McDermott Will & Emery expand life sciences team see more
McDermott Will & Emery, the nation's leading health law firm, announced Brian Malkin has joined as partner in the FDA practice of its Health Industry Advisory group based in Washington, DC. Brian's practice complements McDermott's broader life sciences and healthcare capabilities with decades of experience and perspective on critical regulatory and strategic business issues that life sciences, pharmaceutical and biologic companies seek in bringing new products to market and managing product life cycles.
The firm also announced that Michael Siekman and Jenny Chen have joined the Intellectual Property (IP) practice as partners based in the Boston office. The duo builds upon Boston’s active and diverse IP practice and will complement the Firm’s robust legal service offering to the life sciences and health industries.
"Aligning FDA regulatory and intellectual property strategy for drug development is more critical than ever and Brian's unique background will give our clients a strategic advantage," said Eric Zimmerman, head of McDermott's Health Industry Advisory practice group and a Washington, DC-based partner. "Incorporating Brian's practice into our existing FDA practice further strengthens our ability to assist innovators through all stages of approval."
"As the market and regulatory landscape evolves to focus on novel therapies, including orphan drugs and biosimilars, our team needs to deftly navigate the complex regulatory, policy and strategic business considerations for this space. Brian is a thought-leader on these issues and has helped several companies successfully bring life-saving products to market. We're thrilled to join forces," added Vernessa Pollard, head of McDermott's FDA practice and a Washington, DC-based partner.
Brian counsels pharmaceutical and biologic clients on FDA regulatory matters and intellectual property law, with an emphasis on patent strategy and litigation. His position at the intersection of FDA regulated products and patent law makes him an invaluable partner to drug developers, biotechnology clients, medical device companies and cannabis companies as they protect their innovations, bring their products to market and pursue transactional opportunities.
He is a key advisor regarding FDA regulated drugs development strategies and patent strategies, including: New Drug Applications (NDAs) and orphan/specialty drugs; 505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products; biologics and biosimilars; and cannabis-derived products. Additionally, he is an experienced litigator of Hatch-Waxman Act cases for both pharmaceutical and biotechnology clients and a strong partner in the boardroom, providing FDA and IP due diligence for deals and transactions in the life sciences space.
Brian holds a JD from The George Washington University Law School and a BA also from The George Washington University. While practicing law, Brian earned a BS in Biochemistry from the University of Maryland.
In commenting on the addition of Mr. Siekman and Ms.Chen, the Firm's Head of Strategy Michael Poulos noted, “We are laser-focused on smart expansion, and virtually every McDermott practice group and geography is focused on legal representation for the life sciences sector. Our new partners reflect our continuing strategic commitment to growing the pre-eminent life sciences practice in our industry.”
“The last few years have shown an increasing need for breakthrough innovations in the life sciences market. Patent protection is essential for bringing necessary technology to market, and Michael and Jenny truly understand what it takes to be a fearless client advocate during every stage of the IP lifecycle,” Bill Gaede, leader of the Firm’s Global Intellectual Property practice, said. “Michael’s and Jenny’s addition in Boston bolsters our IP capabilities in this leading region for life sciences innovators and research institutions as well as across our international platform.”
“This IP team is a natural part of our planned Boston expansion given the significance of the life sciences industry to our region,” Tony Bongiorno, litigation partner and Boston office managing partner, added. “We look forward to collaborating with Michael and Jenny on exciting opportunities across all of our practices in Boston.”
Michael focuses his practice on a broad range of intellectual property matters, including architecting patent prosecution strategies, life sciences partnering and transactions, licensing, post-grant proceedings and litigation. Leveraging more than 25 years of experience, Michael has built in-depth patent portfolios, advising clients in the biotechnology and pharmaceutical industries.
Jenny counsels both US and international clients in a variety of patent-related matters in the biotech and life sciences space, including prosecution, due diligence and post-grant proceedings. Her practice focuses on matters including cell and gene therapies, antibodies, diagnosis and pharmaceutical formulations. She is particularly experienced in strategic counseling on life cycle management of both biological and small molecule products.
Michael received his BS at Bates College and his JD at Boston University School of Law. Jenny received her BS from Fudan University, her PhD in pharmacology from Baylor College of Medicine and her JD from Northeastern University School of Law.
