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.”
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.
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.
Nephron CEO and SCBIO Board Chair Lou Kennedy speaks out see more
The team at Nephron Pharmaceuticals Corp. in West Columbia has been honored to answer the call to serve during the unprecedented COVID-19 pandemic.
We have shipped hundreds of millions of doses of life-saving respiratory medications to patients nationwide. We have provided tens of thousands of gallons of Nephron-made, FDA-approved hand sanitizer to students, businesses, families and those in need. And we recently announced a $216 million expansion that includes factory production space where we will fill COVID-19 vaccines.
Every Nephron employee has a sense of pride. Of patriotism. But I would be remiss if I failed to mention that we also share a sense of concern.
China is one of the world’s largest suppliers of the precursor chemicals used to make active pharmaceutical ingredients and personal protective equipment. What we have come to recognize firsthand are the perils of dependence on foreign counties, such as China, for medicine and medical supplies.
As trade tensions between China and the United States grew last year, I was afraid China could intentionally disrupt the drug supply chain to the United States, exacerbating the drug shortage crisis, increasing the cost of drugs and potentially killing American patients.
The recurring question I had was: What can America do to break this dangerous dependence?
Now, as the world considers how to deal with China in the aftermath of this pandemic, the picture of a potential supply chain disruption is grimmer, serving as a vivid reminder that we are talking about matters of life and death.
I have been vocal about this issue for quite some time. In fact, I discussed America’s dependence on China for drug ingredients last year with federal officials, including President Donald Trump, Vice President Mike Pence and Health and Human Services Secretary Alex Azar. When U.S. Sen. Lindsey Graham visited our plant a few weeks ago, we agreed: Something must be done to find American solutions to this American public health crisis.
So, it should be no surprise that I am excited about the executive order President Trump signed last week to shore up the domestic supply chain for life-saving medicines, reduce dependence on foreign sources of drugs and medical supplies and expand domestic production of both.
When the president signed this new executive order, he said: “As we’ve seen in this pandemic, the United States must produce essential equipment, supplies and pharmaceuticals for ourselves. We cannot rely on China and other nations across the globe that could one day deny us products in a time of need. We can’t do it. We can’t do it. We have to be smart.”
I could not agree more.
This is a no-brainer. The pandemic has taught us an important lesson. The best way to protect American patients, families and businesses is onshoring production of the things we need to keep them healthy and safe.
Over the past five months, the American people have endured hardships no one could have foreseen. We grieve with those who have lost loved ones to this unrelenting silent enemy. We support business owners small and large who want to slow the spread of this virus so we can reopen the world’s greatest economy. And we share the frustrations many people feel with politicians who are focused on winning the next election, rather than preparing for the next public health crisis.
We are grateful for these first steps President Trump is taking to make sure we never end up in this place again.
At Nephron, we have the technology, resources and people it takes to successfully partner with the federal government to make the public health preparedness infrastructure of this nation stronger than ever. South Carolina can and will be a leader in the effort to find American solutions for American public health.
This new executive order is the right way to do it.
Nephron Pharmaceuticals Corporation expanding operations again, adding 380 jobs, $215.8 million investment$215.8 million investment will create 380 new jobs in Lexington County, SC see more
Nephron Pharmaceuticals Corporation (Nephron), a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing, today announced plans to expand operations in Lexington County. The company's $215.8 million investment will create 380 new jobs.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19.
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. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Headquartered at 4500 12th Street in West Columbia, Nephron’s expansion will add new offices, a new warehouse and production space at its campus in Saxe-Gotha Industrial Park.
The expansion is expected to be completed by Q1 of 2021. Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
The Coordinating Council for Economic Development has approved job development credits related to this project.
