GE Healthcare Life Sciences and Childrens Medical Research Institute will jointly drive the development of new affinity ligands for the purification of adeno-associated viral (AAV) vectors used in gene therapies. The focus of the collaboration is to bring to market specific ligands for multiple AAV types, enhancing the chromatographic separation of AAV-based vectors. This will improve the manufacturing efficiency and scalability of gene therapies, enabling the availability of viral vectors on a global scale.

With more than 800 gene therapies currently in clinical trials, there is an increasing demand for the raw materials needed in the manufacturing process of viral vectors. AAVs are viral vectors used in more than 70% of the in vivo gene therapy clinical trials. According to GlobalData, the 2025 gene therapy in vivo therapeutic market is expected to reach USD 32 billion with an estimated CAGR of 105% between 2019-2025.

The collaboration combines the expertise from the latest available research on AAVs with application testing, advancing a comprehensive understanding of the clinical functionality and the commercial opportunities of AAV-based gene therapies. Children’s Medical Research Institute will share with GE Healthcare Life Sciences AAV capsid variants targeting different tissues. GE Healthcare Life Sciences will then design and test ligand prototypes, which Children’s Medical Research Institute will assess. Based on the performance results, GE Healthcare Life Sciences will manufacture and commercialize novel improved AAV affinity ligands.

Dr Leszek Lisowski, lead gene therapy scientist at Children’s Medical Research Institute, says: “Bringing the fruits of our work to the patients requires a joint effort between academia and the industry. The collaboration with GE Healthcare Life Sciences will allow us to expedite the development of novel clinical options at a lower cost.”

Olivier Loeillot, General Manager, Bioprocess at GE Healthcare Life Sciences, says: “The industry needs better and more personalized technologies to speed biopharmaceuticals through clinical trials and bring them to market. Our long biomanufacturing expertise combined with Children’s Medical Research Institute’s pioneering research will lead to purification technologies that will streamline the production of gene therapies.”

Catarina Flyborg, General Manager, Cell and Gene Therapy at GE Healthcare Life Sciences, says: “Collaborations with organizations such as Children’s Medical Research Institute are critical to developing the technologies needed to move the industry forward. By working directly with the world-class researchers, GE Healthcare Life Sciences can develop the purification technologies that will contribute to increase the availability of viral vectors globally.”

Children’s Medical Research Institute in Australia is globally recognized for its work on microsurgery, cancer research, neurobiology, embryology and gene therapy. The AAV affinity ligands resulting from this collaboration will be compatible with GE Healthcare Life Sciences’ resin-based chromatography portfolio used in the purification of most FDA-approved biopharmaceuticals.

About GE Healthcare Life Sciences

GE Healthcare Life Sciences helps therapy innovators, researchers and healthcare providers accelerate how precision diagnostics and therapies are invented, made and used. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE (NYSE: GE). With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, GE Healthcare helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world. Visit our website https://www.gelifesciences.com/about-us for more information.

About Children’s Medical Research Institute

Children’s Medical Research Institute (CMRI) pioneered microsurgery, immunizations against lethal childhood illnesses, and care for premature babies, all of which has improved the lives of countless Australian children over the last 60 years. Today, CMRI is an independent institute and the site of world-leading research in the areas of cancer, neurobiology, embryology, genomics and gene therapy. CMRI’s achievements are made possible by a network of devoted community supporters, as well as the iconic Jeans for Genes® campaign.

Axuall and The MetroHealth System will collaborate to test digital credentials for segments of its physician staff. The pilot will use new technologies and workflows to acquire, manage, and share digital credentials via a nationwide network of practitioners, health systems, and primary source issuers.

When fully deployed, practitioners will hold an up-to-date, reusable, and verified set of digital credentials that will enable a considerably faster and more efficient privileging and payor enrollment process.

The goal will be to apply this technology to standard processes and bylaws to reduce credentialing wait times, improve accuracy, and alleviate practitioner administrative burden. Ultimately this will improve patient access to care by shortening the hiring process for health care systems, especially as delivery channels move beyond brick-and-mortar to telehealth and other innovative approaches.

The Axuall Network leverages blockchain and portable digital wallets to enable secure, real-time sharing and monitoring of credentials. The technology uses biometrics to confirm practitioner identity and protect privacy, enabling practitioners to control how and when their credentials are shared.

These new digital portfolios will include documentation of a practitioner’s education, specialty training and board certifications, licenses, sanctions or medical malpractice judgments, evaluations, work history and hospital affiliations. In short, a verified, instantly accessible professional profile that otherwise might take an employer or accreditation agency weeks or even months to assemble.

