The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?Long term impacts of COVID-19 across the health care spectrum are still to be determined see more
Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.
The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.
The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.
Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.
COVID-19 Resulted in an Acceleration of the Clinical Research Process
When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future.”
As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.
A New Focus on the Clinical Research Participant
Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial.
Use of More Decentralized Clinical Research
A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by increasing both access to clinical trials and the overall diversity of trial participants. Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective.
Increased use of Digital Technology
The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies.
Is there a silver lining from COVID-19 when it comes to clinical trials?
The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.
For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.
Upstate company makes its mark see more
Ahh, that fresh, crisp aroma of a craft beer — your tongue tingles at the first whiff. The concoction in question may have the fragrance of a “juicy, double-dry-hopped IPA,” a popular locally brewed label on tap here, but Do-Not-Drink-This-Stuff. It’s hand sanitizer.
“It was like, wow, this stuff actually still smells like Bluprint, one of our IPAs,” says Shawn Johnson, co-owner of Birds Fly South Ale Project, which teamed with Parimer Scientific at the onset of the pandemic to make a pharmaceutical-grade product for local health care providers.
Which is why the South Carolina Manufacturing Extension Partnership recognized Parimer last November with an SCMEP COVID-19 Response Award. In September, the South Carolina Research Authority bestowed Parimer a coveted “Member Company” status, noting that the company shipped more than 10,000 pharmaceutical units in 2020.
Dick Pace, 33, owner and principal scientist, launched the company three years ago. Today, Parimer, which is known as a “contract research organization,” provides turnkey chemical solutions, custom compounds, polymers and way more complicated stuff, along with R&D.
Customers, so far, have included farmers and academia and now Big Pharma, Pace says. Within six months, Parimer was operating in the black and has grown from its $3,000 in startup costs to more than $600,000 annually, he says.
Mike Klepfer, Parimer’s vice president of business development, joined the company in July. The Air Force veteran, who has lived in the Upstate for 21 years, has worked for the likes of Bayer and Merck.
After the pandemic forced Klepfer to close his 4-year-old executive-recruitment shop, he arrived at Parimer when the company’s year-over-year growth was already around 25%, he says. Now, with mega-deals in the pipeline from marquee companies — all under non-disclosure agreements — he sees near-term growth upwards of 100%.
Quite a pace for Pace, who found himself overqualified to work as a scientist in his native Greenville after earning his Ph.D. in bioengineering from Clemson in 2014. This even though he had already published at least nine papers and presented at conferences from Denver to Paris. He also worked at the French version of the U.S. National Institutes of Health (he speaks fluent French) and on NIH and Department of Defense grants, among other accomplishments.
“We are excited to partner with Parimer on their growth path. The specialty laboratory services they are offer is unique to the Greenville area and they are one of only two operations in South Carolina approved as an active pharmaceutical-Ingredient manufacturer. ” — Steve Johnson, South Carolina Research Authority investment manager
He applied for 250 jobs. Two companies responded, he says, their highest salary offers coming in at $35,000 a year. “I felt that I had skills to offer, but I wasn’t able to market those, and the pay rate is so low for Ph.D. scientists, so I thought, how hard would it be to make $40K on my own?” Now he hires young scientists in similar straits, while he also avoids the entrepreneurial pitfalls — and failures — he saw in multiple life sciences startups.
“People were buying this extremely expensive equipment and they were having to hire scientists to run it,” he says. “And almost always, the senior owners of these companies were venture capitalists.”
Among his hires is Victoria Bobo. In 2015, she earned a bachelor’s degree in chemistry from Converse College (now University), then her Ph.D. from the University of South Carolina in 2020. Like Pace, she wanted to stay and work in her native Upstate.
“I had the misfortune of graduating during the pandemic when no one was hiring,” says Bobo, 28, who joined Parimer after sending out, according to Pace, some 150 job applications.
Bobo is Parimer’s “Quality Chemist.” But like her three colleagues at the Easley lab, she does everything else there, too.
As Klepfer says, “We all take the trash out each week and we vacuum the floors and clean the lab and do all the stuff that needs to be done to maintain the business.”
“We’re totally happy,” Pace says. “It’s doing what we’re doing and not making, you know, $300K. Maybe one day, but not yet. I started this to basically provide myself a job, and now we’re able to provide others a job, and that’s really, really rewarding.”
The quick Pace of delivering FDA-grade hand sanitizer
Dick Pace recalls driving to Birds Fly South Ale Project at the outset of the pandemic to load his truck with 500 gallons of beer and bring it to his laboratory.
At Parimer Scientific in Easley, where he is owner and principal scientist, his team concocted a hand sanitizer that would meet FDA specifications for use in hospitals—at a pharmaceutical strength the agency categorizes as an over-the-country drug, Pace says.
After winning FDA approval in just two weeks, Pace began frequenting Ace Hardware and Home Depot to build his own production line for distilling BFS’s beer to 95% alcohol, bottling the new product, labeling and shipping it.
In roughly five weeks, with everyone scrambling for the stuff, Birds Fly South sold Parimer, at cost, somewhere around 180 barrels of nearly expired beer, says Shawn Johnson, owner of the Hampton Station craft brewer along with his wife, Lindsay.
Pace says the two businesses—emphasis on local—churned out some 30,000 bottles until the big manufacturers finally stepped up.
A bunch of those containers went to Greenville Office Supply. Turns out, McLain Scales, the venerable company’s Director of Sales-Janitorial and Facility, grew up with Pace.
