Velocity Clinical Research's acquisition of South Carolina's VitaLink Research signals new frontier for clinical site management industryInvestment 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
Makes top list for fifth year in a row see more
For the fifth consecutive year, Furman University is one of the “Most Innovative Schools” among national liberal arts colleges and universities, according to the U.S. News & World Report “Best Colleges” rankings released Sept. 13. Furman also was included in the top-50 among its peers for undergraduate teaching, first-year experience and undergraduate research.
Overall, Furman climbed six places to No. 46 among all “National Liberal Arts Colleges,” placing it again in the top quarter of all liberal arts and sciences universities. The top-ranked university in South Carolina, Furman ranks sixth in the Southeast in its category, behind the U.S. Naval Academy in Maryland (6), Washington and Lee University in Virginia (11), Davidson College in North Carolina (13), the University of Richmond (22) and Berea College in Kentucky (30).
“Furman faculty and staff demonstrate every day their commitment to helping all of our students find their pathway through their four years at Furman by integrating curricular, co-curricular and extra-curricular experiences,” said Elizabeth Davis, president of Furman University. “These rankings, and the recognition by university leaders across the country, reflect the value of a Furman education and our innovation in delivering it.”
Furman has been voted a “Most Innovative School” by its peers every year since launching The Furman Advantage in 2016, coming in at No. 32 this year. Furman was also recognized among its peer universities for “Best College for Veterans” (2) and “Undergraduate Teaching” (46), and among all universities for “Best First-Year Experience” (49) and “Undergraduate Research” (46). Furman also ranked No. 37 for faculty resources and No. 50 for financial resources for students.
The “most innovative,” “undergraduate teaching,” “first-year experience” and “undergraduate research” rankings are decided by university presidents, provosts and deans of admissions who are asked to rank the top schools that come to mind in the respective categories.
Also this year, Furman was included among “The Best 387 Colleges” in the country by The Princeton Review. The publication also ranked Furman No. 15 on its list of “schools for making an impact” in its “Best Value Colleges” guide.
In 2020, Furman was the top college or university in South Carolina in the Best Colleges 2021 rankings by The Wall Street Journal and Times Higher Education. Furman ranked No. 135 out of nearly 800 U.S. colleges or universities that made the list. The WSJ/THE College Ranking is designed to “put graduate success and student learning at its heart.”
For more information, contact the Furman News and Media Strategy office at 864-294-3107.
Two life sciences companies make list for SCRA support see more
Advent Innovations, LLC and DPX Technologies, LLC have been accepted as South Carolina Research Authority (SCRA) Member Companies and awarded grant funding. Parimer Scientific, LLC and Prewrite, Inc. have been accepted as Member Companies. As Member Companies, they will 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 affiliate, SC Launch, Inc.
Advent Innovations Limited Company has been accepted as an SCRA Member Company and awarded a $50,000 Federal Matching Grant. The University of South Carolina-affiliated startup provides services in modeling, analysis, design, and product development using cutting-edge research with novel sensors, big data analytics, and other smart technology such as robotics. Their customers include private corporations and government entities in aerospace, automotive, civil infrastructure, and energy.
DPX Technologies, LLC has been accepted as an SCRA Member Company and awarded a $50,000 Federal Matching Grant. The University of South Carolina-affiliated company manufactures sample lab preparation products and develops custom methods for a diverse client base. Their proprietary and patented INTip™ technologies provide efficient, automated solutions for laboratories that are easy to customize and implement with any workflow or method.
Parimer Scientific, LLC has been accepted as an SCRA Member Company. The Easley-based company provides turn-key laboratory services at competitive rates to biotech and pharmaceutical companies with no upfront capital or long-term commitment needed. In 2020 alone, more than 10,000 units of pharmaceutical products were made at Parimer and shipped directly to the end-users at hospitals, doctor’s offices, and nursing homes.
Prewrite, Inc. has been accepted as an SCRA Member Company. The Greenville-based startup offers a story development platform for writers, producers, and content creators of all types. Their powerful tool ensures the writer is using good story fundamentals. Stories of any complexity are easily built, piece-by-piece. Originally designed for screenplays, Prewrite is used around the world by professionals and amateurs alike.
SCRA welcomes these new Member Companies!
Grant funding is made possible, in part, by Industry Partnership Fund (IPF) contributions that fuel the state’s innovation economy. Contributors to the IPF receive a dollar-for-dollar state tax credit, making it an easy and effective way to help one of the fastest growing segments of the South Carolina economy. Grant funding for Member Companies creates a direct, positive economic effect and job creation.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
Furman commitment to Greenville and South Carolina growing see more
Furman is expanding its downtown presence – and planning one of the school’s greatest investments in the Greenville community – with the addition of a 2,000-square-foot space on the ground floor of 101 N. Main St. in One City Plaza.
