Agreement expands contract manufacturing services for Zeus customers see more
Zeus Industrial Products has agreed to integrate catheter-based contract manufacturer CathX Medical into its organization.
The financial terms of the agreement were not disclosed in yesterday’s announcement.
San Jose, Calif.–based CathX provides catheter design engineering services, rapid prototyping, manufacturing, and full or sub-assemblies. CathX’s leadership will continue to manage the San Jose facility, services, and team members under the global leadership of Zeus CEO Steve Peterson.
Zeus (Orangeburg, S.C.) has a core business centered on component manufacturing across medical and industrial markets. However, the integration with CathX extends Zeus’ capabilities to include contract manufacturing services for medical customers.
“Like Zeus, CathX is very much a ‘people-first’ company,” Peterson said. “We share the same core values across excellence, people, integrity and creativity, and are delighted to welcome the entire CathX team into our Zeus family.”
Nephron's Lou Kennedy making a big impact on industry see more
Courtesy of SC Manufacturing
Drug shortages have plagued the health care system for decades. Even prior to COVID-19, hospitals incurred more than $400 million in labor costs and alternative treatment options due to national generic drug shortages, especially for those administered via injection.
More important, research shows shortages lead to adverse patient outcomes – things like delaying critical procedures, rationing doses based on supply levels and prescribing suboptimal treatment plans with substitute drugs.
Manufacturing tops the list as the most common cause of shortages, pushing those in the pharmaceutical supply chain to look for new ways to increase productivity – and thanks to a partnership between Clemson University and Nephron Pharmaceuticals Corporation, a solution may be on the horizon.
Led by Dr. Yue “Sophie” Wang, the ambitious project combines robotics and medicine to ensure sterility, quality, safety and efficiency in pharmaceutical manufacturing. The team worked in partnership with South Carolina-based Nephron Pharmaceuticals Corporation to develop a flexible, easy to use, open-source benchtop robot that can fill, cap and seal sterile syringes.
“Pharmaceutical collaborative robots is a new and quickly growing research area,” said Wang, who serves as the Warren H. Owen Duke Energy Associate Professor of Engineering at Clemson University. “By combining our expertise with unique applications in pharmaceutical manufacturing, we hope to benefit both patients and the industry through increased efficiency in syringe manufacturing.”
The project supports the Nephron 503B Outsourcing Facility, a cGMP manufacturer providing sterile, pre-filled medications to address persistent drug shortages in hospitals and medical facilities across America. Pre-filled syringes help control costs by minimizing drug overfill and minimizing microbial contamination. Without robotics, filling these syringes is a delicate, highly regulated process completed by specialized technicians under laminar airflow hoods in ISO classified clean rooms to keep their work environments sterile.
It can take up to five employees a day per hood to meet the incredible demand for pre-filled syringes at Nephron. Unlike humans, robots don’t get tired, offering advantages in quality control, production planning and compliance.
Technicians can then be re-deployed for higher value functions that let them improve their skills, experience and pay, said Nephron CEO Lou Kennedy.
“Anything we can do to improve drug shortages, that’s just good for patients,” she added. “It’s a very big crisis, not just in the U.S. but globally as well.”
The next phase of the project is further development, starting with the completion of a purpose-built clean room on Clemson’s campus. Kennedy hopes to commercialize the benchtop system for use inside healthcare facilities across the country.
“Hospitals often have two or three pharmacists working the phones every day searching for the drugs they need,” said Kennedy. “You don’t go to school for eight years to spend your day on the phone looking for product.”
Partnering for change
Clemson and Nephron are at the forefront of a larger trend shaping pharmaceutical manufacturing today. The integration of automation, AI and robotics are catalyzing the industry, and rising demand paired with major market disruptions such as COVID-19 are only accelerating change. The pharmaceutical robotic systems market is expected to nearly double to $119.46 million from just five years ago, driven by innovations in packaging, inspection and lab work, according to one report.
Part of what has made the project successful is the complementary strengths Nephron and Clemson brought to the table. Wang needed an insider’s perspective on pharmaceutical manufacturing to understand the exact requirements and processes involved in sterile syringe production.
Based in West Columbia, Nephron is a certified woman-owned business and one of the fastest-growing companies in South Carolina. The partnership was developed through External Affairs’ Office of Corporate Partnerships and Strategic Initiatives at Clemson University.
