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  • sam patrick posted an article
    Hundreds of nation’s industry leaders to gather for strategic partnership development, insights see more

    With the biggest story of 2021 – the global COVID-19 pandemic – serving as a backdrop, the largest life sciences conference in Palmetto State history will convene both in-person and virtually February 22-24 to address how South Carolina and America are accepting the challenge of  achieving health and prosperity for all, South Carolina life sciences industry officials have announced.

    Themed “Challenge Accepted,” the 2-day SCBIO 2022 event will feature national speaker sessions on Transformational Technologies, Next Generation Patient Care, Ensuring Opportunity for All, and Embracing Collaboration & Innovation – fundamental forces driving the state’s fastest growing industry: life sciences.

    Currently listed as a $12 billion industry, national economist Dr. Joseph Von Nessen of University of South Carolina’s Moore School of Business will report findings of a just-completed economic impact study of the state’s life sciences cluster, last analyzed in 2017.

    FDA Associate Director of the CDER Drug Shortage Staff Valerie Jensen is the first announced featured major speaker for the 2-day conference, addressing the gathering in a Program “Challenge Accepted:  Delivering Next Generation Care to Patients Now.”  A trained clinical pharmacist, Captain Jensen was one of the initial developers of FDA’s Drug Shortage Program and was named Associate Director in 2012. She continues to manage the Drug Shortage Staff at FDA. Joined by MUSC Health CEO Dr. Pat Cawley, Velocity Clinical Research executive Steve Clemons, and USC Provost Dr. Stephen Cutler, the panel will focus on the industry’s success in to expediting development of medicine, devices, technologies and vaccines in record time and with startling efficacy – and what it means for care around the world going forward.

    Captain Jensen will be joined by more than 25 additional presenters and honorees at SCBIO 2022, which brings together leaders and executives from life science organizations across the nation to South Carolina. In deference to the pandemic, FDA protocols on safety are being rigorously adhered to and events are also being presented and distributed virtually, organizers revealed.

    The conference will feature a significantly expanded exhibit hall showcasing scores of life sciences industry businesses, institutions of higher learning and essential support industry partners from across America, as well as presentation of the prestigious Pinnacle Awards by South Carolina Life Sciences to the outstanding 2021 Organization of the Year and Individual of the Year. Also to be honored with Pinnacle Awards will be an inductee into the SC Life Sciences Hall of Fame, and an award for an industry Rising Star under 40 years of age.  

    New SCBIO CEO James Chappell will deliver a highly anticipated “State of South Carolina’s Life Sciences Industry” address, while hundreds of in-person and virtual attendees will take advantage of meetings and connection sessions through the conference’s Partnering Portal. Additional speakers will be announced shortly, as well as posted online.

    Registration to attend the 2-day conference is now open online.  For more details, visit the 2022 Annual Conference section at www.scbio.org. Registration and exhibiting are free to many SCBIO investors. Early bird general admission pricing provides significant discounts to interested companies, industry supporters, students interested in life sciences, faculty and teachers. Limited Exhibit  space and sponsorships are also available by inquiring at info@scbio.org.

    The 2-day conference annually draws attendees from across America for networking, innovation updates, opportunity discovery, partnership making and strategic discussion. Already committed attendees include officials across a broad spectrum of life sciences industries including medical devices, bio manufacturing, drug discovery, R&D, pharmaceuticals, diagnostics and testing, digital health and health IT, bio-ag and more.

    SCBIO is South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has more than 700 firms directly involved and over 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental, and agricultural biotechnology products.  In early 2021, Governor Henry McMaster issued an Executive Order making it a state priority to continue to grow and expand the life sciences industry in the Palmetto State.

    “Life sciences is a major driver of South Carolina’s economy, and this conference’s growth is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and region,” noted SCBIO President and CEO James Chappell. “Already accounting for thousands of highly-skilled jobs in the Palmetto State, this sector has tremendous growth potential, and we’re excited to showcase top companies, research universities and leaders from across our state and country at SCBIO 2022.” 

    Among leading biotech and med-tech industry brands participating in the conference are Nephron Pharmaceuticals, BIO, Johnson & Johnson, AVX, PhRMA, Medpoint, AdvaMed, Poly-Med, VWR, Rhythmlink, SoftBox Systems, ZEUS, Patheon Thermo Fisher, Zverse, Abbott, Alcami and more. All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, and economic development entities including the South Carolina Department of Commerce, SCRA, South Carolina Hospital Association and others.

    As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include academic institutions, biotech 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 biotechnology products that transform how we heal, fuel and feed the world.

    For additional information on SCBIO or to register for SCBIO 2021, visit www.SCBIO.org.