The storefront suite in the former Bank of America building next to Methodical Coffee is being designed as “an experiential learning environment,” said Anthony Herrera, Furman’s chief innovation officer and executive director of The Institute for Innovation and Entrepreneurship.
“This will be one of our most visible commitments to connect Furman’s main campus with the local community,” he said.
The One City Plaza location is the latest example of Furman’s growing presence and engagement with the community, said Liz Seman, chief of staff and liaison to Furman’s Board of Trustees.
“From the West End to Heritage Green, to our beautiful campus on Poinsett Highway, Furman is proud to be Greenville’s University,” said Seman. “We are excited to add the space at One City Plaza to our downtown footprint. Students, faculty, staff and alumni will now have the opportunity to engage with the Greenville community at Fluor Field, M. Judson Booksellers, the Upcountry History Museum and the Bon Secours Wellness Arena. All of these venues provide unique opportunities for collaboration and high-impact experiences, which are the hallmark of The Furman Advantage.”
A multipurpose area with flexible furniture, the space will be quickly convertible to host a wide array of programs, workshops and events, Herrera said. Select graduate and undergraduate courses, continuing education certificates, workshops, speaker series and networking events will be delivered throughout the week to develop leaders and “lifelong learners” throughout the city.
Along with the Institute for Innovation and Entrepreneurship, Furman’s three other institutes – The Riley Institute, The Shi Institute for Sustainable Communities and The Institute for Advancement of Community Health – will offer programming. Furman’s Center for Corporate and Professional Development and the Osher Lifelong Learning Institute, as well as the school’s academic, alumni relations and athletics departments, will also present events.
The facility, expected to open later this year or soon after the new year, can benefit both Furman and Greenville by encouraging students to ultimately get full-time positions and stay in the city, said Herrera.
“This space will connect our students and faculty more intentionally with the business and nonprofit community for a pipeline of talent for internships, full-time jobs, research and impactful collaborations,” he said. “It will further carry out Furman’s mission of delivering transformative experiences for lifelong learners. We want to expand our commitment to serving the Greenville community and ensuring Greenville continues to thrive.”
Another catalyst for the development is this fall’s launch of the GVL Starts program, an eight-week program for aspiring entrepreneurs to network and learn skills to develop their potential startups and small businesses, he said.
The ground floor space won’t be the only place to find Furman purple in the former Bank of America building. In December 2020, Furman University President Elizabeth Davis announced that the Institute for Innovation and Entrepreneurship will join the city of Greenville’s economic development team in locating offices in downtown Greenville with NEXT, an entrepreneurial-support organization that operates under the Greenville Chamber Foundation, on the third floor of 101 N. Main St.
Xcelerate, Inc. Signs Definitive Memorandum of Understanding with HS Pharmaceuticals, LLC of South CarolinaGreenville company enters MOU with global player see more
Xcelerate, Inc. (OTC pink sheets: "XCRT") today announced that it has signed a Definitive Memorandum of Understanding with HS Pharmaceuticals, LLC of Greenville, SC defining the terms under which Xcelerate, Inc. will acquire 100% of the membership interests in HS Pharmaceuticals, LLC as well as a 51% interest in HS Cosmetics, Inc.
The DMOU calls for the drafting and signing of an Acquisition Agreement with a pre-determined valuation of HS Pharmaceuticals as well as the raising of capital sufficient to progress the development of HS Pharmaceuticals IP and to fulfill the expansion of the current HS Cosmetics marketing plan launched in April of 2021.
"Since the announcement of a letter of intent with HS Pharmaceuticals in May, the teams at Xcelerate and HS have been working to define the terms that have resulted in this DMOU and were able to agreement with the assistance of our advisors at Network1 Financial who will be working with us going forward in our capital raising efforts" said Michael O'Shea, Xcelerate CEO."
"Xcelerate remains focused on joining early-stage medical technology companies in a setting of controlled clinical care where these new developments can be trialed, tested and applied," said O'Shea.
For more information, please visit www.xcelerate.global.
Life sciences among segments leading SC growth see more
When Commerce Secretary Harry Lightsey saw his first iPhone, he was seeing one of the first in the world. In 2007, it was one of only two.
At the time, he was the Southeast president of AT&T, in a room among the company’s top leadership.
When all eyes were on the company chairman, he reached into the pocket of his suit.
