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  • sam patrick posted an article
    Will expand the chemical conglomerate’s production of flexible tubing for the medical industry. see more

    DuPont marked the opening of a new biopharmaceutical plant near Moncks Corner that will expand the chemical conglomerate’s production of flexible tubing for the medical industry. 

    The Liveo Healthcare Solutions manufacturing factory at the Charleston International Manufacturing Center near Moncks Corner employs 25 workers and is expected to double that number by mid-2024, according to Bill Alexander, site leader.

    The tubing that will be produced at the Berkeley County plant near the Cooper River can be used in medical devices such as catheters and intravenous bags.

    The facility is on property that DuPont originally purchased in 1970. It joins a sister plant in Hemlock, Mich.

    South Carolina Gov. Henry McMaster (sixth from left) joins officials from DuPont and local governments in a ribbon-cutting ceremony at DuPont’s Liveo Healthcare Solutions manufacturing campus Charleston International Manufacturing Center near Moncks Corner. DuPont/Provided

    DuPont previously said it spent about $66 million to reopen the empty factory in Goose Creek, which previously produced the company’s Kevlar-branded high-strength fabric used in bulletproof vests.

    “The Cooper River site will bring additional production capacity online over the next two years to serve strategic customers and expand our Liveo Healthcare Solutions customer base,” Eugene Toccalino, global business director for DuPont’s health care and specialty lubricants division, said in a written statement. “We’re committed to investing in our healthcare business, and this biopharma processing manufacturing investment ... is a key milestone in our growth strategy that will help us offer a highly reliable and sustainable product supply.”

    DuPont said it worked with local companies, including more than 40 subcontractors, on the expansion project. Gov. Henry McMaster and DuPont officials joined local government leaders in the July 28 ribbon-cutting.

    In addition to the Cooper River expansion, DuPont said it will add silicone tubing capacity in China during the second half of this year to meet growing needs in Asia.

    DuPont marked the opening of its Liveo Healthcare Solutions manufacturing facility in Berkeley County on July 28. The plant will make will tubing for medical devices. File/AP

    Wilmington, Del.-based DuPont arrived in the Charleston region more than half a century ago, when it bought about 2,100 acres at the end of Cypress Garden Road in 1970.

    Several years went by before it unveiled plans for a large manufacturing plant on 275 acres, where about 1,500 workers made a new variety of polyester called Dacron. The $266 million investment covered an area the size of seven football fields.

    But even before it was completed, the factory was already in trouble as the global market for synthetic fibers was becoming oversaturated. Also, polyester clothing began to fall out of fashion, and low-wage overseas rivals were able to sell the material at cheaper prices.

    DuPont eventually sold the Dacron business, but it also plowed money into other product lines in Berkeley County. A $167 million plant making resins under the Hytrel and Castrin brands was announced in 1997. DuPont announced in February that it is selling that division to Irving, Texas-based Celanese Corp. in a deal that’s expected to close by the end of the year.

    The company also shelled out $500 million to build its Kevlar plant in Berkeley County, but it shut the operation down after about six years because demand for the material fell well short of expectations. 

  • sam patrick posted an article
    Excellent Safety and Tolerability Profile for iNexin™ for the Treatment of Corneal Injury see more

    Xequel Bio, Inc., a clinical stage biopharmaceutical company developing ophthalmic and dermatologic therapeutics utilizing its patented new chemical entity aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide), announced positive results from its Phase 1b clinical trial with iNexin™ (aCT1 ophthalmic solution) for the treatment of corneal injury in patients with dry eye disease. The study demonstrated that iNexin was safe and well-tolerated at the doses tested, and early efficacy signals were observed.

    This Phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin for the treatment of corneal injury in patients with dry eye disease. There were no serious adverse events or dose-limiting toxicities associated with iNexin treatment. Improvements in both signs (e.g., corneal staining) and symptoms (e.g., ocular discomfort) of dry eye disease were observed within two weeks of treatment in both the environment and Ora’s controlled adverse environment (CAE®) model, which exacerbates signs and symptoms of dry eye disease in a safe and standardized manner for greater precision in predicting treatment efficacy.

