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clinical trials

  • sam patrick posted an article
    Long term impacts of COVID-19 across the health care spectrum are still to be determined see more

    12.02.2021

    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[1]. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites[2]. 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[3]. 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[4]. 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[5]. 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[6].”

    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[7].

    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[8]. 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[9]. 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[10].  Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective[11].

    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[12]. 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[13]. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies[14].

    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.

  • sam patrick posted an article
    Clemson researchers pursue cutting-edge science and targeted medicine to improve lifespan, quality see more

    In the last 25 years, rigorous research, broad medical collaborations and lifesaving interventions have made huge strides for cancer treatment. That means survival rates are up across the board for almost all forms of cancer, including the two most common ones for South Carolinians: breast and prostate cancer.

    As recently as the late 1990s, there were clinical trials, and there were heroic efforts, but there were very few effective treatments for combatting some of the most highly aggressive forms of cancer. Twenty-five years later, some of those same cancers have a more than 80 percent survival rate. 

    Clemson can point to health innovation through research that has played notable roles in improving health outcomes for patients statewide. And that’s because cancer intervention isn’t isolated to bedside care from a nurse or petri-dish analysis from the lab.

    Today, cancer treatment is:

    • Powered by huge data sets that build the artificial intelligence needed to identify root causes of and precision cures for cancer. 
    • Innovative approaches, such as precision radio frequency that targets cancer cells rather than an IV drip administering chemotherapy drugs.  
    • Cellular research to develop new methods of finding and eliminating cancer faster, more safely and more efficiently. 
    • Identifying and preventing the side effects of treatment drugs and improving quality of life for patients even as they and their health care teams aggressively fight cancer. 

    Read the rest of this article by clicking here.

  • 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
    Expanded use of test builds on previous month’s publication of successful interim clinical data see more

    Functional precision oncology innovator Kiyatec announced today that it is initiating use of the 3D Predict™ Glioma test outside of its 3D-PREDICT clinical study. Recently published peer-reviewed data demonstrated successful use of this test for patients with either newly diagnosed or recurrent high-grade gliomas, which includes glioblastoma (GBM).

    In choosing July 21, 2021, to announce the expanded use of its test, KIYATEC joins the country in shining a light on glioblastoma, which is the most common, treatment-resistant, and deadliest type of brain cancer. A recent bipartisan U.S. Senate resolution declared today as Glioblastoma Awareness Day in order to highlight the severity of GBM, and show support for individuals who are currently living with GBM, as well as caregivers and families. Additionally, the resolution encourages continued investment into glioblastoma research and treatments.

    “At the core of KIYATEC’s mission is the desire to improve cancer patients’ lives. We’re excited to take the next step in fulfilling this mission by expanding the use of our testing for patients with GBM, which is such an aggressive cancer with few treatment options,” said Lillia Holmes, Chief Operations Officer at KIYATEC.

    In a patient, the biological interaction between their live cancer cells and the administered therapy drives treatment outcomes. Measurement of this interaction, before prescribing a treatment plan, is not typically part of today’s cancer treatment paradigm. KIYATEC’s test results add this measurement into the information that informs oncologists’ treatment decisions for a given patient. This approach translated to patient benefit while demonstrating clinically relevant accuracy, as documented in the June Neuro-Oncology Advances publication.

    The 3D Predict™ Glioma test is designed to work within the current framework of standard of care for high-grade glioma patients. Since live cells are required for the test, a patient’s oncologist must sync sample submission with the timing of the first surgery for newly diagnosed patients, or recurrent surgeries for relapsed patients. Oncologists interested in the potential use of the test to inform their decision-making, or requesting test kits to provide samples, should contact the company at medical.affairs@kiyatec.com.

    “Our goal is to provide oncologists with a more effective decision-making tool, by combining individual patient’s cancer cells with potential treatment drugs,” said Stephen Shuford, first author on the company’s recent Neuro-Oncology Advances publication.

    The Senate resolution recognizes that:

    • The five-year survival rate for GBM patients is 7%,
    • The median length of survival is 8 months,
    • Approximately 13,000 Americans will be diagnosed with GBM in 2021,
    • Brain cancer has the highest per-patient initial cost of care, and
    • Despite being first described over a century ago, there are only four FDA approved drugs and one device for GBM.

    KIYATEC aims to make a meaningful impact for patients who are facing this challenging cancer.

    About KIYATEC

    KIYATEC is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services business offers or is developing clinical tests for high-grade glioma, ovarian, breast, and non-small cell lung cancers, and rare tumors in its CLIA-certified lab. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

  • sam patrick posted an article
    Life sciences booming in Spartanburg, Upstate see more

    Spartanburg County – and the entire Upstate – are welcoming a growing interest and investments from life sciences companies. The Upstate has a long-established history and infrastructure that have supported life sciences companies with raw materials, production and packaging operations, and distribution.