GOS couldn’t sell below-FDA-grade product to its hospital clients and first-responder customers, among others, he says.
“So we had to get creative with our partners, and fortunately Parimer Scientific had all the knowledge on how to manufacture it,” he says, adding that GOS ultimately sold more than 6,000 Parimer bottles — complete with the Birds Fly South logo.
The Johnsons credit Parimer with helping keep their business afloat and some of their employees employed. They could also sell two-ounce bottles, which Parimer provided at cost, Lindsay says.
Of Pace and their brief stint as hand-sanitizer partners, Shawn says, “It’s a testament to ingenuity — he’s an incredibly smart man — and to the agility of small business and the connection to the community.”Parimer Scientific’s team says their equipment room is one of the best equipped labs in SC, but to the untrained eye it doesn’t look like much. However, they are able to take any product or chemical and reverse engineer it to figure out exactly what it makes up.
Pace’s Parimer People
Mike Klepfer, vice president of Business Development
Worked in biotech, pharmaceuticals and medical device companies. Sales rep for such global med-tech giants as Stryker, Bayer and Merck
Five years in the Air Force, leaving as captain, serving as a supply and logistics officer. Citadel graduate, class of 1995
Victoria Bobo, quality chemist, joined Parimer in October 2020
Ph.D., Analytical Chemistry — University of South Carolina, 2020
Bachelor of Science in Chemistry, with a minor in Spanish — Converse College, 2015
Stephen Lee, Research Manager at Parimer since November 2020
M.S. in Chemistry — Georgia Tech, 2011.
Bachelor of Science in Chemistry, University of Wisconsin-Madison, 2009.
Adjunct instructor at Greenville Technical and Spartanburg Community colleges for more than a year each.
Work experience includes technical assistant at Milliken & Co. and certifying scientist at LabSource in Greenville, among others.
South Carolina and National executive address what's next for South Carolina as we battle COVID. see more
On September 9, 2021 SCBIO hosted a statewide webinar program entitled "COVID-19 and South Carolina: What's Next?". The program was attended by a large audience across South Carolina, including business leaders, healthcare executives, elected officials, and regional media.
BIO’s Phyllis Arthur, Nephron Pharmaceutical’s Lou Kennedy and VCOM’s Matt Cannon shared their views on what obstacles we have to overcome to get through this latest surge, using science as the foundation. This discussion also addressed the science, data and real life experiences confronting us all as we manage our response to the Delta Variant of COVID-19. It’s a conversation you won’t want to miss if you aren’t sure about vaccines, antibodies, masks and more.
Top executives opine on what's next for SC as Covid surges see more
After attending a Chamber of Commerce breakfast where a hospital CEO ticked off statistics about the number of unvaccinated patients suffering from Covid – many in their 20s and 30s – Nephron Pharmaceuticals CEO Lou Kennedy decided something had to be done.
So she mandated vaccination at her company and today, everyone at the West Columbia business, which manufactures generic respiratory products, has had the shot, she said. And she lost just 30 out of 2,000 employees over the decision.
“It was the right thing to do, and I encourage my fellow business leaders to follow suit,” Kennedy said. “Somebody had to be the first to do it, and why not make it us.”
In addition, Kennedy said, the company spent $2.5 million last year on people being out of work and overtime to cover them – money that could have been spent on innovation, such as the mask the company introduced for patients getting nebulizer treatments that protects the health care provider from respiratory droplets.
Kennedy spoke at an online event hosted by SC BIO, the Palmetto State’s life sciences group, to discuss what comes next in the pandemic.
South Carolina is still lagging in vaccinations, said SC BIO interim CEO Erin Ford, with Covid deaths on the rise.
By Sept. 7, just 49 percent of residents had been fully vaccinated, and 58 percent had had at least one shot, according to the state Department of Health and Environmental Control.
Meanwhile, nearly 780,000 cases had been confirmed by that date and 11,050 South Carolinians had died, DHEC reports.
But the number of vaccinations is slowly rising, Ford said, offering some hope that things will turn around.
The full FDA approval of the Pfizer vaccine pushed some people to get vaccinated in recent weeks, said Phyllis Arthur, vice president of infectious diseases and diagnostic policy at BIO Global, the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions.
But many are rolling up their sleeves after seeing how the Delta variant left loved ones sick and dying, she said.
“Delta is nearly twice as contagious as the previous variants,” she said. “And … (it) moved so quickly and spread so fast we saw a giant spike in cases and deaths. When immunization numbers go up, we will see cases come down.”
The speakers agreed that the greatest obstacle to making progress in the fight against the virus is the politicization of the pandemic and misinformation.
“There’s no R or D in the word science. It has nothing to do with your favorite politician,” said Kennedy. “This is science.”
Arthur said people should beware of misinformation and trust the scientists who’ve done the work on the virus.
“One of the things I ask people to do is look at the source of what you’re reading and hearing,” she said. “Look at the data yourself. It’s all publicly available and it’s very transparent.
And Dr. Matthew Cannon, dean of the Carolinas Campus of the Edward Via College of Osteopathic Medicine, agreed.
“(It’s) being politicized, in my opinion, and I just hope people would look at it objectively, not through partisanship,” he said. “This is a public health crisis.”