“He pulled out this object that none of us recognized and said, ‘This is one of two existing iPhones in the world. The other one is held by Stephen Jobs, and I’ve got this one. This device has convinced me that it is going to change the world, but I have no idea how it’s going to change the world, but I’m convinced it’s going to change the world,’” Lightsey recounted at Upstate SC Alliance’s midyear meeting, held at the Crowne Plaza Greenville Wednesday.
How today’s developments will mold the business landscape as we know it is yet to be seen, he said.
No one knows.
But, Lightsey assured the crowd of alliance investors, it’s shifting in the direction of ever-growing mobility, communications and biotech capabilities. And it’s shifting fast.
It’s South Carolina’s job to keep up and stay ahead, he said during one of his first public appearances in the Upstate since he took the secretary’s post.
“I do know this, that we have to be ready for change,” he said. “We have to be ready for the opportunities that the change is going to present to us. We shouldn’t view change as a threat or a concern, but as certainly something we can capitalize on.”
Much of the afternoon meeting focused on economic development victories of the past year within the life sciences, tech or R&D realms: a few vignettes from the 22 companies that moved to or expanded in the 10 counties in 2021 with Upstate SC Alliance’s assistance.
Upstate SC Alliance projects Pozyx, a Belgian information technology firm, and Oshkosh Defense’s manufacturing facility for the next generation mail truck held the spotlight, alongside BMW’s electrification efforts and Upstate biotech companies Zylo Therapeutics, Chartspan and Epica International.
Upstate SC Alliance’s announcements for the year thus far have prompted the creation of an expected 3,963 jobs and $930 million total investment.
“When many areas saw contractions in service, South Carolina’s manufacturing sector actually grew last year,” John Lummus, CEO and president of Upstate SC Alliance, said during the meeting. “And manufacturing and its need for engineering, technology and creative solutions will continue to drive our growth strategy moving forward. That’s why you’re seeing a stronger focus on innovation as a complement to our business recruitment program.”
He added that on the economic development announcement front, so far, 2021 has brought in three times the capital investment and twice the number of created jobs as 2019, especially in sectors bolstering enhanced mobility and health care services.
According to the group’s midyear report, the largest number of projects in the pipeline are in the engineered materials (263), automotive and transport (238), industrial manufacturing (155), life sciences (146) and aerospace and defense (144) fields. The first half of 2021 prompted 23 requests for information on economic development opportunities in the Upstate.
Domestic companies — 414 contacts to be exact — are the most likely, judging by the number of active contacts, to make the move to the Upstate in the months ahead.
International supply chains and travel may have been hampered by COVID-19 restrictions, but it didn’t completely derail progress, especially with the virtual playing field provided by a tectonic shift to Zoom conference rooms and continued in-person visits from leaders like Belgium’s Consul General in Atlanta, Michael Gerebtzoff.
The majority — almost 60% — of the companies that expanded in or moved to the area throughout 2021 were foreign-owned businesses: Deutsche Post DHL’s subsidiary DHL Supply Chain, Sweden’s Frauenthal Gnotec, Ireland’s E+I Engineering USA and China’s Gissing North America, just to name a few.
Looking forward, the United Kingdom, Germany, Canada, Spain, China, France, India, Belgium and Italy respectively are the hottest international sources for Upstate economic development prospects based off the number of active contacts.
“We have a lot of strengths and inherent advantages just because of who we are and where are,” Lightsey said. “But one of our main strengths is that we are a small state and we understand what it means to work together as a team. Commerce is a state agency that has supported the alliances’ growth and maturation of the alliances across the state, and the Upstate Alliance has certainly led the way, is something that’s incredible strength for our state: the ability to be able to work together for both our existing businesses, as well as those businesses that are looking to be partners with our state.”
New leader for entrepreneurial organization to start in September see more
Entrepreneur Eric Weissmann has been named the new Executive Director of NEXT, an entrepreneur support organization in Greenville, SC that has impacted more than 120 companies, who in turn have raised $28 million in capital. NEXT provides connections to mentoring, capital, facilities, and access to a peer community of aspiring founders across the region.
Weissmann was part of the founding team at Cintrifuse, a similar ecosystem catalyst, in Cincinnati, Ohio, where he serves as Vice President of External Relations. Weissmann launched “StartupCincy,” an initiative that started as a simple social media hashtag and bloomed into a full-fledged, connected community. He previously worked in the marketing and creative services industries. Weissmann has helped establish the Disney Cruise Line brand leading up to the maiden voyage of the Disney Magic.
“I’m excited by the opportunity and encouraged by the amount of collaboration I already see in the Greenville community,” said Weissmann. “We’re at a unique moment in time where cities across the country are fostering entrepreneurship by leveraging their unique strengths to attract talent and dollars with the goal of increasing economic development. Greenville’s got the raw materials to make a huge impact on the region and I’m ready to get to work!”
