Charles River offers rebuttal to earlier article see more
As a native South Carolinian and senior corporate vice president of Charles River Laboratories in Charleston, I was appalled by the inaccurate accusations from Defenders of Wildlife in an Oct. 10 op-ed, “Cape Romain is protected, but work remains to safeguard SC’s horseshoe crab.” Out-of-state environmentalists are irresponsibly using misinformation that could put your health at risk, and that is dangerous.
The facts and the science are clear: The Limulus amebocyte lysate (LAL) obtained from the Atlantic horseshoe crab is critical to the safety of patients around the globe. This unique, natural substance is used to test every injectable pharmaceutical and implantable medical device, including every approved COVID-19 vaccine, for contamination. Without these tests, endotoxins could enter your body and produce sepsis, which can be life-threatening.
Charles River has been manufacturing these tests in Charleston County for more than 34 years. We have invested more than $70 million in our operation over the past 25 years and employ more than 300 people. We take pride in our work in developing quality control microbial testing solutions globally and servicing more than 6,000 customers in 101 countries.
Recently, we have been responding to a variety of concerned special-interest groups over the use of horseshoe crab blood within the biopharmaceutical industry. We welcome questions and conversations on this topic. These are the facts: We partner with licensed local fishermen to hand-collect horseshoe crabs. They are transported to our facility in Charleston County, where they are cleaned, and we extract a portion of their blood. They are then returned to the water, unharmed. All of this we strive to complete within 24 hours.
Last week, Christian Hunt of Defenders of Wildlife wrote that a synthetic alternative to FDA-approved LAL tests is “readily” available. This is incorrect. Synthetic LAL is not readily available, and more importantly, it is not licensed by the FDA. While offered for a very narrow sampling of pharmaceuticals, no industry leader has moved 100% to synthetic LAL. Why? If we stop using horseshoe crab-derived LAL, we cannot guarantee the safety of IVs, syringes and vaccines, among many other medical products. This is an unacceptable risk to patient safety.
This does not mean alternatives may not be viable one day. Charles River is researching, and will continue to study, alternative ways to do what we do best: keep patients safe from bacteria and infection when they are in their most vulnerable medical state. We are investing in the research and development of our own synthetic alternatives. While we work to prove these alternatives are safe and effective, we are also reducing how much horseshoe crab-derived LAL is required for each test. Our FDA-licensed LAL cartridge technology reduces the amount of raw LAL needed by 95%.
Charles River is committed to doing what’s right, which is why we supported legislation to ban the use of horseshoe crabs as bait for eel and welk in the Southeast. South Carolina is the only state with this protection.
The Oct. 10 op-ed claimed that “DNR noted as early as 2012 that ‘worrisome’ decline in crab sampling were correlated with increases in harvesting,” but that information is based on a nearly decade-old report. A more current report, released in 2019 by the Atlantic States Marine Fisheries Commission, stated that horseshoe crab populations are strong along South Carolina’s coast.
South Carolina is in a unique and critical position of leadership in the global biopharmaceutical supply chain. Over the past few months, our company has been meeting with S.C. environmental groups and local leaders to have honest conversations. We live here, and we care about wildlife and the environment. We want to work with all reasonable parties to maintain the critical balance between protecting the environment and ensuring that our global public health system is safe and effective.
Visit hsc.criver.com/south-carolina.html for more facts and information.
South Carolina company a leader in organ transportation see more
You might not realize it, but there’s a company right here in the Upstate that’s on the cutting edge of organ transplant technology.
Duncan-based Global Transplant Solutions is quite literally named for what they do. They provide the solutions in which organs are transported to medical facilities all over the world for transplant procedures.
In the past four years, Global Transplant Solutions has blazed an innovative trail. They’re supplying a complete portfolio of organ preservation solutions to the Canadian transplant market, they’ve received FDA clearance for two products in the United States market, and there are four more GTS solutions awaiting FDA approval.
The company has been able to do this in a relatively short amount of time thanks in part to the South Carolina Research Authority. The SCRA is a public, nonprofit corporation that supports South Carolina’s innovation economy.
Since 2017, Global Transplant Solutions has received $350,000 in investments from the SCRA-affiliated corporation, SC Launch, Inc., which provides loans and investments to select, South Carolina-based companies across three areas: Life Science, Information Technology, and Advanced Materials & Manufacturing.
“With the assistance of SCRA and many other places, we went forward, raised private money, started the company and pursued FDA approval of our first product, which we got in 2016,” says John Bruens, the CEO of Global Transplant Solutions. “We’ll eventually have seven FDA-cleared products, exclusively geared towards the organ transplant market, and we are the only company on the planet to have anything like that.”