Cannon said that as of Sept. 7, one Upstate hospital had 278 Covid patients and all but 25 were unvaccinated. Another had 566 Covid patients and all but 41 were unvaccinated. The average age of the vaccinated patients was 75 to 78, he said, and they were immunocompromised. The average age of the unvaccinated patients was 50, he said.
Though breakthrough cases occasionally occur among the vaccinated, Arthur said they typically are milder and of shorter duration.
She said she expects FDA approval of the Pfizer vaccine for children younger than 12 in the next month or so and the Moderna vaccine in the next few months.
Kennedy said her antibody level dropped from 6,900 to 3,800 in recent weeks and is watching to see when the booster is approved.
There are still two steps to go before a booster is approved for the general population, but that it could come in a matter of weeks, Arthur said.
And Cannon said the college is working on research to determine when boosters should be given, noting the mRNA technology used in the Pfizer and Moderna vaccines has been around for years.
Arthur added that the mRNA technology will be able to be used for many vaccines and even disease treatments.
“You can speed the next product, and that can allow us to have many more innovations from the treatment perspective and the vaccine perspective,” she said. “It’s the same for monoclonal antibodies. And that will ripple through the industry for years to come.”
Cannon said he’s proud of the health care workers who are surrounded by contagious Covid patients putting them and their families at risk, but continue to step up every day for the greater good of the community.
Nonetheless, he said, he worries about the stress they endure, seeing so much loss and knowing it could be prevented.
Meanwhile, he said, although medical residents got the experience of learning how to work in the midst of a pandemic - something their predecessors never had - they are missing out on some hands-on training because hospitals are canceling elective procedures.
Kennedy said the employees who refused vaccination weren’t willing to listen to the science. And while she got lots of phone calls asking whether there were protests in the street about her mandate, it all went smoothly.
“There were a couple people grumbling in the plant,” she said, “but it amounted to much ado about nothing.”
All the speakers encouraged everyone to be vaccinated and wear masks.
“It will prevent you from giving the virus to someone else,” said Cannon, “or from them giving it to you.”
“We’re in this together,” said Arthur, “and we can get out of it together.”
University of South Carolina initiative saving lives see more
A gentle hum can be heard from a lab in the depths of the University of South Carolina's life sciences building. Take a peek inside, and you'll find something unusual.
Thousands of tubes of the spit belonging to the university's students, faculty, staff and Columbia residents.
Almost a year ago, the school's colon cancer lab changed course from its usual area of study and started analyzing how it could help as COVID-19 ravaged the world, killing hundreds of thousands across the country and shutting down campuses.
USC professors had a breakthrough when they started studying saliva there, said biomedical sciences professor Phillip Buckhaults.
They ended up creating what looks like a blue cocktail — and it exposes the COVID-19 genome in our saliva.
"We figured out a way to photocopy bits of the COVID genome," Buckhaults said. "It's like a liquid photocopier."
It's proven to be more efficient than nasal swabs for COVID-19 testing. There's no uncomfortable nasal swab involved. Materials for nasal-swab testing are often limited. And these saliva results come quicker. Those who get tested on USC's campus typically receive results within 24 hours.
When the saliva testing first began on campus, scientists were pipetting saliva samples with the "photocopier" liquid to see the COVID-19 genome appeared in the DNA when the saliva was "photocopied" several times.
Because it was done solely by hand, they were able to test only several dozen samples a day.
"The demand was more than we could keep up with," Buckhaults said.
So he sent an email pleading with USC president Harris Pastides for a liquid-handling robot that's able to do the pipetting automatically, saving a lot of time.
Pastides then got South Carolina-based Nephron Pharmaceuticals owner Lou Kennedy to write Buckhault a $14,000 check to buy one of the robots.
"Within two weeks, we went from a junkie, underutilized, decrepit lab space to really state-of-the-art," said laboratory director and professor Carolyn Banister.
Buckhaults also credited former USC president Bob Caslen for removing roadblocks to get more machines and a bigger lab — speeding up the process to speed up the process, so to speak.
Caslen worked with the state government and university officials to get thousands of dollars for lab equipment and borrowed testing machines from nearby labs, Buckhaults said.
"He saved a lot of lives in the Midlands by pouring resources into (Banister) and that lab and getting this test running," Buckhaults said.
Now, the lab is testing about 2,000 samples a day and returning samples within 24 hours, and its reach is beyond the Midlands. Quick-turnaround testing allows people to identify themselves as COVID-19-positive earlier and isolate themselves, reducing the spread of the virus and saving lives.
The testing technology has expanded across the state. USC satellite campuses, including Upstate and Union, as well as Clemson, Winthrop, the College of Charleston and Trident Technical College are able to use the saliva tests created at the USC lab.
The testing is able to recognize different variants of COVID-19 as well.
Another hospital system mandates vaccines for workers see more
Another hospital system in the Lowcountry will soon mandate that workers get a COVID-19 vaccine as a condition of employment.
Roper St. Francis alerted its approximately 6,000 employees of the impending requirement on Aug. 24. The announcement comes a day after the federal Food and Drug Administration granted full approval to the Pfizer vaccine for people 16 and older and comes amid a new surge of COVID patients flooding hospitals and intensive care units across South Carolina.
“We are proceeding with this requirement because we care about you and our patients,” Roper St. Francis wrote in an email to employees. “This mandate is unanimously supported by the RSFH Board of Directors, senior leadership and our medical staff.”