Find Great People led a nationwide, comprehensive search. The interview committee selected Weissmann because of his extensive experience developing innovation ecosystems, supporting entrepreneurs in securing venture capital, leading diversity and inclusion programs, and supporting ventures from concept to exit.
“Eric embodies the qualities we desired in the leader of NEXT: a proven leader with experience building world-class ecosystems for start-ups and developing innovative, collaborative teams and communities where entrepreneurs can thrive,” said Carlos Phillips, Greenville Chamber President/CEO.
NEXT was founded in 2006 and has three locations including NEXT Innovation, NEXT on Main and NEXT Manufacturing.
“As we look to the future, NEXT has a goal of tripling investment in the entrepreneurial ecosystem that we serve,” said Scott Millwood, Chair of NEXT. “Under Weissmann’s leadership, we are confident NEXT will have the strategic and visionary leadership needed to accomplish these goals.”
The City of Greenville is an investor in NEXT, as part of its Economic Development strategy to attract small and medium sized companies that provide high wage, knowledge-based jobs. The Greenville Area Development Corporation (GADC) is also an active supporter.
“NEXT is the vehicle the city utilizes to support early-stage scalable businesses,” said Greenville City Manager John McDonough. “We ‘get’ entrepreneurs and the dreams that drive them. Hiring a founder who has successfully started companies, grown companies and marketed companies, to lead the NEXT organization showcases our commitment to becoming “the place” for brilliant minds to start and grow their business.”
Weissmann is expected to begin in September.
NEXT, launched as a production of the Greenville Chamber in 2006, is an entrepreneurial support organization that attracts and helps high-impact, knowledge-based companies grow by developing an entrepreneurial ecosystem and connecting entrepreneurs to it. NEXT currently supports over 120 knowledge-based companies in Upstate South Carolina. For more information, visit www.nextsc.org
Zylö Receives $1,700,000 NIH Phase II Grant to Advance Erectile Dysfunction Program into Human TrialsFunds to be used for scale-up, implementation of cGMP quality system see more
Zylö Therapeutics Inc., developer of the transformational Z-pod™ topical delivery platform, has been awarded a $1,700,000 Small Business Innovation Research (SBIR) grant to advance Zylö’s proprietary nitric-oxide-releasing topical drug candidate into clinical trials. The grant, titled “Development of microparticle-based topical treatments for treating erectile dysfunction [‘ED’] in patients refractory to oral PDE5 inhibitors,” was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (a division of the NIH).
The principal investigator of the project is Andrew Draganski, Ph.D., Zylö’s head of product development and adjunct professor at Clemson University; the primary collaborator is Kelvin Davies, Ph.D., professor of urology and professor of physiology and biophysics at Albert Einstein College of Medicine.
Using ~$225,000 of NIH funds from a Phase I award, Zylö demonstrated compelling results in a radical prostatectomy rat model of ED, whereby the cavernous nerve of the rat is surgically severed such that the rat is sexually dysfunctional and does not respond to sildenafil (a.k.a. Viagra®) and other PDE5 inhibitors. With a single topical application of the nitric-oxide-releasing Z-pod™ formulation, the rats experienced 2.0 erections on average during the 60-minute observation period immediately following topical administration; when the rats were pre-dosed with a 1/10th human-equivalent dose of sildenafil/Viagra, the average number of erections increased to 4.6 and the time-to-initial-erection was approximately cut in half.
The goal of this Phase II work is to (i) test other PDE5 inhibitors (Cialis®, Levitra®, Stendra®), (ii) scale-up the manufacturing process and to overlay a cGMP quality program, (iii) conduct certain toxicity testing required for an Investigational New Drug [IND] application, and (iv) hold a pre-IND meeting with the FDA to secure feedback critical to successful development of the program.
If eventually approved, this Z-pod™-based drug candidate will target two distinct market segments, as follows:
- Men with ED secondary to radical prostatectomy: It has been reported that 86% of men that have undergone radical prostatectomy (which typically impacts the cavernous nerve) will suffer from ED, with no approved treatment available to them (just like with rats with severed cavernous nerves, these men do not respond to Viagra et al.)
- Men with the more typical ‘age-related’ ED symptoms that either do not respond well to the PDE5 inhibitors or cannot take the medication due to medication side-effects or drug interactions.
In the U.S. alone, these two market segments represent an addressable market of over $2 billion per year.
Andrew Draganski Ph.D. commented, “Zylö’s nitric-oxide technology is a potential breakthrough in the treatment of ED in men that are refractory to the PDE5 inhibitors such as Viagra. This commitment by the National Institute of Diabetes and Digestives and Kidney Diseases is quite validating, and we are grateful to the NIDDK for their funding.”
