DPX Technologies has invested more than $2.5 million and announced an expansion in Columbia, SC see more
Columbia, SC – DPX Technologies, a manufacturer of laboratory consumable products, has invested more than $2.5 million and announced an expansion in Columbia, SC. The biotechnology company purchased and renovated a 12,000 sq. ft facility on 5 acres in the SCRA Carolina Research Park.
DPX manufactures patented sample preparation products and specializes in custom workflows for a diverse client base including clinical, forensic, food safety, and pharmaceutical industries. Their products offer sample preparation solutions that are compatible with semi-automated and fully automated liquid handling systems. This enables high sample throughput and high laboratory efficiency.
SCBIO Strategic Partner SCMA Financial Services has changed their brand name. see more
SCMA Financial Services, a full-service brokerage and consulting firm that has served the health care community of South Carolina for 25 years, will now operate as Fulcrum Risk Solutions. The new name reflects the firm’s expansion to provide innovative risk management solutions to all industry sectors throughout the Southeast.
“Today’s successful companies need customized risk management plans to help stabilize costs and improve employee wellbeing,” said Fulcrum Risk Solutions President Brian Morris. “Our holistic approach to risk management goes beyond just saving organizations money. At Fulcrum, we leverage our decades of experience working for and with health care professionals to ensure that your entire organization understands your wellbeing goals and can work to achieve them.”
Greenwood, South Carolina's globally recognized genetics center is further investing... see more
Greenwood Genetic Center has invested more than $1.75 million in laboratory equipment and a new on-site aquaculture facility that the organization says is the largest zebrafish facility in the state.
The new equipment includes a NovaSeq DNA sequencing system and a confocal microscopy system. The Illumina NovaSeq 6000 System offers high-throughput sequencing across a broad range of applications. The NovaSeq also meets the research needs of both the center and the Clemson Center for Human Genetics. Read the full news release here.
A Columbia, SC-based biotech firm has introduced a new INTip solution with a proprietry design... see more
Columbia, SC – DPX Technologies announces a new INTip solution that utilizes a proprietary design for micro-elution dispersive solid phase extraction. DPX INTip solutions are designed to simplify sample preparation methods, and the μElution dSPE tip provides an automated solution for optimal sensitivity.
“The μElution dSPE tips were developed as an addition to the dSPE product line, that give our customers the ability to reduce elution volumes and increase sensitivity for downstream analysis,” said William E. Brewer, Ph.D., Founder and CEO of DPX Technologies. “DPX micro-elution methods eliminate solvent evaporation and reduce the challenges for sample preparation of high throughput, high sensitivity assays.”
FDA head Scott Gottlieb has resigned in an unexpected move see more
WASHINGTON, March 5 (Reuters) - U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a sudden resignation that calls into question how the agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs.
Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars.
Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S. consumers and had the agency actively looking into possible solutions.
EUROPEAN MARKETING CLEARANCE RECEIVED FOR MACIMORELIN see more
CHARLESTON, S.C., Jan. 16, 2019 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX: AEZS) announced that the European Medicines Agency (EMA) has granted marketing authorization for macimorelin, an orally available ghrelin agonist, for diagnosis of adult growth hormone deficiency (AGHD). The approval came following the Committee for Medicinal Products for Human Use (CHMP) positive opinion of macimorelin on November 15, 2018.
“Clinical studies have demonstrated that macimorelin is safer and much simpler to administer than the current methods of testing for insulin-induced hypoglycemia, and is well-tolerated by patients and reliable in diagnosing the condition,” said Dr. Christian Strasburger, the Head of Clinical Endocrinology at Charité Unversitaetsmedizin Berlin and the principal investigator for macimorelin. “Both patients and healthcare-providers will undoubtedly welcome the general availability of macimorelin and I believe that macimorelin will become the generally accepted new reference procedure for diagnosing adult growth hormone deficiency.”
AGHD may occur in an adult subject who has a history of childhood onset growth hormone deficiency (GHD) or may occur during adulthood as an acquired condition. Considering a population of 510 million for the European Community, research based on incidence prevalence suggests that at least 35,000 adults could be afflicted with GHD.
