South Carolina featured in JD Supra article see more
South Carolina has long been known for its colorful history, beautiful beaches and vibrant tourist industry. In recent decades, it has also come to be well known for its high-tech manufacturing with the likes of BMW, Boeing, Honda, Michelin, Samsung and Volvo, all locating large manufacturing facilities throughout the State. What you might not know is that South Carolina is also home to another rapidly growing high-tech industry—the Life Sciences industry.
The term Life Sciences is generally used to include companies in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, and biomedical devices. The Life Sciences industry also includes organizations and institutions that devote the majority of their efforts in the various stages of research, development, technology transfer and commercialization, as well as the companies who support these entities.
According to SCBIO, the trade association which represents the Life Sciences industry in South Carolina, there are over 700 companies and businesses actively engaged in the Life Sciences industry in South Carolina and at least one Life Sciences organization is located in 42 of the State’s 46 counties. The economic impact of the Life Sciences industry is approaching $12 billion per year and is continuing to increase, according to a recent study. It is also estimated that the Life Sciences industry has created over 40,000 high paying jobs in South Carolina over the last several years, with an average annual salary of over $70,000.
The Life Sciences industry in South Carolina is very diverse. It includes companies ranging from small startups focusing on developing new technology like Okra Medical, to a unique genetic clinical and research institution like Greenwood Genetic Center, which has been serving the State for decades, to large established companies like Nephron Pharmaceuticals. Nephron is a pharmaceutical manufacturer and cGMP compliant 503(B) Outsourcing facility, and a global leader in the manufacture of generic respiratory medication that has rapidly expanded its manufacturing capacity and services over the last seven years. Nephron is owned and led by Lou Kennedy, whose vision and leadership have spurred the Company’s growth and success and have also made her one of the State’s most important business leaders, as well as an important thought leader in the Life Sciences industry.
South Carolina is a pro-business state that has worked diligently to attract large companies looking for a friendlier business climate from a tax and regulatory perspective. An additional driver for the growth of the Life Sciences industry is the existing ecosystem for Life Sciences, which is supported by the State’s three major research universities: University of South Carolina, Medical University of South Carolina and Clemson University as well as over ten additional universities and colleges in the State - from Furman University with its innovation program and nationally recognized chemistry department, to Newberry College launching new curriculum and a degree focused on pharmaceutical manufacturing. These universities and colleges further validate the increasing depth of the existing ecosystem and the positive impact it will have on strengthening the talent pool available to the Life Sciences industry. Other factors contributing towards this growth are the efforts of the South Carolina Department of Commerce and the South Carolina Research Authority, the strong system of hospitals and health care systems within the State, the support of various economic development alliances, the State’s expanding technical college system, the support of elected officials and the growth and leadership of SCBIO over the last several years.
SCBIO has spearheaded a series of joint private / public initiatives to promote the growth of the Life Sciences industry in South Carolina. These efforts include promoting statewide economic development strategies to attract Life Sciences companies to locate or relocate in South Carolina and consistently promoting and strengthening the existing ecosystem which allows established South Carolina Life Sciences organizations to collaborate, grow and flourish. In addition to its economic development efforts, SCBIO has integrated its efforts with the broader mission to transform and positively impact healthcare as evidenced by its unique alliances forged with the South Carolina Hospital Association, several large health systems and large payers like Blue Cross Blue Shield of South Carolina. For the past four years, SCBIO has been led by its CEO, Sam Konduros. Konduros has experience with economic development, operations of Life Sciences companies, developing start-up companies and most importantly—developing and implementing an ambitious strategic plan for the Life Sciences industry. During his time at SCBIO, Konduros has assembled a talented team. His vision and energy have fueled a rapid growth in membership and engagement and an increased in awareness and support for the Life Sciences industry across the State. Under his leadership, SCBIO significantly expanded its membership and quadrupled its revenues, while at the same time establishing itself as a powerful force for economic development and creating a new platform for Life Sciences companies to collaborate on innovations and research. Earlier this month, Konduros announced his departure from SCBIO to serve on the Board of Vikor Scientific, another successful company within the Life Sciences space in South Carolina that is rapidly expanding. He will also serve as CEO of a new health innovation company powered by artificial intelligence (AI) and blockchain technologies focusing on science personalized medicine strategies that will be a part of Vikor Scientific’s expanding portfolio of companies. SCBIO is conducting a national search for Konduros’ replacement and there is no doubt that the association and its members will continue to benefit from the momentum created over the last four years as it continues to push the Life Sciences industry forward.