Webinar features inside details on beating back the COVID pandemic see more
Top executives from five of the Palmetto State’s leading life sciences organizations shared how they have found opportunity by pivoting, product adjustment, service expansion and partnering to overcome the global COVID pandemic and find accelerating opportunity and growth.
The SCBIO webinar took place August 25th and featured Shea Harrelson and Scotty Branch, co-Founders of Vikor Scientific; John Carrington, CEO of Zverse; Jen Thorson, COO of Modjoul; Steve Clemons, CEO of VitaLink Research; and Lou Kennedy, CEO of Nephron Pharmaceuticals. Erin Ford EVP of SCBIO – South Carolina’s official life sciences industry organization -- moderated. Enjoy the whole program here.
Nephron CEO and SCBIO Board Chair Lou Kennedy speaks out see more
The team at Nephron Pharmaceuticals Corp. in West Columbia has been honored to answer the call to serve during the unprecedented COVID-19 pandemic.
We have shipped hundreds of millions of doses of life-saving respiratory medications to patients nationwide. We have provided tens of thousands of gallons of Nephron-made, FDA-approved hand sanitizer to students, businesses, families and those in need. And we recently announced a $216 million expansion that includes factory production space where we will fill COVID-19 vaccines.
Every Nephron employee has a sense of pride. Of patriotism. But I would be remiss if I failed to mention that we also share a sense of concern.
China is one of the world’s largest suppliers of the precursor chemicals used to make active pharmaceutical ingredients and personal protective equipment. What we have come to recognize firsthand are the perils of dependence on foreign counties, such as China, for medicine and medical supplies.
As trade tensions between China and the United States grew last year, I was afraid China could intentionally disrupt the drug supply chain to the United States, exacerbating the drug shortage crisis, increasing the cost of drugs and potentially killing American patients.
The recurring question I had was: What can America do to break this dangerous dependence?
Now, as the world considers how to deal with China in the aftermath of this pandemic, the picture of a potential supply chain disruption is grimmer, serving as a vivid reminder that we are talking about matters of life and death.
I have been vocal about this issue for quite some time. In fact, I discussed America’s dependence on China for drug ingredients last year with federal officials, including President Donald Trump, Vice President Mike Pence and Health and Human Services Secretary Alex Azar. When U.S. Sen. Lindsey Graham visited our plant a few weeks ago, we agreed: Something must be done to find American solutions to this American public health crisis.
So, it should be no surprise that I am excited about the executive order President Trump signed last week to shore up the domestic supply chain for life-saving medicines, reduce dependence on foreign sources of drugs and medical supplies and expand domestic production of both.
When the president signed this new executive order, he said: “As we’ve seen in this pandemic, the United States must produce essential equipment, supplies and pharmaceuticals for ourselves. We cannot rely on China and other nations across the globe that could one day deny us products in a time of need. We can’t do it. We can’t do it. We have to be smart.”
I could not agree more.
This is a no-brainer. The pandemic has taught us an important lesson. The best way to protect American patients, families and businesses is onshoring production of the things we need to keep them healthy and safe.
Over the past five months, the American people have endured hardships no one could have foreseen. We grieve with those who have lost loved ones to this unrelenting silent enemy. We support business owners small and large who want to slow the spread of this virus so we can reopen the world’s greatest economy. And we share the frustrations many people feel with politicians who are focused on winning the next election, rather than preparing for the next public health crisis.
We are grateful for these first steps President Trump is taking to make sure we never end up in this place again.
At Nephron, we have the technology, resources and people it takes to successfully partner with the federal government to make the public health preparedness infrastructure of this nation stronger than ever. South Carolina can and will be a leader in the effort to find American solutions for American public health.
This new executive order is the right way to do it.
News you can use on SC life sciences see more
SCBIO's latest Monday Moment arrives to welcome your week with meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from Tressa Gardner, Associate Vice President of the Southeastern Institute of Manufacturing Technology (SiMT)... great health equity news from BMS... an exciting upcoming webinar, plus lots of uplifting information... get details here...
Dr. David Cole chronicled many MUSC achievements during the 2020 fiscal year see more
CHARLESTON, S.C. (Aug. 14, 2020) – Recently, the Medical University of South Carolina (MUSC) and Medical University Hospital Authority (MUHA) Board of Trustees held their regularly scheduled combined committee sessions and board meeting. With its fiscal year-end closing on June 30, MUSC administrators focused on the multilayered impacts of the novel coronavirus on the operations of all three missions of the institution – education, research and patient care – along with MUSC’s leadership role across the community and state during this pandemic. To support established social distancing guidelines in the COVID-19 era, the MUSC trustees and administrators met via teleconference.