“As a leading pharmaceutical manufacturer, Nephron is the perfect partner for specialized, high-impact research to improve health outcomes for patients,” said Angie Leidinger, Clemson’s vice president for External Affairs. “Thanks to our partners, our breakthrough research continues to build Clemson’s and South Carolina’s reputation for leadership in both advanced manufacturing and life sciences.”
In addition to Clemson’s world-class research talent, Nephron was also drawn to the University’s steady stream of talented graduates that could hit the ground running at their facilities.
“We’re a young company and want to play a role in developing all of this great talent we have around us,” said Kennedy. “I decided it was time to put game day feelings aside and look at where our talent was really coming from.”
Women taking the lead
Like most STEM industries, women continue to be a minority in the pharmaceutical manufacturing workforce, at 42.3 percent of total employment. If the partnership between Clemson and Nephron is any indication, that gap could be shrinking fast.
With Kennedy at the helm, Nephron is a certified woman-owned business and boasts a 53 percent female workforce. Ratios like that are unheard of in our industry, she says. It’s only fitting that project leadership from the Clemson side is female.
Clemson is home to many groundbreaking women in the industry, including Martine LaBerge as chair of the Department of Bioengineering, Saara DeWalt as chair of the Department of Biological Sciences, and Delphine Dean as the Ron and Jane Lindsay Family Innovation Professor, among many others. Dean is also a key researcher and first line of defense in the University’s response to the global pandemic.
“It’s so pleasant to see women thriving in STEM careers,” said Kennedy.
Multi-year plan designed to help drive growth of industry across Palmetto State see more
SCBIO CEO Erin Ford only has to look at recent history to understand the opportunity in front of South Carolina life sciences.
Life sciences has a $12+ billion economic impact in the Palmetto State, with more than 700 firms involved and over 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental, and agricultural biotechnology products.
It represents a significant economic development focus for the state, with strong life science recruiting initiatives led by the South Carolina Department of Commerce and regional economic development teams – so much so that Governor McMaster recently issued an Executive Order to emphasize the industry in domestic and international recruiting efforts.
Now armed with the industry’s third multi-year Strategic Plan to build, advance, innovate and grow the industry, Ms. Ford sees an opportunity to “take South Carolina life sciences to an entirely new level” over the next handful of years, she said as SCBIO published the 2021-2022 Life Sciences Strategic Plan recently.
Ms. Ford is no stranger to leading the industry. Since taking over as interim CEO for the departed Sam Konduros just weeks ago, she has expanded emphasis on investor relations and existing industry support strategies, the spearheading of integrated marketing initiatives, implementation of the new SCBIO innovation platform, and a strong emphasis on economic development initiatives – from an industrywide presence at this week’s PGA Tournament at Kiawah to next month’s BIO Global conference and the Fall MEDICA event in Germany.
Guided by the new Strategic Plan, which spans 24 months and continues the vision of the last two editions, SCBIO and SC life sciences are clearly focused on doing “the right things to continue to build, advance, innovate and grow” the multifaceted industry.
SC Life Sciences 2021-2022 Strategic Plan is shaped by input from SCBIO’s Board of Directors and dozens of contributors from industry, higher education, economic development, government and supporting organizations and authored by the SCBIO team. The 70-page document includes detailed sections on the COVID Effect on the industry, 2020 Highlights, documentation of the breadth and depth of the Industry Segments in the state, Priority Initiatives, and specific Objectives, Plans and Budgets to advance life sciences.
A shorter summarized version is available to media and business leaders interested in learning more about the fastest-growing industry in South Carolina, as documented recently by Dr. Joseph Von Nessen, economist with the Moore School of Business at the University of South Carolina. To request a copy, interested persons should email firstname.lastname@example.org.
South Carolina life sciences has seen a near-doubling of firms and 40% increase in life sciences’ direct employment since 2017 alone, which combine to make it the fastest growing industry sector in the state, according to recent data provided by Dr. Von Nessen, state research economist and a noted economic development expert. It also has companies in 42 of 46 counties – a far greater penetration than most major industries possess.
The 2021-2022 plan seeks to continue the growth strategies of the industry evident over the last four years during which Ms. Ford served as EVP/COO prior to assuming the interim role of CEO. During those four years, SCBIO has more than doubled membership and quadrupled revenues, implemented a strong economic development focus, and launched a new innovation platform. It expanded its role as the voice of the life sciences industry, implemented a surging workforce development initiative and created ongoing programs to encourage participation by women in life sciences, to support diversity-equity-inclusion initiatives and to encourage student participation in the industry. The organization also successfully led industry and organizational pivots during the COVID pandemic.
