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.
Rockwell to lead growth strategy at PAI see more
Pharmaceutical Associates, Inc. (PAI) today announced the appointment of Brandon Rockwell as Chief Operating Officer, bringing 15 years of business development experience to the company. In his new role, Rockwell will oversee PAI’s growth strategy, further solidifying the company’s position as the number one manufacturer of quality liquid pharmaceuticals in the US.
Rockwell has led teams in business development and strategy, portfolio management, and project management for nearly 15 years, most recently as Senior Vice President of Business Development and Strategy for Endo, where he was responsible for the generic, hospital, and branded divisions. Prior to that, he worked for Par Pharmaceutical where he led the Business Development and Licensing function. In this role, he helped shape the strategic direction of the company through its acquisitions of Edict, Anchen, JHP and the integration between Qualitest and Par.
Under Rockwell’s tutelage, PAI will implement more advanced strategies and continue to revolutionize the space of unit dose medicine and liquid pharmaceuticals so they can meet the ever-growing number of healthcare facilities that PAI serves.
For more information about Pharmaceutical Associates Inc., please visit www.paipharma.com.
About Pharmaceutical Associates, Inc.
Among North America’s leaders in quality, safety, and productivity, Pharmaceutical Associates Inc. (PAI) manufactures and markets generic liquid pharmaceuticals. PAI has been at the forefront of producing better-targeted suspensions, oral solutions, elixirs, syrups, and liquids for nearly 50 years. To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities, and government agencies, PAI offers standard bottle packaging and ready-to-dispense packaging. In fact, PAI was the first independent manufacturer to develop vertically integrated unit-dose (UD) packaging and the first to offer complete lines of hard-to-find liquid products in both out-patient and UD packaging.
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.
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.
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.”
Moderna vaccine results looking very good early see more
The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.
Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.
Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
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.
Bristol Myers Squibb, BMS Foundation Commit $300 Million to Accelerate and Expand Health Equity and Diversity and Inclusion EffortsFive–year commitment by BMS builds on long-standing investment in health equity see more
-Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation announced today a combined investment of $300 million as part of a series of commitments. For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.
The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.
“Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science.”
This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.
Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.
The commitments include:
- Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.
“Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.”
- Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.
- Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.
- Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.
“As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve,” added Ann Powell, chief human resources officer, Bristol Myers Squibb. “We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce.”
- Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.
The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
About the Bristol Myers Squibb Foundation
The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about the Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.
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.
Softbox Systems works with global pharmaceuticals to transport medications and sustainability globallySoftbox Systems is making its mark globally see more
It might not be the first supply chain you think about, but while countries around the world are rushing to find a vaccine for COVID-19, the cold chain behind medical transport is more and more relevant. A company in Greenville, Softbox Systems, has become a global leader in temperature-controlled packaging, helping transport the products of top pharmaceutical companies to hospitals, doctors’ offices and homes around the world.
Softbox Systems creates packaging — often for the pharmaceutical sector — for different temperature ranges. The packaging is used to transfer individual vials, finished products or active pharmaceutical ingredients from one location to another while keeping the necessary temperature steady for the item. These products can be flu vaccines, EpiPens, inhalers or one of the other countless medications that need to be kept at certain temperatures..
“If the shipment gets too hot or cold, it can break down molecular properties of said item, and it becomes ineffective,” John Hammes, general manager for the Americas at Softbox Systems explained. “It might work differently with what the intention was, or it may not work at all.”
Softbox Systems was founded in the U.K. in 1995, and the company maintains its global headquarters there. Hammes started with the company in 2009 to help spearhead U.S. operations since they had been relying on a third party for distribution. The company also has locations in Spain, India, Singapore, Belgium and elsewhere.
“We had a good product. We knew the industry, so we just put our head down and got to work,” Hammes said.
In 2013, the company opened a 29,000-square-foot facility off of Pelham Road in Greenville for its Americas division. Eventually, the company grew too large for that facility and moved to Park Commerce Road in a 65,000-square-foot ISO-certified facility where almost 60 Softbox System employees work.
While what they do is simple, how they do it isn’t, since medications require different temperatures, Hammes explained. They’ve even worked with Merck Pharmaceuticals on a drone shipper that could be used to transport medicine across disaster areas or war zones, he said.
Another product that’s caught people’s attention is Tempcell ECO — an all paper-based packaging unit launched six months ago that won recognition for innovation by Fast Company. There’s a push, Hammes said, to be more sustainable.
Besides developing sustainable products, Softbox Systems also partnered with American Forests. For each Tempcell ECO sold, the company makes a monetary donation to plant a tree. So far, they’ve been able to donate enough to plant more than 20,000 trees.
“What we are looking at as a company is to be the global leader not only in temperature control packaging but sustainability,” Hammes said. “We have a corporate drive to do that.”
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.
New leadership named at helm of BIO see more
The Executive Committee of the Biotechnology Innovation Organization (BIO) and its Board of Directors have announced the appointment of Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020.
"With her background as a scientist and physician, her health policy and experience in federal government, her leadership within industry as a champion of scientific progress, her commitment as an advocate for patients, and her gifts as a communicator, Dr. McMurry-Heath is the right person at the right time to lead us into the future," the official announcement released today stated.
Dr. McMurry-Heath is a coalition-builder and change agent who comes to BIO from Johnson & Johnson (J&J). She served in numerous senior leadership roles at J&J since 2014, most recently serving as Vice President of External Innovation, Global Leader for Regulatory Science and Executive Director of Scientific Partnerships for JLABS @ Washington, D.C. There, she led a large global team charting the evidence generation and regulatory strategy across J&J’s medical device companies. And she worked to knock down regulatory barriers that were hindering the ability of small innovators to partner and grow.
Prior to her work at J&J, Dr. McMurry-Heath served in scientific leadership roles at the FDA from 2010 to 2014. Her driving purpose at the FDA was to devise strategies to incorporate the patient point of view into FDA decision-making and develop new ways for patients to collaborate with innovators.
BIO’s incoming leader is a clinician-scientist with experience working at the bench in molecular immunology. She is the first African-American to graduate from Duke’s Medical Scientist Training Program, receiving an MD/PhD in immunology along the way. While Harvard-educated, she was raised in the San Francisco Bay Area – one of the great epicenters of biotechnology.
Throughout her impressive career, Dr. McMurry-Heath has been focused on the social impact of medicine so that more people in our society can benefit from its transformative potential. She led health and science policy on Capitol Hill for Senator Joe Lieberman, where she drafted legislation to protect the country from biological attacks, and then went on to sharpen her policy skills at the Robert Wood Foundation.
Dr. McMurry-Heath will become just the third leader of BIO since our organization’s founding in 1993. She will succeed a towering figure in our industry, the Honorable Jim Greenwood, who for 16 years has built the most consequential biotechnology advocacy organization in the world. Mr. Greenwood was a champion of the cause even before he was BIO's leader, reforming the FDA and fighting for broad acceptance of stem-cell science during his 12 years of principled, pragmatic leadership in the United States Congress.
As BIO’s leader, Mr. Greenwood has brought incomparable political and policy acumen to bear on the needs of our industry. During his tenure at BIO and as the United States built an innovation ecosystem that is the envy of the world, he played a pivotal role. After he hands over the reins on June 1st to Dr. McMurry-Heath, he has committed to work with her and will stay on in a strategic advisory role. The industry and BIO are grateful for his outstanding leadership, professionalism and continued contribution.
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.”
It's Monday... start your day right with two minutes of good news, right here 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 South Carolina Hospital Association's Thornton Kirby that expresses appreciation to the SC life sciences industry, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.