Steve Johnson, investment manager at SC Launch, says their investment in GTS started small but they saw great potential in the company.
“We gave them a very small grant of $15,000 in April of 2017 when we discovered them,” Johnson says. “They were in the world where there is always much, much higher demand than there is supply. So once you have a patient that is in dire need of an organ, it is everything everybody can do to get an organ donor found and then get that organs safely transported to where it’s going to be done. And Global Transplant has the solutions, literally. They make the solutions that the organs are put in during the shipment process so that they will be fully functional when they’re implanted into the patient.”
Johnson says the SCRA and SC Launch are thrilled with the results they’ve seen so far.
“Our relationship is one of communication,” he says. “It’s one of trust and it’s one where we are very closely following their financial situation. It’s been a very fulfilling relationship; that $15,000 grant to help them get started led to a pretty major investment in them and then, a second investment.”
In fact, SC Launch, Inc. recently stepped in again and helped GTS when COVID threw them a curveball.
“In April 2020, the biggest transplant centers like the Cleveland Clinic and the Mayo Clinic basically said, ‘We’re not accepting any more of your solutions from FedEx or UPS,’” Johnson says. “’We want them to be shipped directly in a truck from your facility in the Upstate of South Carolina and delivered directly to our door.’ Well, that was a whole other twist of logistics for them because they’d never done that. They came to us and said, ‘We’ve got to get trucks. We’ve got to hire people. We’ve got to hand-deliver these solutions.”
“There was a concern amongst our customers that standard shipping groups were exposing, through no fault of their own, groups to potential infection,” John Bruens adds. “And the one thing you cannot do when you’re in the organ transplant is accidentally infect somebody. Our solutions are very sensitive; they’re temperature sensitive, they’re not made to be out on tarmacs getting hot. So we needed to figure out how to continue to deliver to these places that absolutely needed our product.”
“Our relationship is one of communication,” he says. “It’s one of trust and it’s one where we are very closely following their financial situation.” – Steve Johnson
Thanks to a loan from the SCRA and SC Launch, the company was able to do just that.
“This company wouldn’t exist if it wasn’t for SCRA and their support,” Bruens says. “We’re always looking for ways to be better, and SC Launch and SCRA helps with that.
“Global Transplant Solutions is a gem of a company,” Johnson adds. “We’re very proud to be associated with them, we’re very proud to have invested in them, and we’re very proud of the work they’re doing.”
According to the United Network for Organ Sharing (UNOS), more than 35,000 organ transplants a year are performed in the U.S. As this article was being completed, GTS announced that the FDA had given clearance to another of their solutions, Servator® P, which is used for safe human lung transportation.
Top executives opine on what's next for SC as Covid surges see more
After attending a Chamber of Commerce breakfast where a hospital CEO ticked off statistics about the number of unvaccinated patients suffering from Covid – many in their 20s and 30s – Nephron Pharmaceuticals CEO Lou Kennedy decided something had to be done.
So she mandated vaccination at her company and today, everyone at the West Columbia business, which manufactures generic respiratory products, has had the shot, she said. And she lost just 30 out of 2,000 employees over the decision.
“It was the right thing to do, and I encourage my fellow business leaders to follow suit,” Kennedy said. “Somebody had to be the first to do it, and why not make it us.”
In addition, Kennedy said, the company spent $2.5 million last year on people being out of work and overtime to cover them – money that could have been spent on innovation, such as the mask the company introduced for patients getting nebulizer treatments that protects the health care provider from respiratory droplets.
Kennedy spoke at an online event hosted by SC BIO, the Palmetto State’s life sciences group, to discuss what comes next in the pandemic.
South Carolina is still lagging in vaccinations, said SC BIO interim CEO Erin Ford, with Covid deaths on the rise.
By Sept. 7, just 49 percent of residents had been fully vaccinated, and 58 percent had had at least one shot, according to the state Department of Health and Environmental Control.
Meanwhile, nearly 780,000 cases had been confirmed by that date and 11,050 South Carolinians had died, DHEC reports.
But the number of vaccinations is slowly rising, Ford said, offering some hope that things will turn around.
The full FDA approval of the Pfizer vaccine pushed some people to get vaccinated in recent weeks, said Phyllis Arthur, vice president of infectious diseases and diagnostic policy at BIO Global, the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions.
But many are rolling up their sleeves after seeing how the Delta variant left loved ones sick and dying, she said.
