believe if I get infected I’ll just go to the hospital and get treated, there is no guarantee we can save your life, nor even a promise we’ll have a bed for you.

    If you believe I’m pregnant and I don’t want the vaccine to affect me, my baby or my future fertility, it matters little if you’re not alive to see your newborn.

    If you believe I won’t get my children vaccinated because I don’t know what the long-term effects will be, it matters little if they don’t live long enough for you to find out.

    If you believe I’ll just let everyone else get vaccinated around me so I don’t have to, there are 93 million eligible, unvaccinated people in the “herd” who think the same way you do and are getting in the way of ending this pandemic.

    If you believe vaccinated people are getting infected anyway, so what’s the point?, the vaccine was built to prevent hospitalizations and deaths from severe illness. Instead of fatal pneumonia, those with breakthrough infections have a short, bad cold, so the vaccine has already proved itself. The vaccinated are not dying of COVID-19.

    SARS-CoV-2, the virus that causes COVID-19, has mutated countless times during this pandemic, adapting to survive. Stacked up against a human race that has resisted change every step of the way — including wearing masks, social distancing, quarantining and now refusing lifesaving vaccines — it is easy to see who will win this war if human behavior fails to change quickly.

    The most effective thing you can do to protect yourself, your loved ones and the world is to GET VACCINATED.

    And it will work.

    Anita Sircar is an infectious-disease physician and clinical instructor of health sciences at the UCLA School of Medicine.

  • sam patrick posted an article
    More than $19 million in grants to several key connected health projects see more

    Compliments of mHealth Intelligence

    The federal government is investing more than $19 million in key telehealth initiatives, including the National Consortium of Telehealth Resource Centers (TRCs) and Telehealth Centers of Excellence (COE) program.

    Some 36 awards are being distributed by the Health and Human Services Department through the Health Resources and Services Administration’s Office for the Advancement of Telehealth to some of the nation’s highest-profile connected health projects. The investments are aimed at strengthening programs and supporting innovation in areas that have seen record adoption and growth during the pandemic.

    “Telehealth expands access to care and is a vital tool for improving health equity by providing timely clinical assessment and treatment for our most vulnerable populations,” HRSA Acting Administrator Diana Espinosa said in a press release issued this morning. “This funding will help drive the innovation necessary to build clinical networks, educational opportunities, and trusted resources to further advance telehealth.”

    The TRC consortium, which consists of 12 regional and two national centers, is getting $4.55 million – or $325,000 per site - to bolster and expand their efforts. The TRCs, which provide a wide range of guidance and resources, have seen heavy traffic over the past year and a half as healthcare providers and other organizations have adopted telehealth to deal with the COVID-19 crisis.

    The Telehealth COE program, meanwhile, is getting $6.5 million to expand services and strategies aimed at improving access and outcomes in underserved parts of the country that deal with high chronic care needs and poverty, and to serve as incubators for new telehealth ideas. Located in academic medical centers, COEs are seen as national models for evidence-based programs and strategies that promote best practices.

    In 2017, the Medical University of South Carolina (MUSC) and University of Mississippi Medical Center (UMMC) were designated Telehealth Centers of Excellence. The award is being split between the two programs.

    The Evidence-Based Direct-to-Consumer Telehealth Network Program (EB-TNP) is getting roughly $3.8 million to bolster its DTC telehealth efforts. Those awards are being issued to 11 organizations: HealthHIE Georgia, Cornerstone Whole Healthcare in Idaho, Drake University in Iowa, the University of Kansas Medical Center Research Institute, Baptist Health Foundation Corbin in Kentucky, MaineHealth, UMMC, Lester E. Cox Medical University in Missouri, the Ben Archer Health Center in New Mexico, East Carolina University in North Carolina and Texas A&M University.

    Finally, the Telehealth Technology-Enabled Learning Program (TTELP) is getting about $4.28 million to “help specialists at academic medical centers provide training and support to primary care providers in rural, frontier, and other underserved areas to help treat patients with complex conditions ranging from long COVID to substance use disorders in their communities.”

    Those awards are going to nine organizations: Community Health Center in Connecticut, the American Academy of Pediatrics in Illinois, the University of Kansas Medical Center Research Institute, Medical Care Development in Maine, the JSI Research and Training Institute in Massachusetts, President and Fellows of Harvard College in Massachusetts, the University of New Mexico, Oregon Health & Science University and the Puerto Rico Science, Technology & Research Trust.

  • sam patrick posted an article
    Will identify and advance therapies for genetic diseases and cancers see more

    BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced three new academic collaborations with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh (Pitt) to translate cutting-edge discoveries into potential therapies for patients with genetic diseases and genetically driven cancers.

    "The chance to partner with exceptional researchers at the Medical University of South Carolina, Stanford University and University of Pittsburgh is a privilege, and we believe will help us advance our mission to discover, create, test and deliver life-changing medicines for patients in need as rapidly as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    To date, BridgeBio has worked with 23 leading institutions throughout the country that are focused on providing treatment options to patients as quickly and safely as possible. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    MUSC Foundation for Research Development
    MUSC Foundation for Research Development provides technology transfer services to Medical University of South Carolina (MUSC), which is a patient-centric research institution with several hospitals in South Carolina and is considered the state's top healthcare provider. MUSC's innovative and high-quality research will allow for early identification of research programs with a strong potential to be beneficial for patients. Through this partnership, BridgeBio may sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

    "Like BridgeBio, we have a patients first mentality, so partnering together on early research will be an excellent opportunity to advance our innovation in the hope of generating new therapies for patients," said Scott Davis, Ph.D., senior director of innovation support and commercialization of MUSC Foundation for Research Development.