  • sam patrick posted an article
    Improving patient care is at the heart of Rhythmlink's success see more

    Compliments of Scribble

    As Columbia, S.C.-based Rhythmlink International, LLC (RLI) prepares to turn 20 years old this year, co-founder and CEO Shawn Regan is reflective on just how far the organization has come since “the early days.”

    After spending more than a decade in the medical device and medical services fields, Shawn and his partners created Rhythmlink in 2002 to meet the needs of neurophysiologic end-users whom they discovered were underserved by both large and small medical device companies. Shawn’s passion to apply innovative engineering solutions to address customer needs while improving patient care and reducing medical costs set him—and Rhythmlink—on a growth path that today has reached over 325 employees worldwide and has landed the organization on the Inc. 5000 list of America’s Fastest-Growing Companies nine times.

    Of greater pride to Regan is the company’s ten straight years on South Carolina’s Best Places to Work list — a testament to Rhythmlink’s culture and the commitment of the organization to valuing the contributions and talents of its associates… whatever their role.

    RLI is in the business of connecting patients to machines to record or elicit physiology information. It designs, manufactures, and distributes medical devices that go on or in a patient to help monitor the brain and the nervous system to identify and prevent serious neurologic conditions such as paralysis, seizures, and strokes. Rhythmlink’s products are commonly used in operating rooms, intensive care units, and other neurological clinical settings in hospitals. The company is now recognized as a leader within its field at providing the important physical connection between patients and the diagnostic equipment to record or elicit neurophysiologic biopotentials.

    Originally founded by neurodiagnostic technicians and engineers, Rhythmlink is resolutely focused on continuous innovation and delivering superior quality in all of its products – and its advancements and improvements in technology and branding have brought national and international recognition to the former South Carolina start-up.

    Indicative of the company’s focus on innovative product development are two notable recent offerings developed and marketed by the company: its MR Conditional/CT Compatible Quick Connect Electrodes and its Guardian Needle Electrode.

    Rhythmlink was the first company in the world to achieve FDA approval for MR Conditional EEG electrodes. Rhythmlink’s FDA-cleared MR Conditional/CT Compatible Quick Connect Electrodes help eliminate the need and cost to have staff available to remove and reapply electroencephalography (EEG) electrodes each time a patient requires magnetic resonance (MR) imaging during critical care continuous EEG monitoring, long term epilepsy monitoring or in many other situations.

    Electroencephalography is the recording of brain activity (i.e., brain waves) to help identify dangerous brain activity such as seizures. Prior to Rhythmlink’s MR Conditional products, any time a patient needed to have their brain monitored and needed to get an imaging study done, caregivers had to take off the electrodes, image the patient and then re-apply the electrodes. Getting electrodes on the head is time-consuming, qualified staffing in hospitals is limited, and application and reapplication can result in skin breakdown at the site of the electrodes. Applying the electrodes once and keeping them on during a patient’s stay saves time and cost while improving patient safety.

    RLI achieved full FDA clearance on its MR Conditional EEG electrodes and the Quick Connect Electrode product line built upon the previous clearance. The product can also be used in a CT without having to take the electrodes off the head and re-apply them, furthering its potential use. 

    Rhythmlink’s Guardian Needle Electrode is a subdermal needle electrode designed to reduce accidental needle sticks and reduce the risk of exposure to cross contamination. Commonly used in the operating room for real-time monitoring and protection of a patient’s nervous system, this subdermal needle can be used for critical care environments, the ICU, Emergency Room or anywhere a needle electrode is called for. Additionally, the Guardian Needle combines to work perfectly with RLI’s EEG template for quick and accurate electrode placement. 

    The product was originally conceived of by Medical University of South Carolina (MUSC) Health clinicians, developed by the Zucker Institute of Applied Neurosciences (ZIAN) engineers and is today manufactured and sold by Rhythmlink, a testament to the power of collaboration in medical device innovation. The effort — ten years in the making — will make the operating room a safer place for health care team members the world over.

    Traditional subdermal needle electrodes are used during surgery to monitor a patient’s nervous system during dangerous cases to identify and prevent paralysis, stroke and other dangerous conditions and outcomes during surgery. The small needles can become dislodged and accidently stick health care personnel during the surgery, whereas the new Guardian needle aims to reduce or eliminate the accidental needle sticks. Following extensive talks, licensing, contribution of additional IP to the patent and obtaining FDA clearance, Rhythmlink launched the product just over one year ago.

    Twenty years of hard work and growth have come and gone quickly at Rhythmlink, yet the founders’ original passion still rings true today: improving patient care is — and always will be — at the very heart of Rhythmlink’s success.