“Delta is nearly twice as contagious as the previous variants,” she said. “And … (it) moved so quickly and spread so fast we saw a giant spike in cases and deaths. When immunization numbers go up, we will see cases come down.”
The speakers agreed that the greatest obstacle to making progress in the fight against the virus is the politicization of the pandemic and misinformation.
“There’s no R or D in the word science. It has nothing to do with your favorite politician,” said Kennedy. “This is science.”
Arthur said people should beware of misinformation and trust the scientists who’ve done the work on the virus.
“One of the things I ask people to do is look at the source of what you’re reading and hearing,” she said. “Look at the data yourself. It’s all publicly available and it’s very transparent.
And Dr. Matthew Cannon, dean of the Carolinas Campus of the Edward Via College of Osteopathic Medicine, agreed.
“(It’s) being politicized, in my opinion, and I just hope people would look at it objectively, not through partisanship,” he said. “This is a public health crisis.”
Cannon said that as of Sept. 7, one Upstate hospital had 278 Covid patients and all but 25 were unvaccinated. Another had 566 Covid patients and all but 41 were unvaccinated. The average age of the vaccinated patients was 75 to 78, he said, and they were immunocompromised. The average age of the unvaccinated patients was 50, he said.
Though breakthrough cases occasionally occur among the vaccinated, Arthur said they typically are milder and of shorter duration.
She said she expects FDA approval of the Pfizer vaccine for children younger than 12 in the next month or so and the Moderna vaccine in the next few months.
Kennedy said her antibody level dropped from 6,900 to 3,800 in recent weeks and is watching to see when the booster is approved.
There are still two steps to go before a booster is approved for the general population, but that it could come in a matter of weeks, Arthur said.
And Cannon said the college is working on research to determine when boosters should be given, noting the mRNA technology used in the Pfizer and Moderna vaccines has been around for years.
Arthur added that the mRNA technology will be able to be used for many vaccines and even disease treatments.
“You can speed the next product, and that can allow us to have many more innovations from the treatment perspective and the vaccine perspective,” she said. “It’s the same for monoclonal antibodies. And that will ripple through the industry for years to come.”
Cannon said he’s proud of the health care workers who are surrounded by contagious Covid patients putting them and their families at risk, but continue to step up every day for the greater good of the community.
Nonetheless, he said, he worries about the stress they endure, seeing so much loss and knowing it could be prevented.
Meanwhile, he said, although medical residents got the experience of learning how to work in the midst of a pandemic - something their predecessors never had - they are missing out on some hands-on training because hospitals are canceling elective procedures.
Kennedy said the employees who refused vaccination weren’t willing to listen to the science. And while she got lots of phone calls asking whether there were protests in the street about her mandate, it all went smoothly.
“There were a couple people grumbling in the plant,” she said, “but it amounted to much ado about nothing.”
All the speakers encouraged everyone to be vaccinated and wear masks.
“It will prevent you from giving the virus to someone else,” said Cannon, “or from them giving it to you.”
“We’re in this together,” said Arthur, “and we can get out of it together.”
Charles River Labs quietly continues its critical work to save lives see more
CHARLESTON, S.C. (AP) — It’s one of the stranger, lesser-known aspects of U.S. health care — the striking, milky-blue blood of horseshoe crabs is a critical component of tests to ensure injectable medications such as coronavirus vaccines aren’t contaminated.
To obtain it, harvesters bring many thousands of the creatures to laboratories to be bled each year, and then return them to the sea — a practice that has drawn criticism from conservationists because some don’t survive the process.
The blood, which is blue due to its copper content, is coveted for proteins used to create the LAL test, a process used to screen medical products for bacteria. Synthetic alternatives aren’t widely accepted by the health care industry and haven’t been approved federally, leaving the crabs as the only domestic source of this key ingredient.
Many of these crabs are harvested along the coast of South Carolina, where Gov. Henry McMaster promoted the niche industry as key to the development of a domestic medical supply chain, while also noting that environmental concerns should be explored.
“We don’t want to have to depend on foreign countries for a lot of reasons, including national security, so it’s good to see this company thriving in the United States,” McMaster told The Associated Press. He spoke this month during a visit to Charles River Laboratories at its Charleston facilities, to which AP was granted rare access. “We want to do everything we can to onshore all of these critical operations.”
Horseshoe crabs — aquatic arthropods shaped like helmets with long tails — are more akin to scorpions than crabs, and older than dinosaurs. They’ve been scurrying along the brackish floors of coastal waters for hundreds of millions of years. Their eggs are considered a primary fat source for more than a dozen species of migratory shore birds, according to South Carolina’s Department of Natural Resources.