“We are thrilled to work with MetroHealth to test, refine, and perfect this technology,” said Charlie Lougheed, Axuall’s CEO. “Reducing unnecessary costs and burdens on practitioners is core to our mission of helping practitioners practice less paperwork and more medicine”.

Axuall was formed in 2018 and raised $3 million in seed capital for R&D in 2019. In December, it began a pilot with Hyr Medical and is expected to announce additional pilots in 2020 as the technology and workflows are perfected and its national network of credential issuing partners grows.

“We are excited to work together with Axuall to bring this innovation to our organization,” said Julie Jacono, MetroHealth Senior Vice President and Chief Strategy Officer. “Meeting the needs of our community requires that the we reduce the barriers to deploying clinical resources across new geographies and delivery channels.”

About the MetroHealth System

The MetroHealth System is an essential health system committed to providing health care to everyone in Cuyahoga County, Ohio. Advancing medical care is only part of what we do. We are driven by the relentless pursuit of healthy, thriving communities for everyone. The health system is home to Cuyahoga County’s most experienced Level I Adult Trauma Center, verified since 1992, and the only adult and pediatric burn center in the state of Ohio.

As an academic medical center, MetroHealth is committed to teaching and research. Each active staff physician holds a faculty appointment at Case Western Reserve University School of Medicine and its main campus hospital houses a Cleveland Metropolitan School District high school of science and health.

About Axuall, Inc.

Axuall is a digital network for verifying identity, credentials, and authenticity in real-time. We address a multibillion-dollar need to eliminate waste, prevent fraud, manage risk, and meet the demand for next-generation products and services in healthcare.

Caption Health, a leading medical AI company, announced that the U.S. FDA authorized marketing of Caption Guidance, software that assists medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance uses artificial intelligence to provide real-time guidance and diagnostic quality assessment of images, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Empowering more clinicians with ultrasound image acquisition capability will bring the benefits of ultrasound to more patients, help standardize the quality of care, and help institutions realize valuable cost and time savings.

Caption Guidance was authorized via the De Novo pathway, a regulatory pathway reserved for novel technologies. The granting of this De Novo is groundbreaking, as Caption Guidance is the first medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition. Caption Guidance is equipped with numerous features that together act as a co-pilot for clinicians when performing an ultrasound exam. The software emulates the guidance that an expert sonographer would provide to optimize the image, including providing real-time guidance on how to manipulate the transducer, and automated feedback on diagnostic image quality.

“No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, chief executive officer of Caption Health. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

FDA’s authorization of Caption Guidance comes at a time when democratization of ultrasound is touted as the future of healthcare due to portable form factors and increasing hardware affordability. Ultrasound is a safe, non-invasive, and powerful diagnostic tool, and its benefits to patients have been demonstrated in a variety of clinical settings, from the emergency department to the operating room. However, performing ultrasound is challenging and requires specialized training to master, which prevents its adoption and can compromise quality and care.

“We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine,” said Charles Cadieu, co-founder and president. “This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.”

Caption Guidance will initially be deployed in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments. These settings serve a high volume of patients; emergency rooms alone are visited by one in five U.S. adults at least once per year.1 In these environments, ultrasound can be used to triage, monitor, and assess patients who have chest pain, shortness of breath, cardiac arrest, and many other conditions, as well as for the detection of heart disease.

“Point-of-care ultrasound has been demonstrated to expedite time to diagnosis, reduce the need for more costly testing, and decrease complications from invasive procedures,” said Dr. John Bailitz, System Point of Care Ultrasound Education Director, Northwestern Medicine. “Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption: the ability to acquire diagnostic quality images quickly.”

Marketing authorization was granted after the FDA reviewed extensive performance testing, including data from a pivotal multi-center prospective clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health, evaluating the use of Caption Guidance by registered nurses (RNs) with no prior ultrasound experience. Caption Guidance successfully met its primary endpoints, meeting the pre-specified criteria for study success.

In this study, eight RNs with no prior ultrasound experience used Caption Guidance to perform ultrasound exams on 240 patients, following a short training course. Patients were stratified to include a wide range of body-mass index and cardiac pathologies. The RNs acquired limited echo exams of 10 views each. Each exam was assessed by a panel of 5 expert cardiologists to determine if the exam was of sufficient quality to make a set of specific qualitative visual assessments.

Caption Guidance successfully met all four primary endpoints, meeting the pre-specified criteria for study success by acquiring images of sufficient quality for specific clinical assessments. Namely, the RNs successfully acquired limited echo exams for qualitative visual assessments of left ventricular size: 98.8%, 95% CI [96.7, 100]; left ventricular function: 98.8% [96.7, 100]; right ventricular size: 92.5% [88.1, 96.9]; and pericardial effusion: 98.8% [96.7, 100].