“The ripple effects of the pandemic continue to reach every area of our institution,” said MUSC President David J. Cole, M.D., FACS. “We are committed to battling this virus at every turn and continue to find innovative ways to deliver safe, top-quality education and patient care in the face of this challenge. In addition, we are engaged in ongoing research projects, many which, in collaboration with national networks, are designed to help define how to best treat and mitigate the impact of this virus.”
“Throughout the pandemic, MUSC Health has been recognized and called upon as an essential health care resource, having performed nearly 138,000 diagnostic screening tests, primarily through mobile testing sites in communities across the state,” said Patrick J. Cawley, M.D., CEO of MUSC Health and vice president for Health Affairs, University. “In partnership with the state legislature, MUSC set up mobile screening and collection sites in rural and underserved areas in an intentional bid to reach those who are most vulnerable and too often underserved when it comes to health care. Reliable diagnostic and antibody testing remain key elements of managing this unprecedented statewide health challenge.”
Despite the hurdles posed by COVID-19, Cole chronicled many MUSC achievements during the 2020 fiscal year, including:
- The MUSC Shawn Jenkins Children’s Hospital and Pearl Tourville Women’s Pavilion opened in February.
- MUSC became the only institution in the country to house both a Digestive Disease Research Core Center and a Center for Biomedical Research Excellence in Digestive and Liver Disease.
- MUSC Health West Ashley Medical Pavilion opened as scheduled in December and served 10,418 patients in the first month, with 214 operative procedures.
- The South Carolina Clinical & Translational Research Institute, one of about 60 Clinical and Translational Science Award hubs nationwide, was awarded a $24M five-year renewal.
- Safely held a series of virtual graduation celebrations, including a drive-through diploma pick-up event for its 660 graduates.
- Transitioned more than 3,000 students to online education in response to the novel coronavirus within 24 hours’ notice.
- MUSC was first in the nation to combine drive-through testing with a virtual screening platform for potential COVID-19 patients.
- MUSC and Clemson collaborated to launch the Healthy Me – Healthy SC program to increase health access and fight health disparities statewide. The program began expanding in early 2020 after successful pilots in Anderson, Barnwell and Williamsburg counties.
- MUSC, Clemson and Siemens Healthineers co-hosted a summit in Columbia about artificial intelligence (AI) to bring together faculty, clinicians and engineers. They shared information about current work, new opportunities and discussed the future of AI in health care. The pilot effort funded three joint AI projects with Clemson.
- U.S. News & World Report named MUSC the state’s best hospital for the fifth consecutive year.
- The inaugural 2019 Lowvelo Bike Ride for Cancer Research engaged more than 709 cyclists and 300 volunteers, raising some $650,000 to support MUSC Hollings Cancer Center.
- The U.S. Patent Office granted the MUSC Foundation for Research Development 18 patents.
- MUSC received $25 million from the General Assembly to partner with the South Carolina Department of Health and Environmental Control and the South Carolina Hospital Association to develop and deploy a statewide testing plan. The focus of the plan is on rural and underserved areas of the state. More than 200 testing events/sites have been implemented.
- MUSC Health continues to support the reopening plan and testing strategy for the University of SC, College of Charleston, The Citadel and Clemson University.
The 16-member MUSC/MUHA board voted unanimously to elect James Lemon, DMD, as chairman and Charles W. Schulze, CPA, as vice chairman. Each will serve a two-year term. Lemon is an oral and maxillofacial surgeon by training. A native of Barnwell, he has lived in Columbia for more than three decades. Elected to the MUSC board in 2014, he serves as the medical professional representative from the 2nd Congressional District. Schulze, a Greenwood native, began his first term as an MUSC trustee in 2002 as the lay representative from the 3rd Congressional District. A retired shareholder of a regional accounting and consulting firm, Schulze currently practices and is an expert in financial forensics.
In other business, the board voted to approve:
- The fiscal year 2021 budgets for MUSC (University), the MUSC Health system and MUSC Physicians.
- Moving the spring commencement and graduation date from its originally scheduled date of May 22 to May 15, 2021.
- A seven-year lease to provide new clinical care space for the MUSC Neuro Rehabilitation Institute in Charleston.