    “These results support our belief that iNexin, our novel aCT1 ophthalmic solution, has the potential to improve patient outcomes by regulating the inflammatory response to promote improved ocular healing,” said Jerry St. Peter, Chief Executive Officer. “We are extremely pleased that the key goals of this study were met, providing clinical evidence of safety, tolerability, and also early signs of efficacy in patients with corneal injury. This data provides a strong basis to further refine our therapeutic focus and dosing regimen as we progress our ophthalmic development program, including designing our Phase 2 clinical trial.”

    Dr. Gail Torkildsen, MD, board certified ophthalmologist at Andover Eye Associates, said, “This study provides an initial look at the safety, tolerability, and potential biological activity of iNexin in treating dry eye disease, with a mechanism of action suggesting additional application in treating ocular injury and inflammation. The results are encouraging and indicate the potential for aCT1 to restore Connexin43, which plays a critical role in the inflammatory cascade. iNexin could represent an innovative solution to treat patients with corneal injuries by promoting healing and rebuilding healthy tissue through accelerated re-epithelialization.”

    This Phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin compared to Vehicle in patients with dry eye disease. A total of 36 participants, with a subject-reported history of dry eye disease in both eyes, were enrolled and randomized in a 2:1 allocation for each of three concentrations of iNexin (0.08%; 0.4%; 2.0% aCT1) to Vehicle (eye drop formulation without aCT1), administered bilaterally twice a day for 14 days. The primary objective of the trial was to evaluate the safety and tolerability of iNexin. The secondary objective was to compare the efficacy of iNexin to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.

    This trial was managed and monitored by Ora, Inc., a leading full-service ophthalmic drug and device development firm, and was supported by the Department of Defense Defense Health Program, Congressionally Directed Medical Research Program through Vision Research Program Award W81XWH-20-1-0879.

    About Xequel’s aCT1 Technology Platform

    Xequel Bio’s aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform is designed to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity, based on the C-terminal sequence of Connexin43, designed to selectively and reversibly inhibit protein binding of endogenous Connexin43 to key binding partners. Connexin43 plays critical roles in multiple aspects of the injury response, including spread of injury signals, extravasation of immune cells, granulation tissue formation and fibrosis. aCT1’s unique, targeted mechanism of action has been demonstrated to restore the coordination of cellular communication, reinforce junctional integrity and temper excessive inflammatory responses in injured tissues for optimal injury response and tissue repair. aCT1 is currently in clinical development for multiple indications across dermatology and ophthalmology, as well as in ongoing preclinical research in pulmonology.

    About Xequel Bio, Inc.

    Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. The Company also has ongoing preclinical research in pulmonology. For more information, please visit www.xequel.com.

    About Ora, Inc.

    Ora is the world's leading full-service ophthalmic drug and device development firm. For over 40 years, their expert teams have proudly helped clients across the globe earn more than 55 product approvals. Ora's unique methodologies and strategies have been proven across thousands of programs to maximize the likelihood of success and efficiently bring new products from concept to market. For more information, please visit www.oraclinical.com.

  • sam patrick posted an article
    Greenville County, SC company makes elite national list see more

    BioPharma companies have been making some huge strides over the last year with innovations driven by both established players and startups entering the scene. With an impressive 7.32% CAGR and a value of $325.17 billion in 2020 it is a huge industry ripe for growth.

    United States is home to a range of established and new BioPharma companies. With a strong foundation & a maturing regulatory space United States offers a wide range of opportunities for BioPharma companies. This list aims to showcase some of the top BioPharma companies and startups in United States focusing on companies with great track records, innovative products or huge future potential.

    Named to the 2022 list of Top Biopharma Start-Ups for the first time is Elastrin Therapeutics of Greenville, South Carolina.  Read the full list here.

  • sam patrick posted an article
    Xequel, formerly First String Research, adds top executives see more

    Xequel Bio, Inc. (formerly FirstString Research, Inc.), a clinical stage biopharmaceutical company developing dermatologic and ophthalmic therapeutics utilizing its patented new chemical entity aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide), announced today the appointments of Jerry St. Peter as Chief Executive Officer and Wes Brazell as Chief Financial Officer.

