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
SCBIO, 3 life sciences companies highlighted in media reports see more
Courtesy Greenville News/Gannett
As the distribution of COVID-19 vaccines have ramped up in recent weeks, life science firms in South Carolina have pivoted to play a role in the vaccination campaign.
After weeks of only 60,000 dose allocations in January, that figure has doubled with over 130,000 first doses expected to arrive in South Carolina this week.
The brands are well known — Pfizer, Moderna, Johnson & Johnson — but lesser known companies have played a role in the clinical trials and ancillary supplies critical to the rollout of the vaccine and some are found in the Palmetto State.
Gov. Henry McMaster celebrated SCBIO, a life sciences non-profit, and the industry in February for their great year. Part of that success was in response to COVID-19.
"While 2020 will forever be remembered as the year of an unmerciful global pandemic, our stakeholders heroically rose to the challenge," Sam Konduros, SCBIO's president and CEO, wrote in the non-profit's 2020 report.
SCBIO and over 100 industry firms supported pandemic efforts such as distribution of personal protective equipment — which includes creating an online PPE exchange portal — creation of a jobs portal, testing and promoted proper mask use on social media.
That list now includes COVID-19 vaccines research and packaging, and potentially its production.
Clinical trials vital to vaccine development
The Moderna vaccine was authorized for emergency use on Dec. 18 after clinical trials proved its effectiveness and safety. VitaLink, a Greenville based research company, played an important role in Moderna's phase 3 trials.
South Carolina had four Moderna phase 3 clinical trial locations out of the nearly 100 locations around the country. Three trial locations — Anderson, Greenville and Spartanburg — were conducted by VitaLink Research, a South Carolina based research company which specializes in respiratory medicine.
"It really was just a natural fit for us," Steve Clemons, VitaLink's CEO and president, said.
Clemons expected roughly 400 participants through the three sites but the Upstate had roughly 1,200 of the 30,000 enrolled participants nationwide.
"There should be an awful lot of pride to the Upstate because, frankly, we as VitaLink couldn't have done this without the volunteers," Clemons said.
Participants were enrolled in the summer and either received the drug or a placebo.
One of these participants was George Acker who has learned since talking with The News in November that he got the placebo — to his surprise.
The studies were unblinded in January and those who received the placebo were able to get the real vaccine.
Acker has received both shots since then.
VitaLink continues to conduct monthly follow-ups with participants for two years to track side effects, safety and efficacy of the vaccine.
Nearly 400,000 doses of the Moderna COVID-19 vaccine have been administered in South Carolina in the last three months.
The Moderna product has played a vital role in vaccinating long-term care facility residents and staff as initial allocations were given to these populations.
Clemons is proud that VitaLink has played a part in the solution to the pandemic but also in their work in general.
"I get to treat people every day using, kind of, tomorrow's therapies," Clemons said. "And I get paid to do it and patients never get billed."
Packaging of Pfizer vaccines
The Pfizer-BioNTech vaccine requires ultra cold storage, around minus 70 degrees Celsius. This makes shipment a little more challenging but a local packaging company had the solution.
They supply ultra-cold temperature shippers which keep vaccines between minus 90 and minus 60 degrees Celsius for at least ten days unopened with the use of dry ice and insulation. If managed well, these reusable containers can store vaccines for about a month by re-icing the dry ice.
"[Softbox] immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine," Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, said in a March 10 press release. "And quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.”
One of two manufacturing centers supporting the vaccine distribution is located in Greenville, the other is in the Netherlands.
"Our Americas headquarters in Greenville features a full qualification testing lab, product engineering capabilities, and a world-class team," John Hammes, Softbox's general manager of the Americas, said. "All of which helped us support Pfizer in the fight against COVID and develop a way to successfully distribute a vaccine to support the global community."
Vaccines could soon be filled in the Lowcountry
Lou Kennedy didn't expect on her company would be filling vaccines, but she also didn't plan on the pandemic — no one did.
In addition to helping with COVID-19 testing efforts, she thought Nephron Pharmaceuticals could take it a step further and help with the vaccinations.