- A supplemental HVAC system for the MUSC Hollings Cancer Center Compounding Pharmacy.
- A lease renewal to provide 140 parking spaces at the intersection of Line Street and Hagood Avenue.
The MUSC/MUHA Board of Trustees serves as separate bodies to govern the university and hospital, normally holding two days of committee and board meetings six times a year. For more information about the MUSC Board of Trustees, visit http://academicdepartments.musc.edu/leadership/board/index.html.
About The Medical University of South Carolina
Founded in 1824 in Charleston, MUSC is the oldest medical school in the South as well as the state’s only integrated academic health sciences center with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. The state’s leader in obtaining biomedical research funds, in fiscal year 2019, MUSC set a new high, bringing in more than $284 million. For information on academic programs, visit musc.edu.
As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality patient care available, while training generations of competent, compassionate health care providers to serve the people of South Carolina and beyond. Comprising some 1,600 beds, more than 100 outreach sites, the MUSC College of Medicine, the physicians’ practice plan, and nearly 275 telehealth locations, MUSC Health owns and operates eight hospitals situated in Charleston, Chester, Florence, Lancaster and Marion counties. In 2020, for the sixth consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.
MUSC and its affiliates have collective annual budgets of $3.2 billion. The more than 17,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.
Bristol Myers Squibb, BMS Foundation Commit $300 Million to Accelerate and Expand Health Equity and Diversity and Inclusion EffortsFive–year commitment by BMS builds on long-standing investment in health equity see more
-Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation announced today a combined investment of $300 million as part of a series of commitments. For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.
The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.
“Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science.”
This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.
Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.
The commitments include:
- Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.
“Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.”
- Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.
- Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.
- Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.
“As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve,” added Ann Powell, chief human resources officer, Bristol Myers Squibb. “We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce.”
- Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.
The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
About the Bristol Myers Squibb Foundation
The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about the Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.
Market is currently valued at $770 million see more
Upsher-Smith Laboratories, LLC (Upsher-Smith) and AmbioPharm, Inc. (AmbioPharm) today announced that the companies have entered into a partnership agreement to develop and market Corticotropin Injection in the U.S. The market for adrenocorticotropic hormone or ACTH (brand Acthar® Gel*) is currently valued at $770 million (IQVIA, 12 months ending June 2020).
Under the terms of the agreement, Upsher-Smith will submit the New Drug Application for Corticotropin Injection to the U.S. Food and Drug Administration (FDA) and market and distribute it under its own label in the U.S. upon FDA approval. AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States. Financial terms related to the deal have not been disclosed.
“We are excited to partner with AmbioPharm, a leader in the field of peptide development and manufacturing, to bring Corticotropin Injection to the U.S. market,” said Rusty Field, President and CEO of Upsher-Smith. “This agreement represents another step in Upsher-Smith’s and Sawai’s strategy to co-invest in highly complex generics and 505(b)(2) products that can drive long-term growth.”
Added Chris Bai, CEO of AmbioPharm, “We are pleased to bring our unsurpassed technical capabilities and peptide manufacturing capacity to our partnership with Upsher-Smith, a company with a long-standing tradition of bringing high-quality products to the patients who rely upon them.”
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.
As Upsher-Smith begins its second century in business, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.
AmbioPharm, Inc. is a full-service peptide manufacturing company headquartered at its North Augusta, South Carolina, USA cGMP production site. Its second cGMP facility in Shanghai, China, performs process development and optimization and manufactures building blocks, raw materials, and custom peptides at a very large scale. Both of its cGMP facilities are capable of handling any manufacturing scale required to produce bulk peptides to custom specifications using a wide range of skill sets in both solid and solution-phase chemistry. Its management team has over 120 years of cumulative experience running a pilot to commercial-scale production. The Company also performs organic conjugations to small molecules, proteins, toxoids, antifungals, KLH, and PEG. For more information, visit www.ambiopharm.com.
Milliken leveraging textile expertise in COVID fight see more
Milliken & Company, a global diversified manufacturer with more than 150 years of textile expertise, has invested significant resources to increase domestic production of its Milliken PerimeterTM advanced medical fabrics. Since March, the company has distributed more than 10 million yards of reusable medical fabrics in response to the global shortage of personal protective equipment (PPE). This recent inventory increase signals Milliken’s continued commitment to ensuring a sustainable, U.S.-based PPE supply chain.
