April 30, 2018 | April was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Oracle, the College of American Pathologists, NVIDIA, and more.

Oracle unveiled its new Oracle Health Sciences mHealth Connector Cloud Service, enabling clinical study teams to remotely collect e-Source data from patient sensors, wearables and apps for use in their clinical trials, while delivering a new level of patient engagement and centricity. The rise of mobile health technologies including mobile sensors, patient engagement apps and telemedicine are reshaping how drugs are developed by improving the efficiency of clinical trials. Oracle’s mHealth Connector Cloud Service makes it easy to connect existing clinical systems with a wide variety of e-Sources, enabling therapeutic teams to obtain more accurate and rich patient data, improve adherence to study protocols, better understand the safety and efficacy of trial drugs and improve patient centricity with remote patient monitoring. “We are thrilled to announce our new mHealth Connector Cloud Service as it holds great promise in speeding clinical trials and bringing more drugs to market faster. Being able to take what used to be patient-recorded data and outcomes via paper forms and site visits can now be done via mobile health sensors and wearables that have the potential to shorten trial times and reduce costs, while allowing sick patients to remain in the comfort of their homes versus traveling to and from trial sites. To improve patient enrollment in clinical trials, study teams must put the patient at the center of everything they do, and emerging technologies such as wearables and sensors hold the key,” said Steve Rosenberg, general manager, Oracle Health Sciences, in a press release. The mHealth Connector Cloud Service supports a number of integration approaches and Oracle Health Sciences is currently exploring integration efforts with a wide ecosystem of mobile health companies such as Validic, MC10 and CMT, as well as solution integrators and developers such as Accenture and POSSIBLE Mobile. Press Release

The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Human Longevity Clinical Labs, San Diego, California, based on results of a recent on-site inspection as part of the CAP's Accreditation Programs. The facility's director, Kenneth J. Bloom, was advised of this national recognition and congratulated for the excellence of the services being provided. Human Longevity Clinical Labs is one of more than 8,000 CAP-accredited facilities worldwide. HLI's CEO, J. Craig Venter, said in a press release, "I am proud of our laboratory team for their hard work and diligence in achieving this important and necessary accreditation from CAP. We look forward to continuing to provide our clients with comprehensive and quality health information as part of our Health Nucleus experience." The United States federal government recognized CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government's own inspection program. During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety programs and record, and overall management. Press Release

NVIDIA and Canon Medical Systems announced a new partnership to develop the research infrastructure for enhanced artificial intelligence (AI) in healthcare. The partners hope to make a significant contribution to promoting the use of data-intensive deep learning techniques in medical and related research, as well as to drive the uptake of AI in the healthcare sector. According to NVIDIA, the healthcare sector needs to analyze scientific reports from around the world, while simultaneously coordinating a variety of patient data to determine the most appropriate treatment options. Given the huge volumes of data involved, big data analysis via deep learning will play a major role in the development of optimized healthcare delivery systems and support early detection and assisted diagnosis. At the same time, medical institutions wanting to use deep learning for independent research need hardware for analysis, systems for the collection, collation and analysis of in-house data, and knowledge of deep learning processes and techniques. Canon Medical Systems will use NVIDIA DGX systems to process large volumes of medical data generated by Abierto VNA (vendor neutral archive), the proprietary, in-house medical data management system it launched in January. Press Release

Vineti announced the closing of $33.5 million in Series B investment to support expansion of the company’s technology platform for individualized therapies. The financing is being led by Canaan and DFJ, with participation from GE Ventures, Section 32, Casdin Capital, and LifeForce Capital, along with other undisclosed investors. The additional capital will be used to further advance the first cloud-based “platform of record” specifically built to move transformative new personalized therapies such as CAR-T cell therapy into mainstream medicine. The funding will also support Vineti’s further expansion in Europe and Asia-Pacific, providing a global solution to a critical personalized medicine barrier. Vineti’s configurable, cloud-based software platform improves cell and gene therapy product performance, promotes regulatory compliance, and enables faster, safer, broader access for patients. The platform automates, orchestrates, and simplifies the complex workflows behind personalized therapies, and helps pharmaceutical partners address emerging opportunities and challenges as these therapies move into mainstream medicine. The Vineti platform also enables seamless integrations with other parts of the therapy ecosystem. Vineti is currently serving patients, healthcare providers, and researchers in a large, growing, global healthcare network. Nina Kjellson, General Partner at Canaan, and Michael Pellini, Managing Partner at Section 32 and Chairman of Foundation Medicine, will join Vineti’s Board of Directors. All of Vineti’s founding investors will continue to participate in the company’s growth, including Mayo Clinic Ventures, and collaborate to drive even more new solutions for patients, healthcare providers, and therapeutic innovators. Press Release