Roper St. Francis staff who are not fully vaccinated must get their first dose by Oct. 1 and their second dose by Nov. 1. Employees who intend to file medical or religious exemptions to the mandate must do so by Sept. 17. Roper St. Francis spokesman Andy Lyons said the details of those exemption forms are still being finalized and he did not yet know if employees who developed natural immunity through a previous COVID-19 infection would qualify for a medical exemption.
Lyons said approximately 1,500 of the system’s 6,000 employees have not been vaccinated yet.
The Medical University of South Carolina and the Ralph H. Johnson VA Medical Center in Charleston already require employees to be vaccinated. In July, MUSC fired five employees who declined to be vaccinated. Vaccines for Trident Health employees remain optional, but encouraged.
In the letter to employees, Roper St. Francis leaders said more than 3,600 health care workers across the country died during the first year of the pandemic and explained that unvaccinated hospital and health care employees create more risks for patients.
According to the latest hospital census, across all four Roper St. Francis hospitals, all but 14 of the 107 COVID-19 inpatients are unvaccinated. None of the vaccinated patients who are hospitalized are on ventilators.
Op-Ed: As a doctor in a COVID unit, I’m running out of compassion for the unvaccinated. Get the shotInfectious disease physician calls for vaccinations see more
My patient sat at the edge of his bed gasping for air while he tried to tell me his story, pausing to catch his breath after each word. The plastic tubes delivering oxygen through his nose hardly seemed adequate to stop his chest from heaving. He looked exhausted.
He had tested positive for the coronavirus 10 days ago. He was under 50, mildly hypertensive but otherwise in good health. Eight days earlier he started coughing and having severe fatigue. His doctor started him on antibiotics. It did not work.
Fearing his symptoms were worsening, he started taking some hydroxychloroquine he had found on the internet. It did not work.
He was now experiencing shortness of breath while doing routine daily activities such as walking from his bedroom to the bathroom or putting on his shoes. He was a shell of his former self. He eventually made his way to a facility where he could receive monoclonal antibodies, a lab-produced transfusion that substitutes for the body’s own antibodies. It did not work.
He finally ended up in the ER with dangerously low oxygen levels, exceedingly high inflammatory markers and patchy areas of infection all over his lungs. Nothing had helped. He was getting worse. He could not breathe. His wife and two young children were at home, all infected with the virus. He and his wife had decided not to get vaccinated.
Last year, a case like this would have flattened me. I would have wrestled with the sadness and how unfair life was. Battled with the angst of how unlucky he was. This year, I struggled to find sympathy. It was August 2021, not 2020. The vaccine had been widely available for months in the U.S., free to anyone who wanted it, even offered in drugstores and supermarkets. Cutting-edge, revolutionary, mind-blowing, lifesaving vaccines were available where people shopped for groceries, and they still didn’t want them.
Outside his hospital door, I took a deep breath — battening down my anger and frustration — and went in. I had been working the COVID-19 units for 17 months straight, all day, every day. I had cared for hundreds of COVID patients. We all had, without being able to take breaks long enough to help us recover from this unending ordeal. Compassion fatigue was setting in. For those of us who hadn’t left after the hardest year of our professional lives, even hope was now in short supply.
Shouting through my N95 mask and the noise of the HEPA filter, I introduced myself. I calmly asked him why he decided not to get vaccinated.
“Well, I’m not an anti-vaxxer or anything. I was just waiting for the FDA to approve the vaccine first. I didn’t want to take anything experimental. I didn’t want to be the government’s guinea pig, and I don’t trust that it’s safe,” he said.
“Well,” I said, “I can pretty much guarantee we would have never met had you gotten vaccinated, because you would have never been hospitalized. All of our COVID units are full and every single patient in them is unvaccinated. Numbers don’t lie. The vaccines work.”
This was a common excuse people gave for not getting vaccinated, fearing the vaccine because the Food and Drug Administration had granted it only emergency use authorization so far, not permanent approval. Yet the treatments he had turned to — antibiotics, monoclonal antibodies and hydroxychloroquine — were considered experimental, with mixed evidence to support their use.
The only proven lifesaver we’ve had in this pandemic is a vaccine that many people don’t want. A vaccine we give away to other countries because supply overwhelms demand in the U.S. A vaccine people in other countries stand in line for hours to receive, if they can get it at all.
“Well,” I said, “I am going to treat you with remdesivir, which only recently received FDA approval.” I explained that it had been under an EUA for most of last year and had not been studied or administered as widely as COVID-19 vaccines. That more than 353 million doses of COVID-19 vaccine had been administered in the U.S. along with more than 4.7 billion doses worldwide without any overwhelming, catastrophic side effects. “Not nearly as many doses of remdesivir have been given or studied in people and its long-term side effects are still unknown,” I said. “Do you still want me to give it to you?”
“Yes” he responded, “Whatever it takes to save my life.”
It did not work.
My patient died nine days later of a stroke. We, the care team, reconciled this loss by telling ourselves: He made a personal choice not to get vaccinated, not to protect himself or his family. We did everything we could with what we had to save him. This year, this tragedy, this unnecessary, entirely preventable loss, was on him.
The burden of this pandemic now rests on the shoulders of the unvaccinated. On those who are eligible to get vaccinated but choose not to, a decision they defend by declaring, “Vaccination is a deeply personal choice.” But perhaps never in history has anyone’s personal choice affected the world as a whole as it does right now. When hundreds and thousands of people continue to die — when the most vulnerable members of society, our children, cannot be vaccinated — the luxury of choice ceases to exist.