In 2018, the FDA granted Breakthrough Device designation to Caption Guidance. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet additional criteria including being a breakthrough technology with no approved alternatives and offers significant advantages over existing alternatives.

“Throughout the process, the FDA demonstrated a sophisticated understanding of AI and its unique regulatory considerations,” said Sam Surette, head of RA & QA at Caption Health. “It has been a privilege to collaborate with the Agency on the development of a new regulatory paradigm for AI-guided image acquisition.”

In addition to Caption Guidance, Caption Health’s full software suite includes automated interpretation and quality assessment capabilities, to assist clinicians throughout their workflow. Caption Guidance software can be integrated onto compatible ultrasound devices. It will be paired with Caption Health’s automated ejection fraction interpretation capability and will be offered to the market as Caption AI.

About Caption Health

Caption Health was founded in 2013 on a simple but powerful concept: what if we could use technology to emulate the expertise of highly trained medical experts and put that ability into the hands of every care provider? Our vision is to move specialty diagnostics and decision making to the point of care for every patient exam. We are developing AI software that empowers healthcare providers with new capabilities to acquire and interpret ultrasound exams.

Adventist HealthCare and Howard University, which operates Howard University Hospital in the District of Columbia, announced that the two organizations have signed a three-year management services agreement in which Adventist HealthCare will bring in a senior leadership team to help strengthen the hospital’s presence in the region. The agreement begins Feb. 17, 2020.

Adventist HealthCare and Howard University Hospital share long traditions of caring for our communities,” said Terry Forde, President & CEO of Adventist HealthCare, one of the longest-serving providers in the D.C. region. We want Howard to continue to be a vital healthcare provider to meet the growing needs of the community, the region and the country now and in the future.

As part of the agreement, Adventist HealthCare will work with Howard University to build a new replacement hospital as part of the overall strategy to continue serving the community and region.

The partnership between these two institutions will provide access for the talented Howard medical trainees, residents, medical students and graduates to train and work within Adventist HealthCare’s network of hospitals. This is vitally important given the national shortage of diverse physicians, nurses, and other healthcare professionals. According to the Association of American Medical Colleges, Howard University is the No. 1 producer of black applicants to U.S. medical schools. announcement will allow Howard to continue to provide high-quality care to the local community in a culturally focused atmosphere.

“This is a historic day for Howard University because this union with Adventist HealthCare signifies a stronger foundation for building our academic programs and it enhances our ability to train the next generation of healthcare professionals,” said President Wayne A. I. Frederick, M.D., MBA. “I’d like to thank Adventist HealthCare, the Howard University Board of Trustees, the leadership of the District of Columbia, our friends in the local unions, and the hard-working men and women of Howard University Hospital who helped to make this dream a reality.”

The new CEO of Howard University Hospital will be Anita L. A. Jenkins, former president of Sycamore Medical Center near Dayton, Ohio. Sycamore is part of the Kettering Health Network in Ohio. Jenkins also served as COO of Kettering Medical Center for four years. Jenkins brings more than 20 years of healthcare experience to the hospital.

“I look forward to working with the dedicated physicians, nurses and employees at the hospital to build upon Howard’s historic legacy of providing quality and compassionate care to the community,” Jenkins said.

Adventist HealthCare, founded in 1907, serves patients throughout the D.C. region. Based in Gaithersburg, MD, it employs close to 6,000 people, has more than 1,700 physicians and cares for more than 750,000 community members each year. It includes three acute-care hospitals: Shady Grove Medical Center, White Oak Medical Center and Fort Washington Medical Center. It also features: two rehabilitation hospitals and outpatient clinics; mental health services; physician practices, home care services and outpatient locations.

“We are excited to utilize the experience and resources of the prestigious Adventist HealthCare network to bring in a new level of best practices to our current systems,” said Hugh Mighty, M.D., Howard University VP of Clinical Affairs and Dean of the College of Medicine. “As the number one producer of black medical graduates, Howard University has a mission to train students to serve diverse communities. This agreement further strengthens our ability to continue this mission right here in the heart of D.C.”

About Adventist HealthCare

Based in Gaithersburg, Md., Adventist HealthCare is one of the longest-serving health systems in the Washington, D.C. region, and one of the largest employers in the state of Maryland. It includes Shady Grove Medical Center, White Oak Medical Center, Fort Washington Medical Center, Adventist HealthCare Rehabilitation, Home Care Services, Adventist Medical Group, Imaging and Urgent Care.

About Howard University Hospital

Howard University Hospital is a private, nonprofit institution that has served the community for more than 150 years. It is one of the most comprehensive health systems in D.C., with a Level 1 Trauma Center and an emergency department that sees approximately 50,000 patients annually. It is recognized as a national leader in training future doctors, nurses and other healthcare professionals.