Their value to avoiding infection emerged after scientists researching their immune response injected bacteria into horseshoe crabs in the 1950s. They ultimately developed the LAL test, and the technique has been used since the 1970s to keep medical materials and supplies free of bacteria.
Their biomedical use has been on the rise, with 464,482 crabs brought to biomedical facilities in 2018, according to the Atlantic States Marine Fisheries Commission.
In South Carolina, that’s done only by Charles River, a Massachusetts-based company that tests 55% of the world’s injectables and medical devices — like IV bags, dialysis solutions and even surgical cleaning wipes, according to company officials.
“We are almost the last line of defense before these drugs leave the manufacturing area and make it to a patient,” senior vice president Foster Jordan told McMaster. “If it touches your blood, it’s been tested by LAL. And, more than likely, it’s been tested by us.”
Charles River employs local fishermen to harvest the crabs by hand, a process governed by wildlife officials that can only happen during a small annual window, when the creatures come ashore to spawn.
Contractors bring them to the company’s bleeding facilities, then return them to the waters from which they came. During a year, Jordan said his harvesters can bring in 100,000 to 150,000 horseshoe crabs, and still can’t satisfy the growing demand.
“We need more, though,” Jordan told McMaster, adding that his company is working with the state to open up more harvesting areas. “The population’s steady. ... We need access to more beaches, to get more crabs.”
The practice is not without its critics, some of whom have argued that bleeding the crabs and hauling them back and forth is harmful. According to the National Oceanic and Atmospheric Administration, 10% to 15% of harvested crabs die during the process.
The International Union for Conservation of Nature listed the species overall as “vulnerable,” noting decreasing numbers as of a 2016 assessment. The Atlantic States Marine Fisheries Commission listed 2019 stock as “good” in the Southeast, but “poor” in areas around New York.
Conservationists sued last year, accusing the U.S. Fish and Wildlife Service of shirking its duty to protect areas including South Carolina’s Cape Romain National Wildlife Refuge by allowing horseshoe crab harvesting. They argued that taking out the crabs affects other species in the protected area. A federal judge temporarily halted the harvest, but was reversed following Charles River’s appeal.
The environmental groups asked to withdraw their complaint this month after federal officials imposed a permitting process for any commercial activity in the refuge, including horseshoe harvesting, beginning Aug. 15. Even if such permits are denied, Jordan told McMaster that only 20% of its harvest came from the refuge, with most coming from further down the South Carolina coast.
There is a synthetic alternative to the horseshoe crab blood, but it hasn’t been widely accepted in the U.S., and meanwhile, Charles River’s international competitors are making synthetics and also pressing for U.S. Food and Drug Administration approval, which Jordan said could hamper domestic efforts like his own.
“My mission is to make sure that any competitor that comes into the United States, from China or any of these other producers, has to go through the same regulatory process that we had to go through, to make sure that it’s safe,” Jordan said. “If all these synthetics start coming in from other countries, we’re going to lose the protection that we’ve had for all these years, and the safety, and the control of the drug supply.”
“We want to have as much stuff made here as we can,” McMaster said in response.
As for the environmental concerns, the governor said maintaining a healthy balance between scientific demands and the state’s ecosystems, which bolster a significant portion of South Carolina’s tourism economy, is paramount.
“It’s like a house of cards. You pull out one part, and the rest of it will fall,” McMaster said. “So I think we have to be very careful, and be sure that any company, any business, any activity, whether it’s commercial or otherwise, meets whatever requirements are there to protect the species — birds, horseshoe crabs, any sort of life.”
Johnson & Johnson COVID-19 Vaccine Authorized by FDA; First Single-Shot Vaccine in Fight Against Global PandemicShipping vaccine immediately, delivering more than 20 million doses to U.S. in March see more
Johnson & Johnson (NYSE: JNJ) (the Company) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
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.”
McDermott Will & Emery expand life sciences team see more
McDermott Will & Emery, the nation's leading health law firm, announced Brian Malkin has joined as partner in the FDA practice of its Health Industry Advisory group based in Washington, DC. Brian's practice complements McDermott's broader life sciences and healthcare capabilities with decades of experience and perspective on critical regulatory and strategic business issues that life sciences, pharmaceutical and biologic companies seek in bringing new products to market and managing product life cycles.
The firm also announced that Michael Siekman and Jenny Chen have joined the Intellectual Property (IP) practice as partners based in the Boston office. The duo builds upon Boston’s active and diverse IP practice and will complement the Firm’s robust legal service offering to the life sciences and health industries.