    “As we embark on a new corporate phase focused on clinical development and approval of novel treatments, we have brought in two seasoned executives, Jerry St. Peter, and Wes Brazell, to lead these efforts,” said Tony Bartsh, Chairman of Xequel’s Board of Directors and partner at Park West Asset Management. “Jerry’s proven track record in building successful, fully integrated biopharmaceutical companies, partnered with Wes’ financial management and operations expertise, provide the right combination to design and execute our strategic transformation. Both Jerry and Wes bring extensive corporate leadership, business development execution and entrepreneurial acumen to Xequel. With these exciting leadership appointments, we have also rebranded the organization from FirstString Research to emphasize our emergence as a growing biopharmaceutical company in late-stage clinical development.”

    “It is a pleasure to join Xequel at such a pivotal moment in its evolution,” said Jerry St. Peter, Chief Executive Officer and Board Member. “Our talented team of scientists and clinical development professionals have established a cutting-edge technology platform culminating in a robust pipeline of product candidates backed by strong preclinical and clinical research. We have also created a strong corporate identity under the Xequel Bio name, reflecting our strategic move into the Company’s next chapter.”

    “Our proprietary aCT1 technology platform provides tremendous opportunity to address unmet needs for patients in dermatologic and ophthalmic treatments. We have multiple, novel late-stage programs with near-term inflection points as well as preclinical research in other valuable target disease states. Wes and I look forward to working with our dedicated team to implement our growth plan, advance our pipeline, deliver meaningful patient outcomes and successful business results,” concluded Mr. St. Peter.

    The Company is in the process of developing a new corporate website and updated social media accounts reflecting the Xequel Bio name.

    Jerry St. Peter, Chief Executive Officer and Board Director

    Jerry St. Peter brings over 30 years of specialty biopharma executive leadership implementing strategic planning, commercial operations, financial management, fundraising, business development, and overall general management. Prior to joining Xequel, Mr. St. Peter was the Chief Executive Officer and President of Eyevance Pharmaceuticals (a Santen Company), a global ophthalmic company focused on serious, unmet treatment needs by developing innovative solutions that protect and restore vision. Mr. St. Peter was Co-founder, Chief Executive Officer, and Board Member of Eyevance Pharmaceuticals prior to its acquisition by Santen for $225 million in 2020. Established in 2017, Eyevance was a private equity backed venture solely focused on ophthalmic diseases that affect millions of patients every day. Prior to co-founding Eyevance, Mr. St. Peter was the Senior Vice President and Head of Sun Pharmaceuticals’ newly formed Ophthalmics division. Before Sun, he was the Executive Vice President and General Manager for Nicox’s Ophthalmic business in the United States and formerly served as the Senior Vice President and Head of the Ophthalmic division at Inspire Pharmaceuticals before Merck acquired Inspire for $450 million in 2011.

    Wes Brazell, Chief Financial Officer

    Wes Brazell brings three decades of leadership and expertise in pharmaceuticals and medical devices with broad experiences in operations management, financial management, business development, portfolio management, corporate finance, international operations and corporate strategy. Prior to joining Xequel, Mr. Brazell was Chief Financial Officer for Eyevance Pharmaceuticals, a private equity backed pharmaceutical company which was acquired by Santen for $225 million in 2020. Prior to Eyevance, Mr. Brazell was the Chief Financial Officer of TearLab, a NASDAQ-traded company focused on the marketing and development of tear related diagnostic products. Mr. Brazell previously spent 21 years in multiple financial management positions with Alcon, a multi-billion-dollar ophthalmology focused pharmaceutical and medical device company, including Vice-President of Finance for Alcon’s business in the United States, Vice-President of Finance for Alcon’s Europe, Middle East and Africa business as well as Vice-President of Corporate Financial Planning and Analysis.