Reusable medical textiles are ideal when cost is a driving factor and when single-use PPE supply is limited or unreliable. Garments made with Perimeter fabric can be laundered for safe reuse at least 25 times. The current demand for protective medical garments and the potential for shortages in the fall and winter prompted Milliken to prioritize production of the advanced material.
“Scaling up U.S. manufacturing of reusable protective fabrics protects the country’s PPE pipeline, which in turn protects more medical professionals,” said Chad McAllister, president of Milliken’s Textile Division and EVP, Milliken & Co. “These brave people have continued to care for us tirelessly, and we are committed to doing all we can to help keep them safe.”
Milliken’s durable Perimeter fabric is not only engineered for manufacturing Level 1 and 2 gowns for critical medical environments such as trauma centers but also provides a smart solution for other industries such as dental, educational and hospitality environments where advanced PPE is now important. The material’s ability to be used multiple times while maintaining a demonstrated protective barrier makes it a cost-effective, made-in-USA alternative to single-use PPE.
“An increasing number of industries and service providers are looking for American-made PPE solutions to protect their employees and customers. This demand highlights the critical need we noted earlier this year, specifically for the U.S. to have a stable PPE supply chain,” McAllister said. “Our goal at Milliken is to be part of the solution, so we’re proactively taking steps to help avoid another shortage of critical PPE.”
Milliken is collaborating with industry partners to ensure protective garments made with Milliken Perimeter fabric are available immediately across the country.
U.S. News & World Report releases annual national rankings see more
MUSC Health University Medical Center in Charleston was named by U.S. News & World Report for the sixth year in a row as the No. 1 hospital in South Carolina, with three of the MUSC Health, Charleston Division, specialty areas ranking among the best in the entire country: ear, nose and throat; gynecology; and cancer. Six other MUSC Health programs based in Charleston are considered “high performing” in the 2020-2021 U.S. News & World Report rankings: gastroenterology and GI surgery; nephrology; neurology and neurosurgery; orthopedics; rheumatology and urology. In addition, MUSC Health Florence Medical Center is designated “high performing” in chronic obstructive pulmonary disease (COPD) and heart failure, and MUSC Health Lancaster Medical Center is designated “high performing” in COPD and heart failure.
“These six consecutive years of recognition demonstrate that our teams remain committed to keeping the needs of patients as the focal points of what we deliver every day,” said Patrick J. Cawley, M.D., MUSC Health CEO and vice president for Health Affairs, University. “With all the pressures bearing on the health care industry right now, especially during this pandemic, yet again earning this level of recognition as the leading health care organization in the Charleston area, the Lowcountry and the state engenders a tremendous sense of accomplishment and pride in our teams’ abilities to change what’s possible for those we serve.”
The Best Hospitals 2020-2021 https://health.usnews.com/best-hospitals report is designed to help patients with life-threatening or rare conditions identify hospitals that excel in treating the most difficult cases. The annual report includes consumer-friendly data and information on 4,500 medical centers nationwide in 16 specialties, 10 procedures and conditions. In the 16 specialty areas, 134 hospitals were ranked in at least one specialty. In rankings by state and metro area, U.S. News & World Report recognizes hospitals as high performing across multiple areas of care.
“It is particularly gratifying to see two of the newest hospitals within the MUSC Health system, in our Florence and Lancaster Divisions, recognized in this year’s report,” Cawley said. “Our teams statewide are engaged in delivering health care that is built on quality, safety and innovation at every level.” The Florence and Lancaster hospitals joined the MUSC Health system in March 2019 when MUSC Health acquired four community hospitals.
The U.S. News & World Report Best Hospitals methodologies, in most areas of care, are based largely or entirely on objective measures such as risk-adjusted survival and readmission rates, volume, patient experience, patient safety and quality of nursing, among other care-related indicators.
“For more than 30 years, U.S. News & World Report has been helping patients, along with the help of their physicians, identify the Best Hospitals in an array of specialties, procedures and conditions,” said Ben Harder, managing editor and chief of health analysis at U.S. News. “The hospitals that rise to the top of our rankings and ratings have deep medical expertise, and each has built a track record of delivering good outcomes for patients.”
U.S. News & World Report produces its Best Hospitals rankings with RTI International, a leading research organization based in Research Triangle Park, N.C.