    About BridgeBio Pharma, Inc.
    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

  • sam patrick posted an article
    Subject matter leaders from across Palmetto State to cover what businesses need to know see more

    March 9, 2020 – SCBIO will host a full day program March 17 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.

    To be held at the SC Hospital Association’s Yates Conference Center in Columbia, the program will run from 8:30 a.m. until 1 p.m. and will feature a light breakfast followed by presentations from over 15 noted life sciences industry leaders.  Confirmed topics and speakers include:

    • Best Practices in Life Sciences Recruiting & Retention – addressing how the state’s life sciences leaders are attracting, training and retaining top talent will be Lou Kennedy, CEO of Nephron Pharmaceuticals; Shawn Regan, CEO of Rhythmlink; Andrew Lee, Founder of IMCS, and Matt Vaadi, CEO of ERG
    • Partnering Effectively with Higher Education & Research Universities – ways to tap into the wealth of resources, knowledge and experience prevalent in the state’s higher education and research universities will be explained by a panel comprised of Anthony Herrera, Executive Director of Furman University Entrepreneurship & Innovation; Angela Lockman, Director of Partnerships and Strategic Initiatives for Clemson University; Chad Hardaway, Assoc. Director of the University of South Carolina Office of Economic Engagement; Carol Moore, President of Columbia College; and Michael Rusnak, Executive Director, MUSC Foundation for Research Development
    • Accessing Capital to Grow Your Life Sciences Organization – the secrets to finding capital to grow and expand your organization, from start-up to growth company, will be unveiled by John Osborne, Principal with Good Growth Capital; Jill Sorensen, Executive Director of SC Launch; and Tyler Tatum of 3Phase SC
    •  Attracting & Retaining Life Sciences Organizations – three economic development experts will share how the Palmetto State is going about growing the life sciences industry here, and what plans are to make it even more attractive tomorrow.  Speaking will be Stephanie Few, Partner with Womble Bond Dickinson; Jeremy Migliara, Shareholder with Elliott Davis; and Will Clarke, Manager with Elliott Davis
    • Protecting Your Life Sciences Organization from Cybercrime – will be addressed by cybersecurity expert Delano Collins, Vice President of Cybersecurity with Corsica Technologies.  He’ll address how planning defense in depth -- from network and systems security to industry compliance and employee training -- can set organizations up for security and success.

    SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations as well as SCBIO registered Members pay only $50 for the program.  The general public and Non-Members can attend for just $100.  Fees include the full program, plus a light breakfast and lunch. To register or for more details, visit the Events page at www.SCBIO.org/.  Interested students and media members are invited to attend, with advance registration, at no cost.

    SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.

  • sam patrick posted an article
    Biopharma research is an important source of jobs, tax revenue and research spending in SC see more

    New findings show biopharma research companies a source of jobs, tax revenue and research spending in state

     

    GREENVILLE, S.C., October 4, 2018 – This week, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report that finds there are more than 572 active clinical trials in the South Carolina, and the life science industry supports 29,500 high-quality jobs and contributes $7.9 billion to South Carolina’s economy. These clinical trials can be responsible for more than half of the $2.6 billion average cost of developing one new medicine. They are investigating some of the biggest health care challenges South Carolinians face, including arthritis, cancer, diabetes, cardiovascular disease, and Alzheimer’s disease.

    The report, titled “Research in Your Backyard: Developing Cures, Creating Jobs, Pharmaceutical Clinical Trials in South Carolina,” was released at a press event held at the Westin Poinsett today, which featured a panel discussion including researchers and executives from the Greenville Health System, KIYATEC, the Hollings Cancer Center at MUSC, and the Greenwood Genetic Center, moderated by SCBIO President and CEO, Sam Konduros.

    “Clinical trials offer patients novel medical treatments right here in the Palmetto State, while also allowing biopharma research organizations to innovate and grow,” said Konduros. “Across South Carolina, the life sciences and healthcare industries have had a profound impact on our economy and citizens, that continues to rapidly increase.”

    Clinical trials are a vital component of bringing new life-saving drugs and treatments to market. On average, it takes approximately a decade for new medicines to go through the rigorous Food and Drug Administration (FDA) approval process. Only 12 percent of drugs successfully make it through clinical trials. Since 2004, biopharmaceutical research companies have conducted or are currently conducting more than 4,700 clinical trials in South Carolina. In 2013 alone, the nearly 1,100 active clinical trials in the state generated an estimated economic impact of $540 million.

    “One of the most important things we want people to understand about medicine development is that clinical trials rely on patient participation,” said Nick McGee, Director of Public Affairs for PhRMA. “It’s incredibly important that patients are aware of ongoing trials and learn how they can help become part of finding a cure for the toughest chronic conditions and diseases we face today.”

    In the United States, there are more than 7,000 open clinical trials being sponsored by the biopharmaceutical industry, universities, individuals and organizations combined. In South Carolina, of the 572 open clinical trials involving the biopharmaceutical research industry, the University of South Carolina Medial School is collaborating on more than 143 clinical trials and the Medical University of South Carolina is collaborating on more than 142.

    “Many top research and medical universities call South Carolina home and are centers of innovation,” Bob Quinn, Executive Director of the South Carolina Research Authority, said. “Maintaining strong partnerships between our universities and life science companies allows us to foster developments right here in South Carolina that can then help save lives far beyond our state lines.”

    You can read the complete report, “Research in Your Backyard: Developing Cures, Creating Jobs, Pharmaceutical Clinical Trials in South Carolina,” here.

    ###

    About PhRMA
    The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $71.4 billion in 2017 alone.

    About SC BIO
    SCBIO is South Carolina’s investor-driven public/private economic development organization focused on building, advancing, and growing the life sciences industry in the state.  With an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms and 15,000 professionals directly involved in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products that make a difference across the Palmetto State and around the world.  Visit us at SCBIO.org.