If you believe the pandemic is almost over and I can ride it out, without getting vaccinated, you could not be more wrong. This virus will find you.
If you believe I’ll just wait until the FDA approves the vaccine first, you may not live to see the day.
If you believe if I get infected I’ll just go to the hospital and get treated, there is no guarantee we can save your life, nor even a promise we’ll have a bed for you.
If you believe I’m pregnant and I don’t want the vaccine to affect me, my baby or my future fertility, it matters little if you’re not alive to see your newborn.
If you believe I won’t get my children vaccinated because I don’t know what the long-term effects will be, it matters little if they don’t live long enough for you to find out.
If you believe I’ll just let everyone else get vaccinated around me so I don’t have to, there are 93 million eligible, unvaccinated people in the “herd” who think the same way you do and are getting in the way of ending this pandemic.
If you believe vaccinated people are getting infected anyway, so what’s the point?, the vaccine was built to prevent hospitalizations and deaths from severe illness. Instead of fatal pneumonia, those with breakthrough infections have a short, bad cold, so the vaccine has already proved itself. The vaccinated are not dying of COVID-19.
SARS-CoV-2, the virus that causes COVID-19, has mutated countless times during this pandemic, adapting to survive. Stacked up against a human race that has resisted change every step of the way — including wearing masks, social distancing, quarantining and now refusing lifesaving vaccines — it is easy to see who will win this war if human behavior fails to change quickly.
The most effective thing you can do to protect yourself, your loved ones and the world is to GET VACCINATED.
And it will work.
Anita Sircar is an infectious-disease physician and clinical instructor of health sciences at the UCLA School of Medicine.
Charles River Labs quietly continues its critical work to save lives see more
CHARLESTON, S.C. (AP) — It’s one of the stranger, lesser-known aspects of U.S. health care — the striking, milky-blue blood of horseshoe crabs is a critical component of tests to ensure injectable medications such as coronavirus vaccines aren’t contaminated.
To obtain it, harvesters bring many thousands of the creatures to laboratories to be bled each year, and then return them to the sea — a practice that has drawn criticism from conservationists because some don’t survive the process.
The blood, which is blue due to its copper content, is coveted for proteins used to create the LAL test, a process used to screen medical products for bacteria. Synthetic alternatives aren’t widely accepted by the health care industry and haven’t been approved federally, leaving the crabs as the only domestic source of this key ingredient.
Many of these crabs are harvested along the coast of South Carolina, where Gov. Henry McMaster promoted the niche industry as key to the development of a domestic medical supply chain, while also noting that environmental concerns should be explored.
“We don’t want to have to depend on foreign countries for a lot of reasons, including national security, so it’s good to see this company thriving in the United States,” McMaster told The Associated Press. He spoke this month during a visit to Charles River Laboratories at its Charleston facilities, to which AP was granted rare access. “We want to do everything we can to onshore all of these critical operations.”
Horseshoe crabs — aquatic arthropods shaped like helmets with long tails — are more akin to scorpions than crabs, and older than dinosaurs. They’ve been scurrying along the brackish floors of coastal waters for hundreds of millions of years. Their eggs are considered a primary fat source for more than a dozen species of migratory shore birds, according to South Carolina’s Department of Natural Resources.
Their value to avoiding infection emerged after scientists researching their immune response injected bacteria into horseshoe crabs in the 1950s. They ultimately developed the LAL test, and the technique has been used since the 1970s to keep medical materials and supplies free of bacteria.
Their biomedical use has been on the rise, with 464,482 crabs brought to biomedical facilities in 2018, according to the Atlantic States Marine Fisheries Commission.
In South Carolina, that’s done only by Charles River, a Massachusetts-based company that tests 55% of the world’s injectables and medical devices — like IV bags, dialysis solutions and even surgical cleaning wipes, according to company officials.
“We are almost the last line of defense before these drugs leave the manufacturing area and make it to a patient,” senior vice president Foster Jordan told McMaster. “If it touches your blood, it’s been tested by LAL. And, more than likely, it’s been tested by us.”
Charles River employs local fishermen to harvest the crabs by hand, a process governed by wildlife officials that can only happen during a small annual window, when the creatures come ashore to spawn.
Contractors bring them to the company’s bleeding facilities, then return them to the waters from which they came. During a year, Jordan said his harvesters can bring in 100,000 to 150,000 horseshoe crabs, and still can’t satisfy the growing demand.
“We need more, though,” Jordan told McMaster, adding that his company is working with the state to open up more harvesting areas. “The population’s steady. ... We need access to more beaches, to get more crabs.”
The practice is not without its critics, some of whom have argued that bleeding the crabs and hauling them back and forth is harmful. According to the National Oceanic and Atmospheric Administration, 10% to 15% of harvested crabs die during the process.
The International Union for Conservation of Nature listed the species overall as “vulnerable,” noting decreasing numbers as of a 2016 assessment. The Atlantic States Marine Fisheries Commission listed 2019 stock as “good” in the Southeast, but “poor” in areas around New York.
Conservationists sued last year, accusing the U.S. Fish and Wildlife Service of shirking its duty to protect areas including South Carolina’s Cape Romain National Wildlife Refuge by allowing horseshoe crab harvesting. They argued that taking out the crabs affects other species in the protected area. A federal judge temporarily halted the harvest, but was reversed following Charles River’s appeal.