The global COVID-19 pandemic presented a profound challenge to the Life Sciences industry as it disrupted the way business was conducted. The Life Sciences industry in South Carolina stepped up to these challenges and turned them into opportunities. Many Life Sciences companies pivoted from their existing strategic plans to address the needs of the State and Nation by providing assistance in key areas that became critical during the pandemic. Companies like Nephron Pharmaceuticals, Vikor Scientific, KIYATEC, Premier Medical Lab Services and others offered much needed expanded COVID-19 testing services inside and outside South Carolina. Others such as ZVerse, a digital manufacturing company, modified its business model to become one of the largest producers of reusable face shields for use during the pandemic and beyond. Over the last 12 months, they have produced millions of these reusable facemasks and have been recognized throughout the country for their efforts. Rhythmlink International, a medical device leader, donated thousands of masks and personal protective equipment (PPE) to hospitals and other healthcare providers across South Carolina. In addition, Milliken & Company boosted its production of biosmart fabrics used in scrubs and lab coats, which uses chlorine bleach-activated technology and molecular engineering to kill up to 99.9% of the bacteria and viruses it touches. Headquartered in Greenville, Vitalink Research was selected by Moderna to run its Phase III vaccine clinical trial, demonstrating national confidence in Life Sciences research operations in South Carolina. These are just a few examples of how South Carolina Life Sciences companies responded to the challenges of the COVID-19 pandemic and highlight why the Life Sciences industry is one of the fastest growing segments of South Carolina’s economy.
The future of the Life Sciences industry is bright in South Carolina. South Carolina has become an attractive place to develop and expand Life Sciences companies and there is great leadership within these companies. The rapid growth of Life Sciences is becoming more apparent to the public and media. In February 2021, Governor McMaster proclaimed February 15-19 as South Carolina Life Sciences Week in the Palmetto State. Our Life Sciences companies are leading the discussions of how to bring more Life Sciences manufacturing back to the U.S, including to South Carolina, and how to develop a domestic source of PPE and other parts of the supply chain. There is also increased collaboration on leveraging increased use of technology like telehealth and digital health to deliver health care services to rural and less developed areas using technology developed and perfected in South Carolina. SCBIO is also leading an effort to expand and improve the workforce to support Life Sciences companies. All signs point to a very bright future for the Life Sciences industry and South Carolina is just beginning to see the benefits of this growth and development.
Life sciences company establishes diversity internship program see more
The ISPE Foundation and Nephron Pharmaceuticals Corporation announced a partnership on the ISPE Foundation Diversity Internship Program's newest cycle to provide world-class opportunities to groups that are typically underrepresented in the pharmaceutical industry.
Established December 2020, the pilot ISPE Foundation Diversity Internship Program received a strong response from applicants. This series with Nephron will be a 12-week experience that offers graduate and undergraduate students in their junior or senior year the opportunity to spend the summer working on priority projects for one of the fastest-growing pharmaceutical companies in the country.
“I am delighted and honored to announce the partnership of Nephron Pharmaceuticals with the ISPE Foundation on its Diversity Internship Program,” said Antonio Moreira, PhD, ISPE Foundation Board Chair, Vice Provost, Academic Affairs, University of Maryland Baltimore County. “Over the coming years, a diverse pool of very talented students will be engaged in a variety of technologically stimulating projects under the guidance and mentorship of Nephron Pharmaceuticals scientists and engineers. These life changing experiences will inspire the interns to continue pursuing the many career opportunities that the pharmaceutical industry offers to these future leaders.”