“Prior SC life sciences plans have performed admirably in helping South Carolina raise its profile as an emerging leader in the life sciences,” said Ms. Ford. “Our innovative companies and exceptional workforce are drivers in strengthening this industry, and we know that the life sciences will continue to play a critically important role in our state’s economic success. We intend to build on our Board’s and team’s vision to continue this momentum and to build, advance and grow life sciences in our state.”
DPX earns SBIR grant see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.
RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.
DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.
The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*
* Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
Gov. Henry McMaster Announces New Economic Development Initiative to Expand Recruitment of Pharmaceutical Companies, Shore Up Emergency Supply ChainsGovernor provides strong support for growing life sciences in state see more
In front of several dozen business leaders, executives and media members at Bausch and Lomb in Greenville today, Governor Henry McMaster today issued Executive Order 2021-17, which directs the Department of Commerce to enhance recruitment efforts of pharmaceutical and medical supply manufacturers in South Carolina and directs state agencies to focus procurement efforts of medicines, medical devices, and medical supplies on those made in South Carolina. The new initiative will safeguard South Carolina from supply chain disruptions experienced during the COVID-19 pandemic by working to manufacture even more essential, life-saving products in South Carolina.
“This last year has made it very clear that relying on China for life-saving medical supplies is a risk we can no longer afford, and South Carolina can lead the way when it comes to bringing the manufacturing of those products back home to the United States," said Gov. Henry McMaster. “By successfully recruiting pharmaceutical and medical manufacturing companies to invest and locate here, we will bring good, high-paying jobs for our people and reliable access to the critical supplies we may need in an emergency.”
The Department of Commerce will work directly with SCBIO on the new initiative. SC BIO is a statewide, not-for-profit life sciences and economic development organization formed to promote and expand South Carolina’s life sciences industry.
“As a major driver and diversification of South Carolina’s growing economy, the surging impact, reach and significance of the multi-billion dollar life sciences industry in our state certainly warrants the strategic emphasis being placed on it by Governor McMaster,” noted SCBIO President and CEO Sam Konduros. “We’re honored by the Governor‘s profound support, and this bold Executive Order further demonstrates his ongoing commitment to empower our statewide mission to build, advance and grow the life sciences and pharmaceutical industry in the Palmetto State like never before.”
To further investment and job creation from businesses in the pharmaceutical industry, the governor’s Order directs the South Carolina Department of Commerce to:
- Prioritize and enhance ongoing economic development and recruitment efforts by identifying, encouraging, and incentivizing pharmaceutical and medical supply manufacturers, both international and domestic, to locate research, development, and production facilities within the State of South Carolina.
- Develop and execute international and domestic marketing campaigns that promote the State of South Carolina as a global leader in this Sector.
- Facilitate, assist, and incentivize growth, expansion, investment, and employment opportunities at existing businesses and industries in the Sector located within the State of South Carolina.
- Identify and advocate for statutory or regulatory changes or enhancements to the state’s existing economic development mechanisms for new business and industry investment or expansion in the Sector.
The Order also directs the Department of Commerce to review its existing operations and organizational structure to determine whether any changes would assist with the recruitment of pharmaceutical companies and to recommend any needed modifications to the General Assembly, if statutory authority is required to make them.
To further ensure supply chain security, the governor’s Order calls upon state agencies to prioritize South Carolina-made products in the procurement of medicines, medical devices, and medical supplies. The move will benefit existing businesses and will give Commerce another resource to attract additional life science investment into South Carolina.
Ahead of Spring Break, Makers of ZShield Product Line Offer Easy Way to Stay Safe, Avoid Coronavirus see more
Digital manufacturing company ZVerse, Inc., makers of the award winning ZShield line of face shield and face mask products, has launched a public service campaign aimed at promoting the best way to stay protected against the COVID-19 virus.
As Spring Break approaches and coronavirus cases remain high across the U.S., ZVerse is recommending a "Good-Better-Best" model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
ZVerse is recommending a “Good-Better-Best” model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
The simple model recommends wearing a face mask as a minimum, or good level of protection, followed by a face mask and a face shield combined for better protection. The best protection comes with wearing a filtered face mask combined with a face shield, according to the ZVerse model.
