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Kennedy & Konduros: Made in America Act would improve access to medicines, provide jobs in SC

BY LOU KENNEDY & SAM KONDUROS
https://www.greenvilleonline.com/story/opinion/2020/10/18/opinion-made-america-would-improve-access-medicines-add-jobs-sc/5977974002/

Patients in the US have faced drug shortages for years. This was illustrated amid the current pandemic, which was exacerbated by shortages of PPE (personal protective equipment), 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, returning the manufacturing and sourcing of life sciences products to our country and state is not only a powerful economic driver – it’s a path to national and global stability. 

Sen. Tim Scott is championing draft legislation that would help bring pharmaceutical manufacturing back to the US. The Manufacturing API, Drugs, and Excipients (MADE) in America Act would incentivize pharmaceutical and PPE manufacturing in designated “Opportunity Zones,” using tax credits to encourage production of vital products and ingredients in America. With 135 eligible Opportunity Zones in South Carolina, thousands of acres could be leveraged for this powerful growth opportunity.

Scott’s legislation would bolster the domestic pharmaceutical supply chain, create new high-paying jobs here, and help our life sciences industry ensure that South Carolina patients can access the care they need. It would improve FDA reporting of facility inspections, tighten relationships with overseas regulators, and streamline the FDA standardization processes for overseeing pharmaceutical manufacturing to help mitigate drug shortages.

Opportunity Zones are already changing the face of America, lifting traditionally underserved areas, and delivering positive impacts here at home. The recent announcement of 1,400 new jobs and a $314-million high-tech agribusiness investment was catalyzed by an opportunity zone in Hampton County, one of South Carolina’s most poverty-stricken and rural locations.

Another powerful testament is Nephron Pharmaceuticals Corp., one of America’s fastest-growing drug companies, which thrives in a Lexington County Opportunity Zone. The company moved to South Carolina from Florida just over five years ago, and has invested hundreds of millions of dollars while creating almost 2,000 full and part-time jobs here.

The company also produces its own FDA-approved hand sanitizer and runs a CLIA-certified lab through which thousands of people have been tested for the virus. In a newly announced expansion, Nephron will focus on manufacturing vaccines and hard-to-source antibiotics. Across the Palmetto State and America, companies like Nephron are answering the call to serve.

With more than 650 companies employing more than 43,000 citizens in 43 of SC’s 46 counties, the booming life sciences industry’s $12 billion annual economic impact shows its ability to help lead our state’s economic recovery. More than 70 firms stepped up to develop vital solutions to the COVID-19 crisis – from managing vaccine trials to producing respiratory therapies, test kits, hand sanitizer and PPE.

These dynamic companies are helping South Carolina patients access new and innovative therapies, from treatments for the common cold to medications for life-threatening diseases such as COVID-19. The fact that the MADE in America Act would generate new life sciences jobs in economically disadvantaged areas across our state is better still, especially at a time when unemployment rates are well above pre-pandemic levels.

While South Carolina bioscience companies will continue to develop innovative treatments, we need policies that encourage and incentivize domestic production to ensure that patients never again worry about being able to access over-the-counter remedies or specialized prescriptions. Reliance on overseas pharmaceutical manufacturing has taught us an important lesson: America needs a greater level of independence in production of vital life sciences products and ingredients.

Despite the many adverse effects of COVID-19 on our nation, this renewed national strategy for onshoring and repatriating of PPE, prescription drug manufacturing and production of active pharmaceutical ingredients has created an unprecedented economic opportunity for America and South Carolina – and reduces risk of having to rely on an uncertain global supply chain.

The MADE in America Act would help South Carolinians access critical medicines, add high-paying jobs here, and encourage companies like Nephron to do what they do best – innovate, grow, and improve untold lives.

Lou Kennedy is the CEO of Nephron Pharmaceuticals and chair of the SCBIO Board of Directors. Sam Konduros is the president and CEO of SCBIO, the South Carolina biotechnology industry organization.

Training initiative helps keep Nephron moving at full speed

By Melinda Waldrop
mwaldrop@scbiznews.com
OCT 13, 2020

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.

Kennedy had already experienced the benefits of workers trained in the system before she teamed up with the Moore School’s certification program, which combines real-world case studies and applied exercises in both online and in-person instruction.

“I’d already learned to hire students that are a part of that global supply chain operations management track in the Moore School of Business,” Kennedy said. “I love those kids because they’re one of the rarest types. They walk in on day one and can solve a problem or begin to solve a problem.”