“We pride ourselves on two things: first, we do everything we can to make sure that everyone has a chance to achieve their dreams, and second, we utilize interns and apprentices in everything we do – they are playing key roles in our expansion and growth,” said Lou Kennedy, CEO, Nephron. “This is why I am so excited to partner with the ISPE Foundation to rollout these new internship opportunities. They represent a win-win – for participants and for our company. We are proud to invest in talented young people, and we are excited they want to invest in us. We cannot wait to get started.”
There are currently multiple internship opportunities through the ISPE Foundation-Nephron partnership, including in the following departments:
- Analytical Services and Formulation
- Molecular Biology
The individuals participating in these internships will play key roles in Nephron’s ongoing projects. They will work directly with the entire Nephron team. And they will make a difference for patients across America.
The deadline to submit is 6 May 2021. To learn more, please visit ISPEFoundation.org/Diversity-Internship-Program.
About ISPE and ISPE Foundation
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its 18,000+ Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. Founded in 2017 as the philanthropic arm of ISPE, the ISPE Foundation supports education, training, and research for the advancement of innovative technologies and provides solutions to global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world. To aide in this endeavor, the Foundation focuses on initiatives related to increasing the technical knowledge of the incoming workforce, fostering diversity within the industry, and supporting efforts to bring quality pharmaceutical manufacturing to new markets. Visit ISPEFoundation.org for more information.
About Nephron Pharmaceuticals Corporation
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs.
Inquiries related to the program may be directed to Foundation@ISPE.org.
Kennedy's honored for continuous service to GSSM, state see more
The South Carolina Governor’s School for Science + Mathematics (GSSM) and its Foundation honored Lou and Bill Kennedy with the 2021 Townes Award during “Empowering STEM Leaders,” the 27th annual Townes Award Celebration, Wednesday, March 17, 6-9 p.m. at 1208 Washington Place in Columbia.
“GSSM was honored to present the Townes Award to Lou and Bill Kennedy in recognition of their transformational leadership and commitment to empowering future generations of scientists, engineers, and innovators,” said Beth Dinndorf, executive director of the GSSM Foundation.
“GSSM seeks out and advances our state’s most talented and motivated students,” said Danny Dorsel, GSSM Interim President and GSSM Class of 1990. “Charles Townes and Lou and Bill Kennedy are shining examples for these young minds to challenge themselves to be innovative and make a difference in our world.”
Named for South Carolinian Dr. Charles Townes, whose visionary spirit and pioneering research led to the invention of the laser, the Townes Award recognizes individuals, businesses, and institutions that have transformed South Carolina and the world.
“Bill and I are very deeply humbled and really excited to accept an award named in honor of an extraordinary South Carolinian who was able to achieve the Nobel Prize and the Templeton Prize, as well as many other things. This is such an auspicious group, and I’m excited to be a part of it,” Lou Kennedy said in her acceptance remarks.
Lou and Bill Kennedy are co-owners, and Lou is the CEO, of Nephron Pharmaceuticals Corporation, a South Carolina-based company that develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19.
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.
Life sciences executive named to national NAMB Board see more
Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.
Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.
“I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”
NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19.
Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.
“Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”
A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.
The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.
Executive Partnering, Virtual Exhibit Hall Add Draw for Power of Us Conference Feb. 16-17 see more
With conference registration surging more than 20% past prior record levels and the addition of a “singularly significant innovation announcement focused on cancer treatments and precision medicine advancement”, SCBIO's “The Power of Us” virtual conference Feb. 16-17 is preparing for its largest gathering ever next week... delivered virtually to registrants from across the Palmetto State plus 25 states and 8 countries.
Adding to the excitement is a just-scheduled “major innovation announcement” by a South Carolina company, in tandem with West Coast and German allies, that has significant implications for cancer diagnosis and treatment on a global level, organizers say.
Already in excess of 500 registrants from across America and around the globe, the acclaimed SCBIO conference – the annual gathering of South Carolina’s life sciences community – will also celebrate the rapid growth of the industry and the contributions of its 800+ organizations in helping America and the world overcome the brutal COVID-19 pandemic.