"Experts are warning of a new pandemic wave if people let down their guard during the upcoming Easter and Spring Break holidays and fail to protect themselves and their loved ones," said ZVerse Founder & CEO John Carrington. "At ZVerse, we have learned so much from our own customers and our own product development journey about how to stay safe. So, we created what we hope is a simple and easy guide for COVID-19 protection."
In addition to raising public awareness, ZVerse is recommending its model to city and state officials looking for an easy way to keep citizens safe.
"ZVerse has been a valuable member of South Carolina's business community for many years, and they really stepped up when they received the call to help combat the COVID-19 pandemic," said Columbia Mayor Steve Benjamin. "Their "Good-Better-Best" model is exactly what we need to not only further the decline of COVID-19 cases, but also build toward a return to normalcy where we work, learn and play in our local communities."
ZVerse designs, manufactures and sells a complete line of acclaimed PPE products popular with consumers, schools, employers and government entities - and often seen covering famous faces across Hollywood
For information about ZShield products and pricing, visit: https://zshield.com/collections/available-products.
ZVerse was founded in 2013 by John Carrington in Columbia SC. ZVerse, a digital manufacturing ecosystem, currently provides the only CAD as a Service (CADaaS) platform and designer marketplace. ZVerse recently launched the next generation of its Digital Manufacturing Enablement (DME) platform, an AI drive workflow solution - a category defining technology for digital manufacturing and OEMs. In 2020, in response to the COVID-19 pandemic, ZVerse adapted its business model to quickly produce and distribute its new personal protective equipment product, ZShield, to hundreds of thousands of citizens. To learn more visit zverse.com and zshield.com.
Matt Bell named to head SC Launch see more
The South Carolina Research Authority (SCRA) has announced that Matt Bell was recently named Director of SC Launch and Executive Director of SC Launch, Inc. Bell replaces Russell Cook who resigned to focus on his recovery from a medical issue.
A member of SCRA’s leadership team, Matt Bell is responsible for leading the strategic direction of the SC Launch program, which provides mentoring, networking, and grant funding to eligible companies that are employing new technologies within the advanced materials and manufacturing, information technology, and life science sectors. He also serves as the liaison to the SC Launch, Inc. board of directors, which makes capital investments in SCRA Member Companies that successfully complete the due diligence process. Established in 2006, SC Launch, Inc., is an independent, nonprofit corporate affiliate of SCRA.
“Matt brings a broad background in startup creation from managing intellectual property and launching startups in academia to early-stage investing and venture capital experience. He is also an expert convener who understands how to bring the right people and resources to the table for economic development through innovation,” said Bob Quinn, SCRA Executive Director. “The SC Launch team has been accelerating the growth and success of Member Companies for many years, and Matt brings the right background and experience to lead this team as they guide our companies to becoming highly investible. We sincerely thank Russell Cook for his service to SCRA and the state, and we wish him a speedy and full recovery.”
Prior to coming to the SCRA, Bell was managing director for Discovery Partners Institute, a University of Illinois-led initiative that leverages the state of Illinois’ university resources to drive economic development through workforce training, student immersion, and research programs. He was also a managing director and a principal with Cultivian Sandbox Venture Fund where he raised capital, managed strategic investor relationships, and managed fund activities.
Matt Bell is a board member and advisor for Michigan State University’s state-wide, agriculture-focused translational fund, a former board member of Abcelex Technologies, and a U.S. Department of Agriculture Small Business Innovation Research grant reviewer. He earned a Master of Business Administration and a Bachelor of Science from the University of Illinois. He will be based in SCRA’s Greenville office.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance multi-institutional, translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
Softbox a key player in battle to beat COVID see more
Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.
Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.
Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.
The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.
When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.
“Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, 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.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”
Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”
“It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.”
For more information about Softbox visit: www.softboxsystems.com
Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.
We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.
For more information about Softbox visit: www.softboxsystems.com
SCBIO, United Community Bank to sponsor development program see more
Furman University’s Women’s Leadership Institute (WLI) will be presented virtually this year with two statewide community partners supporting the effort. United Community Bank will be the program’s presenting sponsor and SCBIO has signed on to be a presenting partner.
The WLI is a seven-week leadership development program open to emerging and established women leaders in South Carolina, with past participants from every corner and many industries of the Palmetto State. It is led by distinguished Furman faculty and expert facilitators from civic and corporate organizations who cover core competencies from team leadership and design thinking to negotiating and developing networks.
The program this year will comprise live, virtual sessions on Tuesdays and Thursdays, from 11:30 a.m. to 1:00 p.m. EST, beginning April 15 and ending June 1. The cost is $1,499 and registration is open now. For more information, or to nominate someone for participation, visit the WLI website.