     

  • sam patrick posted an article
    Thorne Healthtech makes name for itself globally from base in Charleston, SC see more

    Compliments of Investment Monitor

    After visiting 100 potential sites across eight different states, nutraceutical company Thorne HealthTech began a huge relocation to Charleston, South Carolina, in 2014 and has never looked back. Here, Thorne COO Tom McKenna explains what drove its decision and subsequent success.

    There are many reasons why a life sciences business might make the monumental decision to relocate their company’s headquarters or manufacturing base either nationally or internationally. Choosing exactly where to move is a significant challenge that requires extensive research, visits and careful evaluation.

    This was a challenge that Tom McKenna, chief operating officer at Thorne HealthTech, faced first-hand when he led the company’s relocation some 3,500 miles (5,600km) across the US, from a small town in northern Idaho to one within greater Charleston, South Carolina. Here, he shares his experience of the big move and why he feels the relocation was more than worthwhile. 

    Thorne was founded in 1989 as a manufacturer of premium-quality nutritional supplements. We have since created digital health solutions providing diagnostics and analytics to identify unmet nutritional deficiencies and provide world-class wellness and prevention education. Our goal is to help people at all stages of life to live and age more gracefully.

    We believe the future of wellness is personal. For the first time in history, with the cutting-edge advancements in sequencing technology, artificial intelligence and nutritional research, we can now efficiently offer personalised approaches to wellness, which were previously reserved for late-stage disease care or academic research. We strive to be the differentiated leader in the wellness industry by deploying our scientifically rigorous approach to supporting personalised health and wellness.

    What prompted the move from Idaho and what were you looking for in your new location?

    In 2013, we recognised that by 2018 we would be out of capacity at our manufacturing facility. While there was plenty of available land in the area, our decision not to expand locally was based on utility capacity, lack of local labour and challenges in attracting talent, as well as the significant distance from the airport and major roadways.

    We first looked at around 1,000 different options across all 50 states. We narrowed it to 100, and I personally visited every one of those over a two-year period. During that time, we were introduced to South Carolina’s then governor of state, [Nikki Haley]. She suggested the Charleston region and we looked at some sites. The place we ended up was a no-brainer compared with all the other options. After two years of trying to find a home, when we finally came to Charleston we thought ‘that’s it’!

    The key criteria in our decision-making included a business-friendly environment; a robust, affordable and available talent pool with comparable salaries to Idaho; proximity to the local airport and major transit ways; an appealing area for staff to relocate; and attractive state and local incentives. Charleston ticked all these boxes.

    What are the risks during a business relocation and how did you mitigate these?

    One risk is losing or damaging a critical asset or transitional requirement among the significant multitude of moving parts. This required detailed, almost military-like planning and execution to move some 2,500 pieces of equipment, furnishings and tens of thousands of inventory items.

    Thorne HealthTech’s corporate office and manufacturing site is located at 620 Industrial Blvd, Summerville, South Carolina. (Photo courtesy of Thorne HealthTech)

    To make sure there are no operational disruptions, you also need a certain critical mass of existing staff to move with you, in many cases early, and to stay at least for a while to initiate operations, recruit and train new staff. We worked with Charleston’s economic development organisation called Charleston Regional Development Alliance (CRDA). CRDA helped facilitate and participate in 14 ‘familiarisation’ trips for a total of 140 employees and nearly 300 persons. We would kick the trip off with a seminar on the area and the community, led by CRDA. We would then hop on a bus and CRDA would take us on a three-hour tour around different neighbourhoods and areas, down to the beach and out for a barbeque.

    It was very informal and almost familial, and to their credit they showed up 14 times to do these things, each time with welcome bags. CRDA was very helpful in getting folks to see the value of the local community. In fact, CRDA was critical in helping us convince 40% of our Idaho-based staff to relocate to South Carolina. When we got here, they were very helpful on the hiring side too.

    What attracted your employees to the Charleston region?

    What the greater Charleston area provides is a culture that is perhaps not a lot different from the Pacific Northwest. Our employees love to be in the outdoors – they love to hunt, fish, camp and hike. You can do all those things that you could do in Idaho here in Charleston. The big difference is that instead of doing those things in a short window in the summer, in Charleston you can enjoy them for 12 months of the year, thanks to the climate.

    The ocean was another big attraction for folks, as was the proximity to multiple downtowns. In Idaho, the closest city was a two-hour drive away. Here, you can generally be in downtown Charleston in 30 minutes or less, depending on where you live. At the same time, it is not a huge metropolitan area like New York City, Philadelphia or Washington DC, for example.

    Are there any ways Thorne HealthTech is more competitive with operations in Charleston?

    We are now able to attract more diversified and talented staff, in greater numbers. The proximity to the airport and interstate highway transit has greatly reduced our freight costs and improved our supply chain management and timelines. When we wanted to ship and receive materials in northern Idaho, the largest interstate was an hour away. Here, it is just blocks away.