    About Xequel’s aCT1 Technology Platform

    Xequel Bio’s aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform is designed to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity, based on the C-terminal sequence of Connexin43, designed to selectively and reversibly inhibit protein binding of endogenous Connexin43 to key binding partners. Connexin43 plays critical roles in multiple aspects of the injury response, including spread of injury signals, extravasation of immune cells, granulation tissue formation and fibrosis. aCT1’s unique, targeted mechanism of action has been demonstrated to restore the coordination of cellular communication, reinforce junctional integrity and temper excessive inflammatory responses in injured tissues for optimal injury response and tissue repair. aCT1 is currently in clinical development for multiple indications across dermatology and ophthalmology, as well as in ongoing preclinical research in pulmonology.

    About Xequel Bio, Inc. (formerly FirstString Research)

    Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. The Company also has ongoing preclinical research in pulmonology. For more information, please visit www.xequel.com.

    Source: Xequel Bio, Inc.

  • sam patrick posted an article
    Will identify and advance therapies for genetic diseases and cancers see more

    BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced three new academic collaborations with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh (Pitt) to translate cutting-edge discoveries into potential therapies for patients with genetic diseases and genetically driven cancers.

    "The chance to partner with exceptional researchers at the Medical University of South Carolina, Stanford University and University of Pittsburgh is a privilege, and we believe will help us advance our mission to discover, create, test and deliver life-changing medicines for patients in need as rapidly as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    To date, BridgeBio has worked with 23 leading institutions throughout the country that are focused on providing treatment options to patients as quickly and safely as possible. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    MUSC Foundation for Research Development
    MUSC Foundation for Research Development provides technology transfer services to Medical University of South Carolina (MUSC), which is a patient-centric research institution with several hospitals in South Carolina and is considered the state's top healthcare provider. MUSC's innovative and high-quality research will allow for early identification of research programs with a strong potential to be beneficial for patients. Through this partnership, BridgeBio may sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

    "Like BridgeBio, we have a patients first mentality, so partnering together on early research will be an excellent opportunity to advance our innovation in the hope of generating new therapies for patients," said Scott Davis, Ph.D., senior director of innovation support and commercialization of MUSC Foundation for Research Development.

    About BridgeBio Pharma, Inc.
    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

  • sam patrick posted an article
    Life sciences executive named to national NAMB Board see more

    Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.

    Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.

    “I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”

    NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19. 

    Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.

    “Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”

    A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.

    The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

  • sam patrick posted an article
    Robotics usage expands at Nephron see more

    Two years ago, Nephron Pharmaceuticals brought a problem to the engineering and pharmacy colleges at the University of South Carolina.

    When employees operating machinery at Nephron called in sick or otherwise couldn’t come to work, production is halted. Nephron CEO Lou Kennedy hoped the company and the two colleges could find a solution.

    Kennedy is no stranger to the university, having graduated from USC. She and her husband Bill also established the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.

    However, she had not been a part of a collaboration with the university that actually shifted the way the West Columbia drug manufacturer operates.

    After several classes of mechanical engineering students and pharmacy students worked to fix the problem, the project was finally completed this year— a robot named Smithers after The Simpsons character. The robot improves productivity by cutting out most of the human involvement in pre-filling sterile syringes with injectable medicines.

    While Nephron has faster robots than Smithers, they require more human intervention.

    “It just continues to make drugs without, frankly, a bathroom break or other things. So a steady machine, even if it’s slower, is better than people who haven’t shown up for the night and we have orders to fill,” Kennedy said.

    Despite increased automation, Kennedy said employment will not be hurt. Nephron is currently in a hiring surge, trying to fill 380 positions including sterile pharmacy technicians and automation engineers. This year, Nephron will open its state-of-the-art vaccine production facility as part of a $215 million expansion.

    “I can’t hire enough sterile pharmacy techs for what I need fast enough because of our growth, so this is just augmenting what we’re already doing— not to replace humans,” Kennedy said.

    The robot consists of four pieces of equipment, all designed by students, that work together to mimic the actions of a human pre-filling sterile syringes, according to Nephron’s chief of engineering and USC mechanical engineering professor Ramy Harik. Separate pieces pick up the syringes, complete the filling process and cap the syringes to seal them.

    Harik led three different teams of senior engineering students over two years to create the robot, while pharmacy students made sure the medical and sterilization aspects of the robot was safe for future human injection. The teams tested nearly ten different designs before finding one that worked.