The environmental groups asked to withdraw their complaint this month after federal officials imposed a permitting process for any commercial activity in the refuge, including horseshoe harvesting, beginning Aug. 15. Even if such permits are denied, Jordan told McMaster that only 20% of its harvest came from the refuge, with most coming from further down the South Carolina coast.
There is a synthetic alternative to the horseshoe crab blood, but it hasn’t been widely accepted in the U.S., and meanwhile, Charles River’s international competitors are making synthetics and also pressing for U.S. Food and Drug Administration approval, which Jordan said could hamper domestic efforts like his own.
“My mission is to make sure that any competitor that comes into the United States, from China or any of these other producers, has to go through the same regulatory process that we had to go through, to make sure that it’s safe,” Jordan said. “If all these synthetics start coming in from other countries, we’re going to lose the protection that we’ve had for all these years, and the safety, and the control of the drug supply.”
“We want to have as much stuff made here as we can,” McMaster said in response.
As for the environmental concerns, the governor said maintaining a healthy balance between scientific demands and the state’s ecosystems, which bolster a significant portion of South Carolina’s tourism economy, is paramount.
“It’s like a house of cards. You pull out one part, and the rest of it will fall,” McMaster said. “So I think we have to be very careful, and be sure that any company, any business, any activity, whether it’s commercial or otherwise, meets whatever requirements are there to protect the species — birds, horseshoe crabs, any sort of life.”
Rhythmlink International honored as a Best Places to Work in South Carolina for tenth consecutive yearTen years in a row for life sciences firm Rhythmlink see more
For the tenth consecutive year Rhythmlink has been awarded a spot on the “Best Places to Work in South Carolina” list in the Small Employer category, honored by the South Carolina Chamber of Commerce. This year Rhythmlink placed 13 out 20 total companies in this category, earning a spot on a final list of the 81 most innovative and top-notch employers across the state.
“Rhythmlink takes pride in achieving this honor for the tenth consecutive year,” said Shawn Regan, Co-founder and Chief Executive Officer for Rhythmlink International, LLC. “We could not achieve our mission of improving patient care or uphold our values and culture without the significant contribution of our employees, and this honor helps us know we remain on the right track for making that possible,” said Regan.
Companies from across the state entered the two-part survey process to determine the Best Places to Work in South Carolina. The first part consisted of evaluating each company’s workplace policies, practices, philosophy, systems and demographics. The second part consisted of an employee survey to measure the employee experience. The combined scores determined the top companies and the final ranking. Several questions on the survey dealt with how Rhythmlink has responded to challenges of the COVID-19 pandemic, and how it has affected the workplace.
Joe Straczek, Chief Financial Officer for Rhythmlink, believes that despite the challenges, Rhythmlink employees remained focused and dedicated to their work. “As a health care company, our employees know the value of their work in our industry, and believe they have an opportunity to make a difference,” said Straczek. “One of the things that makes our culture special is a willingness and ability to adapt to changes and struggles, while always keeping the customer top of mind.”
Ranked companies were recognized at an annual reception and awards dinner at the Columbia Convention Center on August 4, 2021.
Rhythmlink International is a medical device manufacturer specializing in devices that help connect patients to machines to record or elicit physiologic information. Rhythmlink designs, manufactures, and distributes a variety of medical devices for intraoperative neuromonitoring, electroencephalography, evoked potentials, polysomnography, long-term epilepsy monitoring and critical care units. Founded by neurodiagnostic technologists and engineers in 2002, Rhythmlink enhances patient care worldwide by transforming medical device technology that links patients to equipment. Rhythmlink also offers custom packaging, custom products, private labeling, and contract manufacturing services.
Once again, Lou Kennedy and Nephron step up for South Carolina see more
A South Carolina-based pharmaceutical manufacturer that has offered coronavirus vaccines to the public and run thousands of COVID-19 tests throughout the pandemic will now require all of its employees to get inoculated.
Nephron Pharmaceuticals Corp. is mandating that all of the company’s nearly 2,000 workers be fully vaccinated or have started a two-dose vaccine series by Aug. 27, unless the employee has “an exemption or reasonable accommodation,” according to CEO Lou Kennedy.
The company is one of the first major businesses in South Carolina, other than hospitals, to publicly declare such a directive. Details of the requirement were shared with The Associated Press ahead of an official announcement Monday.
“As COVID-19 cases, driven by the deadly serious Delta variant, continue to impact communities and businesses alike, we can be one of the first businesses of our size to have a fully-vaccinated workforce,” Kennedy wrote in a company-wide letter.
Kennedy told reporters that employees who are not vaccinated by the deadline and can’t provide a medical or religious exemption will be fired, and she isn’t worried about lawsuits.
“I’ll be very sad if we lose even the first person,” Kennedy said. “I hate that, but we’ve got to do what is right, to keep us healthy so we can keep others healthy.”
Nephron, which makes a number of drugs used to treat COVID-19 patients, is also mandating all visitors, vendors and guests be fully vaccinated. Those who need the shots can get them from Nephron itself, which has run a vaccine site in West Columbia since February.
The company is still compiling data on how many of its workers are vaccinated.
A growing number of hospitals around the state, including the Medical University of South Carolina and Tidelands, have made vaccination a requirement for health care employees. Prisma Health, South Carolina’s largest hospital system, has offered incentives to staffers instead, news outlets have reported.
The Nephron announcement comes as vaccine rates continue to lag. Less than half of eligible South Carolinians were fully vaccinated as of last week, according to data from the South Carolina Department of Health and Environmental Control.