“The Nephron family is extraordinarily grateful for the opportunity to grow in South Carolina. Thanks to our partnerships with state and local officials, and the trust they have placed in us, we have been able to provide life-saving medications to patients around the world and establish ourselves as the global leader in what we do. We are proud of these achievements and more, and we know our best days are ahead of us. That is what makes this latest announcement so special.” -Nephron Owner & CEO Lou Kennedy
“We are proud to have Nephron Pharmaceuticals in South Carolina. Since coming here they have become an integral part of the community, and recently have been vital in the fight against COVID-19. This new investment of more than $215 million creating 380 new jobs in Lexington County is a great win for Team South Carolina.” -Gov. Henry McMaster
“Nephron is a longtime steward of South Carolina’s business community, and we congratulate them on their continued growth within our state. Today’s announcement is yet another big win for South Carolina, our people and our burgeoning life sciences sector.” -Secretary of Commerce Bobby Hitt
“We are excited to continue to partner with such an innovative and forward-thinking company like Nephron Pharmaceuticals. We know that Lexington County is a great place to establish and grow a business, and Nephron’s continued success is a testament to good government-business relations.” -Lexington County Council Chairman Scott Whetstone
FIVE FAST FACTS
• Nephron Pharmaceuticals Corporation (Nephron) is expanding operations in Lexington County.
• The $215.8 million investment is projected to create 380 new jobs.
• Nephron is a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing.
• Headquartered at 4500 12th Street in West Columbia, S.C.
• Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers see more
Compliments of MidlandsBiz
Partnership Reduces Barriers to Testing, Provides Top Quality to Customers
Nephron Pharmaceuticals Corporation, one of the fastest-growing pharmaceuticals companies in the country, announced a new collaboration with Methapharm.
As a part of this collaboration, Nephron will produce kits of methacholine chloride sterile inhalation solution in ready-to-administer concentrations for bronchoprovocation challenge testing, when diagnosing respiratory illnesses, such as asthma.
“Methapharm will be a fantastic partner,” said Nephron CEO Lou Kennedy. “Patients deserve access to the very best respiratory tests available, that’s what this collaboration will offer, and that’s why we are looking forward to working with Methapharm.”
Working together with Methapharm, Nephron will be able to supply stable room temperature solution kits, ensuring that testing facilities can continue to rely on the quality and reliability of Provocholine for their bronchoprovocation testing needs.
“Through this partnership with Nephron, Methapharm continues its mission to help reduce barriers to testing, provide the level of quality our customers expect, and contribute to better healthcare outcomes for our patients,” said Craig Baxter CEO of Methapharm. “We’ve been impressed by Nephron’s capabilities and professionalism.”
Provocholine® is the only FDA-approved methacholine chloride powder for use in humans. Methapharm, the manufacturer of Provocholine, has always tried to be responsive to needs of our testing partners. For example, in response to the revised ERS technical standard, Methapharm initiated a comprehensive nebulizer characterization study to support the recommendation of PD20 as a clinical endpoint. This was published in a technical bulletin earlier this year.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19. 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. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Lindsay Cobbs named to head KPIC at USC see more
The Kennedy Pharmacy Innovation Center (KPIC) announced that James Lindsay Cobbs has been named chair for the center.
In his role, Cobbs will focus on creating a regulatory affairs program for students in the College of Pharmacy, including classroom, cocurricular, experiential, and post-graduate opportunities, as well as supporting Nephron Pharmaceuticals in regulatory affairs.
“My priorities will hone in on developing experiential training opportunities that will enable our students to build skills for both traditional and nontraditional pharmacy roles, developing key partnerships that can support training for our students and to identify ways that will make the College of Pharmacy stand light years apart from other colleges across the country,” says Cobbs.
Cobbs brings a wide array of career experiences to KPIC, ranging from clinical pharmacy to global policy development in the pharmaceutical industry. After graduating from the UofSC College of Pharmacy in 1992, he launched his career as a staff pharmacist at Johns Hopkins Medical Center. After four years, he entered public service as a regulatory affairs professional at the U.S. Food and Drug Administration (FDA) where he served as regulatory project manager, special assistant and lead project manager in the Office of Compliance and later as associate director for regulatory affairs (ADRA) in the Office of Translational Sciences.
Cobbs then transitioned to the corporate sector at Janssen Pharmaceuticals, a division of Johnson & Johnson as a policy lead in the Americas, Global Regulatory and Policy Intelligence Department. Cobbs later became the head of US Policy, Global Regulatory Policy and Intelligence for UCB (Union Chimique Belge translated as Union Chemical of Belgium), a multinational biopharmaceutical company headquartered in Brussels, Belgium.
Cobbs says his various roles have led him to this next challenge. “My experience as a pharmacist at a major teaching institution, working as a public health servant, co-leading drug review teams for novel drug products, and regulatory policy and intelligence in the pharmaceutical industry have prepared me for this unique role,” he says.