“The Women’s Leadership Institute at Furman is a wonderful opportunity to network with other female leaders in the community, learn more about my own natural strengths and abilities, and discover how I can use my voice to be an advocate for change in our local community,” says Jessica McCoy, a 2020 WLI graduate.
“I would recommend this program to anyone who is actively seeking to make a difference in every area of their life. I promise you won’t regret a single second of it,” said McCoy, the business development manager for Brasfield and Gorrie, one of the country’s largest privately held construction companies.
“The Women’s Leadership Institute has a long history of helping women succeed in their chosen careers and in life,” said Elizabeth Davis, Furman University president. “We are excited to have two cornerstone organizations join us this year to help extend our leadership training and advance equality, equity and diversity in the workplace.”
Furman’s WLI began in 1998, and has helped more than 600 women from diverse sectors develop their leadership skills that are essential to advancing within their organizations.
“Having United Community Bank and SCBIO join as presenting sponsor and presenting partner, respectively, increases the breadth and depth of the program into South Carolina’s business community,” says Anthony Herrera, executive director of Furman’s Institute for Innovation and Entrepreneurship.
“United Community Bank is committed to making a difference in our community and we believe that is achieved through sponsoring programs that support the development of those who serve others,” said Moryah Jackson, vice president of community development and engagement for United Community Bank. “We are excited to be this year’s presenting sponsor and provide women with a professional development opportunity that will help them go out and make the world a better place.”
“Furman’s Women’s Leadership Institute is among the premier programs in the Southeast devoted to promoting talent development, fostering invaluable connections and expanding new opportunities for current and emerging women leaders across the business ecosystem,” said Erin Ford, executive vice president and chief operating officer for SCBIO. “We are honored and enthusiastic supporters of the WLI program and mission, and look forward to being actively involved in this fantastic program.”
Ford and Sam Konduros, chief executive officer and president of SCBIO, will present during one session, and a panel from United Community Bank will close the program on June 1.
Vikor Scientific and Quantgene announce major advance in precision genomics see more
Starting this March, a South Carolina lab will become ground zero for a preventative test that can detect cancer-causing mutations, risks or tumors in advance through a quick blood sample taken at home or a physician’s office.
S.C. life science organization SCBio and the Charleston Regional Development Alliance linked together Charleston’s Vikor Scientific and California’s Quantgene Inc. when the West Coast company was on the hunt for a lab that could commercialize its AI and genomic-powered preventative care program, Serenity.
Serenity puts to task a deep genomic sequence process that covers 20,000 genes in combination with the disease, medication and lifestyle risks that could contribute to multiple variations of cancer. Along with the blood test, or “liquid biopsy,” it can detect cancerous mutations in the blood, according to Vikor Scientific co-founder Shea Harrelson.
“What this means is that we can detect cancer early enough so that patients don’t have to resort to chemotherapy,” she said during SCBio’s Virtual Meeting Wednesday morning. “They may have options for immunotherapy or aggressive preventative strategies or even excisional therapy.”
Patient-specific health profiles covering personal and family history, as well as lifestyle choices, will brief analysts on how additional risks may contribute to a patient’s likelihood of developing early-stage cancer, thus prompting preventative care.
“With Serenity, we are first-to-market in combining liquid biopsy cancer detection with whole exome sequencing and advanced medical intelligence,” Johannes Bhakdi, founder and CEO of Quantgene, said in a news release. “We hope to unlock a new era in medicine in which trained physicians can detect multiple cancers at early stages in the blood with single molecule precision. Serenity brings genomic technologies to patients within an innovative system of preventative care that we believe will set a new standard in patient-centered personalized medicine. We are excited to take this important step with our partners at Vikor Scientific.”
Vikor Scientific, a hub for medical testing, will process test results in collaboration with Serenity’s proprietary cloud for both individual end-users and health care professionals.
The South Carolina company will launch its public awareness and physician education campaigns alongside the concierge-product release on March 1, according to Scotty Branch, co-founder of Vikor Scientific, and will soon build out its current location in Charleston.
“Our number one goal is to educate physicians throughout the country, which is what we do best,” Branch told GSA Business Report, adding that the team is working to get insurance companies on board with the treatment program now.
“Until then, the liquid biopsy, or the early detection portion, will be on a concierge or cash-paid basis,” he said.