Although most businesses in the state have yet to implement such requirements, the resurgence of the virus with the highly contagious delta variant has prompted many to consider a mandate, S.C. Chamber of Commerce President and CEO Bob Morgan told The Associated Press on Monday.
More and more businesses will likely require employees to be vaccinated, following Nephron’s lead and the expected full approval of the vaccine by the Food and Drug Administration later this fall, Morgan said: “Momentum is growing.”
Lawmakers in the South Carolina Senate did approve a proposal that would prevent employers from requiring COVID-19 vaccines for workers earlier this year. That measure still awaits House action.
Lou Kennedy authors a perspective every South Carolina resident should read see more
Nephron Pharmaceuticals Corp. manufactures lifesaving medications that help people breathe. In the midst of a pandemic, it is more critical than ever that our team stays healthy, so we can keep patients healthy.
This was one reason we stayed motivated over the past year to step up for our community, state and nation to aid the response to COVID-19. When the opportunity arose for Nephron to partner with Dominion Energy South Carolina and launch a COVID-19 vaccination drive-thru, we embraced it — just as many of our employees, myself included, jumped at the chance to be vaccinated.
It was the least we could do to help keep South Carolina’s recovery on track. After all, we have been proud of the way our state, guided by Gov. Henry McMaster, has led. We struck the right balance between public health and economic prosperity. We never closed down, and we avoided many of the problems neighboring states have battled.
However, I would be remiss if I failed to mention the lag our state — and, frankly, our company — has seen in citizens being vaccinated. The initial enthusiasm for getting vaccinated has given way to hesitancy. I want to change that. I hope my colleagues around the business community will join me in the effort.
Why is it important to me for the people of South Carolina, the employees of our company and workers everywhere to get vaccinated?
After a year of masks and mandates, viruses and virtual meetings, I am tired of having the economy impacted, and recreation curtailed, by concerns that interacting with people could lead to long-term health challenges, such as those associated with COVID-19. I agree with our governor: We do not need new restrictions in South Carolina. It is time to return to normal — for good.
I also believe in science. As the CEO of one of the fastest-growing pharmaceuticals manufacturers in the country, I work with dozens of brilliant scientists. We know there are real concerns about contracting COVID-19 and the new, dangerous strains of the virus cropping up around the world.
If we truly want to return to normal, and do so in a permanent way, then there is no alternative to getting vaccinated. Luckily, in South Carolina, there are countless places where vaccines are available. Come to the Nephron drive-thru vaccination location (in West Columbia) and get your shot. There is no charge. Or contact the state Department of Health and Environmental Control about where to get vaccinated. Again, there is no charge.
Do you own a business? Give your employees incentives to get the shot. We did. Employees who received the vaccine by a certain date at Nephron were entered into a drawing to receive free paid time off. This was a win-win — for workers, it was a chance to earn a meaningful prize, and for the company, it meant a safer and healthier work environment.
Nephron employees who still have not been vaccinated are required to wear masks. Like other critical health care and manufacturing facilities, Nephron is a place too many people depend on for us to risk a widespread outbreak of any virus. What we hope is that we can encourage enough of our employees to get vaccinated that we do not have to consider additional mandates or more serious measures in response to unvaccinated employees.
Vaccinations remain one of the surest ways each of us can do the right thing — by our friends, families, state and nation — during these unprecedented days. If you have not been vaccinated, I hope you will join me and get the shot. Each of us can contribute to the health and safety of our companies and our country. Doing so may mean the difference between keeping the place where you work open and seeing it closed — not to mention the difference between life and death.
Lou Kennedy is CEO of Nephron Pharmaceuticals Corporation and a Lexington resident.
USC earns award of excellence see more
In recognition of their dedication and innovations in overcoming the challenges of delivering the experiential curriculum during the past year, the American Association of Colleges of Pharmacy Experiential Education Section has bestowed the Award for Excellence in Experiential Education upon the faculty and staff of experiential offices at the colleges and schools of pharmacy, including the University of South Carolina College of Pharmacy.
The Experiential Education team of Jennifer Baker, director of experiential programs; Whitney Maxwell, associate director of experiential programs; Kathryn Kenard, student service program coordinator; and Nancy Blaisdell, administrative assistant, received certificates of recognition from the AACP during a presentation by Julie Sease, interim dean of the College of Pharmacy.
The AACP Experiential Education Section Award of Excellence in Experiential Education is normally presented each year to an individual, but this year, the organization chose to recognize programs across the country.
When the University closed in March 2020, the Office of Experiential Education for the College of Pharmacy mobilized to a virtual unit overnight as there could be no pause in operations to keep students progressing through the Pharm.D. curriculum. With the status of hundreds of rotations changing on what seemed like an hourly basis during the spring and summer of 2020, Baker and Maxwell navigated rotation rescheduling while Kenard and Blaisdell tirelessly worked through site onboarding requirements to efficiently move students on and off rotation without missing a beat.
“Through the hard work and commitment of our preceptors and practice sites, we were able to successfully graduate the Classes of 2020 and 2021 on time,” says Baker. “Our team was dedicated to our students even while serving on the front lines of the battle against COVID-19. While our experiences were not unique, as everyone’s worlds were turned upside down during the pandemic, I can confidently say that our students and College are blessed with the best preceptors and faculty.
