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
South Carolina life sciences is booming, with new organizations growing and moving here see more
Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. It’s a powerful force in today’s Palmetto State economy.
The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.
Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag. Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.
What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare. An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.
To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point. Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.
Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.
SCBIO has become a catalyst for and voice of South Carolina life sciences. From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.
And innovation is the lifeblood of progress. For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.
Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.
From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.
Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level. Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis. Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.
A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields. ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.
The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association — is an important step in helping organizations share best practices and stimulate innovation.
Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital.
Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:
- Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them;
- Accelerate best solutions through development and into commercialization; and
- Scale startups and networks to drive investment and job creation across South Carolina and Georgia.
With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.
As American poet Robert Frost penned:
“The woods are lovely, dark and deep, but I have promises to keep,
And miles to go before I sleep.”
Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources. With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter.
ZVerse and Phoenix Specialty Manufacturing step up for South Carolina see more
Two South Carolina companies -- ZVerse and Phoenix Specialty Manufacturing -- jumped into action to meet the needs of the response to the coronavirus, manufacturing vital pieces of equipment at a time when they were urgently needed and unlikely to be easily available for import.
In doing so, they played key roles as the country rushed to provide the medical supplies needed to protect the lives of the sick and their caregivers.
In Columbia, ZVerse began March as a company that helped manufacturers by creating more effective computer files for their production processes. It had the capability to do some 3D printing but did not usually do manufacturing.
SCRA added three advisory groups for biomedical sciences, cybersecurity and industry see more
Summerville, S.C.—South Carolina Research Authority (SCRA) announces the formation of three Business and Science Advisory Boards (BSABs). The purpose of the BSABs is to advise SCRA’s Board of Trustees when requested by it. The boards include representatives from South Carolina research universities, the venture capital/angel investment community, South Carolina Department of Commerce, and industry leaders in the following areas:
Each board provides key business and technical expertise, acts as an independent/ unbiased sounding board for input on SCRA’s program implementation and performance and provides guidance to SCRA regarding funding opportunities. One upcoming funding opportunity on which the BSABs will advise is the SCRA-Academia Collaboration Team (SACT) Collaborative Research Grants. These grants will be available for multi-institutional, collaborative research teams that seek to advance commercially relevant research and address key industry challenges to foster technology-enabled growth of the state’s innovation economy. The solicitation will be released in June.
“SCRA serves as a bridge between industry and academia. It is imperative that the applied research SCRA funds benefits not only its academic stakeholders, but also South Carolina’s industrial base. The development of the BSABs ensures that the new SACT program achieves those objectives for both stakeholder groups,” said Christine Dixon Thiesing, SCRA Director of Academic Innovations.
The SCRA fuels South Carolina’s innovation economy by accelerating technology-enabled growth in academia, entrepreneurship and industry. SCRA works with public and private sectors, including industry, to identify market trends and validate the commercial relevance of academic research that SCRA funds. SCRA’s programs and operations had an almost $700 million impact on the state’s economy during the last fiscal year.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, SCRA fuels South Carolina’s Innovation Economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.
Precision Genetics receives SCRA grant see more
SCRA announces a $250,000 SC Launch, Inc. investment in Precision Genetics. The life sciences company, located in Greenville, was recently accepted into SCRA’s entrepreneurial program, SC Launch.
Precision Genetics validated the Emergency Use Authorization (EUA) via the Food and Drug Administration (FDA) to process COVID-19 test kits. Precision Genetics is now available to support state and local healthcare systems in need of public health surveillance, and has priority access to test reagents from commercial reagent manufacturers, which have received EUA from the FDA.
Precision Genetics provides the test kits for healthcare facilities and providers looking to test patients using real-time RT-polymerase chain reaction (RT-PCR) detection of the SARS-CoV-2 virus (the virus that causes COVID-19) in respiratory specimens. The test uses RT-PCR to detect the virus in upper and lower respiratory specimens.
Currently, results will be available within 24 hours (one business day) from time of receipt of the sample in the laboratory, with plans to boost testing capacity in the coming week. Precision Genetics’ healthcare technology laboratory has the capability to direct-connect to other laboratories, healthcare systems, and practitioners’ offices to deliver test information within seconds of the results being reported. The laboratory uses a cloud-based information system, Ovation.io, to help expedite the test orders, specimen tracking, and results to support faster response times to the COVID-19 pandemic.