Vikor Scientific will conduct whole exome sequencing and send that information to the Serenity cloud for both physicians and individual consumers, potentially for a variety of uses.
While existing genetic tests on the market like those sold by 23 and Me may be able to offer a surface level detection of certain cancer-causing genetic variations in a patient, Serenity takes genomic testing to the next step of preventative treatment, the company said.
“Genetic mutations only play a role in about 5% to 10% of cancer,” Harrelson said. “So, there’s about 90-95% of cancers that don’t have genetic mutations, and without that, you still have a lot of familial cancers. And most people die from cancer than heart disease or automobile accidents, so this liquid biopsy test will be very important, because if patients have put stress on their body or smoke or other risk factors that can increase their chance for cancer, this liquid biopsy test is pretty painless and a great screening tool for this and other cancers that … like pancreatic cancer. We often don’t find out about pancreatic cancer until stage three or four.”
Taking into account detected at-risk genetic variations, the Vikor-Quantgene team will analyze additional risks for early stages of cancer through the liquid biopsy test, in lieu of more invasive measures, which can detect whether nascent tumors are forming in the body.
“It’s a great continuum of care,” he added. The test analysis could then be used, in tandem with additional data, to launch preventative treatment and care.
“We need to use liquid biopsy as part of an annual or bi-annual screening,” Branch said.
After a Monday Vikor Scientific Board meeting, Branch said 99% of the plans for the facility buildout have been nailed down. The full announcement will come when the company approves the final portion of its development strategy.
“This is an amazing announcement for South Carolina and for economic development, where we are going to build out at our location at 22 West Edge, where Vikor’s location is currently,” he said. The company will start small with 10 to 20 new employees and scale up from there. “That is exciting news that a corporate hub would be located here in Charleston’s West Edge Medical Innovation District."
Greenwood Genetic Center project receives grant to expand access for genetics services see more
The Greenwood Genetic Center (GGC), through the Self Regional Healthcare Foundation, has been awarded a grant of $899,000 from The Duke Endowment for 'Genetics Access for All,' a project to expand access to genetics services for patients and providers.
"In this current era of genomic medicine, there is an increasing demand for clinical genetics services, but our workforce is insufficient to meet this demand, and our current work flows are inefficient," said Mike Lyons, MD, Director of Clinical Services at GGC and lead on the funded project. "This leads to families facing long waits to be evaluated and tested, and subsequent delays in managing and treating their child's condition."
GGC has provided clinical genetics services since 1974; however, with the increase in demand for services, and inability of genetics training programs to keep up with the ensuing workforce demand, patients often wait for six months or longer to be seen.
"This is not just a GGC issue. Genetics clinics around the country are facing wait times that are as long or longer than ours," said Steve Skinner, MD, GGC Director. "And we have found that as genomic technology has been evolving at such a rapid pace, many non-genetics providers do not feel comfortable ordering and interpreting genetic tests on their own."
'Genetics Access for All' proposes a new standard of genetics care by optimizing access for patients and employing a new system of communication to transform how non-genetics providers engage with genetics providers in order to better manage their patients.
In 2019, GGC and the Medical University of South Carolina (MUSC) signed an affiliation agreement with the goal of improving access to genetic services for patients across SC.
One initiative that has grown out of this affiliation is a pilot project with the MUSC Center for Telehealth to develop an electronic consult (e-consult) system for genetics referrals. The project initially offered the option only to a limited number of referring providers in the MUSC system. Funding from The Duke Endowment will allow that project to expand on a much larger scale.
During the first year of the funded project, GGC will implement e-consults through an online platform to allow non-genetics providers to upload patient information, and receive clinical impressions and testing recommendations within two business days. E-consults will help avoid unnecessary referrals, improve communication with non-genetic providers, and enhance efficiency by decreasing the amount of time needed for in-person and telemedicine visits.
In year two, GGC plans to expand the concept to provide electronic patient visits (e-visits) allowing patients to upload their information electronically and quickly receive clinical feedback and recommendations. The goal of e-visits is not to replace in-person or telegenetics visits, but to provide another care option that improves communication with and access for patients.
Lyons says that the ultimate goal of this project is to change the model of genetics care from a long diagnostic odyssey to a more efficient system that decreases unnecessary referrals, expedites diagnoses, and decreases wait times for appointments.
"Through e-consults, we'll be able to more quickly identify patients who need genetic testing and facilitate the appropriate testing," he said. "A rapid diagnosis will allow for more timely and precise management and treatment for all patients impacted by a genetic disorder."