"Aligning FDA regulatory and intellectual property strategy for drug development is more critical than ever and Brian's unique background will give our clients a strategic advantage," said Eric Zimmerman, head of McDermott's Health Industry Advisory practice group and a Washington, DC-based partner. "Incorporating Brian's practice into our existing FDA practice further strengthens our ability to assist innovators through all stages of approval."
"As the market and regulatory landscape evolves to focus on novel therapies, including orphan drugs and biosimilars, our team needs to deftly navigate the complex regulatory, policy and strategic business considerations for this space. Brian is a thought-leader on these issues and has helped several companies successfully bring life-saving products to market. We're thrilled to join forces," added Vernessa Pollard, head of McDermott's FDA practice and a Washington, DC-based partner.
Brian counsels pharmaceutical and biologic clients on FDA regulatory matters and intellectual property law, with an emphasis on patent strategy and litigation. His position at the intersection of FDA regulated products and patent law makes him an invaluable partner to drug developers, biotechnology clients, medical device companies and cannabis companies as they protect their innovations, bring their products to market and pursue transactional opportunities.
He is a key advisor regarding FDA regulated drugs development strategies and patent strategies, including: New Drug Applications (NDAs) and orphan/specialty drugs; 505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products; biologics and biosimilars; and cannabis-derived products. Additionally, he is an experienced litigator of Hatch-Waxman Act cases for both pharmaceutical and biotechnology clients and a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space.
Brian holds a JD from The George Washington University Law School and a BA also from The George Washington University. While practicing law, Brian earned a BS in Biochemistry from the University of Maryland.
In commenting on the addition of Mr. Siekman and Ms.Chen, the Firm's Head of Strategy Michael Poulos noted, “We are laser-focused on smart expansion, and virtually every McDermott practice group and geography is focused on legal representation for the life sciences sector. Our new partners reflect our continuing strategic commitment to growing the pre-eminent life sciences practice in our industry.”
“The last few years have shown an increasing need for breakthrough innovations in the life sciences market. Patent protection is essential for bringing necessary technology to market, and Michael and Jenny truly understand what it takes to be a fearless client advocate during every stage of the IP lifecycle,” Bill Gaede, leader of the Firm’s Global Intellectual Property practice, said. “Michael’s and Jenny’s addition in Boston bolsters our IP capabilities in this leading region for life sciences innovators and research institutions as well as across our international platform.”
“This IP team is a natural part of our planned Boston expansion given the significance of the life sciences industry to our region,” Tony Bongiorno, litigation partner and Boston office managing partner, added. “We look forward to collaborating with Michael and Jenny on exciting opportunities across all of our practices in Boston.”
Michael focuses his practice on a broad range of intellectual property matters, including architecting patent prosecution strategies, life sciences partnering and transactions, licensing, post-grant proceedings and litigation. Leveraging more than 25 years of experience, Michael has built in-depth patent portfolios, advising clients in the biotechnology and pharmaceutical industries.
Jenny counsels both US and international clients in a variety of patent-related matters in the biotech and life sciences space, including prosecution, due diligence and post-grant proceedings. Her practice focuses on matters including cell and gene therapies, antibodies, diagnosis and pharmaceutical formulations. She is particularly experienced in strategic counseling on life cycle management of both biological and small molecule products.
Michael received his BS at Bates College and his JD at Boston University School of Law. Jenny received her BS from Fudan University, her PhD in pharmacology from Baylor College of Medicine and her JD from Northeastern University School of Law.
MUSC partners with AstraZeneca, IQVIA in chase for vaccine for COVID see more
As researchers from across the globe race to find a vaccine for the coronavirus, the Medical University of South Carolina has entered as a key player in that fight. Along with AstraZeneca and IQVIA, MUSC was selected to be part of a Phase III trial of a vaccine that has shown promise in battling COVID-19.
“The science behind it looks good,” said MUSC emergency medicine physician Gary Headden, M.D., who will be leading the trial. “So, I’d say I’m optimistic.”
MUSC and Charleston will be part of the first wave of locations across the United States to test the vaccine. In total, manufacturers and researchers hope to enroll and collect data on 30,000 people across 20 cities in the U.S., with as many as 1,500 of those being from right here in Charleston.
For context: Once a pharmaceutical company thinks it has a promising vaccine on its hands, it begins clinical trials. According to the U.S. Food and Drug Administration, these trials consist of three phases:
- Phase 1, also referred to as initial human studies, is performed on small groups and focused on safety and the recipient’s immune response to the vaccine.
- Phase 2, which are usually administered on hundreds of people, are still focused on safety and fine-tuning the dosage and treatment regimen required.