Added Jay Blankenship MD, Zylö’s head of business development, “We are enthused by the opportunity afforded by the NIH to advance our innovative approach to delivering nitric oxide through topical administration. This patent-pending technology holds great promise not just for ED, but for a myriad of other clinical applications such as wound-healing, atopic dermatitis, gingivitis, and sports recovery.”
About Zylö Therapeutics: Zylö has developed the Z-pod™ technology platform, a disruptive topical delivery system that extends the duration of effect, improves the solubility/targeting, and enhances the product performance of many therapeutic and cosmetic agents. Notably, the Z-pod™ technology has successfully harnessed the therapeutic potential of nitric oxide, one of the most powerful—and short-lived—biomolecules produced by our bodies. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).
Helping patients stay out of hospital, recover faster see more
Prisma Health is taking key elements of inpatient care into patients’ homes to help them stay out of the hospital under a new program for the Midlands called Home Recovery Care.
The model has been used at Prisma Health hospitals in the Upstate, according to a news release.
For patients under care through Prisma Health Richland Hospital, the organization partners with Nashville, Tenn.-based Contessa to deliver the service at its third site, the news release said.
The program launched at Greenville Memorial Hospital in 2019 and expanded to Oconee Memorial Hospital last year. In the Upstate, the program has a 90% acceptance rate and an average patient satisfaction score of 98%, according to the release.
Prisma Health was one of the first health systems approved to provide Home Recovery Care to Medicare fee-for-service patients under the Center for Medicare and Medicaid Services’ Hospitals Without Walls waiver, the release said. Programs that encourage hospitals to find healthy ways to stay out of emergency rooms and hospital rooms have been part of Medicare/Medicaid rules for years, with the COVID-19 pandemic spurring more efforts.
“Prisma Health has had great success with the program in the Upstate, and we are thrilled to provide this level of home care to more South Carolinians by adding it at Richland,” Bo Cofield, Prisma Health Richland Hospital CEO, said in the release. “The COVID-19 pandemic reinforced that going beyond the walls of the traditional hospital setting often gives our patients a better option for acute-level health care. Home Recovery Care was in place before the pandemic, but it is now gaining momentum. We believe this kind of service is essential to the care of our patients and is an important component of health care.”
Home recovery is more satisfying for patients and costs less than traditional recovery in a hospital, according to the release.
The care is for patients with acute, non-life-threatening medical conditions. Roughly 150 diagnoses are considered eligible for the service and range from congestive heart failure and pneumonia to dehydration, cellulitis and urinary tract infections. Patients must be evaluated by a Prisma Health doctor to determine if their conditions can be safely treated in the home instead of a standard hospital environment, according to the release.
The program includes 24-hour access to a recovery care coordinator and continual monitoring for up to 30 days, the release said. The in-home work is done by Prisma Health’s home-health registered nurses and by physician consultation utilizing telehealth.
“Since we launched the program, we have served 300 patients and saved patients from being hospitalized for 1,000 additional inpatient days,” Angela Orsky, vice president of post-acute services at Prisma Health, said in the release. “Our patient likelihood to recommend scores are 100, and we are exceeding all our quality targets. Our home health clinicians in partnership with our hospitalists have exceled in the ability to care for complex patients safely in their homes.”
PMLS donates rapid antigen tests to Diabetes Education camps see more
Premier Medical Laboratory Services donates rapid antigen tests to Diabetes Education and Camping Association Camps
Many children with diabetes look forward to summer camp each year to, not only spend time with friends, but with other children who can relate to similar day-to-day obstacles that living with diabetes can present. The Diabetes Education and Camping Association (DECA) unites the global diabetes camping community, providing leadership, education, and resources to make camps for those with diabetes more impactful. As most summer camps across the US resumed this year, diabetes camps were faced with the extraordinary obstacle of protecting children who are at higher risk for COVID-19 complications due to diabetes. To bring summer camps for children living with diabetes back this year and to help protect these children, one of the nation’s largest laboratories, Premier Medical Laboratory Services, donated thousands of COVID-19 tests to DECA camps in 19 states across the nation, enabling them to safely return to camp this year.
“We know DECA and each of their camps do so much for the diabetes community - helping kids to learn how to manage the disease as well as support emotional wellbeing,” said Kevin Murdock, Founder and CEO of PMLS. “With diabetes being a global pandemic, it’s a large focus for Premier Medical Laboratory Services to provide top healthcare solutions for patients with diabetes. We are honored to help camps that improve the lives of children and adolescents with diabetes.”