    Our new facility and others we are now expanding into have materially improved our productivity and lowered the cost of operations. We now produce more items in-house and have greater control over our supply, and as a result have dramatically reduced our order fulfilment timelines, which are now comparable to Amazon. We continue to feel we made the right decision in our move to Charleston.

  • sam patrick posted an article
    MUSC making its mark in cancer treatments see more

    Many cancer treatments such as chemotherapy and radiation kill cancer cells by inducing significant DNA damage beyond repair. But some tumors still develop alternative ways to survive. Now, scientists at the Medical University of South Carolina (MUSC) and Beth Israel Deaconess Medical Center have identified such a molecular pathway that helps cancer cells evade destruction.

    The protein ECT2 is critical for the activation of a backup survival mechanism cancer cells resort to as part of their response to DNA damage, the scientists described in a study published in the journal Science Signaling.

    As DNA damage response is essential for cell survival or death, better understanding of its mechanisms could lead to better combination therapies that can overcome tumor resistance, three researchers at the University of Illinois Chicago (UIC) said in an accompanying editorial.

    Scientists know that the kinase AKT is a key regulator of genome stability—hence cell survival—by mediating downstream signaling involved in DNA damage response and DNA repair. Increased activation of the enzyme has been linked to cancer progression and resistance to drugs. However, the exact mechanisms of AKT activation in the face of DNA damage were unclear.

    For its study, the MUSC and Beth Israel team treated multiple cancer cell lines with ionizing radiation or the chemotherapy etoposide and examined their responses. The researchers found that in response to drug-induced DNA damage, the DNA-PK enzyme modified a subunit of the mTORC2 protein complex.

    ECT2 recognized that interaction and subsequently promoted AKT activation, according to the team. When ECT2 was removed in cancer cells, treatment with etoposide didn’t induce AKT activation. Compared with control cells, these ECT2-depleted cells responded better to etoposide, showing decreased colony formation.

    What’s more, reintroducing ECT2 to the cells enhanced AKT activity, while an ECT2 mutant failed to do so, the team showed. Between the two groups, cells expressing normal ECT2 were less sensitive to etoposide partly because of reduced cell death.

    A cancer patient may go through multiple lines of treatment as cancer cells outsmart the drugs they encounter. Many research groups are exploring ways to render resilient tumors vulnerable to existing treatment. Last year, two teams of scientists demonstrated the promising effects of inhibiting an enzyme called POLQ on BRCA-mutated tumors that had stopped responding to traditional PARP inhibitors.

    A research team at the Swiss Federal Institute of Technology in Lausanne recently proposed adding CSF1R inhibition to control tumor-associated macrophages as a strategy to restore responses to the combination of PD-1/L1 immune checkpoint inhibitors, antiangiogenic drugs and chemo.   

    “Targeting the [DNA damage response] in cancer is of great clinical importance to traditional, current and emerging therapies including immunotherapy given the observed induction of antitumor immunity by DDR-targeted therapies,” the UIC researchers wrote in the editorial. 

    Findings from the current study pointed to combining DNA damage with DNA-PK-ECT2-mTORC2 network inhibition as a more efficient therapy against cancer, they said.

  • sam patrick posted an article
    Australian company locates in Charleston see more

    An Australian wellness company is making the trek overseas and investing more than $100,000 to establish operations in Charleston County.

    Evolt, founded in 2015 in Gold Coast, Australia, offers end-to-end solutions that track body composition, activity and nutrition using data analytics.

    With the new location at 2457 Aviation Ave. in North Charleston, the company plans to create 80 jobs. The Evolt facility will serve as the company’s North American corporate headquarters and distribution center, Gov. Henry McMaster’s office said in a news release.

    CEO Ed Zouroudis founded the company with Kelly Weideman. Their products are used in 26 countries, with a five-year plan to expand into pharmacies, supplement retail stores, corporate wellness programs and body contouring industry, Zouroudis said.

    “As body scanners drive member engagement and pivot the self-care movement through the power of data and health metrics, consumers are leaning further into personalized solutions,” Zouroudis said in a statement. “We have already partnered with one of the largest fitness brands in the world – Anytime Fitness – and are currently rolling out to their network across the U.S. and worldwide.”

    Evolt’s primary products are the Evolt 360 Body Composition Analyzer, a 60-second scanner that provides detailed data about your body through more than 40 measurements and an accompanying app that allows users to track their health with calorie counts, macronutrient profiling and healthy lifestyle scoring.

    “Evolt locating its North American corporate headquarters and distribution center in Charleston County proves once again how international companies recognize the advantages of doing business in South Carolina,” McMaster said in a statement.