    The machine, which was installed last week, is being validated for commercial use and should be up and running in a couple of weeks, said Kennedy. She has already ordered the parts to make another one to put into production and hopes to have several of them going at the same time one day.

    “My dream for the university is that we could commercially market these robots for hospitals around the world,” said Kennedy. “If we had the ultimate dream, it would be to sell these and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”

    From the partnership, Harik created a pharmaceutical manufacturing class at USC for the next semester, and Nephron donated the equipment needed for students in the form of a glass cleanroom. The room allows students to work in a sterile environment for pharmacy manufacturing.

    “Usually an entry-level engineer wouldn’t be given the opportunity to build an entire system from the ground up and it’s just been a great opportunity,” said John Diamond, one of the engineering students who started the project and now works at Nephron.

  • sam patrick posted an article
    Nephron expanding again in Columbia, SC see more

    Courtesy of SCBIZ News

    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.”

    Read the full article here, courtesy of Columbia Business Report

  • sam patrick posted an article
    Moderna vaccine results looking very good early see more

    The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.

    Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.

    Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.

    Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.

    Read the entire story here.

  • sam patrick posted an article
    South Carolina life sciences is booming, with new organizations growing and moving here see more

    Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  It’s a powerful force in today’s Palmetto State economy.  

    The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.  

    Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag.  Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.

    What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare.  An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.

    To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point.  Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.  

    Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.  

    SCBIO has become a catalyst for and voice of South Carolina life sciences.  From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.

    Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.

    And innovation is the lifeblood of progress.  For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.

    Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.  

    From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.

    Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level.  Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis.  Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.

    A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields.  ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.

    The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association —  is an important step in helping organizations share best practices and stimulate innovation.  

    Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital. 

    Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:

    • Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them; 
    • Accelerate best solutions through development and into commercialization; and 
    • Scale startups and networks to drive investment and job creation across South Carolina and Georgia. 

    With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.

    As American poet Robert Frost penned:

      “The woods are lovely, dark and deep, but I have promises to keep, 

       And miles to go before I sleep.”

    Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources.  With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter

     September 28, 2020
  • sam patrick posted an article
    Market is currently valued at $770 million see more

    Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).

    Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.

    “We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”

    Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”

    About Upsher-Smith

    Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.

    As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.

    About AmbioPharm

    AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.

    https://www.upsher-smith.com/news/upsher-smith-and-ambiopharm-announce-partnership-agreement-to-develop-and-market-corticotropin-injection/

  • sam patrick posted an article
    Partnership Reduces Barriers to Testing, Provides Top Quality to Customers see more

    Compliments of MidlandsBiz

    Partnership Reduces Barriers to Testing, Provides Top Quality to Customers

    Nephron Pharmaceuticals Corporation, one of the fastest-growing pharmaceuticals companies in the country, announced a new collaboration with Methapharm.

    As a part of this collaboration, Nephron will produce kits of methacholine chloride sterile inhalation solution in ready-to-administer concentrations for bronchoprovocation challenge testing, when diagnosing respiratory illnesses, such as asthma.

    “Methapharm will be a fantastic partner,” said Nephron CEO Lou Kennedy. “Patients deserve access to the very best respiratory tests available, that’s what this collaboration will offer, and that’s why we are looking forward to working with Methapharm.”

    Working together with Methapharm, Nephron will be able to supply stable room temperature solution kits, ensuring that testing facilities can continue to rely on the quality and reliability of Provocholine for their bronchoprovocation testing needs.

    “Through this partnership with Nephron, Methapharm continues its mission to help reduce barriers to testing, provide the level of quality our customers expect, and contribute to better healthcare outcomes for our patients,” said Craig Baxter CEO of Methapharm. “We’ve been impressed by Nephron’s capabilities and professionalism.”

    Provocholine® is the only FDA-approved methacholine chloride powder for use in humans. Methapharm, the manufacturer of Provocholine, has always tried to be responsive to needs of our testing partners. For example, in response to the revised ERS technical standard, Methapharm initiated a comprehensive nebulizer characterization study to support the recommendation of PD20 as a clinical endpoint. This was published in a technical bulletin earlier this year.

     

    Nephron

    A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.