“The EMA approval of macimorelin further validates the value of the product and will assist in our efforts to create value for our shareholders from macimorelin,” said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris.
Macimorelin stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company focused on developing and commercializing, principally through out-licensing arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor agonist, to be administered in the diagnosis of patients with adult growth hormone deficiency. Aeterna Zentaris is a party to a license and assignment agreement with a subsidiary of Novo Nordisk A/S to carry out development, manufacturing, registration and commercialization of Macrilen™ (macimorelin) in the United States and Canada. For more information, visit www.zentaris.com.
This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully launch the product, the ability of Aeterna Zentaris to enter into out-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, reliance on third parties for the manufacturing and commercialization of our product candidates, potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, and, more generally, uncertainties related to the regulatory process, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our products, the impact of securities class action litigation or other litigation on our cash flow, results of operations and financial position, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
Michael V. Ward
Chief Executive Officer
Aeterna Zentaris Inc.
MUSC Health to build, operate new rural hospital in South Carolina see more
MUSC Health, the clinical enterprise of the Medical University of South Carolina, has signed a letter of intent with Lake City Community Hospital and Williamsburg Regional Hospital that authorizes MUSC to construct, own and operate a new $50 million replacement hospital. The new hospital will be a 25-bed critical access facility, providing care through traditional on-site delivery as well as through virtual visits via the extensive MUSC Telehealth Network.
Critical access hospitals serve small, rural populations and receive cost-based adjusted reimbursements for Medicare services. These cost adjustments help to stabilize rural hospitals, making them less vulnerable to financial issues. The cost-based reimbursements also improve access to much-needed health care, ensuring that essential services are available and sustainable in rural communities.
The new MUSC Health facility will serve the health care needs of the Lower Florence County Hospital District, other areas of Florence, residents of Williamsburg County, as well as neighbors from other adjacent counties. When the new MUSC facility opens, both Lake City Community Hospital and Williamsburg Regional Hospital will transfer all operations for inpatient and outpatient services to the new MUSC hospital.
"Maintaining and expanding access to health care in rural areas across our state is a challenge that my administration is committed to addressing head on," said Gov. Henry McMaster. "With tremendous partners like MUSC, the innovation and creativity that is required to succeed in this endeavor is on full display. We can all be encouraged by what today's news means for the future of health care in Williamsburg and Florence counties, and grateful for what MUSC's commitment to seeing a healthier South Carolina means for our future."
“MUSC is charged with preserving and optimizing the health of the people of our state through education, research and patient care,” said MUSC President David J. Cole, M.D., FACS. “To fulfill our mission, we must be ready to serve patients across the expanse of the Palmetto State, not just in urban areas.”
“Through our many affiliations with community and regional hospitals, and through our extended telehealth network, MUSC Health has established meaningful, life-saving collaborations and outreach across the state,” said MUSC Health CEO Patrick J. Cawley. M.D. “The restoration of a critical access hospital in this rural community and the added connectivity to MUSC specialists and resources will benefit the lives of everyone in the area.”
“We are excited by the Medical University of South Carolina’s continued commitment to rural health care and I am hopeful that this partnership will preserve and improve access to vital primary and critical care services in the region,” said Joshua Baker, director of the South Carolina Department of Health and Human Services. “We are proud to support this rural transformation endeavor and continue our commitment to improving the health of all South Carolinians.”
A replacement hospital is desperately needed in Williamsburg County due to the October 2015 thousand-year floods in Kingstree, S.C., the county seat of Williamsburg and location of Williamsburg Regional Hospital. More than three years ago, some 31 inches of rainfall caused massive flooding throughout the area. Torrents of water inside the hospital building, multiplied by standing water and black mold, damaged the Williamsburg Regional Hospital building beyond repair, rendering the structure unsafe and unusable.