In addition to COVID-19 testing, Precision Genetics uses an advanced scientific approach to treating employees and patients, using healthcare data to determine the risks associated with medications and complex drug regimens. By combining genetic markers, molecular data, and clinical evidence into a comprehensive and actionable solution, they allow providers to immediately develop individualized treatment and prevention plans for their patients.
“Healthcare facilities throughout South Carolina were struggling to find COVID-19 test facilities that could provide both accurate and timely results”, said Steve Johnson, SCRA Investment Manager. “Some institutions were waiting eight days or more before receiving results. Other testing services were no longer even accepting any further samples. It was critical that an experienced South Carolina-based lab have the throughput capacity to handle the volume of COVID-19 testing that was predicted to be coming. Because of Precision Genetics’ existing track record of providing excellent advanced molecular testing and innovative solutions to healthcare institutions in the state, SCRA and SC Launch, Inc. are proud to provide this investment to Precision Genetics at a time when their capabilities are critically needed in our state.”
“This national and statewide pandemic has challenged us as business leaders to create immediate solutions on behalf of our patients and healthcare providers. The challenge in South Carolina is that we lack sufficient laboratory infrastructure to deploy testing solutions in rapid form in order to manage the immenent demand that our state requires. All labs face a similar obstacle of obtaining the necessary resources and supplies to accommodate our patient volumes. SCRA and SC Launch, Inc. stepped up and provided financial commitment and strategic support for us to expedite our efforts. We are desperately trying to serve our community in this time of need, and we are very grateful for the support from SCRA and SC Launch, Inc.” said Nate Wilbourne, CEO of Precision Genetics.
SCRA is a state-chartered organization that fuels job creation and grows South Carolina’s innovation economy. Through SCRA’s programs, early-stage companies are provided mentoring and grants and may be eligible for an investment from SCRA’s investment affiliate, SC Launch, Inc.
Blinktbi of Charleston, SC pinpoints concussions see more
A startup that grew out of research at the Medical University of South Carolina and The Citadel has hit the market and closed on a new round of funding.
Blinktbi Inc.’s EyeStat device, now being sold to schools and athletic programs, puffs food-grade carbon dioxide into a subject’s eye, triggering the blink reflex. Then, high-speed cameras within the device capture thousands of images and gauge how long it took for the person to blink.
The upstart raised nearly $5 million in 2017, its first year. Those early funds were used in part to finance ongoing research at The Citadel to prove the device can be used to detect concussions and other maladies.
Ryan Fiorini, Blinktbi’s chief operations officer, said the EyeStat prototype weighed 100 pounds, and it utilized a gaming computer to process the images.
The next job was to cut it down to size.
“It didn’t fit in the back of my full-size SUV,” said Fiorini, who has a doctorate immunology and microbiology from MUSC. “We rolled that into the engineer’s office and said, ‘We need this to be four-and-a-half pounds.’”
They were able to pull it off.
The company cleared a formidable hurdle at the end of 2019, when the U.S. Food and Drug Administration gave Blinktbi permission to market its device, after a rigorous review process that took months to complete. One study published in 2013 found the FDA’s process to get medical devices to market from the idea phase typically takes between three and seven years.
Now free to begin selling EyeStat, Fiorini said the company is leasing the technology to lessen the blow of the device’s full cost of about $10,000.
The latest round of funding, for about $6 million, will help offset the costs of manufacturing the medical devices, to make that option possible.
Fiorini said organizations can rent EyeStat for around $200 per month.
One day, the company hopes insurance will cover the use of the technology.
The University of Pittsburgh Schools of the Health Sciences estimated the number sports-related concussions every year falls between 1.7 million and 3 million. About 300,000 are football injuries. Half go unreported.
Concussions happen when a blow to the head causes the brain to bounce around in the skull, leading to a chemical response, according to the Centers for Disease Control and Prevention. Those chemical changes make the brain more sensitive to stress until it heals.
The CDC found in one study that children and teens account for 65 percent of all concussions.
Fiorini’s own son suffered a concussion when he fell off a dock as a toddler.
“What we would come to find out is that there was no way to test him,” Fiorini said in a TEDx talk in Charleston last year.
Studies of how the blink reflex can indicate diseases like Parkinson’s and schizophrenia date back to the 1950s. But no tool has been developed in the intervening decades to use the response to help with diagnosis.
Dr. Nancey Tsai, a neurosurgeon at MUSC, came up with the idea for a portable machine that could measure the blink reflex in 2011.
From there, the Zucker Institute for Applied Neurosciences, which is embedded within MUSC, helped to license the technology. Mark Semler, CEO of the institute and now an adviser to Blinktbi, said the startup is the second in the institute’s portfolio to pass FDA clearance.