Patti Fabel, Pharm.D. and executive director of KPIC is looking forward to joining efforts with Cobbs. “Our faculty, staff, and students can learn a great deal from him due to his background, experience and skill set,” Fabel says. “He will broaden the scope of what KPIC can offer our students and alumni by developing a regulatory affairs program. I’m excited to see the impact he has on the center and college.”
Dean Stephen J. Cutler says Cobbs is an exceedingly accomplished expert in pharmaceutical regulatory affairs. “His addition to our faculty will bring added depth and breadth to our educational program as we launch our college’s latest initiative, the Regulatory Affairs Academic Program,” Cutler adds. “This academic program will offer regulatory education to our pharmacy students, provide postgraduate education for residents and fellows, and give another educational track to our graduate program. Our partnership with Nephron Pharmaceuticals will afford us a working laboratory for the development of future pharmacists and scientists serving in regulatory affairs. We are thrilled that Lindsay Cobbs will shepherd this initiative for the College of Pharmacy.”
Cobbs will begin his role on July 1, 2020.
SC's Post-COVID Future to be discussed June 23 in free webinar see more
Four leaders from the Palmetto State will be joined by a national expert on Infectious Disease June 23 at 10 a.m. for a free webinar discussion on leadership strategies to help South Carolina weather the challenges of COVID-19 and rebound rapidly from the health, social and economic impacts of the pandemic.
Entitled “Bold Leadership in the Eye of the Storm: Insights & Strategies to Secure Our Future", the program will feature U.S. Senator Lindsey Graham; University of South Carolina President Robert Caslen; Lou Kennedy, CEO of Nephron Pharmaceuticals; and Dr. Phyllis Arthur, VP Infectious Diseases and Diagnostics Policy, BIO. The group discussion will be moderated by Sam Konduros, CEO of SCBIO, the state’s life sciences economic development organization.
The group will discuss such topics as:
- How major universities, colleges and school systems will strive to safely reopen to welcome back students in the Fall, while also encouraging participation in related educational and social activities that are core to the educational experience
- National/global feedback on how the life sciences industry has fared to date in the ongoing battle against COVID-19 and other infectious diseases, and the likelihood and timing for major advances in testing, treatment and vaccines becoming available across the country
- Industry’s perspective on the approach taken to accelerate the reopening of South Carolina’s economy, and what must be done to ensure safety for citizens while battling against the troublesome economic downturn the pandemic has created
- The strategic importance of developing policy around the re-shoring production of essential healthcare equipment, pharmaceuticals and ingredients, personal protective equipment and other medical products and devices back to the US and South Carolina from abroad.
Participation in the webinar is free to all interested parties. Those wishing to participate can register while space remains at https://www.scbio.org/events/lessons-learned-by-industry-government-higher-education-from-the-covid-crisis.
The 60-minute program will provide attendees with a real-time review of the pandemic’s impact in South Carolina to date, implications for returning to normalcy in the upcoming months, and insights and strategies to secure and enhance the state’s future. The panelists will also address a realistic path forward as South Carolina begins the move to return to normalcy while still navigating a virus with no clear endpoint.
“Our goal is to bring the diverse viewpoints of top leaders in government, industry, education and the life sciences industry together in one forum to assess where we are, and how we can make a difference for our citizens in recovering from COVID-19’s impact in the weeks to come,” said SCBIO CEO Sam Konduros.
“The panelists will also share their insights on important lessons learned, strategies for the future, and ways for all South Carolinians to come together to solve health, social and economic challenges and improve quality of life for our citizens,” he added.
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 600 firms directly involved and 43,000 professionals employed directly or indirectly 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. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
For additional information on SCBIO, visit www.SCBIO.org.
Nephron steps up to support USC's planned reopening with donations of sanitizer see more
Nephron Pharmaceuticals Corp. is donating more than 100,000 bottles of company-manufactured hand sanitizer to the University of South Carolina as part of the West Columbia-based company's ongoing efforts to help fight COVID-19.
The first 5,000 bottles arrived on campus today, hand-delivered by Nephron president and CEO Lou Kennedy and Nephron's new van bearing its clinical lab logo to a group of student leaders on the university’s Horseshoe.
