South Carolina Life Sciences Conference to Feature J&J Innovation Leader Michal Preminger, Over 40 National SpeakersSCBIO 2019 Conference Draws Speakers, Takes Center Stage October 29-31 see more
Conference registrations soar with sell-out expected; CEOs and top industry leaders from 30 states and countries expected in Greenville for strategic partnership development, industry insights
SOUTH CAROLINA – September 11, 2019 – Johnson & Johnson Innovation Leader Michal Preminger will join more than 40 additional national speakers at SCBIO 2019 – the annual conference bringing top leaders and executives from life sciences organizations across the state and nation to South Carolina October 29-31.
Following an October 29 welcome reception showcasing downtown Greenville, Ms. Preminger will address an expected sold-out conference at the Hyatt Regency with a keynote presentation entitled “Innovation for a Better Tomorrow” as the main program gets underway the morning of October 30. Her presentation will be followed by a high-powered panel comprised of regional healthcare executives entitled “Optimizing the Future of Healthcare in SC and Beyond.”
Among other featured Conference programs are EY’s “NextWave Wellness: An Interactive View of the Future of Our Industry”, and an address by South Carolina Lieutenant Governor Pamela Evette entitled “South Carolina: Just Right for Life Sciences.” Clemson University President Jim Clements headlines Day 2 with an address entitled “The Power of Partnerships in Fueling Life Sciences”, while Medtronic global executive Christian Howell will address “Driving Value-Based Care Through Collaboration".
Scores of top industry chief executives, leaders in government and higher education, biotechnology and pharma executives, clinicians and researchers, and industry supporters from across America have already registered to attend SCBIO 2019, with registration nearly doubling the record-setting pace of 2018. Other committed speakers and panelists include IQVIA Institute of Health Data Science SVP Murray Aitken, Innova Therapeutics CEO and Founder Robert Ryan, ChartSpan CEO & Founder Jon-MIchial Carter, Firststring Research President Dr. Gautam Ghatnekar, Nephron Pharmaceuticals CEO Lou Kennedy, USC President (Ret.) Harris Pastides, PhRMA Senior Regional Director Thomas Hardaway and numerous others. More than 20 programs will be featured over two days.
Themed “Ignite The Future!”, the 2+ day conference draws attendees from across America for networking, innovation updates, opportunity discovery, partnership making and strategic discussion. Committed attendees include officials across a broad spectrum of life sciences industries including medical devices, bio manufacturing, drug discovery, pharmaceuticals, diagnostics and testing, digital health and health IT, bio-ag and more. Space is limited and advance registration is still available at https://www.scbio.org/cpages/register-now-for-scbio-2019.
SCBIO is South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has a $12 billion economic impact in the Palmetto State, with more than 670 firms directly involved and over 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotechnology products.
SCBIO 2019 kicks off Tuesday evening October 29 with a Grand Opening Reception for conference registrants, speakers and sponsors at Greenville’s ONE Center, presented by Prisma Health. Wednesday will feature a complete day of sessions beginning at breakfast and continuing through an evening reception presented by the Greenville Area Development Corp., Greenwood Partnership Alliance and City of Greenville. The conference will conclude Thursday at lunchtime.
“Life sciences is a major driver of South Carolina’s economy, and this conference’s growth is testament to the industry’s surging impact, reach and rapidly rising economic significance in our state and region,” noted SCBIO President and CEO Sam Konduros. “Already accounting for thousands of highly-skilled jobs in the Palmetto State, this sector has tremendous growth potential, and we’re excited to showcase the top companies, research universities and leaders from across our state and country at SCBIO 2019.”
Among leading biotech and med-tech industry brands participating in the conference are Nephron Pharmaceutical, BIO, Johnson & Johnson, AVX, PhRMA, Medpoint, AdvaMed, Poly-Med, VWR, Ritedose Corporation, Rhythmlink, SoftBox Systems, ZEUS, Patheon Thermo Fisher and more. All of South Carolina’s research universities – MUSC, Clemson and the University of South Carolina – are represented, as are major healthcare systems, and economic development entities including the South Carolina Department of Commerce, SCRA, the Upstate SC Alliance, the Charleston Regional Development Alliance, Central Carolina Alliance, Economic Development Partnership and SiMT.
As the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations – along with PhRMA and AdvaMed, SCBIO members include academic institutions, biotech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products that transform how we heal, fuel and feed the world. For additional information on SCBIO, visit www.SCBIO.org.
Two SC organizations have launched a new investment fund designed to boost health care innovation see more
GREENVILLE, South Carolina — Two leading South Carolina organizations have launched a new investment fund designed to boost health care innovation in the state. The Clemson University Division of Research and the Health Sciences Center (HSC) at Prisma Health recently signed agreements to fund up to $200,000 per year in grants through the new Innovation Maturation Fund.
The health care-focused grants are intended to advance the development and implementation of new medical initiatives, advance translational science, create job and educational opportunities, improve health care and drive economic growth in the region.
“This is an important step to support health sciences research in our state,” said David Sudduth, vice president and chief operating officer of the Health Sciences Center at Prisma Health. “While we have a strong history of academic, research and innovation partnership in the Upstate through the Health Sciences Center, this is the first of what we hope will be many grant-making opportunities designed with our academic partners in order to support our community.”