Determined not to abandon the citizens of Williamsburg County and the surrounding area, the leadership and providers of Williamsburg Regional Hospital have been operating a temporary hospital to serve patients since April 2016. Modular housing units serve as emergency, exam and other patient care rooms; however, a long-term solution had to be found.
“This collaboration with MUSC opens the door to a new model for rural health care, one that leverages telehealth and advanced practice providers,” said Julie Floyd, chair of the board for Williamsburg Regional Hospital. “This partnership is the right step to take for the state and for our friends and neighbors in the city and region.”
Like many other rural health care facilities, Lake City Community Hospital has also experienced financial challenges. Its leaders are working diligently to balance the uncertainties of the future with the need to expand access to health care for its citizens. For small community hospitals, the threats to long-term viability are all too real due to significant declines in both rural populations and hospital admissions.
“Our hospital has always maintained a focus on delivering the best care available to our patients and families,” said Scotty Campbell, chair of the board for Lake City Community Hospital. “To extend that focus, we must recognize the added value that MUSC Health brings to the equation. Collaborating on a new hospital to serve our friends and neighbors is the most logical, productive and fiscally responsible solution possible.”
The people served by Lake City Community Hospital and Williamsburg Regional Hospital have a history of social, economic and, to some degree, political connections dating from pre-revolutionary war times to present day. The concept of establishing a new hospital facility to serve the patient base of both community hospitals has been discussed periodically since the 1950s when the two community hospitals were being created. Bringing these discussions to fruition appears to be the most appropriate method to meet the needs of both hospitals and their patient base most effectively.
Funding options for the new MUSC Health facility in the Williamsburg and Florence communities are currently being explored. The location for the new hospital has not been finalized; however, several options are under review. Construction of the new hospital is expected to take between 24 and 36 months, thus the opening date is projected as fall 2022.
At this juncture, no decisions have been made about the disposition of either of the old hospital buildings in Kingstree and Lake City. In the coming months, leaders from MUSC, Lake City Community Hospital and Williamsburg Regional Hospital will be involved in the decision-making.
MUSC works diligently to fulfill its mission through prudent financial management, dedicated philanthropic support and strategic business growth. Roughly 60 percent of all MUSC Health patient care revenues are generated from statewide communities outside of the Tri-county area, while the remaining 40 percent of patient care revenues are driven by services delivered within the tri-county market (Charleston, Berkeley and Dorchester counties).
Multimillion-dollar grant to support heart health research at Clemson University see more
Clemson University bioengineers picked Valentine’s Day to announce $4.1 million in grants to support new heart health research.
Will Richardson and Naren Vyavahare are conducting research with the potential to affect millions of patients who suffer from many forms of cardiovascular disease and related illness, including heart failure, hypertension, chronic kidney disease and Type 2 diabetes, according to a university news release.
Richardson, an assistant professor of bioengineering, is creating computer models aimed at providing better treatment for cardiac fibrosis, a condition that contributes to heart failure. As many as 60% of patients die within five years of developing heart failure, which afflicts 6.5 million Americans, Richardson said in the news release.
No drugs have been approved to treat cardiac fibrosis specifically, and doctors are often left with trial-and-error experimentation when treating patients who have it, he said in the release.
Richardson said he hopes his research will lead to a day when measurements from a patient’s blood or tissue sample can be plugged into mathematical equations based on how molecules interact in the body. Overnight, patients would have personalized risk assessments and treatments plan, he said in the release.
Details about his research is available online.
Vyavahare, the Hunter Endowed Chair of Bioengineering, is working on what could be the first treatment to reverse vascular calcification, a condition that occurs when mineral deposits build up on blood vessel walls and stiffen them, according to the news release. It is most prevalent in aging patients and those with chronic kidney disease and Type 2 diabetes, Vyavahare said. Complications from vascular calcification can range from hypertension to death.
The nanoparticles that Vyavahare is developing are many times smaller than the width of a human hair and would deliver two medicines to calcified blood vessels. One medicine would remove the mineral deposits that cause blood vessels to become calcified, and another would return elasticity to the blood vessels.
More details about his work is online.