    Evolt will be surrounded with opportunities in Charleston, as the region is home the Charleston Bridge Run and a number of recreational activities that draw in individuals seeking opportunities to stay active and healthy, Charleston County Council Chairman Teddie Pryor said.

    “Charleston County’s exceptional assets continue to attract international companies, and today’s announcement by Evolt is a testament to our business-friendly climate and globally connected infrastructure,” Pryor said.

    S.C. Commerce Secretary Harry M. Lightsey III also welcomed the company stateside.

    “When an international company decides to locate to South Carolina, it speaks volumes not only about our way of doing business, but about our workforce. Evolt’s new North American corporate headquarters and distribution center – along with the 80 new jobs the company is creating – are big wins for the Charleston community,” Lightsey said in a statement.

  • sam patrick posted an article
    Challenges in locating lab space impact Palmetto State as well as life sciences hotbeds see more

    Compliments of Axios

    Office occupancy rates remain deflated across industries, but one type of workplace is in high demand: labs.

    The big picture: A number of trends — in public health, American demographics and venture capital funding — are colliding to supercharge the life sciences industry.

    Driving the news: U.S. office vacancy rates are at 17%, but lab vacancy rates are at 5%, according to a new report from the commercial real estate firm CBRE.

    Money is pouring into life sciences companies. Venture capitalists are throwing money at gene editing and other promising therapies, at the same time that an aging American population is driving up health care spending.

    • The annual amount of venture capital flowing to life sciences companies has roughly doubled since 2019 to a whopping $32 billion, per CBRE and CB Insights data in the report.
    • Federal health care spending made up around 4% of GDP in 2006, but that's expected to swell to over 8% by 2040, according to the Congressional Budget Office.

    What's happening: "This was a sector that was white-hot prior to the pandemic," says Jon Varholak, a vice chairman at CBRE who specializes in life sciences real estate. "The pandemic poured more gasoline on the fire."

    • "People now more than ever are realizing we may need to be at the ready for something like this," he says.
    • That's goading established life sciences companies to come up with innovative therapies and vaccines, and giving rise to startups that bring a fresh perspective to public health issues.

    Biotech job openings are growing at their fastest pace on record, outpacing the notoriously hot tech sector, per a CBRE analysis of Bureau of Labor Statistics data.

    Certain metro areas are benefiting from this boom more than others, according to the CBRE report.

    • In Boston, lab vacancies are at 1.7%. Demand for lab space is so high that the city's "office market has become the envy of landlords across the country," the Wall Street Journal's Peter Grant writes.
    • New York's lab vacancy rate is 1.1%, and San Francisco's is 2.6%.

    And here's another new trend: Even though life sciences jobs have traditionally been located outside of cities — where there's ample inexpensive space for big labs and campuses — the strongest demand for lab space is actually in urban areas, says Ian Anderson, CBRE’s head of office research in the Americas.

    • Employment growth between 2017 and 2020 was 25% in Middlesex County, Massachusetts — which is composed of the Greater Boston suburbs — but 35% in Boston proper.
    • Growth was around 18% in San Mateo County, California, but nearly 92% in San Francisco.
    • There's nearly 0% growth in Suffolk County, New York — which encompasses the Long Island suburbs — but over 25% in Manhattan.

    The bottom line: "The whole industry is moving closer to where the intellectual capital is," Anderson says.

  • sam patrick posted an article
    Long term impacts of COVID-19 across the health care spectrum are still to be determined see more

    12.02.2021

    Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.

    The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.

    The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19[1]. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites[2]. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.

    Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.

    COVID-19 Resulted in an Acceleration of the Clinical Research Process

    When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s[3]. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV[4]. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine[5]. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future[6].”

    As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.

    A New Focus on the Clinical Research Participant

    Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial[7].

    Use of More Decentralized Clinical Research

    A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site[8]. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site[9]. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by  increasing both access to clinical trials and the overall diversity of trial participants[10].  Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective[11].

    Increased use of Digital Technology

    The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased[12]. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE[13]. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies[14].

    Is there a silver lining from COVID-19 when it comes to clinical trials?

    The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.

    For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.

  • sam patrick posted an article
    More than $750,000 investment will create 22 new jobs see more

    COLUMBIA, S.C. Belimed Life Science, Inc., a leading supplier of steam sterilizers and parts washers, today announced plans to establish operations in Charleston County. The more than $750,000 investment will create 22 new jobs.

    Founded in 2019 in Switzerland, Belimed Life Science, Inc. provides Current Good Manufacturing Practices (cGMP) sterilizers and washers for the pharmaceutical and biotech markets. Specializing in machine process solutions for cleaning and sterilization, the company supplies customers on a global scale.