“Pairing Clemson University’s health research and bioengineering capabilities with Prisma Health’s industry-leading clinical environment provides an incredible opportunity for the development of medical technologies and initiatives that will improve health care for South Carolinians and many others,” said Tanju Karanfil, Clemson University vice president for research. “I am excited to see the ideas and impactful innovations that stem from this partnership.”
The fund will be managed by the Clemson University Research Foundation (CURF), which manages the process of moving Clemson’s hundreds of innovative technologies from the laboratory into commercial markets. CURF has awarded more than $870,000 in maturation funds to Clemson researchers across academic disciplines since the launch of a similar fund in 2014. Those funds have led to startup companies, new technologies available for license and follow-on research investments.
The new Innovation Maturation Fund — launched in cooperation with the HSC and Prisma Health — is the first such fund targeted exclusively toward researchers in the health sciences.
“We look forward to working with Prisma Health to leverage this fund to advance promising medical technologies from ideation through initial phases of translational product development,” said Chris Gesswein, executive director of CURF. “By identifying and targeting unmet clinical needs early in the research process, we have a wonderful opportunity to impact successful downstream commercialization of technologies developed and matured through this Innovation Maturation Fund.”
Prisma Health clinicians, Clemson research faculty and graduate students are eligible for grant funds. Applications for the first round of grants will be accepted this fall. For more information, click here.
Innovation Maturation Fund Partners
The Clemson University Research Foundation (CURF) is an independent 501(c)3 organization and was created to support the Clemson University research enterprise, guiding Clemson researchers through the technology transfer process by identifying, protecting, and developing university intellectual property. CURF is committed to creating a sustainable model for research by connecting Clemson researchers to external organizations and identifying opportunities for research collaboration to feed back into Clemson University.
The Health Sciences Center at Prisma Health is a collaboration between Prisma Health, Clemson University, Furman University and University of South Carolina. Located on the Greenville Memorial Medical Campus, this nationally recognized center seeks to bridge the gap between academics, research, clinical practice and health care transformation in a way that is innovative, inter-institutional, interprofessional and interdisciplinary. Regional community, education and business leaders also participate in the Health Sciences Center’s shared governance.
Prisma Health, a not-for-profit health company, is committed to excellence in patient care, clinical research and teaching the next generation of medical professionals. Our organization – South Carolina’s largest private employer – was formed when Greenville Health System and Palmetto Health joined together in late 2017, officially becoming Prisma Health in January 2019. With 32,000 team members (including volunteers), 18 hospitals and over 300 physician practice sites, we serve more than 1.2 million patients annually – about a quarter of the state’s population. Our goal is to improve the health of all South Carolinians by enhancing clinical quality, the patient experience and access to affordable care. Our cardiovascular, neuroscience, OB/GYN, oncology and orthopedic programs attract patients throughout the region. Also noteworthy are our two renowned children’s hospitals, comprehensive diabetes care and extensive primary care network. Ultimately, we are dedicated to transforming the health care experience for our patients and families, our team members and guests by bringing our purpose to life: Inspire health. Serve with compassion. Be the difference. Learn more at PrismaHealth.org.
Greenville, SC gains more accolades as a key cog in the state's emerging knowledge economy see more
Greenville and South Carolina are in the national spotlight again as among America's emerging knowledge economy destinations. SCBIO supporters Zylo Therapeutics, KIYATEC, VentureSouth and Chartspan are among the features companies in Bloomberg Businessweek's fabulous article. Read on for the full story.
South Carolina Life Sciences Industry Honors Commerce Secretary Hitt, Abbott's Tom Strange, Nephron Pharmaceuticals for Leadership, Contributions to IndustrySC Commerce's Bobby Hitt, Abbott's Tom Strange, Nephron saluted by SCBIO see more
Nearly 350 industry leaders on hand to salute inaugural honorees for commitment to advancing South Carolina’s booming life sciences industry
NOVEMBER 2, 2018 – To resounding applause from a record gathering from 4 countries, 22 states and virtually every county in South Carolina, life sciences leaders saluted three leaders – two individuals and one organization – for profound positive impact and exceptional contributions to the advancement of South Carolina’s $11.4 billion life sciences industry.
South Carolina Secretary of Commerce Robert M. “Bobby” Hitt III was presented with the inaugural South Carolina Life Sciences Hall of Fame Award for his personal championing of the life sciences industry, which today 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 biotechnology products. SC Commerce is a Founding Partner and strategic supporter of SCBIO, and has been highly instrumental in helping the rapid growth of life sciences in the Palmetto State.
Mr. Hitt has served as South Carolina Secretary of Commerce since January 2011. Promoting a team-first approach to economic development, Hitt has positioned the S.C. Department of Commerce and its many partners and allies for industry recruitment success. Since 2011, Team South Carolina has recruited more than $35 billion in capital investment and approximately 125,000 new jobs to the state. This year alone, multiple world-class companies have made significant investments in South Carolina, including BMW, Samsung and Volvo Cars. Before his time as Secretary of Commerce, Hitt served as manager of Corporate Affairs at the BMW Manufacturing Company in Spartanburg County after 17 years as managing editor of The State and Columbia Record newspapers.