South Carolina life sciences has seen a doubling of firms and 40% increase in life sciences’ direct employment since 2017, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Joseph Von Nessen, the state's research economist and noted economic development expert with the Moore School of Business at the University of South Carolina.
“Dr. Von Nessen’s data validates that the life sciences industry in South Carolina is experiencing stunning growth, thanks to the combined efforts of our state’s economic development teams, industry partners, research universities, elected officials and other partners,” said SCBIO CEO Sam Konduros. “It’s an exciting time to be a part of an industry that is saving lives and improving quality of care.”
The industry has a $12+ billion economic impact in the Palmetto State, with more than 800 firms located in 42 of 46 counties across the state and over 43,000 professionals employed directly or indirectly in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.
Organizers are tight-lipped about the Innovation Announcement details, which will be unveiled at 8:30 a.m. on the second day of the conference—February 17.
“We will say that the implications of the announcement include a new technology that has the ability to detect cancers at the earliest time ever, to further lifespans, and to unlock a new era of precision medicine, ” said Mr. Konduros.
Adding to the draw of the conference are scores of organizations from across America showcasing their capabilities in a virtual exhibit hall, direct 1-to-1 executive meetings on demand via a Partnering Portal, major industry awards and – naturally – top speakers.
Committed presenters include BIO Global CEO Dr. Michelle McMurry-Heath; Microsoft Vice President Jamie Harper, who leads the global team supporting higher education and K-12 initiatives; and Bill Stadtlander, Commercial Leader of Verily, the Google subsidiary focused on life sciences and use of health data and AI to improve lives.
Also speaking at SCBIO 2021 are Courtney Christian, Senior Director of Policy and Research at PhRMA and former leader of the Black Women's Health Imperative; Dr. Harris Pastides, former USC President and outgoing chair of the SC Institute of Medicine and Public Health; Dr. Pat Cawley, CEO of MUSC Health; and Dr. Marjorie Jenkins, Dean of the USC School of Medicine - Upstate and Chief Academic Officer of Prisma Health Upstate, among others.
Themed “The Power of Us,” the 2-day SCBIO 2021 virtual event will feature sessions on The Power of Innovation, The Power of Partnership, and The Power of People – each a fundamental force which drives the state’s surging $12 billion industry that is a key contributor to South Carolina’s expanding knowledge economy.
The conference will also feature SCBIO CEO Sam Konduros delivering the “State of South Carolina’s Life Sciences Industry” address, and release of SCBIO’s 2020 annual report.
Leaders already registered to attend include executives from Presenting Sponsor Vikor Scientific, Champion Sponsor Nephron Pharmaceuticals, Keynote Sponsor Medpoint, Pinnacle Awards Sponsor Softbox and others. Leading biotech and med-tech industry brands participating include BIO, Johnson & Johnson, AVX, PhRMA, AdvaMed, Poly-Med, VWR, Ritedose Corporation, Rhythmlink, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami, SSOE – Stevens & Wilkinson, and more. All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.
Registration is open online at the 2021 Virtual Conference section of www.scbio.org. Registration is free to employees of most SCBIO investors and supporters as well as to students interested in life sciences careers, while faculty and teachers can attend the entire conference for $25. General admission tickets are available for as little as $75. Virtual Exhibit space and sponsorships are also available by inquiring at email@example.com.
For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.
Nephron, Lexington County businesses step up again see more
WEST COLUMBIA — Nephron Pharmaceuticals CEO Lou Kennedy watched proudly from her office window as a company security guard rushed out to help a woman with a hot pink walker from her vehicle into the West Columbia drug company’s headquarters.
Having found the location on the state Department of Health and Environmental Control’s website, the woman was there to receive a COVID-19 vaccine.
Nephron, along with Cayce-based Dominion Energy and two Lexington County road sign companies, Stay Alert Safety Services and Optec Displays, are donating time and services to put on a free drive-thru vaccine clinic. Eligible participants, age 65 or older, must have an appointment to receive a shot.
“I’m so proud we can do this,” Kennedy said.