    Now, new research and innovation businesses are further supporting industry growth and fueling an ecosystem ripe for start-ups.

    More than 670 life sciences firms of all sizes call the Upstate home, with 13 companies announcing new locations in the area in the last few years.

    The newest of those companies in Spartanburg is Epica International, the leader in advanced, ultra-high-resolution mobile medical imaging and robotic applications for human and animal health, and industrial enterprises.

    The company announced its headquarters and operations in Spartanburg, covering its subsidiary companies Epica Human Health, Epica Animal Health and Roboticom. Epica established corporate, imaging and robotic system demos at its facility, currently located inside the Spark Center SC on the Tyger River Campus of Spartanburg Community College.

    “Epica’s investment in Spartanburg goes hand-in-hand with a diversified economic development strategy we’ve put in place countywide, targeting specifically investments from bioscience and life sciences industries,” said OneSpartanburg, Inc. Chief Economic Development Officer Katherine O’Neill. “These types of advanced, heavy-technology industries coming to our county gives us a considerable strategic advantage for future development and job growth.”

    Another life sciences company – Pall Corporation – announced its intent to invest in Spartanburg County earlier in 2021. Pall announced its Spartanburg County operations would create 425 new jobs and $30.2 million in investment.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies. The company’s Spartanburg facility supports the rapid development of vaccines and therapeutics, including COVID-19 vaccines.

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county,” said Pall Life Sciences President Joseph Repp at the time of the company’s announcement.

    Statewide, South Carolina has a significant presence in the medical device sector. And the manufacturing supply chain is robust when it comes to life sciences, mirroring the strength of the area’s overall manufacturing prowess.

    From 2015-2019, medical devices and equipment companies added 35% more jobs and accounted for 11.5% of the new companies coming to the Upstate. And on top of that, more than 700 clinical trials are being undertaken across the Upstate at any given time in the fields of oncology, companion diagnostics, genetics and more.

    The Upstate in particular has a network of acclaimed hospitals, technical training schools and more than 26 colleges and universities actively working with industry leaders and educators on all levels to ensure access a highly-skilled workforce for decades to come.

    “Spartanburg’s historic advantages when it comes to infrastructure, distribution capabilities and even the county’s location, make it a favorable home for continued investments from biosciences and life science industries,” said O’Neill. “That positions us well for the future as these industries continue to bring higher-wage, knowledge-based jobs to Spartanburg.”

  • sam patrick posted an article
    Validated platform with clinically actionable results creates real possibilities to improve care see more

    Validated platform with clinically actionable results creates real possibilities to improve care for glioblastoma (GBM) and other high-grade glioma patients

     

    GREENVILLE, S.C. – June 17, 2021 – KIYATEC, Inc. announced today the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients. The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

    A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict™ Glioma assay.

    The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

    KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

    Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

    “Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment,” said Matthew Gevaert, PhD, CEO of KIYATEC.

    Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

    About KIYATEC
    KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

  • sam patrick posted an article
    First release of 3D-PREDICT clinical study data fuels momentum of company’s glioblastoma program see more

    GREENVILLE, SC – December 17, 2020 – KIYATEC, Inc. today announced the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients. Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.

    Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.

    “In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center,” said Dr. Lipinski. “Our results show that we are far along in the paradigm shift toward individualized medicine.”

    Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.

    KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.

    “Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this.” 

    This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.
     

    About KIYATEC, Inc.
    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

     

    Citation:

    Lindsay Lipinski, et al., INNV-16. Clinical applicability of individualized drug response profiling utilizing ex-vivo tissue-derived 3D cell culture assays in high-grade glioma: a single institution case series using 3D-PREDICT results, Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Pages ii119–ii120, https://doi.org/10.1093/neuonc/noaa215.499.

     

  • sam patrick posted an article
    SE Life Sciences launches new initiative designed to expand clinical trial diversity see more

    Compliments of Columbia Business Monthly & Greenville Business magazines

    National polls show that anywhere from 51 percent to 64 percent of Americans would be willing to be vaccinated against coronavirus.

    But the number is far lower for minorities.

    Some 49 percent of African Americans and 37 percent of Hispanics say they won’t take the vaccine, according to the Kaiser Family Foundation.
       
    About 39 percent of Blacks cited safety concerns in the poll, while 35 percent cited distrust of the health care system.

    That distrust goes back decades to the Tuskegee Experiment, a federal study that allowed syphilis in Black men to go untreated so scientists could observe its progression.