    Located at 2154 N. Center Street in North Charleston, Belimed Life Science, Inc.’s new facility will provide product sales and support to the company’s North American customer base.

    Hiring is underway, and individuals interested in joining the Belimed Life Science, Inc. team should visit the company’s careers website.

     

    QUOTES

    “As a manufacturer of products used in the manufacturing process of life-saving vaccines and drug therapies, Belimed Life Science is excited to open our first U.S. site in Charleston, South Carolina. As the pharmaceutical and biotech industries continue to innovate for the benefit of all of us, the need for our products and services will continue to increase requiring future growth of Belimed Life Science. What better place to begin than here in Charleston.” -Belimed Life Science, Inc. President Ken Blankenship 

    “Today's announcement by Belimed Life Science, Inc. is another win for our state's booming life sciences industry and is further testament that South Carolina is an ideal place for life science companies to locate. We celebrate the life-saving work of Belimed Life Science, Inc., and we look forward to their success in South Carolina. -Gov. Henry McMaster

    “South Carolina's growing roster of life sciences companies proves that the state has the business environment in place to meet this industry's specific needs. And, with South Carolina's commitment to supporting research, training skilled workers and advancing supplier infrastructure, we’re an ideal location for companies like Belimed Life Science, Inc. to grow and thrive.” -Secretary of Commerce Harry M. Lightsey III

    “When an international company like Belimed Life Science, Inc. invests in Charleston County, it is a testament to our people and community. We have the proven workforce and business-friendly climate that is attractive to life science companies.” -Charleston County Council Chairman Teddie Pryor

     

    FIVE FAST FACTS

    • Belimed Life Science, Inc. is establishing operations in Charleston County.
    • The more than $750,000 investment will create 22 new jobs.
    • Belimed Life Science, Inc. is a leading supplier of steam sterilizers and parts washers.
    • Located at 2154 N. Center Street in North Charleston, S.C.
    • Individuals interested in joining the Belimed Life Science, Inc. team should visit the company’s careers website.

  • sam patrick posted an article
    First-rate infrastructure is one of the attractive facets of Charleston see more

    Life science businesses like Horizon Scientific depend on Charleston’s intermodal transportation infrastructure to deliver products to the marketplace by road, sea, air and rail. Continued investments in the metro area ensure they won’t be let down.

    First-rate infrastructure is one of the hallmarks of a thriving economy, with transportation something all businesses depend on. A well-functioning system of roads, railroads, seaports and airports facilitate the production and exchange of goods – the basic principle at the heart of most life science business models.

    One metro area of the US that has got it all is Charleston | South Carolina. Within the three counties (Berkeley, Charleston and Dorchester) that comprise Charleston, a highly efficient network of transportation infrastructure offers the global marketplace access to local businesses. The region’s central position between New York and Florida provides prime East Coast connections while also facilitating efficient transatlantic travel and transportation – including a nonstop British Airways flight to London Heathrow from Charleston International Airport.

    Click here to enjoy the complete article.

  • sam patrick posted an article
    The life sciences cluster in Charleston, SC -- and across the state -- is booming see more

    Compliments of CRDA and Investment Monitor

    Aligned by a shared vision for a healthier world, a united life sciences sector is a powerful thing. In the Charleston, South Carolina, market, strong synergies between new and established businesses, academic institutions and state-led initiatives provide prime opportunities for scientific innovation and business success. A growing cluster of life science companies prove testament to the power of the region’s networks.

    When considering possible locations for a new office, laboratory or manufacturing site, life science businesses will have a long checklist. This includes a provision of talent, access to markets, ease of transport and connectivity, quality of life and support from local government. When these elements come together an additional benefit is created: a thriving scientific ecosystem that generates a virtuous circle of advantages for businesses and their employees.

    The Charleston region’s ecosystem helps companies solve business challenges and mitigate risks. As a result, an increasing number of biotech and medtech manufacturers, research laboratories and service companies are calling the area home, giving birth to a burgeoning life sciences community and all the network effects that come with it. For companies seeking to enter or expand in the US, the professional economic development organization, Charleston Regional Development Alliance, exists to guide you through the process. The Alliance provides multiple services at no cost to the company.

    Click here to continue reading the entire article.

  • sam patrick posted an article
    South Carolina Company Offers Free Personalized Support to Purchasers see more

    Charleston-based health innovation company KOR Medical --which produces unique cannabinoid products designed to support physical and mental wellness through expert engineering coupled with an individualized approach -- launches its initial consumer product line of CBD, CBN and CBG product offerings across the United States today.