While the vaccine itself is free, providers are legally able to bill people or their insurance for the doctor or pharmacy visit. Nephron is not charging.
With about 30 nurses on staff and almost as many doctors of pharmacy, the West Columbia drug maker applied for the certification needed to give the shots and administered its first 500 doses to Lexington County seniors inside its building over the week of Feb. 1.
It has 1,000 more doses to start giving out on Feb. 8, this time without people having to get out of their vehicles in an effort to make recipients more comfortable, Kennedy said.
When she first had the idea, she called Keller Kissam, president of electric operations at Dominion Energy South Carolina, to ask if they could use the power company’s vehicle turnaround area. Dominion’s headquarters a 10-minute drive from Nephron.
“Keller didn’t even hesitate,” Kennedy said. “It was ‘What can we do? How do we help?’ You talk about community spirit.”
In addition to the drive-thru space, Dominion is providing power to the site to power the computers needed to make appointments for recipients’ second doses. Stay Alert, Optec, as well as the town and county of Lexington are providing signage.
Those wishing to receive a vaccine from Nephron can go online to DHEC’s website in order to sign up for an appointment.
Robotics usage expands at Nephron see more
Two years ago, Nephron Pharmaceuticals brought a problem to the engineering and pharmacy colleges at the University of South Carolina.
When employees operating machinery at Nephron called in sick or otherwise couldn’t come to work, production is halted. Nephron CEO Lou Kennedy hoped the company and the two colleges could find a solution.
Kennedy is no stranger to the university, having graduated from USC. She and her husband Bill also established the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.
However, she had not been a part of a collaboration with the university that actually shifted the way the West Columbia drug manufacturer operates.
After several classes of mechanical engineering students and pharmacy students worked to fix the problem, the project was finally completed this year— a robot named Smithers after The Simpsons character. The robot improves productivity by cutting out most of the human involvement in pre-filling sterile syringes with injectable medicines.
While Nephron has faster robots than Smithers, they require more human intervention.
“It just continues to make drugs without, frankly, a bathroom break or other things. So a steady machine, even if it’s slower, is better than people who haven’t shown up for the night and we have orders to fill,” Kennedy said.
Despite increased automation, Kennedy said employment will not be hurt. Nephron is currently in a hiring surge, trying to fill 380 positions including sterile pharmacy technicians and automation engineers. This year, Nephron will open its state-of-the-art vaccine production facility as part of a $215 million expansion.
“I can’t hire enough sterile pharmacy techs for what I need fast enough because of our growth, so this is just augmenting what we’re already doing— not to replace humans,” Kennedy said.
The robot consists of four pieces of equipment, all designed by students, that work together to mimic the actions of a human pre-filling sterile syringes, according to Nephron’s chief of engineering and USC mechanical engineering professor Ramy Harik. Separate pieces pick up the syringes, complete the filling process and cap the syringes to seal them.
Harik led three different teams of senior engineering students over two years to create the robot, while pharmacy students made sure the medical and sterilization aspects of the robot was safe for future human injection. The teams tested nearly ten different designs before finding one that worked.
The machine, which was installed last week, is being validated for commercial use and should be up and running in a couple of weeks, said Kennedy. She has already ordered the parts to make another one to put into production and hopes to have several of them going at the same time one day.
“My dream for the university is that we could commercially market these robots for hospitals around the world,” said Kennedy. “If we had the ultimate dream, it would be to sell these and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”
From the partnership, Harik created a pharmaceutical manufacturing class at USC for the next semester, and Nephron donated the equipment needed for students in the form of a glass cleanroom. The room allows students to work in a sterile environment for pharmacy manufacturing.
“Usually an entry-level engineer wouldn’t be given the opportunity to build an entire system from the ground up and it’s just been a great opportunity,” said John Diamond, one of the engineering students who started the project and now works at Nephron.
Company Excited to Expand Generic Portfolio see more
WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation is celebrating another milestone.
The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a “luer lock” interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology.
Ketorolac Tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year.