- Phase 3 typically enrolls thousands of individuals and focuses on the safety and efficacy (how well it works) in a population.
If successful, the manufacturer can then submit an application to the FDA for approval.
Because of the unique world we’re living in, the U.S. government has implemented “Operation Warp Speed,” which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. In other words, a process that often takes years is being compressed into mere months. To facilitate this process, the government is speeding up all aspects that can safely be sped up and is pumping billions of dollars into the pharmaceutical industry. AstraZeneca, the company that has manufactured the vaccine being tested at MUSC, received $1.2 billion alone.
According to Amanda Cameron, Trial Innovation Network manager at MUSC and a key figure in bringing the trial to the university, even with Operation Warp Speed in play, this is one of few Phase III vaccine trials out there.
“For us to get to bring a trial here to MUSC is incredible, but the fact that it’s one that researchers are optimistic about is even more exciting,” she said.
Recently, Russia claimed to have a vaccine ready. U.S. researchers believe it has effectively only cleared Phase I, so to roll it out so quickly could prove to be reckless, Headden said.
This week, MUSC will go live with a webpage, officially opening the trial to applicants. The hopes are that soon thereafter, the study's first patients will be seen at the Clinical Sciences Building on MUSC’s downtown campus. Several hundred have already expressed interest in participation, and MUSC clinical research manager Ashley Warden said the team would love to get as many people involved as possible.
“This is a really important research opportunity,” Warden said. “We need to have a therapy that can bring this pandemic into control. It would be best that those that participate in this trial are representative of our region.”
The trial – which will be double-blind, randomized and placebo-controlled in a 2:1 ratio, meaning that for every two people who get the active vaccine, one will get the placebo – will require the participants to come in at Day 1 and Day 29 to receive their vaccines or the placebo.
Researchers and doctors hope each of these two visits will last about 90 minutes, during which time the participants will undergo a physical examination that includes having their medical histories reviewed, blood drawn for testing and a nasal swab test for COVID-19. The vaccine will then be administered.
All subjects will be monitored over a period of two years. During this time, those who show any signs of illness that could be due to COVID-19 will undergo additional testing. Compensation will be provided for participants’ time.
“This is a big study with an aggressive time frame, which is expected of a trial of this importance,” Headden said. “As for the science behind it, it’s totally solid. Put it this way: I would let my family take this vaccine.”
To learn more about the trial or to enroll, visit https://research.musc.edu/clinical-trials/coronavirus-clinical-trials.
SC invention provides a solution for reducing accidental needle sticks see more
Medical University of South Carolina neurophysiologist Jessica Barley, Ph.D., and neurologist Jonathan C. Edwards, M.D., noticed a clinical problem and decided to do something about it. The needle electrodes used to monitor a patient’s nervous system function during surgery can also pose a safety risk. Stranded uncapped needles can find their way into health care workers or even patients. Working with the Zucker Institute for Applied Neurosciences (ZIAN), an MUSC technology accelerator, and Rhythmlink International LLC, a medical device manufacturer headquartered in Columbia, South Carolina, the team created a novel safety electrode that has the potential to reduce needle sticks.
The electrode, known as the Guardian Needle, was recently approved by the U.S. Food and Drug Administration for intraoperative monitoring (IOM). The technology has been licensed to Rhythmlink, which is ramping up production for a rollout to hospitals nationwide this autumn.
“We thought it was unacceptable and unfair that the team providing the care to the patient should be put in harm's way by equipment that was meant to do the opposite and ensure patient safety,” said Barley, who runs the intraoperative neurophysiology program at MUSC Health and is co-inventor of the Guardian Needle. “This is how we first came up with the design.”
During high-risk surgical cases, the neurophysiology team uses IOM to monitor a patient’s nervous system. The process involves inserting approximately 40 needles throughout the patient’s body and connecting them with long wires to the IOM machine.
“IOM serves as a vital early warning system,” explained Barley. “It preserves neurologic function in real time.”
However, the setup increases the risk of needle dislocation. Currently available needles can become uncapped when dislodged from the patient’s skin. This results in a danger of needles sticking the staff while in the operating room (OR).
“We don't have to accept that a certain number of our staff are going to get stuck by an IOM needle,” said Edwards, chief of the Integrated Centers of Clinical Excellence in Neuroscience at MUSC Health and co-inventor of the Guardian Needle. “That's a problem, and it's our responsibility as people in the field to solve it.”