Presented with the inaugural South Carolina Life Sciences Pinnacle Award for Individual Contribution to the industry was Tom Strange, Senior Director of Research & Development for Abbott Labs in Liberty, South Carolina. With an extensive background in materials science, Mr. Strange holds 48 patents and has authored numerous papers covering all aspects of capacitor development. He began his illustrious career with Philips Components in 1979 leading research activity involving development of capacitors that made thoracic implantable cardioverter defibrillators possible. Today, with over 20 years at St Jude Medical/Abbott, his team continues to define state of the art in implantable medical devices for pacing and arrhythmia correction, neuromodulation and battery performance.
Honored for his exceptional industry-related contributions and profound impact on the state, its citizens and the life sciences industry, Mr. Strange led efforts to establish SC Launch!, the public/private initiative with the SC legislature to fund start-up activities in SC under SCRA, and helped to launch SCBIO as an affiliate of the national BIO organization. He holds numerous honors and awards, and earned undergraduate and graduate degrees in Physics from the University of South Carolina.
Presented with the inaugural South Carolina Life Sciences Pinnacle Award for Organizational Contribution to the industry was Nephron Pharmaceuticals of West Columbia, represented by owners Lou and Bill Kennedy. A Vision Partner of SCBIO, CEO Lou Kennedy joined Nephron Pharmaceuticals in 2001, and was named President/CEO in 2007. She led the creation of a state of the art manufacturing facility in West Columbia in 2014, and oversaw development of a national sales force which helped Nephron grow by 300% and increased shipped product to over one billion doses annually.
Honored for Nephron’s economic, innovation, social and quality of life impact in the state, the Kennedy’s helped establish the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy. Ms. Kennedy serves on or chairs numerous boards including those of SCBIO, the SC Chamber of Commerce, the National Bank of South Carolina, and the South Carolina Manufacturers Alliance.
The three honorees joined BIO global CEO Jim Greenwood and more than 50 additional national speakers at SCBIO 2018 – the annual conference which brought top leaders and executives from life sciences organizations across the state and nation to Charleston, South Carolina October 23-25.
Included among attendees were scores of top industry chief executives, leaders in government and higher education, biotechnology and pharma executives, clinicians and researchers, and industry supporters from across America including DePuy Synthes Global Orthopedic Leader I.V. Hall, J.P. Morgan Executive Director of Healthcare Investment Banking Bell Zhong, MUSC President David Cole, USC President Harris Pastides, Siemens Healthineers North Americas President Dave Pacitti, and numerous others.
SCBIO is South Carolina’s investor-driven economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion 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 biotechnology products.
“The life sciences industry is a major driver of South Carolina’s economy, and these noted honorees and this conference is testament to the industry’s growing impact, reach and rapidly rising economic significance in our state and region,” noted SCBIO President and CEO Sam Konduros. “We’re pleased to honor them for their many contributions, and salute them for the advances they have facilitated for this industry.”
As the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations – SCBIO members include hundreds of academic institutions, biotech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products that transform how we heal, fuel and feed the world.
For additional information on SCBIO, visit www.SCBIO.org.
MUSC and Siemens Healthineers Form Strategic Partnership to Disrupt and Reshape Health Care DeliveryMUSC, Siemens Healthineers craft extraordinary agreement to advance healthcare see more
The Medical University of South Carolina and Siemens Healthineers have formed a first-of-its-kind strategic partnership with the mutual goal of advancing the quality of health care in South Carolina. The partnership will capitalize on the coupling of MUSC’s clinical care, research and education expertise with Siemens Healthineers’ engineering innovations and workflow-improvement capabilities.
“We are leveraging a longstanding relationship to reshape what we can both deliver in health care,” said David J. Cole, M.D., MUSC president. “Our nation is demanding that we address our fractured, costly and inefficient health care delivery systems. As the leading academic health sciences center in this state, MUSC’s purpose must be to drive the highest quality care for our patients at the lowest cost through commitment and partnerships. In discussions with the Siemens Healthineers team, we discovered a high degree of alignment with these concepts, and we are very excited to have them move forward with us. Our mutual goal is to not merely provide the best care possible for just our patients; we will define the new gold standard for others to follow.”
Specifically, this new agreement will focus on driving performance excellence at MUSC and generating significant clinical and value-driven innovations in focused target areas including pediatrics, cardiovascular care, radiology, and neurosciences.
“Ultimately, our goal is to enable health care providers to get better outcomes at lower cost. We will achieve that by empowering MUSC clinicians on this journey through four specific areas of focus – expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing health care,” said Dave Pacitti, president of North America for Siemens Healthineers. “These four core values of Siemens Healthineers are representative of the goals of our strategic relationship with MUSC, and we hope that the spirit of this flagship partnership will initiate a trend in value based care within the industry.”
USC sets record for research funding see more
University of South Carolina faculty have again broken their previous record-high external funding by garnering $278.6 million in research and sponsored awards in fiscal year 2019 (July 1, 2018 through June 30, 2019). FY2019 was the fifth consecutive year of record-breaking funding totals, beating the previous record of $258.1 million, set in fiscal year 2018, by 8 percent.
UofSC Vice President for Research Prakash Nagarkatti said, “Sustained growth of this magnitude does not happen by accident. By making strategic investments in our exceptional scholars and our infrastructure, the University of South Carolina is building a research community characterized by innovation and excellence that has made and will continue to make an enormous positive impact on our state, nation and world. I am so honored to work with such outstanding faculty, students and staff, who continue to raise the bar year after year.”