  • sam patrick posted an article
    New leadership named at helm of BIO see more

    The Executive Committee of the Biotechnology Innovation Organization (BIO) and its Board of Directors have announced the appointment of Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020.  

    "With her background as a scientist and physician, her health policy and experience in federal government, her leadership within industry as a champion of scientific progress, her commitment as an advocate for patients, and her gifts as a communicator, Dr. McMurry-Heath is the right person at the right time to lead us into the future," the official announcement released today stated.

    Dr. McMurry-Heath is a coalition-builder and change agent who comes to BIO from Johnson & Johnson (J&J). She served in numerous senior leadership roles at J&J since 2014, most recently serving as Vice President of External Innovation, Global Leader for Regulatory Science and Executive Director of Scientific Partnerships for JLABS @ Washington, D.C. There, she led a large global team charting the evidence generation and regulatory strategy across J&J’s medical device companies. And she worked to knock down regulatory barriers that were hindering the ability of small innovators to partner and grow.

    Prior to her work at J&J, Dr. McMurry-Heath served in scientific leadership roles at the FDA from 2010 to 2014. Her driving purpose at the FDA was to devise strategies to incorporate the patient point of view into FDA decision-making and develop new ways for patients to collaborate with innovators.

    BIO’s incoming leader is a clinician-scientist with experience working at the bench in molecular immunology. She is the first African-American to graduate from Duke’s Medical Scientist Training Program, receiving an MD/PhD in immunology along the way. While Harvard-educated, she was raised in the San Francisco Bay Area – one of the great epicenters of biotechnology.

    Throughout her impressive career, Dr. McMurry-Heath has been focused on the social impact of medicine so that more people in our society can benefit from its transformative potential. She led health and science policy on Capitol Hill for Senator Joe Lieberman, where she drafted legislation to protect the country from biological attacks, and then went on to sharpen her policy skills at the Robert Wood Foundation.

    Dr. McMurry-Heath will become just the third leader of BIO since our organization’s founding in 1993. She will succeed a towering figure in our industry, the Honorable Jim Greenwood, who for 16 years has built the most consequential biotechnology advocacy organization in the world.  Mr. Greenwood was a champion of the cause even before he was BIO's leader, reforming the FDA and fighting for broad acceptance of stem-cell science during his 12 years of principled, pragmatic leadership in the United States Congress.

    As BIO’s leader, Mr. Greenwood has brought incomparable political and policy acumen to bear on the needs of our industry. During his tenure at BIO and as the United States built an innovation ecosystem that is the envy of the world, he played a pivotal role. After he hands over the reins on June 1st to Dr. McMurry-Heath, he has committed to work with her and will stay on in a strategic advisory role. The industry and BIO are grateful for his outstanding leadership, professionalism and continued contribution.

  • sam patrick posted an article
    Softbox Systems honored with national recognition see more

    Tempcell® ECO, the latest sustainable innovation from Softbox Systems, a global provider of temperature control packaging for the life science industry, has been recognized by Fast Company’s 2020 World Changing Ideas Awards—honoring companies, products and ideas that are making the world a better place.

    According to John Hammes, General Manager of the America’s for Softbox Systems, Tempcell ECO’s innovative design addresses the challenges the pharmaceutical sector and the world face around plastics while offering the ease of curbside recycling for the end user. 

    “In the temperature-controlled shipping container space, we continue to push towards a more sustainable future - Tempcell® ECO is an innovative corrugated cardboard packaging system that protects temperature-sensitive life-science products and the planet,” he said. “It’s good for the pharmaceutical industry, great for the environment, and an even more sustainable solution for the world.”

    Launched in the US in January 2020, Tempcell® ECO offers the pharmaceutical sector a 100 percent curbside-recyclable temperature control packaging system to support a more sustainable future for customers, consumers and the planet.

    Made of the most reusable material on the planet, Tempcell® ECO is made from 100 percent recycled corrugated cardboard, and capable of being repurposed seven times over. This innovative packaging system saves end users from costly or unsustainable disposal, and drastically helps reduce pharmaceutical companies’ carbon footprint.

    Using its own innovative corrugated cardboard insulating technology, Softbox Systems created Thermaflute™, a patent-pending design that is qualified against industry accepted test profiles. It is able to control temperature sensitive products with wide stability data in different temperatures ranges between +2°C to +25°C.