Enjoy this week's Monday Moment from SC Life Sciences see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from Will Williams, President & CEO of the Economic Development Partnership... plus lots of uplifting news... get details here
Blue Eye Soft launches AI-driven imaging software see more
Blue Eye Soft, an innovative IT-solutions and software development company, announced that it has received acknowledgment from the U.S. Food and Drug Administration (FDA) of its pre-submission package for its proprietary artificial intelligence (AI)-driven medical imaging software, BluedocaiTM, to assist with the medical diagnosis of diseases such as COVID-19, said a press release issued by the company.
BluedocaiTM is a clinical decision support tool that uses AI-driven deep learning algorithms to assist radiologists and other healthcare professionals with fast and accurate diagnosis of diseases, such as COVID-19. BluedocaiTM has the capability to rapidly analyze chest X-rays to detect the presence of COVID-19 with >90% accuracy and may therefore help improve the efficiency and accuracy of radiology departments in the wake of the overwhelming workload caused by the COVID-19 pandemic.1
BluedocaiTM is also under development to support the medical diagnosis of other diseases such as pneumonia, pneumothorax, tuberculosis, cancer, and stroke. BluedocaiTM has the potential to be used with a variety of medical imaging technologies across different hospital settings and locations. The pioneering technology behind BluedocaiTM is based on well-established medical image processing research of Russell C Hardie, PhD and Barath Narayanan, PhD from University of Dayton, Ohio and is currently exclusively licensed by Blue Eye Soft.
In addition, Blue Eye Soft has announced that the U.S. Department of Commerce Bureau of Industry and Security has granted the commodity classification number (ECCN ) for BluedocaiTM, clearing the pathway for Blue Eye Soft to international export. The Blue Eye Soft team believes this is an important step forward for a company rooted in South Carolina to be able to export locally developed AI-powered diagnostic technology beyond the United States with potential reach-out from around 16 countries. Srikanth Kodeboyina, CEO of Blue Eye Soft said, “Our team at Blue Eye Soft is looking forward to serving as a pivotal partner for radiology departments worldwide, helping them deliver precise and high-value patient care — even in the challenging times of this ongoing pandemic.”
Following the commodity classification of BluedocaiTM, Blue Eye Soft is awaiting FDA approval of its submission for use in clinical settings and topline readouts from ongoing BluedocaiTM pivotal trials.
There is a constant unmet need in radiology departments as imaging data continue to grow exponentially when compared with the number of available trained readers.2 AI-driven medical imaging tools have the potential to transform radiology departments in terms of enhanced productivity, increased diagnostic accuracy, more personalized treatment planning, and ultimately, improved clinical outcomes.2,3 The general principle behind AI-driven medical imaging tools is the ability to rapidly and accurately quantify and provide assessments based on the radiographic characteristics from images using deep-learning algorithms.2,3
Blue Eye Soft, a multinational corporation of South Carolina Research Authority SC Launch, U.S. Air Force Research Labs CSA cohort, and Innosphere Ventures client company, has paired its AI and computer-aided detection expertise with its fast-moving and innovative market approach to solve problems for commercial and government defense departments worldwide, the press release said.
AI efforts to fall under Artificial Intelligence Research Institute for Science and Engineering see more
Clemson University is consolidating its ongoing and future artificial intelligence research and education initiatives under one umbrella: the Clemson Artificial Intelligence Research Institute for Science and Engineering.
Eighty faculty members, including some researchers who have used and researched AI for years, will work under the umbrella organization, which also will spearhead STEM workforce development projects at the school to strengthen skills in science, technology, engineering and math, according to a news release. The move follows a presidential executive order last year that called for intensified AI training across the country, which led Google, Facebook, Microsoft and Amazon to establish AI labs.
“AI is pervasive now, and we have to prepare our students for a different world,” professor Mitch Shue, executive director of AIRISE, said in the news release. “Combining all of Clemson’s resources in one institute will help us recruit top students and faculty and better compete for federal grants that fund cutting-edge research.”
Feng Luo, AIRISE’s director and founder, hopes the institute will help open new opportunities for Clemson students to meet mounting demand in the field.
“The requirement for AI from industry has dramatically increased. When a company has data, it wants to make sense of the data, and AI is one of the ways to help them,” Luo said in the release. He is also a computer science professor.