"We have the type of equipment already in our possession, we will have it retooled," Kennedy said. "We'll build a wing and it is our sincere desire to find a vaccine partner — like Moderna, Pfizer or Johnson & Johnson — and say, let us fill some of the capacity that the American patient needs."
The Lexington County-based company is currently undergoing a $215 million expansions which includes a 110,000 square foot vaccine production space. Kennedy expects at least 380 new jobs with the expansion.
About 300 of those could be centered around the vaccine production and she hopes to partner with a COVID-19 vaccine manufacturer to fill vaccines and help ramp up vaccine supply.
Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson, or it could be another brand who could receive authorization in the U.S., Kennedy said.
"Between now and the time we move in there, there could be 10 new ones, so we're keeping our eyes and ears open," Kennedy said.
They've already hired about half the people they need. The building is still being worked on but once it's completed, Kennedy believes the production lines could be operational by the summer.
The expansion, originally announced in July, will also include a new office, a new warehouse, expanded secondary packaging operations and a 20,000 square foot machine shop.
In the meantime, Nephron Pharmaceuticals already partnered with Dominion Energy to set up a drive-thru vaccination site in Lexington County in February.
"I had this idea that why can't we help the vaccination," Kennedy said. "We have nurses on staff and we have [doctors of pharmacy]."
Dominion Energy provided the space and set up a temporary power pole for Nephron's nurses and staff. They also enlisted the help of Rick Lee, a Department of Environmental Control board member from Rock Hill, on how to best setup a drive-thru clinic.
Like health systems across the state, Nephron is running this clinic out of their own pocket. Vaccines and ancillary supplies are supplied by the government, but staff and other costs are not.
"We're not getting reimbursed for any of this," Kennedy said. "We're doing this out of the bottom of our heart."
The drive-thru site has ramped up from about 30 vaccinations per day when it first opened to about 150 vaccinations per day by March. Kennedy hopes to get this up to 300 per day.
Zverse steps up for South Carolina see more
John Carrington remembers the chaos from the spreading coronavirus reaching his small Columbia, S.C., company about Saturday, March 14, three days after the World Health Organization declared Covid-19 a pandemic.
It started with a phone call from a hospital executive that Saturday saying the hospital was running critically short of personal protective equipment (PPE), ventilator parts, and ventilators altogether. “What can you do?,” the hospital executive asked.
The Zverse CEO recalled that the executive “was pretty urgent,” and the gist of the message was open-ended: “We need a lot of problems solved and fast, and how can you help?”
How indeed? Carrington couldn’t offer the hospital a catalog of PPE, or a catalog of anything.
His workers were specialists in being manufacturing enablers, providing software and a cadre of experts who linked customers with ideas with manufacturing partners to convert those ideas into objects as quickly and efficiently as possible.
Within days, the company would shift into designing its own face shields for use in hospitals, later designing other models for schools or other crowded spaces.
Zverse would go from being able to make 1,000 face shields a day using 3-D printers to making the heavy investments to build molds for injection molding that allowed its production rate to climb to 120,000 units per day within about a month. That process would typically take about two or three months.
In March, Zverse had 20 employees. By September, it had 80. It expects to end the year with 100 to 120 employees — more designers, product managers, account managers, customer service and support, shipping and logistics specialists.
“It’s been a wild ride,” Carrington said.
Zverse is just one of hundreds of South Carolina businesses that were called to action by the pandemic and responded with innovations to help their customers and communities in a time of need. Several of those companies in the biotech field were highlighted in an Aug. 25 webinar by SCBIO, a not-for-profit industry association promoting the life sciences in South Carolina.
The others were:
VitaLink Research, a clinical research site network based in Greenville. VitaLink was commissioned by Moderna to conduct its Covid-19 vaccine study in South Carolina.
Vikor Scientific LLC, a Charleston testing laboratory founded in May 2018 by physician and entrepreneur Shea Harrelson and medical entrepreneur Scotty Branch. Its lab is accredited by the Centers for Medicare and Medicaid Services under its Clinical Laboratory Improvement Amendments (CLIA) certification. They have dedicated 2,000 square feet of its new 22,000-square-foot facility to Covid-19 testing. In late August it was testing about 10,000 Covid-19 swabs per day, and had the capacity to test for 20,000 per day.