“The market is huge, because there’s no good option out there,” Semler said. “The blink can’t be cheated.”
Right now, Fiorini said the company has fewer than 10 employees working out of its office on Rutledge Avenue. Among its advisers are heavy-hitters in the world of sports, including Danny Morrison, the former president of the Carolina Panthers, Steve Smith, a longtime wide receiver in the NFL, and Harvey Schiller, former executive director of the United States Olympic Committee and former president of the International Baseball Federation.
Looking forward, Blinktbi is researching whether its technology could help to detect Alzheimer’s disease and multiple sclerosis.
Fiorini said he can see EyeStat in the hands of police for field tests, giving officers an immediate, objective measure of sobriety — though each new application for the device would require a new round of FDA approvals.
SCBIO has named Erin Ford as the organization's first VP see more
SCBIO’s executive committee announced today that Erin Ford, currently the director of sales at Anderson-based Poly-Med Inc. and Chair of the Board of Directors of the South Carolina Biotechnology Industry Organization (SCBIO), is joining the non-profit life sciences industry organization as its inaugural Vice President.
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 already 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.
“Erin is an extraordinarily talented, multi-faceted executive with magnetic relationship-building skills, along with being a proven leader,” said SCBIO President/CEO, Sam Konduros. “As I was vetting and interviewing a number of extremely worthy candidates for this critical executive position, it occurred to me that our board chair was the absolute perfect fit, and I felt humbly compelled to ask Erin to consider exploring the role. To my and the Executive Committee’s great delight, she ultimately committed to bring her signature career to SCBIO on a full-time basis starting January 2nd. We are extremely fortunate to have such a knowledgeable and seasoned pro like Erin join the executive team and hit the ground running in 2018, following a year of her outstanding leadership as our board chair.”
Ms. Ford departs Poly-Med, a global innovation company that is developing absorbable polymers and constructs for the medical device industry, for her new role at SCBIO, where she will work closely with the CEO on various corporate strategies emanating from the organization’s 3 statewide offices. Her comprehensive responsibilities will include serving as primary lead for SCBIO’s business operations, championing investor relations and existing industry strategies, and spearheading major integrated marketing initiatives.
She previously served as a business recruitment officer at the Upstate SC Alliance, where she was the main point of contact for life sciences companies interested in expanding or locating in Upstate South Carolina, and gained in-depth economic development experience. While at the Upstate Alliance, Ms. Ford served as an ex-officio SCBIO board member from 2013-2015, and led a regional biosciences task force comprised of industry executives from across the region. She also has extensive television experience as a documentary producer and sportscaster, and received her B.A. in Communication from La Salle University in Philadelphia.
"SCBIO presents a unique career opportunity to work in an arena whose constituent members and companies make a tangible difference in the quality of people's lives," said Ms. Ford. "Our hundreds of members include academic institutions, biotech companies, service providers, thought leaders, and economic development groups whose members are leading the research and development of innovative healthcare, industrial and environmental biotechnology and med-tech products that can transform and extend people’s lives. While I have loved my time at Poly-Med, which served as an invaluable life science industry experience for my new career path with SCBIO, this unique opportunity to touch lives and grow South Carolina's knowledge economy was simply too powerful to pass up."
Ms. Ford joins SCBIO's recently named President and CEO Sam Konduros atop the growing organization's leadership team. Konduros, also a former SCBIO board member, assumed the leadership reins of the group earlier this year after departing Greenville Health System, where he ran the Research Development Corporation forging industry partnerships, developing economic development strategies, and helping doctors take their inventions to market. Previously, he was the first president of the Upstate SC Alliance, the Upstate region’s economic-development agency.
The addition of Ms. Ford occurs as SCBIO continues to flex new muscles to advance and grow the business of life sciences in South Carolina. It comes on the heels of the organization's recent restructuring and rebranding efforts, and its highly successful annual conference, which drew hundreds of industry leaders, national executives, academics, economic development organizations, government officials and others to Charleston October 24-26. The organization has already attained record membership and investor levels, and recently formed a partnership with the South Carolina Department of Commerce to develop and implement strategic growth recommendations for the state’s fast-expanding industry.
"This industry is at a critical time for accelerating our growth and impact in South Carolina and well beyond," said Ms. Ford. "When you have such a unique opportunity, you have to seize the day and make positive things happen. That's our goal."
SCBIO is the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations. SCBIO members include academic institutions, biotech companies, med-tech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the 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.