“We are extraordinarily excited to expand our generic medication portfolio to include non-respiratory products,” said Nephron CEO Lou Kennedy. “This is the latest sign that Nephron is growing, and it represents a real reason for our entire team to celebrate.”
Nephron-manufactured Ketorolac Tromethamine is an injectable medication for the short-term treatment (up to 5 days) of moderately severe acute pain. Commonly used after surgeries and other medical procedures, Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products.
The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. The company recently opened a CLIA-certified diagnostics lab and conducts COVID-19 tests for people across South Carolina.
Prescribing information for Ketorolac Tromethamine Injection Vial UPS, 60 mg/2 mL (30 mg/mL) is available on the product package insert. More product information regarding Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials is available here
Nephron prepping to fill COVID vaccines in state see more
LEXINGTON COUNTY, SC (WSPA) — With a potential COVID-19 vaccine looming, one South Carolina company said they’ll be able to fill vaccines next year.
According to Nephron Pharmaceuticals CEO and Founder Lou Kennedy, the company is in the midst of a $215 million expansion. They are adding new office and new warehouse space. The investment will also create more than 380 jobs the company said.
The expansion also includes vaccine production space. Kennedy said once completed, they’ll be able to fill COVID-19 vaccines at their facility.
“We’re actively looking for the right partner that will produce and we’ll fill the vaccine. We’re speaking with people throughout the federal government and Department of Defense to find the right partner,” Kennedy said.
Tuesday, the company held a beam raising ceremony to celebrate their expansion. Kennedy said she expects to have the vaccine production space completed by March 2021.
As of Tuesday afternoon, the FDA has not approved a COVID-19 vaccine for distribution. However, preliminary reports on vaccines from Moderna Inc. and Pfizer Inc. show their vaccines have at least a 90% effectiveness rate.
Kennedy said they are anticipating a medical grade glass shortage because of the high demand for the vaccine. She said they have the ability to work around that. “Our option will be to put the vaccine in plastic. We have the technology and the capability.”
Under the South Carolina Department of Health and Environmental Control’s (SCDHEC) statewide vaccine plan, front line medical personnel and nursing home residents will be some of the first South Carolinians to get doses of an approved vaccine. They anticipate vaccine supply will be limited to start off, but Kennedy hopes they can help alleviate that.
She said, “We’re right in tandem with the research work and the clinical trials that are going on. We’re trying to time that perfectly for the vaccine filling side of it.”
Nephron expanding again in Columbia, SC see more
With promising news about a COVID-19 vaccine making headlines, Lou Kennedy had reason for optimism during a beam-raising ceremony marking a milestone for a $215.8 million expansion at Nephron Pharmaceutical Corp.’s Saxe-Gotha Industrial Park campus.
Part of the expansion is a 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that Kennedy, Nephron owner and CEO, expects to be operational around March 2021. She said Nephron is actively looking for a vaccine production partner to provide the ammunition for the pre-filled sterile syringes that make up the booming 503B Outsourcing Facility arm of the company.
“It’s a Chamber of Commerce day,” Kennedy said after signing the final beam of the 240,000-square-foot Kennedy Innovation Center’s steel skeleton on Tuesday morning. “This marks a milestone in 2020. This is good news. This is giving us the space to continue to grow.”
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.”
OpEd published 10-14-20 by SCBIO see more
OpEd published courtesy of Gannett/Greenville News
Patients in the U.S. have faced drug shortages for years. This was illustrated amid the current pandemic, which was exacerbated by shortages of PPE, testing ingredients and drugs required for COVID-19 treatment. Although America remains the world’s top innovator in life sciences, it dramatically lags countries such as China and India in the manufacture of antibiotics, active pharmaceutical ingredients formulated into tablets, capsules and medicines (API), vitamin C, many medical devices and PPE.
While South Carolina reaps extraordinary benefits from foreign investment by international manufacturers that contribute significantly to our economy and quality of life, returning the manufacturing and sourcing of life sciences products to our country is not only a powerful economic development driver – it’s a path to national and global stability. Read on for full article here.