GGC expects to see significant improvements in patient care as the project expands. "Our goals are to complete 50 outpatient and 25 inpatient e-consults and 25 e-visits per month by the end of the grant cycle," said Lyons. "We anticipate this project to dramatically improve wait times for all types of visits, and hope that our success can be translated into a new model for genetics care in clinics nationwide."
About Greenwood Genetic Center
The Greenwood Genetic Center (GGC), founded in 1974, is a nonprofit organization advancing the field of medical genetics and caring for families impacted by genetic disease and birth defects. At its home campus in Greenwood, South Carolina, a talented team of physicians and scientists provides clinical genetic services, diagnostic laboratory testing, educational programs and resources, and research in the field of medical genetics. GGC’s faculty and staff are committed to the goal of developing preventive and curative therapies for the individuals and families they serve. GGC extends its reach as a resource to all residents of South Carolina with satellite offices in Charleston, Columbia, Florence and Greenville. For more information about GGC please visit www.ggc.org.
About The Duke Endowment
Based in Charlotte and established in 1924 by industrialist and philanthropist James B. Duke, The Duke Endowment is a private foundation that strengthens communities in North Carolina and South Carolina by nurturing children, promoting health, educating minds and enriching spirits. Since its founding, it has distributed more than $4 billion in grants. The Endowment shares a name with Duke University and Duke Energy, but all are separate organizations.
Pensievision earns a rare perfect score from the National Institutes of Health (NIH) on its grant applicationNIH recognizes outstanding performance bySouth Carolina organization see more
Pensievision, the Charleston based company that develops AI-based, 3D medical imaging technologies, earned a rare perfect score from the National Institutes of Health (NIH) on its grant application for developing a low-cost, handheld, 3D imaging system for improved screening of cervical neoplasia, to help prevent cervical cancer. The grant funds awarded by the National Cancer Institute (NCI) will be used for a clinical study, in collaboration with the University of California, San Diego (UCSD).
The proposal submission, led by Pensievision’s CTO, Dr. Joe Carson, who is also an Associate Professor in the Department of Physics & Astronomy at College of Charleston, received a perfect score of 10, ranking in the top one percentile of all grants submitted to the NIH.
The NIH review board indicated that “the proposal was perceived as exciting, highly innovative, extremely significant, with an exceptional investigative team, and outstanding environment”.
“We knew that we wrote a strong grant proposal, but we were still surprised by the rare perfect score” says Tal Almog, Pensievision’s Co-founder and President. “We are honored and very excited with the opportunity to enhance screening and diagnostic technologies that could save lives”
Earlier this year, Pensievision completed development of CervImage™, the world’s first portable colposcope capable of producing high-resolution 3D images to assist in early-stage detection and analysis of pre-cancer cervical lesions. The team decided to focus on cervical cancer (the third most common cancer worldwide and the leading cause of cancer death in women in developing economies) where screening efforts in low resource communities have only achieved limited success due to lack of laboratory infrastructure, shortage of trained personnel, and high costs, leading to high mortality rates. CervImage™ could improve existing screening methods by offering a point of care screening & diagnostics solution to enable single-visit screen-and–treat without the need for return visits or lab results.
Experienced Team and Advisory Board
Pensievision was founded by a unique team of four interdisciplinary professionals: Dr. Joe Carson, a professor of Astrophysics, Dr. YT Liu, a medical doctor, Tal Almog, a technology entrepreneur/executive, and Ben Carson, a business attorney. They are assisted by a seasoned advisory board, including Dr. Dennis Carson, a renowned cancer researcher and the former Director of the UCSD Moores Cancer Center, and Raymond McDaniel, CEO and President of Moody’s Corporation, a $50B financial services company.
Novel Imaging Technology
The company develops medical-grade 3D imaging technologies using Dr. Carson’s untraditional approach of borrowing imaging techniques used in astronomy, such as for NASA’s space telescopes. He used his own experience in extraterrestrial imaging, including his direct-imaging discovery of a ‘super-Jupiter’, and his discovery of the coldest imaged companion of a sun-like star (which was recognized as ‘TIME magazine top 10 science discoveries of 2009’).
Pensievision is working to miniaturize its devices and is developing a fiber-optic based endoscope to achieve precise 3D imaging of pre-cancerous lesions inside the body, including within the cervical canal, the ovaries, and the esophagus.