Vice President Nagarkatti credits strategic internal investments in research and infrastructure with helping to generate the growth that has increased research and sponsored awards totals for each of the past five years. The Advanced Support for Innovative Research Excellence, or ASPIRE program, provides an example of how internal programs that fund meritorious research and multi-user infrastructure generate strong returns on investment. Since its inception in 2012, ASPIRE has provided $16.1 million to fund 597 faculty and postdoctoral scholar research projects in subject areas from art to mathematics and from medicine to library science. Past ASPIRE recipients have garnered more than $171.2 million in subsequent extramural funding, including $71.8 million in funding that was directly attributable to groundwork laid with an ASPIRE award. This represents more than a four-fold direct return on investment.
USC, Nephron partner to improve safety through automation see more
Nephron Pharmaceuticals Corporation has joined forces with the University of South Carolina's College of Engineering and Computing and the College of Pharmacy to design and implement an automation process that significantly boosts production of pre-filled medication, reducing the physical burden on workers and increasing patient safety.
Traditionally, pre-filled syringes are filled by hand in clean-room environments. In recent years, federal regulations governing sterile compounding have become more stringent and complex as a result of accidental contaminations. The use of robots to compound prescription products exceeds those new federal guidelines and provides a more sterile environment with better accuracy and precision than traditional methods of compounding.
The research collaboration with Nephron will position UofSC to develop state-of-the-art sterile compounding methods benefiting hospitals throughout South Carolina and the nation.
“Demand for pre-filled medication has exploded in recent years, and our company is responding to the market needs for affordable and accessible life-saving medications in pre-filled syringes,” said Nephron CEO Lou Kennedy. “We are excited to partner with innovative students and leading researchers from Engineering and Pharmacy at the University of South Carolina to meet the demands of hospitals and patients, and we look forward to working together for years to come.”
To help Nephron meet the market demand, the College of Engineering and Computing and the College of Pharmacy have finalized plans to build a fully functional sterile compounding lab at the McNAIR Aerospace Center. This fully functional, first-of-its-kind compounding suite will offer students the opportunity to learn and develop the techniques of sterile, robotic manufacturing processes for human drug compounding.
Between the College of Engineering and Computing and the College of Pharmacy, well over a dozen undergraduate, graduate and doctoral students are involved in the project. Utilizing a state-of-the-art robot from UofSC corporate partner Yaskawa Motoman Robotics, as well as Process Simulate — a Siemens software package included in its $628 million gift to McNAIR Center and to the College of Engineering and Computing in 2017 — these students are learning skills that will immediately translate to increased job opportunities upon graduation.
“This team is a unique collection of talents, not just from engineering but with advisers from the College of Pharmacy and partners from Office of Economic Engagement as well,” said Ramy Harik of the McNAIR Aerospace Center, who leads the project design team. “By bringing together a cross-disciplinary team, and constantly seeking feedback from Nephron engineers and pharmacists, our students are building a real-life application that, when completed, will be implemented in production. Particularly for our undergraduate students, this type of impactful research experience is invaluable.”
The Nephron project is a continuation of an ongoing university partnership with the company. When Nephron Pharmaceuticals Corp. opened its manufacturing campus in West Columbia in 2015, proximity to the flagship research university was an important factor. Owned and operated by UofSC alumni Lou (’84) and Bill (’66) Kennedy, whose $30 million endowment created The Kennedy Pharmacy Innovation Center (KPIC) in the College of Pharmacy in 2010, Nephron has found success by meeting the increasing demand for pre-filled medications at medical facilities nationwide.
“Our engagement with industry leaders like Nephron is key to helping our students gain important knowledge and experience while solving real-world problems,” said UofSC President Bob Caslen. “By tapping into our research expertise, our corporate partners can bring innovative products to market, which grows their businesses and the state’s economy. That ensures more opportunity for all South Carolinians and furthers our university system’s mission of service.”
Nephron is a certified woman-owned business and one of the fastest-growing pharmaceutical companies in the country. In 2017, they added a $12.5 million, 36,000-square-foot expansion to its manufacturing facility so they would be strategic in meeting the U.S. drug shortages. By partnering with UofSC students and researchers, Nephron seeks to fully automate parts of the syringe-filling process.
Vikor Scientific names new CSO see more
CHARLESTON, S.C. (PRWEB) AUGUST 07, 2019
Bill W. Massey, Ph.D. will be joining Vikor Scientific™ as Chief Scientific Officer to provide scientific leadership for Vikor’s molecular diagnostic and therapeutic management services, lead Vikor’s clinical research efforts related to their strategic alliances in the pharmaceutical and healthcare industries and continue to develop their model of personalized healthcare.
"I am very excited to be joining Vikor Scientific at this crucial point in their growth and evolution. They have an incredible vision to step beyond the traditional model for clinical laboratory services and to become the premier provider of therapeutic management services. This transition to becoming a partner with providers and healthcare organizations in the delivery of optimal, personalized care is paradigm changing and will set the standard for coordinated diagnostics and collaborative care," said Dr. Massey.