The Richardson and Vyavahare projects were both funded through the National Institutes of Health’s R01 program. Richardson is receiving $1.9 million, and Vyavahare is receiving $2.2 million, the news release said.
Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, congratulated Richardson and Vyvahare on their grants.
Agneta Simionescu, an assistant professor of bioengineering, has also received $1.38 million through the R01 program. The Simionescu award was announced in November and is aimed at better understanding cardiovascular disease in patients with diabetes, the news release said.
Richardson and Simionescu were among the faculty members trained as part of SC BioCRAFT, a National Institutes of Health Center of Excellence. The center’s primary goal is to increase the number of South Carolina biomedical researchers who are supported by grants from the National Institutes of Health.
Vyavahare leads SC BioCRAFT, which stands for the South Carolina Bioengineering Center for Regeneration and Formation of Tissues.
Medtronic partnering with MUSC to improve patient outcomes in healthcare see more
CHARLESTON, S.C., AND DUBLIN – Medtronic plc (NYSE:MDT) and the Medical University of South Carolina (MUSC) today announced a five-year value-based health care partnership intended to transform and improve care for patients in South Carolina. The collaboration will focus on developing solutions that improve the health outcomes and care experiences for patients while also reducing costs.
More than three million South Carolinians have at least one chronic disease such as cardiovascular disease, and the projected total cost of chronic disease between 2016-2030 in South Carolina is $687 billion. The initial focus of the partnership will be on addressing chronic diseases and acute conditions prevalent in South Carolina.
“Together with MUSC, we are committed to fundamentally improving the way patient care is delivered,” said Omar Ishrak, Medtronic chairman and chief executive officer. “Medtronic has a long history of collaboration with health care providers to invent and develop new markets to solve a variety of clinical problems. The partnership with MUSC is an extension of that collaboration, as we look to systematically work together to develop scalable programs aimed at improving patient outcomes while reducing the cost of care.”
Medtronic and MUSC are committed to jointly creating and deploying new programs that will drive better outcomes for patients while reducing costs. For example, the two organizations plan to standardize a comprehensive vascular disease care pathway across the entire continuum of patient care, ultimately implementing a model for the identification, diagnosis, treatment and follow-up care of patients with vascular disease who can benefit most from therapy. This evidence-based model is designed to help clinicians identify and treat patients earlier in their disease progression.
The two organizations also plan to implement a standardized care pathway program for joint replacement patients that addresses the bundled payment methodology implemented by the Centers for Medicare and Medicaid Services (CMS). The episodic care pathway intends to establish best practices and streamline processes to improve the quality of care for patients while reducing costs. Similarly, Medtronic and MUSC also plan to standardize care pathways designed to reduce adverse events and optimize care for patients who are at risk for respiratory compromise, or who need a tracheostomy procedure for breathing assistance.
The partnership also creates a unique opportunity for MUSC to build upon existing curriculum to educate future health care professionals about value-based health care.
“This strategic partnership with Medtronic is based on our shared vision and drive to lead the transformation of health care delivery,” said MUSC President David J. Cole, M.D., FACS. “It’s about providing what’s best for our patients. The mutual goal of our organizations is to deliver the best patient outcomes at the lowest cost possible. That’s the true meaning of value-based health care. Through our collaborative partnership, we plan to combat chronic disease and address community health needs in South Carolina and beyond. We look forward to an innovative and productive relationship with Medtronic and will share tangible results of our efforts as our strategic partnership evolves.”
Both MUSC and Medtronic have networks of like-minded partners focused on advancing value-based health care in the United States. This month, Medtronic is celebrating its one-year anniversary of a partnership with Lehigh Valley Health Network in Allentown, Pennsylvania, designed to find ways to improve patient care across more than 70 major medical conditions, focusing on value. The partnership progress at Lehigh Valley Health Network is generating blueprints to help implement and scale value-based programs at MUSC.
In August 2018, MUSC announced a strategic partnership with Siemens Healthineers designed to create a blueprint of a transformed health care system that provides safe, equitable, timely, effective, efficient and patient-centered care.