For some children, a diabetes camp is their first opportunity to meet a friend who also has diabetes, or their first time staying somewhere without their parents. It’s a great place for them to adopt a new hobby or learn skills that give them more self-confidence. Along with the feeling of independence and support, diabetes camps have been shown to provide children with an increase in diabetes self-care abilities and decreased diabetes-specific distress. (1) For caregivers, diabetes camps provide a medically sound environment where they can feel assured that their children are safe and their diabetes care needs are met.
Terry Ackley, Executive Director of DECA added: “The safety of children with diabetes is the highest priority of diabetes camps. Covid-19 has presented significant challenges to the operation of diabetes camps this year. It has required that they carefully study their program delivery model and incorporate additional health and safety protocols following the newest guidelines from the Centers for Disease Control. A tool that is very important to safely serving children with diabetes at camp is Covid-19 testing. Premier Medical Laboratory Services approached the diabetes camping community to offer their much-needed support. Our community greatly appreciates their generous donation of a large quantity of rapid antigen tests to diabetes camps across the United States. Premier Medical Laboratory Services has been instrumental to the ability of diabetes camps to operate this year. Their support is helping children learn more about how to manage their diabetes, build resilience to living with this difficult health condition, develop cherished friendships and have lots of fun!”
Aside from offering COVID-19 testing and many other medical diagnostics solutions, PMLS is continually searching for innovative diabetes prevention and maintenance applications. With some of the most advanced testing panels for both type 1 and type 2 diabetes, PMLS also introduced to the US a first of its kind predictive genetic test for type 2 diabetes, which allows patients to know their risk of future onset of the disease determined by their individual genetic make-up. Along with this, Premier Medical Laboratory Services is currently working with the Juvenile Diabetes Research Foundation on initiatives to bring soccer clinics to diabetes communities as part of their mission to improve patient lives both medically and through community outreach. PMLS is soon to announce more breakthrough solutions for diabetes care.
For more information on Premier Medical Laboratory Services, please visit www.premedinc.com or call 866-387-2909.
Test results are delivered straight to the customer in 48 hours or less see more
Diversified Medical Healthcare, a conglomerate of four Greenville health care companies specializing in advanced molecular diagnostics, medical supplies and laboratory equipment, recently acquired the COVID-19 home testing company, RapidRona.
RapidRona test results are delivered straight to the customer in 48 hours or less, according to a news release.
“We know that COVID-19, unfortunately, is something our population will continue to face,” Kevin Murdock, CEO and founder of Diversified Medical Healthcare, said in the news release. “As recent reports show that the new variants spread faster, cause more severe symptoms, and are causing a decrease in vaccine efficacy, the acquisition of RapidRona is our logical next step in providing necessary solutions for the future of COVID-19. We’re proud to add at-home diagnostic and wellness testing to all that we offer at Diversified Medical Healthcare.”
According to a recent Yale Medicine article cited by the release, the Delta variant is spreading 50% faster than the Alpha variant, which was 50% more contagious than the original strain of COVID-19.
According to data cited by the press release, “1,271 of 1,528 total new infections were fully vaccinated individuals as were 23 of 27 hospitalizations and 11 out of 17 cases of severe illness.”
Pivoting from a trend of at-home COVID-19 antigen tests, RapidRona kits provide RT-PCR tests.
“We are excited to see the technology platform in good hands advancing the consumer’s ability to proactively direct their health care from home,” Former RapidRona CEO Heather Mlodinow said in the release.
Diversified Medical Healthcare has reached one of the highest testing capacities in the nation with the capability to process more than 300,000 tests per day, according to the release. They’ve also shifted production to add in-house manufacturing of COVID-19 testing kits and reagents to combat infrastructure limitations and make testing more accessible.
Former Toyota executive to drive university’s innovation agenda see more
Furman University has taken another step to deeply engage its students and the greater Greenville community in innovation and entrepreneurship by naming Anthony Herrera the university’s first chief innovation officer, effective July 1.
In his new role, Herrera will create opportunities for undergraduate students to engage in entrepreneurial and innovative activities, build corporate and professional development certificates and drive the university’s innovation agenda.
He will also continue in his role as executive director of the Furman Institute for Innovation and Entrepreneurship (Furman I&E), which has built a strong foundation of relationships with public and private organizations and community leaders in Greenville, the Upstate and across South Carolina.
“Anthony has led the way in creating an innovation and entrepreneurial environment at Furman, both within the university and with state and local organizations,” said Furman University President Elizabeth Davis. “This new title recognizes the work that Anthony has already been doing — expanding and enhancing opportunities for students and helping our university work more innovatively with the community.”
Other universities across the country are creating chief innovation officer positions. The new roles reflect a convergence of factors happening in higher education, Herrera said.