    In combination with a number of temperature-regulating cool packs, layers of cardboard fluting are engineered to create an insulating barrier to protect life-enhancing, temperature-sensitive pharmaceutical products during shipping. The fit-for-purpose design maintains a shipment’s internal temperature for up to 72 hours and is light, strong and versatile, ideal for all parcel delivery networks.

    In partnership with American Forests, Softbox Systems pledges to plant one tree for every 10 Tempcell® ECOs sold in the United States. This equates to three trees being planted for each one used in production. Through the sale of Tempcell® ECO in the first quarter of 2020, Softbox Systems has already enabled American Forests to plant more than 20,000 trees.

    The World Changing Ideas Awards entries were judged on the key ingredients of innovation: functionality, originality, beauty, sustainability, user insight, cultural impact, and business impact.

    “There seems no better time to recognize organizations that are using their ingenuity, resources, and, in some cases, their scale to tackle society’s biggest problems,” says Stephanie Mehta, editor-in-chief of Fast Company. “Our journalists, under the leadership of senior editor Morgan Clendaniel, have uncovered some of the smartest and most inspiring projects of the year.”

    Now in its fourth year, the World Changing Ideas Awards showcase 26 winners, more than 200 finalists, and more than 500 honorable mentions—with Health and Wellness, Corporate Social Responsibility, and AI and Data among the most popular categories. A panel of eminent judges selected winners and finalists from a pool of more than 3,000 entries across transportation, education, food, politics, technology, and more. The 2020 awards feature entries from across the globe, from Vancouver to Singapore to Tel Aviv.

     

    About the World Changing Ideas Awards

    World Changing Ideas is one of Fast Company’s major annual awards programs and is focused on social good, seeking to elevate finished products and brave concepts that make the world better. A panel of judges from across sectors choose winners, finalists, and honorable mentions based on feasibility and the potential for impact. With a goal of awarding ingenuity and fostering innovation, Fast Company draws attention to ideas with great potential and helps them expand their reach to inspire more people to start working on solving the problems that affect us all.

    About Softbox Systems

    Softbox Systems 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 North America, Latin America, Europe, India and Asia Pacific.

    Softbox Systems has 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 commercialized products.

  • sam patrick posted an article
    SCRA added three advisory groups for biomedical sciences, cybersecurity and industry see more

    Summerville, S.C.—South Carolina Research Authority (SCRA) announces the formation of three Business and Science Advisory Boards (BSABs). The purpose of the BSABs is to advise SCRA’s Board of Trustees when requested by it. The boards include representatives from South Carolina research universities, the venture capital/angel investment community, South Carolina Department of Commerce, and industry leaders in the following areas:

    1. Biomedical Sciences
    2. Cybersecurity
    3. Industry 4.0

    Each board provides key business and technical expertise, acts as an independent/ unbiased sounding board for input on SCRA’s program implementation and performance and provides guidance to SCRA regarding funding opportunities. One upcoming funding opportunity on which the BSABs will advise is the SCRA-Academia Collaboration Team (SACT) Collaborative Research Grants. These grants will be available for multi-institutional, collaborative research teams that seek to advance commercially relevant research and address key industry challenges to foster technology-enabled growth of the state’s innovation economy. The solicitation will be released in June.

    “SCRA serves as a bridge between industry and academia. It is imperative that the applied research SCRA funds benefits not only its academic stakeholders, but also South Carolina’s industrial base. The development of the BSABs ensures that the new SACT program achieves those objectives for both stakeholder groups,” said Christine Dixon Thiesing, SCRA Director of Academic Innovations.

    The SCRA fuels South Carolina’s innovation economy by accelerating technology-enabled growth in academia, entrepreneurship and industry. SCRA works with public and private sectors, including industry, to identify market trends and validate the commercial relevance of academic research that SCRA funds. SCRA’s programs and operations had an almost $700 million impact on the state’s economy during the last fiscal year.

     

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    About SCRA

    http://www.scra.org

    Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, SCRA fuels South Carolina’s Innovation Economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.