Dr. Massey is a world-renowned neuropharmacologist, pharmacogeneticist, life sciences professional, inventor and entrepreneur. Dr. Massey received his Ph.D. in Pharmacology at the University of Arkansas for Medical Sciences and subsequently an investigator at the Pritzker School of Medicine’s Drug Abuse Research Center at The University of Chicago. Dr. Massey holds long-standing adjunct faculty appointments at the University of Arkansas for Medical Sciences (Associate Professor, Dept. of Pharmacology and Interdisciplinary Toxicology) and the University of Mississippi Medical Center (Clinical Assistant Professor, Dept. of Psychiatry).
Dr. Massey has held leadership positions at Merck, Astra Merck, Quintiles, Scirex, Astra Zeneca, Scientific Commercialization, Litmus Molecular Design, SureGene, and GeneAlign. He has played a leadership role in placing 28 new drugs into human testing and 8 new drugs onto the market. Dr. Massey formerly held the Jack Martin, MD Research Professorship in Psychopharmacology at Vanderbilt University, where he conducted research into the genetics, biological basis and pharmacological treatment of schizophrenia and serious mental illness in collaboration with Dr. Herbert Y. Meltzer. Dr. Massey is currently a Visiting Scholar at the Feinberg School of Medicine’s Dept. of Psychiatry and Human Behavior at Northwestern University where he continues his research collaboration with Dr. Meltzer.
Dr. Massey has been a leader in the field of pharmacogenetics and personalized medicine for over two decades. Dr. Massey invented an easy-to-use combinatorial pharmacogenetic algorithm that makes clinical use of PGx practical for any physician and is currently patenting a direct-to-consumer product for weight loss.
KIYATEC advances published in Scientific Reports see more
KIYATEC, Inc. today announces that results from its prospective, multi-center pilot study, to investigate their assay’s predictive accuracy and correlation to outcome among newly diagnosed ovarian cancer patients, have been published in Scientific Reports. Study findings represent both a preliminary clinical validation for the company’s ovarian cancer assay and a significant developmental milestone for the assay’s technology platform, known as Ex Vivo 3D Cell Culture (EV3D).
“For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes,” said Matthew Gevaert, CEO of KIYATEC. “Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care.”
In the study, primary tissue from 92 newly diagnosed ovarian cancer patients were prospectively collected and tested for response to National Comprehensive Cancer Network (NCCN)-recommended frontline chemotherapy drugs at KIYATEC’s central laboratory. Assay results were successfully generated for 83 (90%) patient samples. All 92 patients received standard of care chemotherapy (80% adjuvant, 20% neoadjuvant) independent of the KIYATEC drug response prediction test result.
A total of 44 patients (of the 83 patients tested) met minimum follow-up time of 6 months post-chemotherapy for inclusion in this publication. The KIYATEC assay successfully predicted responders (i.e. platinum sensitive) and non-responders (i.e. platinum resistant) with an accuracy of 89% (39/44, p<0.0001).
Investigators also assessed assay accuracy and correlation to outcome among the 35 of 44 (80%) patients who received adjuvant chemotherapy. In this cohort, the KIYATEC assay correctly predicted responders and non-responders with 89% accuracy (31/35, p=0.0004). From date of surgical debulk, progression free survival (PFS) among test subjects predicted to respond to the first line chemotherapy they received was over 20 months v. 9 months for patients predicted not to respond (p=0.01).
“At present, clinicians have no way of knowing, prior to treatment, which of our newly diagnosed or relapsed ovarian cancer patients will respond or not to approved drug therapies,” said Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC), and an author of the study. “To predict a complex future result with very high accuracy is a meaningful achievement, especially given that sometimes these outcomes take months to define. Similar test performance in larger, follow-on studies would establish this as a go-to tool in cancer drug selection that should help improve patient outcomes in ovarian cancer.”
Based on these promising findings, KIYATEC has opened a prospective, pivotal clinical study, 3D-PREDICT (NCT03561207), in 500 patients to further validate EV3D-enabled clinical assays for newly diagnosed and recurrent ovarian cancer (8-drug panel) and glioblastoma (12-drug panel). The study is currently open to enrollment.
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.
SC life sciences seeks to maintain Medicare Part B see more
South Carolina's life sciences industry has signed on in support of the Part B Access for Seniors and Physicians (ASP) Coalition’s efforts to continue protecting the Part B program and patient access to Part B medicines. This letter, complete with 104 signers, was sent to Chairman Grassley, Ranking Member Wyden, Leader McConnell, Minority Leader Schumer, and the entire Senate Finance Committee.
The final version can be downloaded and read here. We will keep you up to date as we receive any comments or feedback on this important issue.
Life sciences booming in Charleston, across South Carolina see more
By Dustin Waters, Charleston Business
With almost 30 new residents moving to the region every day, Charleston County has no difficulty attracting talent and businesses. Instead, the main concern locally is maintaining a balance between industry and quality of life that keeps the region’s economic engines humming.
“I think it’s safe to say that manufacturing is alive and well. It accounted for about 33 percent of what’s going on,” says Steve Dykes, Charleston County’s executive director of economic development, describing industry growth over the past two years. “Manufacturing, that broad category, also includes automotive and aerospace.”
He adds, “The other thing that I think is very noteworthy in Charleston County is life sciences. We had six announcements in the life sciences space. That includes drug makers, medical devices, research organizations that perform clinical trials.”
Since 2017, Charleston County has been home to 39 major new business announcements, accounting for 2,246 new jobs created in the area and $241 million in capital investments. Including Charleston County’s ever-expanding lineup of brewers and distillers, manufacturing made up almost half of these new and expanding businesses, followed by the life science sector and IT.