“There is a need to deliver increased value and more opportunities for students, to be a contributor to communities in solving our greatest challenges, and to do this in ways that are financially sustainable,” he said.
For Furman, Herrera said, Greenville is becoming distinguished as an innovation and entrepreneurial hub among mid-size cities, “so the city’s putting intentional effort and resources toward this and the university can come alongside and be catalytic for greater impact. When the university and the city work together for common goals, everyone wins.”
As Greenville thrives, the opportunities for students include increased internship and job placements, and access to expert speakers and mentors from the business and non-profit sectors. Meanwhile, Furman continues to be a source of talent for the local area.
Herrera also will lead an effort to increase the offering of corporate and professional development programs and non-degree certificate programs, such the Women’s Leadership Institute, Design Thinking and Adaptive Leadership.
Furman I&E, which was named an Outstanding Emerging Entrepreneurship Center in 2020 by the Global Consortium of Entrepreneurship Centers, has already established relationships with area innovation organizations. In December 2020, Furman I&E joined the City of Greenville’s economic development team, NEXT and VentureSouth, to co-locate in offices in downtown. It also will launch this fall a program called GVL Starts, an eight-week experience that teaches community members how to launch a successful venture and provides access to coaching, mentoring and start-up grants needed to make it happen. The Greenville Local Development Corporation, the South Carolina Department of Commerce, the City of Greenville and Venture South are all partners in the program.
“This is an exciting opportunity to be a part of a leading liberal arts and sciences university in a city that is being recognized on a national and global level, and at a time that is such a pivotal moment in higher education,” Herrera said. “Furman has all the right ingredients to be a national leader in the space of innovation and entrepreneurship and an integral partner to the city and Upstate’s entrepreneurial and innovation community.”
Before coming to Furman in 2018, Herrera spent more than 18 years in talent management and development roles for global organizations, including as the former leader for Toyota Motor North America’s executive succession and leadership development team. Prior to Toyota, Herrera served as the executive director at SMU Cox School of Business and launched a nationally recognized center of excellence assisting Fortune 1,000 and non-profits recruit, retain and develop diverse leaders. Herrera earned his bachelor’s and master’s degrees in accounting from the SMU Cox School of Business.
Okra debuts only solution in the nation with verified DEA licensed lab results see more
After four-and-a-half years of testing, Okra Medical has perfected its formula for destroying addictive controlled substances, rendering them 100% non-retrievable and irreversible.
This product, called SafeMedWaste, is the only solution in the nation with verified Drug Enforcement Administration licensed lab results. Besides incineration, the solution is the only tested way to completely break down controlled pharmaceutical substances so that they cannot be reused by humans or animals.
SafeMedWaste’s formula covers more than 30 types of Schedule I-IV liquid, pill and patch controlled substances, including opioids, cannabis, narcotics and benzodiazepines. It has been patented in the U.S. and is now waiting on approval in other parts of the world.
“We’ve hired an independent lab out of Michigan that has done all of our testing,” said Marshall Hartmann, CEO of the company founded in 2018 on Johns Island. “They have verified that our product in nature covers a wide range of controlled substances, where no other product has that proof of efficacy.”
With onsite denaturation, SafeMedWaste works with Drug Enforcement Administration registrants, such as opioid manufacturers, hospitals, surgery centers and law enforcement agencies, to dispose of substances quickly and effectively at a low-cost.
Rather than having to safely transport discarded substances to incinerators and landfills in an expensive process, sites with a SafeMedWaste container simply dispose of products inside, where molecules will be broken down and chemically denatured to its basic elements.
Destroyed products can then be thrown away as nonhazardous waste, also reducing the environmental impact of incineration. Denatured controlled substances do not leach into landfills either.
This process also prevents the chance of diversion, in which an individual’s prescribed controlled substance is transferred to someone else for illicit use, Hartmann said.
“Our current compatible drug list encompasses every drug that you’ll find in a hospital or prescribed to a patient that’s commonly abused in society,” said Justin Stas, the company’s chief technology officer. “We focused on what the DEA was seeing people abuse, what people were dying from and what was being diverted by health care workers and people in health care settings.”
The product comes in different sizes, including a 55-gallon drum for places like law enforcement agencies or pharmaceutical companies, where substances accumulate quickly. Substances of different kinds can be disposed of in these containers simultaneously.
“A lot of facilities store active drugs, so our product gives them the ability to destroy stuff onsite without harboring those drugs in a container, waiting for pickup,” Stas said. “So it completely renders them inert at the facility, stopping that ability for diversion until incineration.”