    To celebrate its nationwide launch, KOR is offering up to 30% off the valued price of its KOR System Bundle – a curated collection of Health, Sleep, Calm and Relief sprays, strips, and transdermal cream. The special can be purchased 24/7 online at www.KORmedical.com by using discount code LAUNCHDEAL at checkout. Shipping is included on each KOR System bundle, and consumers can also order KOR products individually.

    Aligning biology with science, KOR’s long-awaited and third-party tested Health, Sleep, Calm and Relief products include sprays, strips and transdermal cream which use a combination of various cannabinoids and advanced delivery techniques developed over years of research, analytics and testing to help consumers feel better both mentally and physically.

    Citing the mental and physical strain on American consumers of the last two years, KOR Medical products utilize the transformative power of cannabinoids to support mental and physical wellness by delivering the right amount for the right individual at the right time. Consumers across America are embracing cannabinoids given their potential as an alternative solution.

    KOR Medical has partnered with Leaf411™ to provide free, personalized support to customers, who can speak directly with a cannabis-trained registered nurse on cannabinoid use and applications.

    KOR Medical’s sublingual sprays, sublingual strips, and transdermal cream are formulated for targeted relief and quick onset. All sublingual products are nano emulsified to accelerate absorption rate within the body.

    All KOR Medical cannabinoid-based product offerings are manufactured in FDA-registered facilities and third-party lab-verified and represent the highest standards of science, innovation, patient experience, compliance, and customer service.

    The cannabis flower has a rich history of usage in the neuropathic industry dating back thousands of years, and produces over 100 cannabinoids including CBN, CBG and CBD – each a key component is KOR Medical products, and with unique benefits and effects. Today, medical researchers are continuing to explore if these molecules can impact anxiety, insomnia, chronic pain, anti-inflammatory diseases, seizures, and such diseases as Alzheimer’s and Parkinson’s disease.

    Visit KOR Medical at www.kormedical.com.

  • sam patrick posted an article
    New DNA-based approach may be wave of the future see more

    Compliments of Greenville Business Magazine

    If your doctor knew your risk for colon cancer or heart disease years before the disease developed, he or she could help you take steps to prevent it.

    And by collecting DNA samples from thousands of South Carolinians, the Medical University of South Carolina is embarking on a project which hopes to do just that. 

    In the initiative, which stakeholders call the first of its kind in the state, MUSC is partnering with population genomics company Helix to study DNA to drive a concept known as precision medicine. It allows providers and patients to develop health care plans with a more preventive approach.

    The power in precision medicine cannot be overstated, said Dr. Lori McMahon, vice president and associate provost for research at MUSC.

    “Genes are what make us who we are,” she told Integrated Media, publisher of Greenville Business Magazine, Columbia Business Monthly and Charleston Business Magazine. 

    “What we learn here … will influence care for individuals across the country and across the globe.” 

    The earlier genes associated with a disease are found, the better the chances of successful treatment, said Dr. Dan Judge, professor of medicine and cardiology at MUSC and director of cardiovascular genetics.

    Theoretically, this concept might have helped “Black Panther” star and Anderson, S.C., native Chadwick Boseman, he said.

    Boseman died last year of colon cancer at the age of 43, seven years before traditional colonoscopy screening typically begins, he said. 

    Had he learned through DNA testing that he had a propensity to develop the disease, that screening could have begun much earlier, perhaps in time to keep the cancer from progressing, he said.

    And a woman with a genetic predisposition to breast cancer might begin mammograms at an earlier age or get more sensitive MRIs instead, Judge said.

    “We hope we’ll be saving lives with this project,” he said. “That’s really the bottom line.”

    The project will focus on certain forms of cancer and cardiovascular disease initially, but hopes to expand to other diseases in time, McMahon said.

    Called “In Our DNA SC,” the project hopes to enlist 100,000 South Carolina adults – 25,000 a year for four years, Judge said.

    The initiative will start with MUSC patients who already have an electronic health record and an upcoming appointment, he said. They will get a message through MyChart to let them know they’re eligible. Later, it will expand across South Carolina.

    “It won’t be something that private physicians can order directly,” he said. “This program requires people to sign up through a review board process so that it’s gone through protocol, and safety and confidentiality issues are all addressed.”

    Similar programs have identified as many as one in 75 participants who were at risk for a serious health issue, 90 percent of which would not have been discovered through traditional practice, said Dr. James Lu, CEO and co-founder of California-based Helix, which describes itself as a population genomics company at the intersection of clinical care, research and genomics.

    “By expanding access and making genomic data actionable for health care providers,” he said, “we will be able to work in tandem with MUSC … to identify risk earlier and prevent or mitigate serious diseases for its community and beyond.”

    The popularity of companies like 23andme shows that people want to understand their genetics, McMahon said.

    “People are even buying DNA kits for their dogs,” she said.