Five to 10 additional projects in Charleston County are expected to be announced by the end of 2019, but the real takeaway is that a vast majority of activity in the area is related to expansions, rather than new businesses coming to the area. Of the 39 new projects announced over the past two years, 74 percent have been news of expansions—meaning that businesses already in Charleston County like what they see.
Working with a wide collection of organizations throughout the county, Charleston County’s Office of Economic Development relies on a healthy partnership between local school districts, municipalities, and private businesses to connect students with careers in the area. One example of this collaborative effort is the S.C. Aeronautical Training Center at Trident Tech. Providing training for those looking to enter into the region’s advanced manufacturing sector, the $80 million center received around a quarter of its funding from the county, according to Dykes.
“We have 24 people a day moving here, two-thirds of which are college-educated. We’ve already got a very strong base of college-educated people living in Charleston County. Much higher than any of our neighboring counties,” says Dykes. “I think we are just going to continue to see a wave of brains, if you will, coming into the area. There was a time back in the ’90s when we were worried about brain drain. We had people go to school here, get educated here, and then promptly leave due to the lack of meaningful career choices. Everything is totally reversed now. We’re a center where people come.”
Dykes points to the closure of the Charleston Naval Base in 1993 as the event that spurred local leaders to reconsider how they do business in Charleston County. Since that time, the area has become home to a diverse and healthy economy. Now, the focus moving forward is making sure all this growth doesn’t ruin what brought so many to Charleston in the first place.
“We never want to have growth in general compromise our quality of life here. There’s a lot of emphasis that’s going on now with all the governments here about the transportation system and affordability,” says Dykes.
In addition to an increased push to improve and expand regional public transportation, the Charleston Regional Development Alliance recently sponsored an effort called Reboot the Commute, for which members of the local business community announced they would be offering more flexible working hours to reduce rush hour traffic congestion. Meanwhile, Dykes says his office is working on outreach into the county’s more impoverished communities, making sure that these residents are aware of any new job openings that may be available.
“We’ve had wild success, but with that wild success has come a lot of infusion of money into the community, a lot of development, and development over time can cause gentrification. We’ve seen things becoming less affordable for some folks in our community,” says Dykes. “We have to be focused on workforce housing. We have to be focused on improving the commute and trying to get better public transportation inaugurated here in Charleston. That’s our big emphasis moving forward.”
Clemson, Prisma health professionals working to develop early cancer screening test see more
When her younger brother was diagnosed with cancer, Clemson bioengineering professor Terri Bruce re solved to tap her knowledge of human cells to find a way to help others suffering from the dis ease. After devouring all the scientific literature she could, she chose to focus on developing a screening test to detect the disease in its earliest stages when it has a better chance of being cured.
“It was a time in my life when I felt helpless,” she told The Greenville News.
“And I felt there’s got to be something I can do — even if I can’t help Greg — to help other people.”
Because he suffered from brain cancer, she looked to another form of the disease that wasn’t as emotionally entangled but had no early screening tests. She decided on ovarian cancer.
Now Bruce and her research team are on the brink of a test that they believe could be a screening tool — not only for ovarian cancer, but other cancers too.
“The hope,” she said, “is to ... catch this deadly cancer much earlier and give women a fighting chance.”
Ovarian cancer will strike 22,530 women this year, according to the American Cancer Society, and about 14,000 will die of the disease.
But only about one in five cases is discovered early because there are no reliable screening tests, the society reports.
A late diagnosis reduces survival. And because the symptoms are so vague, about three quarters of all women are diagnosed at a late stage, said Dr. Larry Puls, the director of gynecologic oncology at Prisma Health Cancer Institute.
Only 10% to 15% of them will survive long-term. And overall survival numbers haven’t changed much in 40 years, he said.
Though blood work can test for a protein that can identify some ovarian cancers, only half of stage 1 patients test positive for it, Puls said.
“One of the things that has eluded us in ovarian cancer is that we have no screening for it,” he said. “But if you can find it when it’s confined to just the ovary alone, 90% of patients beat their cancer.
“If we could shift women out of stage 3 and into stage 1,” he added, “we can make a huge impact on this disease.”
For some time, Bruce has been studying exosomes, which are microscopic droplets found in body fluids that were traditionally regarded as a way for cells to rid themselves of debris.
But further research revealed that they contain parts of the cell they are from as well as proteins that can serve as biomarkers of what’s going on in that cell, she said.
Cancer often develops because something goes awry in the DNA, leading to aberrant proteins and tumor growth, she said. So she theorized that finding those protein signatures in exosomes could be a way to diagnose cancer.
“If we can find those aberrant protein signatures and see them on the cells and exosomes,” she said, “ ... it potentially could be used for any type of cancer, as long as you find the biomarker.”
The process has the potential to be used as a diagnostic tool for other diseases as well, she said.
So Bruce approached Clemson chemistry professor Ken Marcus, who’d been separating whole human cells for years using fiber strips, and asked if he could separate exosomes.
“I said, ‘I don’t even know what they are,’ ” he recalls with a chuckle.
“But she got us some samples and in pretty short order ... we made some really good educated guesses and it worked.”
Marcus and his “very talented students” were not only able to separate the exosomes, but reduced the time needed to do it from 2 1 / 2 hours to 8 min utes using a test strip made of a polymer that is grooved much like the top of a zip lock bag.