One of Luo’s earlier AI projects included an initiative to help quell citrus-greening disease with a $4.3 million federal grant, according to the release. Other studies undertaken by Clemson researchers include deploying a cyber attack defense system for autonomous vehicles, inspecting vehicles on an assembly line for defects and earlier diagnosis of Alzheimer’s disease.
“With AIRISE, Clemson will be well-positioned to play a key role in conducting cutting-edge research and creating the STEM workforce of the future,” Amy Apon, director of Clemson’s School of Computing, said in the release. “We have a real opportunity to help enhance economic development and U.S. competitiveness.”
Yes, Virginia, there is good news, and SCBIO serves it up right here... see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from Jeff Stover, shareholder with Haynsworth Sinkler Boyd... plus lots of uplifting news... get details here ...
Nephron Pharmaceuticals Corporation expanding operations again, adding 380 jobs, $215.8 million investment$215.8 million investment will create 380 new jobs in Lexington County, SC see more
Nephron Pharmaceuticals Corporation (Nephron), a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing, today announced plans to expand operations in Lexington County. The company's $215.8 million investment will create 380 new jobs.
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with COVID-19.
The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. Nephron fills the needs of patients and health care professionals as they arise nationwide, and recently opened a CLIA-certified diagnostics lab.
Headquartered at 4500 12th Street in West Columbia, Nephron’s expansion will add new offices, a new warehouse and production space at its campus in Saxe-Gotha Industrial Park.
The expansion is expected to be completed by Q1 of 2021. Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
The Coordinating Council for Economic Development has approved job development credits related to this project.
“The Nephron family is extraordinarily grateful for the opportunity to grow in South Carolina. Thanks to our partnerships with state and local officials, and the trust they have placed in us, we have been able to provide life-saving medications to patients around the world and establish ourselves as the global leader in what we do. We are proud of these achievements and more, and we know our best days are ahead of us. That is what makes this latest announcement so special.” -Nephron Owner & CEO Lou Kennedy
“We are proud to have Nephron Pharmaceuticals in South Carolina. Since coming here they have become an integral part of the community, and recently have been vital in the fight against COVID-19. This new investment of more than $215 million creating 380 new jobs in Lexington County is a great win for Team South Carolina.” -Gov. Henry McMaster
“Nephron is a longtime steward of South Carolina’s business community, and we congratulate them on their continued growth within our state. Today’s announcement is yet another big win for South Carolina, our people and our burgeoning life sciences sector.” -Secretary of Commerce Bobby Hitt
“We are excited to continue to partner with such an innovative and forward-thinking company like Nephron Pharmaceuticals. We know that Lexington County is a great place to establish and grow a business, and Nephron’s continued success is a testament to good government-business relations.” -Lexington County Council Chairman Scott Whetstone
FIVE FAST FACTS
• Nephron Pharmaceuticals Corporation (Nephron) is expanding operations in Lexington County.
• The $215.8 million investment is projected to create 380 new jobs.
• Nephron is a global leader in the production of generic respiratory medications and blow-fill-seal contract manufacturing.
• Headquartered at 4500 12th Street in West Columbia, S.C.
• Individuals interested in joining the Nephron team should visit https://www.nephronpharm.com/careers.
ZEUS Names New President and CEO see more
Frank P. Tourville, Sr., Founder and Chairman of the Board of Zeus Industrial Products, Inc. announced on Wednesday, July 1, 2020 that Steve Peterson, President of Zeus, assumed the role of Chief Executive Officer. This organizational change comes with the recent retirement of former CEO, John Winarchick, who dedicated over 30 years of service to the company.
Peterson, who joined Zeus in 2017, previously held the position of Senior Vice President of Global Sales and Marketing. Before joining Zeus, Peterson held global leadership positions with TE Connectivity, Samsung Electronics, and General Electric. During that time, he assumed roles of increasing responsibility in sales, marketing, product management, supply chain management, and executive management.
As President and CEO of Zeus, Peterson will continue to play an instrumental role in leading the company forward by focusing on developing powerful growth strategies and providing ongoing value to customers, team members, and the surrounding communities. His invaluable contributions have already helped to shape the company Zeus is today.
“Steve Peterson has shown the true measure of a leader in unprecedented times of difficulty. His charisma, resilience, dedication, and vast industry knowledge are huge assets to Zeus,” said Frank P. Tourville, Sr., Founder and Chairman of the Board, Zeus Industrial Products, Inc.