Pensievision’s 3D imaging software could further be adapted to applications in consumer electronics, smartphones, and digital health. The company is currently working with market-leading strategic partners to license its technology.
South Carolina life sciences company adding 148 new jobs to booming industry see more
Vikor Scientific, LLC, a molecular diagnostics company, today announced plans to expand operations in Charleston County. The $1 million investment will create 148 new jobs.
Founded in 2018, Vikor Scientific, LLC specializes in antibiotic stewardship and tangible solutions for the practice of value-based medicine in the treatment of infectious disease. The company provides clinicians with advanced molecular methodology for pathogen detection, quantification and resistance gene identification.
Located at 22 Westedge Street in Charleston, Vikor Scientific, LLC's expansion will increase the company's capacity to assemble and distribute both COVID-19 and full molecular panel testing kits across the country.
The expansion is expected to be completed by January 2021. Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
"The prior backorder of testing supplies was crippling for the U.S. during the beginning of the pandemic, and no one wants to experience that again. This expansion will help us to continue to stay ahead and increase the production of our testing kits for both COVID and our other infectious disease molecular panels by the hundreds of thousands, which is vital as we enter the sick season." -Vikor Scientific Co-Founder Shea Harrelson
"Vikor Scientific, LLC's expansion and the 148 new jobs it will create will have a huge impact in Charleston County and across the state. We couldn't be more excited to continue this partnership and watch them succeed here for years to come." -Gov. Henry McMaster
"Team South Carolina works hard to offer businesses a strong foundation to foster growth and be successful. Vikor Scientific, LLC's decision to expand in Charleston County is an indication that we are doing it right, and we look forward to supporting this great company every step of the way." -Secretary of Commerce Bobby Hitt
"Charleston County offers an environment supportive of innovation, which is a catalyst for our growth in the life sciences industry. We welcome Vikor Scientific's expansion, as it will have a positive impact on our economy with the creation of 148 new jobs." -Charleston County Council Chairman Elliott Summey
"As we continue to respond to the effects of the coronavirus pandemic, the remarkable work of companies like Vikor Scientific has proven critical to keeping our citizens healthy and safe. Not only will this expansion create 148 new jobs in Charleston, but it will increase our ability to provide COVID-19 tests to those who need them throughout the state and across the country. On behalf of the citizens of Charleston, I'd like to thank Vikor Scientific for the lifesaving work they do in our community and wish them Godspeed as they continue to expand operations." -Charleston Mayor John J. Tecklenburg
"Vikor Scientific is a young company making a monumental impact within the life sciences industry, and we are grateful this important work is happening in our backyard. Congratulations to Vikor Scientific on this significant expansion and we look forward to our continued partnership." -Charleston County Economic Development Executive Director Steve Dykes
FIVE FAST FACTS
- Vikor Scientific, LLC is expanding operations in Charleston County.
- The $1 million investment will create 148 new jobs.
- Vikor Scientific, LLC is a molecular diagnostics company.
- Located at 22 Westedge Street in Charleston, S.C.
- Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
Nephron expanding again in Columbia, SC see more
With promising news about a COVID-19 vaccine making headlines, Lou Kennedy had reason for optimism during a beam-raising ceremony marking a milestone for a $215.8 million expansion at Nephron Pharmaceutical Corp.’s Saxe-Gotha Industrial Park campus.
Part of the expansion is a 110,000-square-foot vaccine production, chemotherapy and antibiotic wing that Kennedy, Nephron owner and CEO, expects to be operational around March 2021. She said Nephron is actively looking for a vaccine production partner to provide the ammunition for the pre-filled sterile syringes that make up the booming 503B Outsourcing Facility arm of the company.
“It’s a Chamber of Commerce day,” Kennedy said after signing the final beam of the 240,000-square-foot Kennedy Innovation Center’s steel skeleton on Tuesday morning. “This marks a milestone in 2020. This is good news. This is giving us the space to continue to grow.”
Newly elected President's plans have major bearing on the medtech industry see more
While former Vice President Joe Biden and the team he builds won't take office for another two months, the campaign’s plans for COVID-19, healthcare and other policy areas offer clues to how changing tides in Washington may impact the medtech industry.
In approaching the top task at hand — getting the pandemic under control — the Democrat's plan includes proposals with implications for the industry, from how diagnostic testing is covered to access to telemedicine services.
In some ways, the act of swapping out administrations, regardless of who's in power, means device makers can anticipate shifts at key government agencies like the FDA.