MUSC and Medtronic will explore opportunities to cross-share learnings with their respective partners and collaborate to improve patient outcomes while reducing costs.
About Medical University of South Carolina (MUSC)
Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and 750 residents in six colleges (Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing, and Pharmacy), and has more than 14,000 employees, including approximately 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $2.6 billion, with an annual economic impact of more than $3.8 billion and annual research funding in excess of $275 million. MUSC operates an 800-bed medical center, which includes a nationally recognized children’s hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (a National Cancer Institute-designated center), Level I trauma center, Institute of Psychiatry, and the state’s only transplant center. In 2018, for the fourth consecutive year, U.S. News & World Report named MUSC Health the number one hospital in South Carolina. For more information on academic programs or clinical services, visit musc.edu. For more information on hospital patient services, visit muschealth.org.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take health care Further, Together.
SCBIO's expanded Board of Directors includes life sciences leaders from across South Carolina see more
Organization’s Boards spans state, industry segments to provide unique blend of expertise for advancing South Carolina’s life sciences industry
GREENVILLE, SC – February 8, 2019 – Less than two years after initiating a comprehensive relaunch of the state’s official life sciences organization, SCBIO has expanded its Board of Directors for its 501c6 operational entity and added a second 10-member Board for its 501c3 research and educational arm for 2019. It does so having authored the state’s first-ever life sciences strategic growth plan, conducted an economic impact study validating the contributions of the $11.4 billion industry, tripled revenues and quadrupled membership – all since Spring 2017.
And according to SCBIO President and CEO Sam Konduros, the best and most exciting days for the industry and organization are still ahead of it.
“In a state perhaps best known for building BMWs and Boeing Dreamliners, there is a very strong life sciences story brewing as well, creating opportunities to diversify and accelerate growth of our state’s knowledge economy,” said Konduros recently. He further cited rapid growth of such national and global brands including Nephron Pharmaceuticals, Arthrex, ZEUS, Abbott, Thorne and AVX as just a few examples of the state’s rapidly rising life sciences industry, which currently spans more than 400 companies in 44 counties and employs over 15,000 well-paid associates.
Leading the policy- and strategy-making efforts of the 501c6 entity of the non-profit organization, the Board of Directors meets regularly to receive updates on SCBIO business objectives, domestic and global initiatives, and to help hone strategies and offer insight. Nephron Pharmaceuticals Corporation CEO Lou Kennedy will serve as SCBIO’s 2019 Board Chair; Stephanie Yarbrough, Womble Bond Dickinson, LLP as Vice Chair; Michael Rusnak, Medical University of South Carolina Research Foundation as Treasurer; and Josh Ridley of ZEUS as Secretary.
Jeff Stover of Haynsworth Sinkler Boyd, PA will serve as Legal Officer; Heather Simmons Jones of the Greenwood Partnership Alliance as Annual Conference Officer; Bryan Davis of Prisma/Greenville Health System’s Office of Innovations as Healthcare/Innovation Officer; Adam Hoots of DPR Construction as Talent/Workforce Officer; and Sam Konduros, President and CEO of SCBIO.
Recently added members of the SCBIO Board of Directors are:
Mike Briggs – President & CEO, Central SC Alliance
Caroline Brown – Director of External Affairs, Medical University of South Carolina
Thornton Kirby – President & CEO, South Carolina Hospital Association
Adam Klonecke – Senior Site Director, Abbott
Angie Leidinger – VP of External Affairs, Clemson University
Tom McKenna – Chief Operating Officer, Thorne
Robert Ryan – CEO & Founder, Innova Therapeutics
Dave Shalaby – President, Poly-Med, Inc.