    The genetic test is free to participants and involves only a saliva sample.

    Genetic counseling will be provided to patients whose DNA reveals a risk for disease so there can be further discussion of what it means for the patient and for family members who might be at risk as well, he said.

    In addition to the clinical component, the project has a research component that will develop a dataset to advance genomics research.

    It also will examine how genetic changes influence the development and progression of disease, McMahon said, and help in the development of new and better therapeutics. 

    For instance, some people respond to certain blood pressure medications while others don’t, but it’s not understood why.

    “This will help us try to understand the genetic basis for that,” she said, “and who may need alternate therapy.” 

    Caroline Brown, chief of external affairs at MUSC, said the hospital system and Helix took steps to ensure that patient data are secure. While the results are linked to the patient’s medical record so his provider has access to them, the information is de-identified for research purposes, she said.

    The genetic results will be entered into the participants’ medical records, like a chest X-ray or MRI results are, where they are available to insurers, Judge said.

    While there is a law called the Genetic Information Nondiscrimination Act that protects people from health insurance or employment discrimination on the basis of genetics, information in medical records can be used to deny life insurance or charge more for it, he said. Patients will be informed of that as part of the consent form for participation, he said.

    Brown said that as a state academic medical center, MUSC is focused on building its genomics prowess to ensure it can be a leader in precision medicine in the future. It chose to partner with Helix because of its established data analytics platform which is capable of large-scale projects like this, she said.

    “MUSC looked for a strategic partner to offer genetic testing that can be provided to the patient and his provider so they better know how their genetic makeup impacts their health,” she said. 

    MUSC has identified funding for the program, Brown said, but she declined to divulge the cost.

    McMahon said that when patients and providers are armed with genetic information, they can make better decisions about care going forward and push health care to a new level.

    “This is the way of the future,” she said.

    And Judge said he expects it will likely be routine within 20 years. 

  • sam patrick posted an article
    ZIAN, MUSC to commercialize new OR tool see more

    The Zucker Institute for Applied Neurosciences, a technology accelerator at the Charleston-based Medical University of South Carolina, said it will commercialize its surgical suction de-clogging tool.

    MUSC neurosurgeon Stephen Kalhorn, MD, invented the tool, named VayuClear, to address the problem of vacuum-assisted suction devices clogging during surgeries. These clogs, which occur as often as four to five times an hour, can take one to three minutes to de-clog or replace, but VayuClear is designed to de-clog surgical suctions in one to three seconds using pressurized saline. 

    "We commonly see clogged suction lines and suction tips during operations, leading to delays," Dr. Kalhorn said in a news release. "Delays in surgery are frustrating and mean more time under anesthesia for the patient."

    The technology already has received a U.S. patent, and it's on track to be FDA-registered and commercially available as early as mid-2022, according to the release.

    The accelerator has partnered with South Carolina company Medical Access Partners to commercialize the tool.

  • sam patrick posted an article
    Vigilent Labs Relocates to New Charleston, SC Facility to Meet Demand for COVID-19 Test Kits see more

    RYSE Asset Management, a United Kingdom-based global financial investment firm, has listed Vigilent Labs as an investment opportunity. RYE Asset Management invests in early-stage health data technology firms that demonstrate promising growth on a global scale. RYSE connects high-potential healthcare firms with established global distribution partners.

    The announcement came as Vigilent Labs announced the relocation of its Headquarters from the Charleston Navy Yard to 3860 Faber Place Drive, North Charleston. The 10,000 square feet of office and light manufacturing space will serve as its headquarters and East Coast manufacturing operations site to streamline with its international partners, SeroClinix and UniBiosciences (UBS), and meet the increasing demand for COVID-19 Antigen and Antibody test kits worldwide. Vigilent Labs is an advanced health and medical technology company providing solutions for the detection and identification of health and bio threats and diseases.

    Established in 2019, the company has an internationally renowned team of medical scientists, healthcare physicians, and business executives. The company offers FDA/EUA approved COVID-19 (and its variants) test kits, Influenza A, Influenza B, and Norovirus, and more.

    Vigilent Labs’ technology is unique, because test results can be loaded onto their proprietary v. Labs Platform© (VLMS), and leverage its v. Resolute Reader, lab in your hand that provides rapid and accurate screening results.

    John Falk, Founder & President of Vigilent Labs said, “We are beyond thrilled to have been listed by the prominent financial firm RYSE Asset Management; while, at the same time, our Leadership Team and Board has made the strategic decision to locate closer to the Charleston Airport opening other logistical channels for the current and future production and distribution of our test kits and devices throughout the United States and around the globe.”

    To learn more information: www.vigilentlabs.com

    To learn more information: www.ryseam.com

  • sam patrick posted an article
    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.