Okra Medical is also awaiting a grant to conduct a home-use product clinical study. This product would allow individual consumers to disable drugs right in their own home through the use of a smaller-sized SafeMedWaste container.
“Most people get addicted to opioids from taking them from a friend or family’s medicine cabinet, so we’re trying to help solve that problem with this product,” Hartmann said.
According to the National Survey on Drug Use and Health, 76% of people who use prescription drugs non-medically gain access to them from someone they know.
While the Food and Drug Administration’s recommended method of at-home disposal includes flushing drugs down the toilet or covering them with undesirable substances like coffee grounds or kitty litter to discourage retrieval, these methods are not 100% effective, Stas said.
“Flushing puts the drugs back into our water supply, and we’ve had conversations with the wastewater treatment facility in Greenville, and like most facilities nationwide, they cannot remove pharmaceuticals from water supplies,” Stas said. “They don’t have the technology or the funding to be able to do that.”
“Our product destroys them, making them inert so they’re not going into the water supply; they can’t be used in the landfill,” Stas said. “With coffee grounds, they go into the landfill, but they’re not rendered, not destroyed at all. They’re just covered in coffee grounds or kitty litter.”
Although Okra Medical originally planned to launch the product during second quarter 2020, the pandemic delayed the process. As the primary focus of hospitals became battling COVID-19 rather than changing procedures on disposing controlled substances, the company has shifted sights to ambulatory surgical centers in its future launch. They also plan to continue testing to expand the list to include chemotherapeutics and steroids, Hartmann said.
Sen. Lindsey Graham Speaks at SC Lab on The Importance of Variant Tracking Amid Increasing Spread of the Delta VariantPremier Medical is conducting one of the largest-scale Next-gen Sequencing initiatives in USA see more
US Senator Lindsey Graham recently viewed one of the largest variant surveillance initiatives in the nation currently underway at Premier Medical Laboratory Services (PMLS). At the PMLS facility headquartered in Greenville, SC, Next Generation Sequencing (NGS) enables the collection of data needed to study the efficacy of current COVID-19 vaccinations and the detection of new mutations of the SARS CoV-2 virus; like that of the Delta variant which has rapidly spread through India and the UK and now is present in the US. With the capability to monitor 84,000 COVID samples per week, the laboratory has the technology to allow the CDC and state health departments to detect this variant’s spread in the US along with any other novel variants of SARS CoV-2.
“This lab, right here in South Carolina, is testing variants for the entire country, and they are one of the first labs to invest heavily in variant testing to make sure that if there is a second comeback of the virus, we will get ahead of it.” Senator Graham stated alongside Kevin Murdock, CEO and Michael Conroy, VP of Compliance of PMLS. Senator Graham went on to speak about the new and emerging variants including the Delta strain, saying that, “Viruses try to survive. They will replicate. They will try to penetrate the vaccines. This is a war between science and the virus, and the virus is very clever.”
According to Dr. Fauci, the Delta variant may be associated with a higher risk of hospitalization and is more contagious than the original COVID-19 strain – Approximately 40% more contagious, but scientists are still trying to pin down the exact number, with estimates ranging from 30% to 100%, as reported by UK Secretary of State for Health and Social Care, Matt Hancock.
Recent NIH studies have shown that while two doses of the Pfizer vaccine were 88% effective against the Delta variant, two doses of the AstraZeneca shot were only 60% effective against the strain. With just under half of the American population having not been vaccinated, as of June 3, Next Generation Sequencing is vital in continued efforts to contain the virus and to keep hospitalization rates low.
Senator Graham expressed that that PMLS has both provided tremendous capability to the public sector for the nation’s COVID response and that it allowed the population to get on with their lives, as the more testing that is conducted, the more is understood about the nature of the illness. Along these same lines, to help the US continue in its progress made against the COVID-19 virus, Premier Medical Laboratory Services plans to provide the data on the new variants that is now needed with their expansive Next Generation Sequencing initiative.
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including Clinical Laboratory Improvement Amendments (CLIA) and COLA. PMLS prides itself on providing high complexity testing with unmatched turnaround times of results and one of the highest testing capacities in the nation. Their testing menu includes pharmacogenomics, COVID-19 testing, advanced cardiovascular testing, diabetes panels, women’s wellness panels, allergen specific Ige blood testing, toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict.
PMLS also offers Virtual Lab, an infrastructure limitation solution allowing other laboratories to utilize PMLS’ fully-automated robotic workflow and team of 360 employees. With this, labs can largely increase their testing capacity and efficiency while bypassing the need to purchase new equipment or endure waiting time of weeks or more for shipping, installation, and validation. For more information, please visit www.PreMedInc.com or call 855-501-1023.
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.
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.