Will Williams – President & CEO, Economic Development Partnership (Aiken)
Cynthia Young – Dean, Clemson University College of Science
Returning members of the SCBIO Board for 2019 are:
Mandy Brawley – South Carolina Department of Commerce
Matthew Couvillion – Wyche Law Firm
John J. Darby – Johnson & Johnson Services
Tressa Gardner – SE Institute of Manufacturing & Technology
Mike Graney – Charleston Regional Development Alliance
Chad Hardaway – University of South Carolina Office of Economic Engagement
Will Harms – Blue Cross Blue Shield of SC
Erica Jackson – K&L Gates
Marc Metcalf – Upstate SC Alliance
Kathy Phlegar – Phlegar & Associates
Christine Dixon Thiesing – SCRA
Courtney Warren – Marsh & McLennan Agency
Comprising the smaller Board of SCBIO’s 501c3 research and educational arm are Kathryn Becker of Translational Science Solutions; Michael Bolick of Treis Blockchain; Matthew Couvillion of Wyche Law Firm; Shontavia Johnson of Clemson University; Steve Johnson of SCRA; Chris Przirembel, retired Clemson University executive; Shawn Regan of Rhythmlink; Craig Walker of Hitachi Healthcare Americas; Erica Jackson of K&L Gates; and SCBIO CEO Sam Konduros.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in advanced medicines, medical devices, diagnostics, IT, and healthcare outcome industries.
SCBIO is the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations. SCBIO members include academic institutions, biotech companies, med-tech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.
KIYATEC Adds Oregon Health & Science University as Study Site for Landmark Clinical Validation TrialKIYATEC and OHSU initiate patient enrollment into key oncology clinical trial. see more
GREENVILLE, S.C.-- KIYATEC, Inc., today announced that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors.
In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.
At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.
“As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable,” said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. “Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic.”
“With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care,” said Matthew Gevaert, CEO of KIYATEC. “We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work.”
The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on https://clinicaltrials.gov/ct2/show/NCT03561207.
About KIYATEC, Inc.
KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to therapies before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.
SCBIO's Morgan Nichols is a STEM advocate, marketing guru and Miss America candidate. see more
CLEMSON, South Carolina – When Morgan Nichols takes the stage at the Miss South Carolina pageant this June, she will fulfill a dream – but maybe not the kind viewers would expect.
Nichols was recently named Miss Clemson and her excitement about the opportunity to showcase her passion for Science is evident in her platform “Stronger with STEM,” which inspires students to stick with STEM through exploration, education, and innovation.
Nichols is a Lexington, South Carolina, native and a senior in the College of Science‘s department of genetics and biochemistry. With a minor in business, she is blazing a career path that she is defining along the way.
SCBIO's Membership & Marketing intern is an emerging voice for life sciences in South Carolina. Read the full story here.
MUSC Foundation for Research Development and Cumberland Emerging Technologies Announce Collaboration AgreementMUSC, Cumberland Emerging Technologies collaborate to develop biomedical products see more
The technology transfer organization for the Medical University of South Carolina, the MUSC Foundation for Research Development, and Cumberland Emerging Technologies Inc. have entered into a collaboration agreement to develop new biomedical products.
Consistent with their longstanding commitment to biomedical innovation and translational research, CET and the MUSC Foundation for Research Development have agreed to collaborate on future co-development programs that combine the strengths of each institution with the goal of advancing new technology to clinical practice. Under the agreement, CET will evaluate MUSC discoveries, license intellectual property rights to promising technologies, and partner with MUSC research scientists to advance product development toward commercialization. CET will pursue new sources of funding for these projects through the Small Business Technology Transfer and Small Business Innovation Research and other grant programs. New development programs are expected to span a variety of therapeutic areas including oncology, inflammatory diseases, and cardiovascular disease.
"Our office receives over 100 product ideas a year, most of which require an industry partner to be further developed," said Michael Rusnak, the executive director of the MUSC Foundation for Research Development. "We are very enthusiastic about having Cumberland as a collaborator to aid in getting technologies to market and ultimately to the patient."
"We are very pleased to have the opportunity to partner with the MUSC Foundation for Research Development to develop technologies invented at MUSC, a nationally-recognized biomedical research institution," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals and CET. "We are excited to facilitate the introduction of promising new products by combining our expertise in drug development and commercialization with the MUSC's research initiatives."
