November 28, 2018 | November was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from SHYFT, the Memorial Sloan Kettering Cancer Center, Pure Storage, and more.

SHYFT announced that the companies have entered into a strategic partnership that establishes SHYFT’s technology as an integral part of PAREXEL’s foundation for Real-World Evidence (RWE) generation and outcomes research for biopharmaceutical and medical device clients. The collaboration combines PAREXEL’s innovative scientific and clinical services with SHYFT’s market-leading suite of RWE products to provide insights and outcomes from patient-level data more efficiently to customers worldwide. The pairing aims to optimize the design and execution of ongoing and retrospective clinical studies, from late-phase research to safety studies to the support of pragmatic clinical trials. SHYFT’s QUANTUM Real-World Evidence platform allows researchers to generate robust “submission-ready” studies 92% faster than industry standard, on average. PAREXEL will be leveraging the SHYFT platform to perform at-scale analyses including cohort modeling, trial feasibility assessment, and large scale observational studies - research that will have broad impact across the drug development and Market Access spectrum. The relationship builds upon PAREXEL’s real-world data strategy that integrates data access, advanced technologies, data science capabilities, and clinical and consulting expertise. “PAREXEL is, and always has been, committed to helping sponsor organizations navigate the complexities of drug development,” said Michelle Hoiseth, Chief Data Officer for PAREXEL, in a press release. “The growing availability of real-world data combined with innovative analytics methods and groundbreaking technologies present an opportunity to assist our organization in delivering on that commitment. As we have evaluated capabilities in this area, we have found SHYFT’s platform to be unmatched among other RWE platforms, in its ability to provide answers to complex scientific and commercial queries quickly, with repeatable precision, in a user-friendly manner. By leveraging SHYFT’s platform, our teams will be able to generate real-time insights spanning strategic consulting to pivotal trial feasibility to late-phase health economics and outcomes research (HEOR) analytics with a much higher level of efficiency. This, combined with our enhanced data linking capabilities, is a significant step forward in our approach to help sponsors leverage real-world data in a meaningful way now and in the future.” Press release

Researchers at Memorial Sloan Kettering Cancer Center (MSK), the University of Sydney, and Resolution Bioscience have reported the first prospective clinical study of circulating tumor DNA (ctDNA) using next generation sequencing (NGS) to rapidly guide treatment of lung cancer patients. The research was published by Sabari and colleagues in the Journal of the National Cancer Institute. These results contributed to the New York State Department of Health's approval of ctDx Lung for clinical use. Assessing patients in New York and Sydney with metastatic non-small cell lung cancer (NSCLC), the study showed Resolution's ctDx Lung assay successfully matched patients with targeted treatments and led to clinical responses. In addition, compared to tissue NGS, the blood-based assay reduced mean turnaround times by half. "This prospective study is an important validation of our blood-based approach," said Mark Li, president and CEO of Resolution, in a press release. "Using a non-invasive test, we identified actionable mutations that helped guide treatment. These findings support further efforts to incorporate plasma NGS into standard of care." Led by MSK-attending medical oncologist Bob T. Li, MD and clinical investigators on two continents, the study enrolled 210 patients with advanced NSCLC, all of whom received the plasma NGS test. In addition to the blood test, 106 of the participants received the MSK-IMPACT tissue biopsy NGS test. Among those who tested positive for cancer-driving mutations by the plasma assay, the results were concordant with MSK-IMPACT in 96% of the cases with tissue biopsy results. Press release

John Snow Labs announced the launch of John Snow Labs’ Data Market. The Data Market is an online store that allows users to subscribe to datasets and/or data packages in the healthcare and life science domain. John Snow Labs helps accelerate progress in data science and analytics by taking on the headache of managing data and AI platforms. The launch of its Data Market will help researchers, data scientists, or anyone looking to collect data to better do their job, by giving them access to the reference datasets they need. Developers building a mobile app to give advice to people with diabetes, for example, can use the Data Market to access diabetes-related datasets that contain essential information, such as nutritional data, diagnosis terminology, or available drugs, that they would require to build the app. Press release

Pure Storage announced Pure Storage Cloud Data Services, a suite of new cloud offerings that run on Amazon Web Services (AWS). With these new products, customers can invest in a single storage architecture that unifies application deployments on-premises and on the cloud to flexibly turn data into value virtually anywhere. Enterprise application mobility, coupled with emerging technologies like artificial intelligence (AI), Machine Learning (ML) and deep analytics, has increased the strategic importance of infrastructure exponentially. Applications of all types -- traditional and emerging -- demand flexible, location-independent data accessibility, and this has had a profound impact on infrastructure. Modern organizations need real-time access to any and all data, which requires applications to move freely between on-premises and the cloud. Historically, a lack of purpose-designed, strategic integrations between on-premises storage and the cloud have been a primary inhibitor of application mobility. “Today, there exists a cloud divide - the cloud is not purpose-built for enterprise applications, and enterprise infrastructure isn’t as user-friendly as the cloud," said Charles Giancarlo, Chairman and CEO of Pure Storage, in a press release. “Customers should be able to make infrastructure choices based on what’s best for their environment, not constrained by what the technology can do or where it lives. Today's announcement extends Pure's data centric architecture to the cloud, allowing our customers to build hybrid applications that provide true mobility and freedom.” Press release

Life Image and Mendel.ai announced a new strategic partnership that will facilitate the adoption and enhancement of AI in oncology site selection and patient recruitment. This new engagement will advance the use of Mendel Brain, which helps life sciences and research facilities by analyzing clinical data at a site location to identify patient cohorts for a given protocol. Research coordinators who continuously prescreen clinical site data augment the AI. Mendel Brain yields 30% to 50% more patients while decreasing the time between patient eligibility and identification to minutes compared to conventional pre-screening practices, which can take months or even years. Mendel Brain will be offered as a component of the Life Image Interoperability Suite to deliver additional value to its large network of research hospitals. With the depth and breadth of Life Image’s network of Academic Medical Centers (AMC), the Mendel Brain solution is in high demand to reduce the administrative burdens of clinical trial participation. In addition, the ease of interoperability and integration available through Life Image will help accelerate the adoption and application of Mendel Brain while providing greater access to clinical data including imaging data to help increase accuracy in patient selection. Press release

IRBM has strengthened its position in neurodegenerative disease research following an extension of its long-standing collaboration with CHDI Foundation, a nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that substantially improve the lives of those affected by Huntington’s disease (HD). The collaboration with CHDI demonstrates IRBM’s commitment and passion for developing novel therapeutic solutions for this devastating disease. Since 2011, IRBM has worked closely with CHDI to investigate innovative therapeutic approaches based on a better understanding of the biology of the disease. This has included significant contributions by IRBM to HD-specific mechanistic and translational research, as well as tailored drug discovery solutions. The extension of this collaboration builds on IRBM’s expertise in the biology of neurodegenerative diseases, its comprehensive screening capabilities and continued access to IRBM’s compound collection and peptide libraries. IRBM will also continue to leverage its significant experience in integrated neuroscience drug discovery with small molecules and biologics, including the development of clinically qualified diagnostic assays and the creation of predictive models for blood-brain barrier permeability. Press release