Nephron Pharmaceuticals Corp., a West Columbia manufacturer of medical products and a leading producer of medical products packaged into single doses using blow-fill seal technology. It is creating space at its Lexington County plant to manufacture vaccine doses when they become available. Since the pandemic, it has created a CLIA-certified lab for Covid-19 testing, and has a mobile lab that visits the University of South Carolina and several area employers.
Modjoul Inc., founded in Clemson in 2016 by Eric Martinez, CEO, and Jen Thorson, COO. Modjoul sells a platform designed to enhance worker safety by having them wear a device called a SmartBelt that tracks their movements. Linked software identifies movements that might be dangerous — from certain bending movements to overly fast cornering with a forklift. With Covid-19, it is enabling employers to use the devices to screen body temperatures and signal workers with a vibration if they are violating social distancing. In the event of an outbreak, the data can be used for rapid contact tracing.
“When you think about it, you’re able to reduce the amount of time businesses are shut down because you know who people have been in contact with,” Thorson said. “It’s one of those happy coincidences that we’re able to use our existing device, not only for safety, but also for that illness, contact tracing and social distancing.”
Thorson said her biggest lesson from the pandemic has been “don’t be afraid to pivot quickly.”
“We have a team of really smart people, and we can figure out almost any problem,” she said.
At Nephron Pharmaceuticals in Lexington County, one of their biggest lines is generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with Covid-19.
The company has grown from 75 employees with two products in 2001 to about 80 products and about 1,100 full-time employees, in addition to 900 part-time workers, interns and apprentices. It announced an expansion this year that will expand its buildings to cover 1 million square feet by early 2021. It expects to add 380 more full-time employees by 2024, and much of the hiring is now underway.
“We want them to be trained and ready as the new buildings come online,” CEO Lou Kennedy said.
About 110,000 square feet of its expansion is for manufacturing vaccine doses, antibiotics or other chemo-therapeutic agents. Nephron Pharmaceuticals is one of seven U.S. companies identified by the federal government as key to getting a vaccine produced — once one has been developed.
“We know we’re going to need a heck of a lot of vaccines all at once if we’re going to get everybody healthy,” she said. “We are doing anything we can within our bandwidth to be patriotic Americans and help with the eradication of Covid-19.”
The New York Times first reported Jan. 8 on the emergence of a novel coronavirus in China’s Wuhan province. Two days later, China reported its first death from the virus.
The first case in the United States was confirmed Jan. 21.
On Feb. 11, the World Health Organization named the disease Covid-19.
By Feb. 26 there were 60 known cases in the United States, and Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, asked the American public to brace itself for a global pandemic.
That day President Trump said infections were “going very substantially down,” and that “we’re going to be pretty soon at only five people.”
Just two weeks later, when Covid-19 was declared a global pandemic, there were at least 1,240 people in 42 states and Washington, D.C., who had tested positive for Covid-19, and 37 had died.
Meanwhile, a wave of change was rolling toward Carrington’s 7-year-old company on Shop Road, named for its location by Columbia’s Norfolk-Southern railroad repair shops and better known for parking for UofSC football games.
His children were home from school, many offices were closing and employees were working from home — if at all.
“It was interesting,” he said. “We were not sure what this meant for us, let alone as a business, because a lot of our manufacturing customers’ factories shut down as well.”
After the weekend call from the hospital executive, Carrington tried to solve its first problem: The hospital needed fully protective face shields that could be worn in the intensive care unit, or other areas with dense aerosols.
“Literally overnight, we went from concept to prototype, rapid prototyping, multiple iterations,” Carrington said. “They were asking for 3,000 units, which was no problem. And they needed them immediately.”
The next day, Zverse got a call from a government agency that needed 10,000 face shields. And on the third day, another hospital system called needing 50,000 shields.
The second hospital system needed face shields that could be sterilized and reused because they were going through disposables at a rate of 5,000 per day for just one of its hospitals.
While 3-D printers are splendid devices for fast turnaround and multiple design changes, they are not designed for a lot of volume.