“No matter how tall the challenge is, Gamecocks step up,” Kennedy, a 1984 USC graduate, said in a news release. “Our company is proud to do our part to help the university make sure it is ready to welcome students, staff and faculty back to campus.”
USC, which closed its campuses in March in response to the COVID-19 pandemic, is resuming in-person instruction in mid-August.
“We’re grateful to Lou and Bill Kennedy and the entire team at Nephron Pharmaceuticals for this generous gift,” Bob Caslen, USC president, said. “This donation helps support the safe return of our students and employees to campus and exemplifies what the Gamecock spirit is all about: making our communities better through selfless service and caring for others.”
The bottles bear a private label requested by the university, Kennedy said.
Nephron develops and produces generic respiratory medication, including inhalation solutions and suspension products that can be used to treat severe respiratory symptoms associated with COVID-19.
In March, Nephron began making its own hand sanitizer, and previously donated 50 liters to the William Jennings Bryan Dorn Veteran Affairs Medical Center. The company added a production line in April be used in the manufacturing of bronchodilator albuterol as demand for its products soars during the pandemic.
Last month, the company announced an expansion of its COVID-19 testing capabilities through a partnership with medical technology company One Medical. Kennedy told the Columbia Regional Business Report today that Nephron’s on-site clinical lab began testing company employees last week and plans to process samples collected during a drive-thru testing clinic June 19 and 20 at Benedict College’s football stadium.
“We are trying to be a good partner with DHEC, a good partner with the local hospitals, and see how we can take some of the stress off of their labs for testing,” said Kennedy, who said Nephron has also developed, in partnership with Lexington Medical Center, a transport medium for nasal swabs used in the testing process.
Nephron has hired its own nurse practitioner and installed a chief medical officer, Kennedy said. She said the department-by-department testing of employees will continue through this week.
“The more we test, we’re going to find people that are asymptomatic, but it’s important for us to get this contact tracing thing figured out, get a baseline, get people home and get them well,” she said.
Nephron announces new partnership see more
Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country, announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees.
“Re-opening businesses, and getting our economy moving again, is one of our highest priorities,” said Nephron CEO Lou Kennedy, who is a member of Governor Henry McMaster’s #accelerateSC, the coordinated COVID-19 advisory team tasked with recommending economic revitalization plans for South Carolina. “Part of the new normal for businesses is testing employees to make sure the workplace is safe. We couldn’t be prouder to offer COVID-19 testing services to our employees and neighbors.”
Kennedy and John Singerling, Chief Network Officer of One Medical and a longstanding healthcare executive based in South Carolina, are working together to make this partnership a reality, hoping that it serves as an example for businesses around the country.
The Nephron CLIA-Certified lab has procured state-of-the-art technology for COVID-19 real-time PCR testing and serological antibody testing for its own employees, and for employees of neighboring businesses. The lab intends to integrate with One Medical’s technology platform, which is capable of supporting a comprehensive workplace reentry COVID-19 testing program. One Medical’s virtual care solutions facilitate scheduling for specimen collection and digitally documenting those test results. It also screens and evaluates clinical risk factors and symptoms and supports employer tracking and reporting needs.
“I am very pleased to be working alongside the Nephron team to leverage One Medical’s digital health platform as a way to help get South Carolinians back to work safely,” said One Medical Chief Network Officer, John Singerling. “Currently working with over 7,000 employers nationwide has allowed One Medical to build a comprehensive workplace reentry program that is grounded in medicine and testing, and powered by our technology, which allows for seamless tracking, tracing and ongoing monitoring.”
SARS-CoV-2 PCR tests diagnose whether a person is infected with the virus by using technology that analyzes viral genetic material. Antibody tests check blood for antibodies. If present, antibodies indicate a person has been previously or is currently infected by the virus.
Nephron Pharmaceuticals Corporation has been on the frontlines of the nationwide COVID-19 response. The West Columbia-based company develops and produces safe, affordable generic inhalation solutions and suspension products that can be used to treat severe respiratory distress symptoms associated with COVID-19. In addition, the company 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. These products are used, many times, to sedate patients and keep them comfortable when health care professionals place them on ventilators in the fight against the virus.
Nephron gets nod from FDA see more
West-Columbia headquartered-Nephron Pharmaceutical Corp.’s fight against the COVID-19 pandemic has received an additional weapon.