When fluid is added, it flows down the channels where it interacts with different antibodies that in turn isolate the exosomes, he said, much the way a pregnancy test works.
Catching it early
Bruce and Marcus were then introduced to Puls, who joined the research team.
He’s collecting samples of cervical fluid containing exosomes and proteins obtained at the same time as a pap test. So far, 49 women have been tested with the strip, Puls said, and two who had no symptoms and normal blood tests were revealed to have stage 1 ovarian cancer.
“That’s the patient we covet the most because we cure 90% of those patients,” he said.
Puls also hopes the test will one day detect precancerous changes, enabling doctors to surgically remove the tissue — like they do when a pap test reveals a precancerous change — and prevent the development of cancer in the first place.
While the initial data will be crunched in the next few weeks, Puls said he’s optimistic that the test could be a promising new tool in the battle against ovarian cancer.
He hopes the test could be used to screen for uterine cancer as well, which strikes another 63,000 women a year.
The Holy Grail for the process, Marcus said, would be a urine test because it can show what’s going on inside the whole body. But the first step is testing cervical fluid in the doctor’s office.
“And even that is an infinite step up from where we are today,” he said.
Because tumors can be caused by a variety of proteins, the test will look for a bank of markers in an effort to capture more cancers, said Bruce, who is also director of Clemson’s Light Imaging Facility.
“I think we’re close on getting some kind of screening tool,” she said. “And we’re in the process now of (getting) all the patents.”
So far, the research has been privately funded, but the team plans to use their initial data to apply for federal grants to continue their work.
They estimate a test could be ready for market in about five years.
Carmen Brotherton hopes the test will be routine in her daughter and grand-daughters’ lifetimes.
The Easley woman’s ovarian cancer was discovered in 2009, making her one of the few to be diagnosed in stage 1.
“I’ve lost some good friends ... who weren’t caught in time,” said Brotherton, who volunteers with the South Carolina Ovarian Cancer Foundation.
“It’s always been one of my prayers that some day they would come up with something that would catch it,” she said.
“This is just a small place compared to the U.S. or the rest of the world. Imagine how many women this could catch. And it might save their lives.”
When Bruce’s brother was diagnosed in 2012, little could be done to stop the progress of the cancer, she said. He died in January, leaving his two sons fatherless.
Now she hopes the test will one day mean that fewer people will be left without a parent like her nephews.
“In conjunction with the discovery of distinct biomarkers, the fibers could lead to finding diseases such as ovarian cancer — and brain cancer — much earlier,” she said.
“Early enough, I hope, to save many lives in the future.”
SCBIO and Nephron Pnarma executive Lou Kennedy honored by E&Y see more
WEST COLUMBIA, S.C., June 28, 2019 /PRNewswire/ -- Ernst & Young (EY) honored Nephron Pharmaceuticals President and CEO Lou Kennedy as Health Care Entrepreneur of the Year for the Southeast on Thursday during a gala at the Coca-Cola Roxy in Atlanta. Kennedy, who is Chairman of the South Carolina Chamber of Commerce and of SCBIO, and a nationwide leader in health care, will now compete for the EY national entrepreneur of the year award in November.
"I am grateful that EY recognizes the hard work our team does every day to deliver safe, effective and affordable drugs to patients, focusing on opiod-free pain treatment," said Kennedy. "As president of a global leader in life-saving drug manufacturing, I hope this award serves as a reminder that women are leading the fight to improve lives across the country and world, and at Nephron, like so many women-owned businesses, we are just getting started."
Business leaders consider the EY entrepreneur of the year award to be one of the highest professional honors a business owner can earn. The award identifies leaders of fast-growth companies who are making a difference for their communities and beyond through innovation.
Nephron is a certified woman-owned business, as recognized by the National Women Business Owners Corporation (NWBOC), the first certifier of Women Business Enterprises. The certification gives Nephron enhanced visibility and a competitive edge.
The Nephron workforce is forty-four percent women, holding the majority of all advanced degrees at the company. Additionally, women hold key management roles in various departments throughout Nephron, such as Quality Assurance, Chemistry and Microbiology, Regulatory Compliance, Human Resources, Training, R&D Engineering, and Product Development.
Nephron Pharmaceuticals Corporation develops and manufactures safe, affordable generic inhalation solution and suspension products specializing in Blow-Fill-Seal technology. In addition, the company 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. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.
Nephron CEO and SCBIO Chair Lou Kennedy interviewed on the growth and success of her organization. see more
Nephron Pharmaceuticals Corporation, located in West Columbia, South Carolina, is a global leader in manufacturing generic respiratory medications and contract manufacturing. Through its innovative approach to sterile manufacturing, Nephron also provides patients access to affordable, high-quality medications. Nephron’s sterile injectables program helps with the drug shortages that hospital across the country are facing.
Nephron has grown from 400 employees in 2018 to now over 1,000. A certified woman-owned business, Nephron is recognized by the National Women Business Owners Corporation (NWBOC), the first certifier of Women Business Enterprises. CEO Lou Kennedy leads the dyunamic organization as well as chairs SCBIO, the life sciences organization for the Palmetto State. Enjoy this interview with Lou Kennedy, courtesy of MidlandsBiz: https://whosonthemove.com/lou-kennedy-nephron-pharmaceuticals/
Greenville-based Health IT firm Chartspan lands $15 million in funding from BIP Capital see more
One of the Upstate’s biggest entrepreneurial success stories is ready to begin its next stage of growth, and with it, the expectation of 200 to 300 more jobs over the next 24 to 36 months, almost all of them in Greenville.