The Guardian Needle should protect the surgical team from harm because it is never uncapped. It was designed to deploy the electrode safely only when inserted in the patient. If the needle is dislodged from the skin, it automatically resheathes into its protective casing.
“The key thing is that you don't have to cap and uncap the needle, and it automatically retracts when it's not in the patient,” said Paul Asper, vice president of commercialization at ZIAN.
The design also includes adhesive bandages around the needles. The adhesives enable the team to secure needles to the patient without manually taping them, thus decreasing OR time and cost. The bandage, like the needle electrode, is sterile, which reduces the risk of infection from nonsterile tape.
“We did timed trials,” said Barley. “Just trying the full setup the very first time using the new design, we were all faster,” she said, comparing the new needles with the needles they had used before.
Not only does the Guardian Needle protect the surgical team and decrease OR time, but it also enables better patient care by reducing the risk of needle sticks to patients and helping to maintain a sterile environment.
The adhesives on the needle also secure it in place despite shifts in patient positioning. The adhesives thus ensure signal integrity as the electrodes monitor nervous system function during surgery.
The clinician-innovators were able to come up with the clever design because they were personally familiar with the clinical problem they were trying to address.
“Clinicians have great ideas all the time,” said Edwards. “But 99% of those ideas die, mostly because we don’t have time.”
Enter ZIAN, with the expertise, knowledge and resources to turn an idea into a product. In the case of the Guardian Needle, the ZIAN team developed a business plan and patent strategy, raised funding for research and development, engineered the prototype and forged a licensing agreement with a world-class medical device company, saving valuable time for the busy clinicians.
“The expertise on the ZIAN team aligns perfectly with the clinical expertise of the inventors, enabling both parties to execute on their strengths,” explained Mark Semler, CEO of ZIAN. The core mission of ZIAN is to develop and bring to market technologies that solve unmet clinical needs.
“We have that clinical perspective to create a pipeline of ideas,” said Edwards. “ZIAN provides the practical implementation of those ideas, and neither of those two would be successful without the other.”
Rhythmlink, a South Carolina-based company specializing in medical devices that record or elicit neurophysiologic biopotentials, has licensed the technology and has begun to ramp up production of the Guardian Needle. Their unique position in the industry allowed them to recognize the importance of this invention. That, combined with their contribution to the intellectual property, design enhancements for manufacturing and expertise in regulatory guidelines, helped the product become a reality.
“This is a great example of South Carolina organizations collaborating in the health care space and an illustration of South Carolina’s prowess in innovation, entrepreneurship, life sciences and manufacturing,” said Shawn Regan, co-founder and chief executive officer of Rhythmlink. “Creating a safer work environment for health care professionals absolutely aligns with our mission to improve patient care. Working with ZIAN and MUSC to develop the Guardian Needle and bring this creation to life was a no-brainer from a collaboration standpoint.”
Successful commercialization of the product and the widespread distribution that Rhythmlink can provide are key to realizing a potentially industry-changing standard of care. As the novel electrode is rolled out in hospitals across the country, researchers will collect needle-stick data to determine whether it is safer than the current standard of care. If it is safer, as its inventors believe, it would likely become the new standard of care, given federal workplace safety rules.
“Being at the forefront of an innovative and potentially industry-changing movement is exciting and exactly where we strive to be,” said Regan.
To the inventors, the Guardian Needle provided a way to make a difference not only for their MUSC Health colleagues but also for surgical team members across the globe.
“In health care, we gladly and eagerly place ourselves at risk every day when we're caring for others. But it does have an element of stress and anxiety,” said Barley. “This invention is particularly special because we're not only caring for our patients in a safer, higher-quality way, we're also protecting our colleagues and teammates. It feels like a way of giving back to them and keeping them safe.”
Edwards explained that it is this type of innovation that has enabled him to help patients and health care providers he will never meet. This he considers a benefit of practicing academic medicine.
“We always think of clinical practice, teaching and research as the three pillars of medicine,” he explained. “There's a fourth pillar, and that fourth pillar is innovation.”
Innovation has led this MUSC team to create a solution for a once-tolerated problem. They encourage other clinicians to do the same.
“Take obstacles as an opportunity to find the solution yourself,” encouraged Barley.
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.”
Nephron seeks to stem coronavirus concerns with expanded offerings see more
In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.
Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.
Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.
“We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.
West Columbia-based Nephron has asked for FDA approval to add up to six filling lines for its respiratory medication manufacturing. CEO Lou Kennedy also announced the company will begin making hand sanitizer this week. (Photo/File)
The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.
“As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”
To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.
“We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”
During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.
“We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”
The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.
Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.
Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.
Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.
Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.
“We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.
Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.
“We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”
Nephron initiates EDI through Global Healthcare Exchange see more
Nephron Pharmaceuticals Corporation initiated Electronic Data Interchange (EDI) ordering through the Global Healthcare Exchange, LLC (GHX) platform, accessible immediately.
Joining GHX allows Nephron customers to purchase products on the FDA drug shortage list in one simple step. This platform enables purchasers to select products from multiple vendors in one place, rather than logging in to the Nephron online ordering system. Utilizing the GHX cloud-based platform helps to reduce manual work and provides real-time data to view and validate order information. Nephron and its customers are working in real time, using all available data to streamline each process.
“Nephron is constantly trying to improve the customer experience,” said Hank Jibaja, Chief Information Officer at Nephron. “We believe utilizing the GHX platform will decrease the time required from the hospital or ordering staff.”
Nephron products including Sodium Bicarbonate, Phenylephrine, Labetalol and more are available for purchase through the GHX platform.
Hospitals and surgery centers may contact Nephron toll free at 1-800-443-4313, or via email at firstname.lastname@example.org.
Nephron 503B Outsourcing is a division of Nephron Pharmaceuticals Corporation. This division produces pre-filled sterile syringes and IV bags for hospitals and surgery centers across America, in an effort to alleviate their drug shortage needs. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration as a sterile manufacturer of generic respiratory medications along with an Outsourcing Facility providing equal sterility and quality. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.
Global Healthcare Exchange, LLC (GHX) is a healthcare business and data automation company, empowering healthcare organizations to enable better patient care and maximize industry savings using its world-class cloud-based supply chain technology platform. GHX brings together healthcare providers, manufacturers and distributors in North America, and Europe, who rely on proven healthcare-focused technology and comprehensive data to automate business processes and make more informed, timely and fact-based decisions. Solutions span procurement and accounts payable automation, contract and inventory management, vendor credentialing and management, business intelligence, payment management and other supply chain-related tools and services. For more information, visit www.ghx.com and The Healthcare Hub.
FDA head Scott Gottlieb has resigned in an unexpected move see more
WASHINGTON, March 5 (Reuters) - U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a sudden resignation that calls into question how the agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs.
Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars.
Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S. consumers and had the agency actively looking into possible solutions.
Learn about South Carolina Life Sciences Feb. 20! see more
Industry subject matter experts to cover what businesses need to know
about life sciences, South Carolina’s fastest-growing industry segment
GREENVILLE, SC – February 4, 2019 – SCBIO will host a full day program February 20, 2019 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.
To be held at the University of South Carolina’s Alumni Center in Columbia, the program will run from 8:30 a.m. until 4:30 p.m. and will feature a light breakfast followed by presentations from over half a dozen noted life sciences industry leaders. Confirmed presenters and their topics are:
- Tushar Chikhliker, Partner, Nexsen Pruet, “Pharma Industry Challenges Opportunities & Legal Insights”
- Kathy Phlegar, Principal, Phlegar & Associates, “Product Development and Commercialization: The Changing Landscape of Bringing MedTech Products to Market”
- Maureen Thomas, National Institute on Aging/National Institutes on Health, “Early Stage Funding: Accessing SBIR-STTR Capital”
- Erica Jackson, Partner, K&L Gates, “Navigating the FDA: An Overview of Medical Product Approvals and Enforcement Trends”
- Dave McGlashan, Life Sciences Team Architect, DPR Construction, “Optimizing Capability & Efficiency in Your Life Sciences Facility”
- Darralyn Alexander, President, Reimbursement Strategies – “How To Gain Reimbursement For My New Technology”
- Sam Konduros, President & CEO, SCBIO – “South Carolina Life Sciences 2019: A Look Forward”
SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations pay only $50 for the entire day. Individual Members of SCBIO pay only $50 for the entire program, while the general public and Non-Members can attend for just $125. To register or for more details, visit the Events page at www.SCBIO.org/.
An additional highlight of the day’s program on “Early Stage Funding: Accessing SBIR-STTR Capital” will be when presenter Maureen Thomas is joined for discussion and open Q&A by Tyler Tatum and Ron Gorman of 3PhaseSC – South Carolina’s only free resource for SBIR/STTR grant consulting. Attendees may also schedule 1-on-1 time for afternoon discussion with Ms. Thomas between 1:15 PM and 3:30 PM for more detailed conversation and guidance.
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 400 firms directly involved and 15,000 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.
SCBIO is also the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations. SCBIO’s diverse membership is leading research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.
For additional information on SCBIO, visit www.SCBIO.org.