The Food and Drug Administration approved the company’s request to add a production line used in the manufacturing of bronchodilator albuterol today, Nephron CEO Lou Kennedy told the Columbia Regional Business Report.
“This news came in 20 minutes ago,” Kennedy said Monday morning. “People are cheering. It’s like The Price is Right or something.”
Kennedy said she expects to hear whether a second production line has been approved later this week.
Last month, Kennedy petitioned the FDA to add up to six production lines moved to Columbia from the company’s previous Florida headquarters in 2019. Kennedy said the additional lines could help the sterile respiratory medication manufacturer keep up with unprecedented demand.
Kennedy said March saw a 141% increase in the doses of inhalation solutions Nephron typically produces a month.
“We went from a regular month of about 80 million shipped to 193 million shipped in March. That’s just for the respiratory side,” she said. “For our sterile injectable medications that we make for all the hospitals in America that have drug shortage needs, that was up by like 22%. We’re seeing the same exact trend in April.”
Kennedy praised the FDA for its quick response, saying the federal agency granted Nephron a CBE-30, “which means Change Being Effected. That’s giving you a goal date of 30 days or less to review your material and be able to say yes or no,” she said.
“That’s really something. You’ve just got to know and feel good as a patient or a potential patient in America that the FDA has been working with me on the phone almost every day, or by email, trying to get this through expeditiously so that we can crank up a few more lines.
“As much as we can make, we’re selling. I don’t want to get behind. So if we can get these other lines approved pretty quickly, then we’ll be able to pump out — if I get four lines, at least another 50 million a month.”
Also helping meet demand, Kennedy said, are the efforts of the S.C. Ports Authority.
Last Thursday, four gigantic containers of automated packaging equipment arrived at Nephron headquarters from Switzerland. Today, the company is expecting air delivery of critical supplies from Italy, one of the countries hardest-hit by the COVID-19 pandemic.
“You know how difficult that was to pull off?” Kennedy said.
Kennedy developed a working relationship with the port as she moved hundreds of millions of dollars in equipment from Florida to West Columbia when Nephron relocated to South Carolina in 2014. During her time as chair of the S.C. Chamber of Commerce from 2018-19, Kennedy came to know S.C. Ports CEO Jim Newsome and COO Barbara Melvin well.
Expecting last week’s shipment of automated equipment to help Nephron workers quickly label, package and ship products, Kennedy called Melvin.
“I reached out to see what the situation was going to be like in getting these pieces of equipment,” she said. “That equipment, which was four giant containers, arrived to the dot at 9 a.m. (Thursday) morning all because of two great South Carolina partners — UPS and its hub that’s located one exit from me, and the Ports Authority.
“All of these drugs that are packaged will go to benefit speedier to-market products for patients with COVID-19. … This is front-line equipment that we need to get our products to market quicker.”
Nephron is also gearing up to begin releasing 100-mL saline bags for administration of sodium chlorine. The minibags, made scarce after the 2017 hurricane season hit manufacturer Baxter Healthcare hard, are once again in short supply, Kennedy said.
“We are very happy to say that we’ve been producing 100-mL saline for the last two weeks in anticipation for this going on shortage,” said Kennedy, who said the bags would be released this past Friday.
While Nephron has ramped up production in response to previous respiratory illnesses such as SARS and H1N1, Kennedy said the COVID-19 crisis is unlike anything she’s ever seen. Nephron began making its own hand sanitizer last month, distributing 50 liters to the William Jennings Bryan Dorn Veteran Affairs Center.
“I had absolutely no idea we’d reach these levels. I couldn’t even imagine, can’t even imagine, still am trying to process,” Kennedy said. “One particular day, two or three weeks ago, one hospital system in New York ordered 3,000 nebulizers from us. A typical thing might be 50, no more than 100. They ordered 3,000.”
S.C. Ports and other transportation partners have helped Nephron fill the exploding demand, Kennedy said, while Nephron workers are proud to be playing a role in combating the virus.
“I couldn’t even begin to compare ourselves with what they’re doing at hospitals, but there is a true sense of patriotism,” she said. “People are coming to work optimistic in the fact that they’re helping, in their own small way, American patients.”
Monday Moment for 4-6-20 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from Nephron's Lou Kennedy that we're all in this together, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.