Nephron employees achieve Lean Six Sigma green belt certification see more
If there were ever a time for improved efficiency to help a fast-moving company, it would be now for Nephron Pharmaceuticals Corp.
With the West Columbia-based manufacturer of sterile respiratory medication churning out product at a record pace during the COVID-19 health crisis, owner and CEO Lou Kennedy is in search of every competitive advantage available.
“In spite of my Southern accent, I do move like a New Yorker, and this company goes at that pace,” she said. “It’s a testament to the team here that everybody’s running on high-test, premium unleaded, and keeping up.”
The most recent example came when nine Nephron employees achieved Lean Six Sigma green belt certification after completing courses at the University of South Carolina’s Darla Moore School of Business. Six Sigma or lean manufacturing, pioneered by the likes of Henry Ford and famously implemented by Toyota in the years following World War II, is a systematic method aimed at reducing waste and variation to improve production quality and efficiency.
Over twenty experts to speak on major business issues see more
Subject matter leaders from across state, nation to cover what business needs to know to thrive despite pandemic, how to leverage state’s fastest-growing knowledge economy segment
SOUTH CAROLINA – September 2, 2020 – SCBIO will host a half-day virtual program September 23 -- Life Sciences Boot Camp: Building Your Brand & Business In a Pandemic – to inform and connect businesses, educators and professionals from across the state on leveraging opportunities, identifying trends and overcoming challenges that face organizations interested in tapping into South Carolina’s fastest-growing industry segment.
To be held completely online, the program will run from 8:15 a.m. until 12:15 p.m. on Wednesday, September 23rd. The program is delivered free to all SCBIO Members and Investors, and for a nominal fee of $50 to all non-Members. Students and media may also attend free of charge. Six sessions featuring over 20 noted presenters will precede a closing Virtual Networking Session for all attendees. Confirmed topics and speakers include:
- Search for a Cure: A National Update on the Global Pandemic – featuring a live national report from PhRMA executive Sharon Lamberton on success in battling the COVID-19 pandemic, and what lies ahead for America
- Marketing in a Pandemic: Building Your Brand & Your Topline – despite the economic turndown, some businesses are enjoying even great success – and are positioning themselves for an even better future. Learn the secrets to thriving, not surviving, during and after the pandemic from Henry Pellerin of Vantage Point, Heather Hoopes-Matthews of NP Strategy and Jessica Cokins of Thorne Research
- Best Practices in Talent Recruiting, Retention & Development – Nephron's Lou Kennedy, Arthrex's Jimmy Dascani and ERG's Matt Vaadi share how the state’s life sciences leaders are attracting, training and retaining top talent – and offer ideas your organization can deploy right now
- Partnering Effectively with Higher Education & Research Universities – tap into the wealth of resources, knowledge and experience prevalent in the state’s research universities to enhance innovation and success. Enjoy insights from Chad Hardaway of USC’s Office of Economic Engagement, Michael Rusnak of MUSC’s Foundation for Research Development, and Angela Lockman of Clemson
- Leading Virtual Teams Effectively – the pandemic has showed us that working virtually is here to stay. Find out how to make your organization collaborate seamlessly, efficiently and effectively -- wherever your colleagues are located -- from Annie McCoy of ChartSpan, Andrew Collins of Alcami and Jenni Dunlap of Parker Poe
- Pivoting with a Partner: Collaborating to Grow Your Business – learn how to successfully identify and partner with other organizations to expand and enhance product/service offerings. Hear incredible stories from the teams at Zverse/Phoenix Specialty and Rhythmlink, ZIAN and MUSC as they share their stories -- and how you can find your next great opportunity.
The program will end with a Virtual Networking session offering attendees to chat with leading economic development professionals including Stephanie Few of Womble Bond Dickinson, Tushar Chikhliker of Nexsen Pruet, and John Osborne of Good Growth Capital for conversations on Onshoring, Incentives, Accessing Capital and more.
To register or for more details, visit the Events page. Interested students and media members are invited to attend, with advance registration, at no cost.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.
For additional information on SCBIO, visit www.SCBIO.org.