Robotics have redefined surgery over the last decade, but it’s been slow to break into the field of neurosurgery. Limitations remain in even the most basic neurosurgical procedures, most of which are still performed by hand. Precision is restricted. Access to crucial areas of the brain is very challenging. Movements are awkward, increasing incision size and diminishing results. A new cranial robot with four working arms and a steerable camera, codeveloped by BSSNY and Honeybee Robotics, will resolve this conundrum, establishing never-before-used technology to improve patient outcomes. Two hands are better than one, so consider how doubling that to four hands – with robotic steadiness – will forever change neurosurgery, and especially life-threatening blood clots and brain tumor resections. Full Article

Spry Health has announced a new scientific and clinical research grant to leverage the company’s technology to advance knowledge of human health and chronic disease progression. Spry Health plans to provide up to 100 Loop wristbands as well as consulting services from its research and development team to partnering researchers selected for the grant. Researchers will have a revolutionary opportunity to build the largest dataset of physiologic identifiers of disease and acute patient events. The ambulatory wristband is designed to passively collect health data from patients throughout the day and night with no user input. Continuous health data collection will create an unprecedented understanding of human health and disease progression. “The ability to continuously track and quantify both a patient’s baseline and stressed state throughout their normal daily routine could not only change the way in which we deliver health care, but also change how we fundamentally understand what health is,” said Steven Steinhubl, Director of Digital Medicine at Scripps Translational Science Institute, in a press release. Press Release

ClinOne will soon finalize integrations with Lyft and Uber (who recently launched their medical transportation dashboard, Uber Health) to offer free transportation services for patients enrolled in clinical trials through ClinTrialConnect. ClinTrialConnect is ClinOne's patient-facing concierge platform that manages a patient's clinical trial experience. The integration completion, planned for June 2018, will allow auto-invoicing for Lyft and Uber trips to and from the study site, so the patient is not charged and doesn't have to submit an expense report to the site and await reimbursement. For the site, it's one less piece of paperwork to process for each patient visit. Patient compliance for a timely visit is important for the clinical trial, clinical data and safety of patients and transportation to visits can be challenging to patients and families. The logistics involved in securing transportation to clinical trial appointments has long been cited as a barrier to clinical trial participation, and missed appointments are detrimental to the patient and to the study site. In particular, the elderly face additional challenges related to transportation. Many elderly patients rely on family for getting to and from their research visit, which complicates the process for patients arriving at their appointments on a consistent schedule. "It's easy to lose track of how complex this process may be for a single study. For example, a phase III study could have 2,000 patients enrolled for 36 months and each patient needs to come in for a monthly visit. That's 72,000 patient visits and 144,000 trips – a staggering number," said Rob Bohacs, CEO of ClinOne, in a press release. He added, "We simplify the process for patients, families, and provide a true concierge service to patients, which is crucial to our mission. The cost of these services is not prohibitive compared to standard reimbursements for travel and parking time. This can average $35 per visit per patient, while Lyft and Uber costs would range from $22 round trip to $45 for most patients." Press Release

Charles River Laboratories announced that it has completed the previously announced acquisition of MPI Research for approximately $800 million in cash, subject to certain customary adjustments. MPI is a premier non-clinical contract research organization (CRO) providing comprehensive testing services to biopharmaceutical and medical device companies worldwide. Acquiring MPI will enhance Charles River’s position as a leading global early-stage CRO by strengthening its ability to partner with clients across the drug discovery and development continuum. James C. Foster, Chairman and Chief Executive Officer of Charles River Laboratories, commented in a press release, “We are pleased to welcome the exceptional team at MPI Research to the Charles River family. The addition of MPI’s scientific expertise, high-quality services, and complementary capabilities will enable us to enhance the support we can provide to clients, as they address the complex challenges of drug discovery and early-stage development. The acquisition of MPI also enhances our ability to achieve our long-term growth goals by building scale to meet current and future demand, and by expanding our biotechnology client base, the fastest-growing market segment.” Press Release