Kennedy first had conversations about extending the training to more of Nephron’s workforce with USC around two years ago, she said. Several months later, she heard back from Darla Moore lecturer Pearse Gaffney and clinical associate professor Giuliano Marodin, who had designed a curriculum focused on creating organizational change through project management, communication and technical process improvement.

Nephron’s inaugural nine-person class divided into two teams charged with identifying and solving problems. The groups came up with methods to improve productivity in the company’s automated syringe-filling process and to reduce inventory levels to create additional warehouse space and cash flow opportunities.

“They were able to prove that we carry too much inventory,” Kennedy said. “They did all these algorithms to say we don’t need 90 days on hand. We need 45 days.”

The combined ideas, when fully implemented, will save Nephron $2 million, she said.

“I’m paying $5,000 per person, so basically it was a $50,000 expenditure. And you think, well, that’s a lot of money to invest,” Kennedy said. “I feel like it’s already paid back.”

The timing of such improvements is especially fortuitous for a company that announced a $215.8 million expansion in July as demand for its inhalation solutions and suspension products, including those used to treat respiratory distress symptoms associated with COVID-19, soars. In March, Nephron saw a 141% increase in its monthly production of inhalation solutions, shipping 193 million doses instead of its standard 80 million. 

The demand has not abated, Kennedy said. Nephron is currently running all 12 of its production lines, she said, and adding new packaging lines and quality efficiency equipment.  

“It can’t be a better time, because we’re building a 200,000-square-foot warehouse as we speak,” Kennedy said. “So all of this is in line to be adapted from the day that place opens.”

The expansion, expected to be completed by the first quarter of 2021, will also add new offices and vaccine production spaces at Nephron’s campus in Saxe-Gotha Industrial Park.   

“When I announced this warehouse expansion, we also talked about a building down the street called the Kennedy Innovation Center,” Kennedy said. “We’re going to be tenants of the first 80,000 square feet, and then the rest of it will be inventory that can be marked by commerce (departments), whether Lexington County or state. It doesn’t matter to me. Just having inventory was something they needed, and it’s in an opportunity zone, which makes it cool, too.”

The first pieces of equipment for Nephron’s expansion arrived last week, Kennedy said, and “the minute I get a roof (in place), we can go ahead and move it into that building. It’s real exciting stuff going on around here.”

Nephron is also performing and processing COVID-19 tests through its on-site Clinical Laboratory Improvement Amendments-certified lab. As a stream of people seeking tests drive through Nephron’s gates each day, the company continues to develop technological innovations including same-day results.

“We made it so that instead of filling out a piece of paper like old school you can text in your name, date of birth and all that, and it’s all HIPAA-protected and you can get your results back via text,” Kennedy said. “We’ve been able to write some software to do some really cool stuff and it’s made it less labor-intensive. We can do both saliva and PCR nose-swabbing test processing here.

“We’re actively going out and looking for new people and businesses. We’ve added some new customers, new businesses. We’re still doing Dominion Energy. We did Mid-Carolina (Electric) Co-op. What I’d love to do is pick up the Amazon (fulfillment center) business. That would be steady all day, every day, and they’re just next door, so that makes it logistically easy.”

The Lean Six Sigma training, with practical applications for increasing efficiency at a critical time, is also helping to streamline everything going on at Nephron — in addition to making its CEO proud.

“I watched these folks that were in the class, and you could just see them. The wheels were turning and they had already started taking ideas from their classroom during the course of the six or more months that it took to do the class into their own areas to drive extra types of efficiencies,” Kennedy said. “I asked each of them to address anything in their own area, and every one of them said, ‘Oh, I learned during this part of our class that we could do x, y and z,’ and they adopted it.”

The personal growth Kennedy witnessed, along with professional development, has her ready to enroll a second class.  

“Some of these people are fairly shy. Part of getting the green belt is they all have to stand up and present,” she said. “There were microbiologists that were never up in front of a crowd. They all dressed in their best outfits and stood up to present. It was a variety of different ages. One was from production. One was from inventory. There were microbiologists and the people from the training department.

“We’re going to start the next class right away.”

The Nephron employees who achieved green belt certification are:

Leah Barber
Rick Bissoondyal
McCrea Sims
Robert Willm
Will McCrackin
Lakin Hinson
Tony Bonofiglio
Aubrey Dooley
Wesley Phibbs
Reach Melinda Waldrop at 803-726-7542.

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