And 50,000 units is what Carrington defined as “a lot of volume.”
So, it was decision time.
More calls were coming in. “Once the word got out to a few people, we started getting direct messages from doctors, family members of nurses, who were all pleading for help, because there was no PPP at all,” Carrington said.
The mulling was not a long process. The company simply wouldn’t be able to keep up with demand using 3-D printers.
So after the call for 50,000 units, Carrington decided to move from the 3-D printing underway to injection molding, “which was a significant step, because it was a real capital investment during a time when everything was very uncertain.”
But he knew it would also allow Zverse to ramp up much more dramatically, “help a lot more people, help the company and give us a little bit more security.”
The actual injection molding would be done by outside manufacturers, but Zverse had to supply them with the molds.
According to Rex Plastics of Vancouver, Wash., an injection mold can cost $1,000 to $80,000 depending on size and complexity. A typical mold costs $12,000.
Zverse dealt with the issue by requiring its customers to pay half the cost up front. Hospitals typically pay net 30, or 30 days after invoice, but they quickly agreed. “These are different times,” Carrington said.
“We were able to get the first 5,000 units coming out of the first mold within about two weeks.”
In all, Zverse built about 24 tools for injection molding.
Carrington credited much of the company’s success to its network of manufacturers.
“We had all the right people in our ecosystem to accomplish all this.
“We sit in the middle of a lot of manufacturing capabilities. That’s what we’ve done forever,” he said. “This is the first time we took a product of our own and went to market with it.”
After injection molding was in place, Zverse spread the word that it had the capacity to make 100,000 units a day — mass manufacturing.
“We got flooded with orders from every hospital, every government agency you can imagine,” he said. “It was completely overwhelming.”
Carrington started calling his shareholders and others in his support network to solve emerging problems, like transportation logistics.
“That whole period was insane for everyone involved,” he said. “But it was super fulfilling.”
One of Zverse’s biggest contracts was for the U.S. Department of Veterans Affairs for 2 million face shields. At the time, there were reports about suppliers not being able to deliver equipment and PPE to the VA.
But Zverse supplied the order from April through June.
“That was a herculean effort to be able to deliver that on time,” he said. “The VA said we were one of the best suppliers that they had.”
In all, Zverse supplied 3 million of its health model ZShields over 75 days.
As businesses began trying to reopen in May, there was a broad need for some forms of barriers and PPE —a need that is likely to last beyond the pandemic.
Some restaurants called for the face shields Zverse was delivering to hospitals.
“I looked at them and said if I walked into a restaurant and saw someone wearing this, I wouldn’t want to eat there. That’s going to be bad for business,” he said.
Instead, Zverse designed ZShield Plex —something that would be a comfortable and effective barrier from transferring droplets from your mouth. The shield attaches at the neck and can flip down when on break or away from where needed.
“That one captured everyone’s attention,” he said.
Zverse started taking pre-orders for the shield in May from businesses, schools and others, and has since shipped millions.
Carrington said Zverse was able to make its huge pivot to meet the demands of the pandemic moment with “brute force and an incredible team.”
“The core group that’s been here since March has been averaging like 16-hour days since March, including weekends,” he said. “Everyone is driven by the fact that we’re able to produce something that is able to solve problems.
“Right now the world needs a lot of problems solved,” Carrington said.
“I don’t think there’s been a time in history when the world has needed as much innovation in one moment as it does right now.”
Webinar features inside details on beating back the COVID pandemic see more
Top executives from five of the Palmetto State’s leading life sciences organizations shared how they have found opportunity by pivoting, product adjustment, service expansion and partnering to overcome the global COVID pandemic and find accelerating opportunity and growth.
The SCBIO webinar took place August 25th and featured Shea Harrelson and Scotty Branch, co-Founders of Vikor Scientific; John Carrington, CEO of Zverse; Jen Thorson, COO of Modjoul; Steve Clemons, CEO of VitaLink Research; and Lou Kennedy, CEO of Nephron Pharmaceuticals. Erin Ford EVP of SCBIO – South Carolina’s official life sciences industry organization -- moderated. Enjoy the whole program here.