Grant to fund creation of the South Carolina Medical Device Alliance to invent and develop products see more
SCRA has been awarded approximately $750,000 in federal grant funding by the U.S. Economic Development Administration (EDA) as part of the 2018 Regional Innovation Strategies Competition. The grant will fund the creation of the South Carolina Medical Device Alliance to invent and develop products and bring them to market. This partnership, comprised of Clemson University, the Medical University of South Carolina and industry leaders, will form a regional innovation cluster to grow the economic impact of the medical device industry through job creation and startup formation, as well as to attract international businesses to establish a presence in South Carolina. The project total is $1,814,846, which includes the federal grant funding and matching funds.
“We are honored to be one of forty recipients nationwide,” said Christine Dixon Thiesing, SCRA’s Director of Academic Programs. “This program will serve South Carolina’s academic institutions and clinical innovators to overcome challenges inherent in the commercialization of medical devices. Building the medical device sector will also diversify South Carolina’s economy strategically by leveraging the existing skilled workforce and fostering a broader range of job opportunities for its workers.”
The Office of Innovation and Entrepreneurship, housed within the U.S. Department of Commerce’s Economic Development Administration, leads the Regional Innovation Strategies Program to spur innovation capacity-building activities in regions across the nation.
“MUSC’s Foundation for Research Development (FRD) is excited to be partnering with SCRA on this project,” said Michael Rusnak, Executive Director of FRD. “This gives MUSC one more vehicle to advance medical device technologies through our company startup activities; a substantial win for local economic development and more importantly, patients.”
To learn more about the South Carolina Medical Device Alliance, including the scope of work and key personnel click here.
SCRA is a state-chartered organization that fuels South Carolina’s innovation economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.
Learn about South Carolina Life Sciences Feb. 20! see more
Industry subject matter experts to cover what businesses need to know
about life sciences, South Carolina’s fastest-growing industry segment
GREENVILLE, SC – February 4, 2019 – SCBIO will host a full day program February 20, 2019 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.
To be held at the University of South Carolina’s Alumni Center in Columbia, the program will run from 8:30 a.m. until 4:30 p.m. and will feature a light breakfast followed by presentations from over half a dozen noted life sciences industry leaders. Confirmed presenters and their topics are:
- Tushar Chikhliker, Partner, Nexsen Pruet, “Pharma Industry Challenges Opportunities & Legal Insights”
- Kathy Phlegar, Principal, Phlegar & Associates, “Product Development and Commercialization: The Changing Landscape of Bringing MedTech Products to Market”
- Maureen Thomas, National Institute on Aging/National Institutes on Health, “Early Stage Funding: Accessing SBIR-STTR Capital”
- Erica Jackson, Partner, K&L Gates, “Navigating the FDA: An Overview of Medical Product Approvals and Enforcement Trends”
- Dave McGlashan, Life Sciences Team Architect, DPR Construction, “Optimizing Capability & Efficiency in Your Life Sciences Facility”
- Darralyn Alexander, President, Reimbursement Strategies – “How To Gain Reimbursement For My New Technology”
- Sam Konduros, President & CEO, SCBIO – “South Carolina Life Sciences 2019: A Look Forward”
SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations pay only $50 for the entire day. Individual Members of SCBIO pay only $50 for the entire program, while the general public and Non-Members can attend for just $125. To register or for more details, visit the Events page at www.SCBIO.org/.
An additional highlight of the day’s program on “Early Stage Funding: Accessing SBIR-STTR Capital” will be when presenter Maureen Thomas is joined for discussion and open Q&A by Tyler Tatum and Ron Gorman of 3PhaseSC – South Carolina’s only free resource for SBIR/STTR grant consulting. Attendees may also schedule 1-on-1 time for afternoon discussion with Ms. Thomas between 1:15 PM and 3:30 PM for more detailed conversation and guidance.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.
SCBIO is also the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations. SCBIO’s diverse membership is leading research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.
For additional information on SCBIO, visit www.SCBIO.org.