With a just-closed funding round of $15 million from a syndicate led by BIP Capital, an Atlanta-based venture capital firm, ChartSpan Medical Technologies is doubling its deployed capital, for a total of $30 million.
Now, new funding in hand, ChartSpan will spend “a majority” of it to embark on a national sales and marketing strategy designed to capture an even larger share of the chronic care management market, said co-founder and CEO Jon-Michial Carter.
Founded in Houston, Texas, ChartSpan chose Greenville for its headquarters in 2013 and soon emerged as the largest managed-service provider affiliated with the Centers for Medicare & Medicaid Services (CMS) chronic care management program. Currently, ChartSpan offers technology-enabled coordination of care to the patients of 106 health systems and medical practices, most of them in the Southeast.
Working from ChartSpan’s offices at 2 N. Main St., trained clinicians assist patients with such varied needs as contacting a nurse 24/7, refilling prescriptions, accessing medical test results, making appointments, and securing transportation, with clinical data exchanged between ChartSpan’s electronic records platform and those used by hospitals and physicians.
Nationally, ChartSpan is the market leader in the space with “the largest enrolled population in the country” served by about 200 employees, Carter said.
“Last month, there were 61 million Medicare and Medicare Advantage patients, and that is the audience that we serve,” said Carter. “CMS says 72% of them are eligible for the program we run … so 45 million available patients and we have just under 30,000 patients enrolled. So, it’s this blue ocean of opportunity.”
To capitalize on such a wide-open market, Carter sought to build on prior funding rounds in a way that would allow his company to reach mid-sized status rapidly.
Ultimately, Carter chose to partner with BIP Capital, a venture capital investment firm whose focus includes health care IT, enterprise software-as-a-service, and digital media.
Founded in 2007, the firm has invested more than $300 million since inception. Its CEO, Mark Buffington, has led investment rounds in more than 35 companies, with BIP Capital offering both funding and operational recommendations.
In a brief telephone interview, Buffington said South Carolina’s Upstate fits his firm’s focus on “second-tier innovation centers” in geographic areas “not nearly as competitive as a Boston market or a Bay Area.”
“We feel there’s just tons of uncovered opportunities,” Buffington said, citing venture partnerships in place in Minneapolis; Indianapolis; and Columbus, Ohio.
BIP Capital was attracted to ChartSpan in large part due to its early understanding of the chronic care management landscape, said Austin Poole, a senior associate.
“They’d figured out the complex parts of the process, where a lot of other groups that we had looked at were still kind of in that developmental phase, and some of them thought they might have had it figured out, but a closer look said that there might be more steps before they actually got there,” Poole said during a visit to Greenville.
The $15 million deal led by BIP includes syndicate partners Blue Heron Capital of Richmond, Virginia; Bailey Southwell & Co. of Nashville, Tennessee; and Croft & Bender of Atlanta. All four members of the syndicate hold preferred stock equity stakes in ChartSpan.
“Blue Heron is interesting because their entire LP [limited partnership] structure are just former health care executives that have run large enterprise companies,” Carter noted. “So, that was obvious, the attraction for us, and we spent time with them in Richmond, and again, loved the regional focus,” Carter said.
Poole, along with BIP Vice President Sarath Degala, will operate out of Greenville’s NEXT on Main incubator and will collaborate with Carter and other ChartSpan personnel on the company’s growth while also becoming familiar with other businesses in the region.
“We expect to hold office hours, take part in pitch events, mentor entrepreneurs and companies, provide guidance in strategies and funding alternatives as well as hopefully become engrained in the VC infrastructure in the community,” Degala said via email.
John Moore, president and CEO of NEXT, believes BIP Capital’s arrival in the Upstate represents a turning point in the evolution of funding for entrepreneurs.
“One of the biggest things obviously in any ecosystem is building access to capital. … We’ve been working on that for a long time, and to see something like this happen and see BIP’s leadership, first and foremost in the investment in ChartSpan, is tremendous,” Moore said.According to Moore and Carter, BIP’s deepening commitment to the Upstate will provide a flight path to growth funding for a variety of local firms that successfully launched with seed money.
VentureSouth, which now operates 12 angel groups across the Carolinas, provides much of that early stage funding, said Matt Dunbar, one of its three managing directors. The combined group, with 320 active investors, has deployed $36 million for 67 companies since 2008.
Using preliminary data, the Angel Capital Association, a national trade group, just placed VentureSouth among the top 10 angel groups in the country in terms of dollars invested, or $7 million in 22 companies during 2018.“Matt was a resource and in some ways a mentor for me early on,” Carter remarked. “All of these things in Houston, Texas, where we came from, we would’ve got lost and drowned. We wouldn’t have had this kind of support.”
Now, Carter’s company looks set to add significantly more clients, revenues, and jobs.
“Part of what was so compelling for us about ChartSpan as an investment was, not only does it bring efficiency to the whole U.S. health care system, but also the impact that it has on the patients,” said BIP’s Austin Poole.
“Any time you’re positively impacting the end-user in that magnitude, we get excited about that,” he said.