“We are so grateful for the unwavering support from College administration and for this recognition by the AACP Experiential Education Section. It was incredible to see the collaboration that occurred within our profession at the local, state and national level to support all pharmacy students.”
Another SC start-up is making good see more
During a procedure with a young patient, Cephus Simmons noticed something wasn’t working as well as it could. Part of the child’s small intestine had slid into the large intestine, causing an obstruction that can be life threatening for small children.
But the catheter used to keep the bladder flowing wasn’t staying firmly in place.
“It became frustrating to me, and it was something that medically I knew wasn’t correct, and something that needed to be fixed,” said Simmons, a Ph.D. and radiology assistant at the Medical University of South Carolina.
The catheter the MUSC team was using, called a Foley catheter, features a balloon to hold it in place internally. After the procedure, Simmons drew up his idea for a different kind of catheter that would have two balloons, one to be placed on the inside and one on the outside of the body. He founded SealCath in 2013.
While Simmons says it solves the problems that were at hand during that procedure, the catheter he developed can be used for colonoscopies and more. It’s also made to work for both pediatric and adult patients.
But it took several years after founding of the company for the catheter to become available on the market. Simmons worked on the effort from his home in Mount Pleasant in between his clinical time at MUSC, getting little sleep.
The company quickly began to take off in 2018. Simmons was awarded a research grant that year from the National Institutes of Health.
The S.C. Research Authority, a tech accelerator program that receives state funding, also enrolled SealCath in its SC Launch program for startups in 2018. The program gives companies mentorship and capital in order to grow.
SealCath went to market in the summer of 2019. Then, Simmons secured a patent in Canada in 2020.
When COVID-19 shut hospitals’ doors to many patients, visitors and vendors, SealCath also had to shut down temporarily. Business picked back up by the end of 2020, and now Simmons plans to bring to market a silicon version of his catheter this fall — it’s available in latex for now, and some buyers are concerned about allergies to the material.
Innovations in the life sciences are some of the most promising in Charleston’s burgeoning technology industry.
Health care technology, along with biotech and pharmaceuticals, make up two of the state’s top three startup industries, according to an annual analysis by BIP Capital. Still, in terms of the amount of outside funding coming in, South Carolina’s startups can’t match the size of Georgia’s, North Carolina’s, Florida’s or Tennessee’s in the Southeast.
SealCath is one of a number of successful spin-offs to come from researchers and clinicians at MUSC.
Simmons didn’t imagine becoming the CEO of a startup company when he decided to go into medicine.
“Innovation does the same thing as what I’ve been doing my whole career, which is helping patients,” he said. “If you find the right product that’s going to improve health care, then innovation is actually just as good or better than what I’ve been doing the whole time as far as taking care of my patients.”
Simmons plans to retire from MUSC, which he now counts among his customers, this year and take his catheter on the road to market it to other hospitals. His long-term goal is to export the device to Canada.
Simmons graduated from Walterboro High School. He is married with four children.
Columbia, SC company aims for growth see more
Compliments of SCBIZ News and Columbia Business Report
Columbia-based Rhino Medical Supply has been named the exclusive distributor of Deltapine cotton medical scrubs in an initiative created to drive demand for U.S.-grown cotton and revitalize an end-to-end U.S. supply chain.
The Field to Closet partnership with Nashville-based Jernigan Global, a consultancy for the cotton supply chain and textile industry, was created in 2019 to create awareness among producers, ginners, millers and retailers of advancements in U.S. upland cotton, specifically Deltapine Select varieties. Rhino will distribute the initiative’s 100% cotton scrubs made with Georgia-grown cotton through the initiative’s Cotton Project.
“We are thrilled to announce an alliance with Rhino Medical Supply as the distributor of our cotton scrubs,” Ed Jernigan, founder and CEO of Field to Closet, said in an online article by Cotton Grower magazine published Tuesday. “Rhino Medical’s focus on sustainable, environmentally friendly, and biodegradable products, along with their emphasis on philanthropy and diversity initiatives, pairs perfectly with our scrubs program. It is truly a perfect union of businesses with similar visions.”
The Cotton Project has also established a Farmer GiveBack program to ensure the grower shares in financial profits of goods sold.
“Rhino Medical Supply seeks companies and products that align with our corporate citizenship commitments, including giving back to others, using renewable resources, and encouraging inclusion,” Rhino CEO Lance Brown said. “Our organization is proud to work with Field to Closet and America Knits to distribute these 100% Deltapine cotton medical scrubs.”
The medical scrubs are treated with PROTX2 AV technology, a metal-free, medical grade anti-viral, anti-bacteria and anti-odor treatment that kills viruses and bacteria, including the virus that causes COVID-19, according to the article. Brown called the technology a “game changer” for the U.S. medical industry in its fight to prevent another pandemic outbreak.
“We are thrilled to partner with Field and Closet to introduce the first OR scrubs powered by PROTX2 AV technology,” Giancarlo Beevis, president and CEO of Intelligent Fabric Technologies North America, said. “This is a key step in breaking the chain of infection and provides healthcare professionals with a new line of defense in infection prevention.”
To launch the initiative, 15 rural Georgia hospitals will receive the scrubs at no cost this summer.
“Partnering with Rhino Medical Supply means our scrubs will be available to hospitals and other health care facilities from coast-to-coast,” said Steve Hawkins, president of America Knits. “This partnership matches perfectly with our focus on providing prosperity for rural, smaller communities and creating quality, environmentally sustainable products in the United States.”
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.