    And it affects the way many African Americans view the health system today, with low participation clinical trials - just 5 percent to 7 percent nationally – among the consequences, according to SE Life Sciences, a trade group representing life science companies in the Southeast.

    Enjoy reading the full article here...

  • sam patrick posted an article
    SE Color initiates “We Are In” Campaign to encourage minority participation in Clinical Trials see more

    On September 9, Southeast Life Sciences announced the formation of SE Color, an organization dedicated to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities.

    The founding advisory board members are Jayne Morgan MD, Clinical Director, Covid Task Force at Piedmont Healthcare, Kornelius Bankston, Managing Partner with techPLUG, and John Newby, Chief Executive Officer for Virginia BIO. As executive director of Southeast Life Sciences, Jason Rupp will staff the organization.

    SE Color’s initial effort will focus on increasing the number of minorities in clinical trials. In an article published in Healthcare Tech Outlook, Dr. Morgan notes that, “African Americans make up 13.4 percent of the US population, yet only 5 – 7 percent of clinical trial participants nationally.”

    Dr. Morgan further states, “Nearly every advance in medicine today was first evaluated in a clinical trial. Clinical trials offer our best and most forward thinking and can be the gateway to provide earlier access to life saving medicines and therapies years ahead of FDA approval. Equitable participation in clinical trials is therefore a critical call to action in ensuring that medicines, devices, and vaccines that are developed are relevant to all populations.”

    Although there are many aspects to facilitate minority recruitment in clinical trials, SE Color will initially focus on education through the “We Are In” campaign. The initial priority will be to share information on clinical trials available throughout the southeast. SE Color will partner with state associations in the region to ensure we have updated information and extend the network.

    Southeast Life Sciences recognizes the great need for effort in these areas and though we will only be one part of the solution, we will be part of it. In closing, Bankston adds “I believe the greatest social injustice in modern history is health inequalities which disproportionately impact people of color. We can create more effective therapeutics, applications and medicines for all populations- by addressing the systemic issues in clinical research.”

  • 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.

  • sam patrick posted an article
    Clinical trials are saving lives in South Carolina see more

    When he was diagnosed with stage 4 lung cancer in 2011, Jimmy Alexander wasn’t expected to live more than a year.

    So doctors enrolled him in a clinical trial of a new chemotherapy cocktail hoping it might make a difference.

    Eight years later, the Simpsonville man is still enjoying Clemson football and time with his family, including two daughters, five grandchildren and six great-grandchildren.

    And now the program that helped Alexander is being expanded into the Midlands with an $8.2 million grant awarded Friday by the National Cancer Institute’s Community Oncology Program, or NCORP.

    “People just don’t realize what clinicals may be able to do,” Alexander said. “They can be a lifesaver.”

    Clinical trials are conducted to determine whether a treatment works while offering patients a shot at experimental therapies that aren’t otherwise available through normal channels.

    They provide physicians with new weapons in the battle against cancer, said Dr. Larry Gluck, medical director of Prisma Health-Upstate’s Cancer Institute in Greenville, which was awarded the grant.

    “Because of our NCI designation and support,” he said, “we can offer hundreds of leading-edge clinical trials that can provide treatments to patients years before approval by the FDA for general use.”

    More than 300 clinical trials are underway at Prisma’s Cancer Institute at any time and the hospital has been awarded more than $30 million in NCI grants since 1995, according to Prisma, formerly Greenville Health System.

    “What we learn from one patient helps that patient – but also many many more,” said Dr. Jeff Giguere, a Prisma oncologist.

    “A unique aspect of research via the NCORP grant is that it interrogates every point on the cancer continuum from diagnosis, treatment, supportive care," he said, "as well as proactively evaluates cancer prevention and more effective and efficient ways of delivering cancer care.”

    The latest six-year grant will enable trials for lymphoma, leukemia and solid tumors to begin in the Midlands this fall. 

    “Our goal ... is to continue to serve our Upstate patients with strengthened options here and extend our reach and expertise to the legacy Palmetto Health institutions via Prisma Health,” said Giguere. “We hope to meet an unmet need for our state.”

    There was no guarantee when Alexander was enrolled in the trial that he would benefit from the drugs. But the 78-year-old said he would have participated anyway in case it would help others.

    “If whatever I am doing helps other people, I was glad to do it,” he said. “But here I am eight years later.”

    Alexander said his cancer is stable, thanks to a weekly infusion of a drug called Erbitux, which is provided through the trial.

    Fortunately, the retired engineer was able to live to see a great-granddaughter born seven months ago.

    “I’m doing pretty good. The only problem I have is old age,” he says with a chuckle. “I’m still around to play with her. It’s a great, great thing.”