High-performance Integrated Virtual Environment (HIVE) Capabilities: A Strategic Look at the Opportunies

 Healthcare stakeholders are increasingly seeking reliable (i.e., science-based, clinically-meaningful, and predictive) evidence to support decision-making about medical products.

Recent implementation of High-Performance Integrated Virtual Environment (HIVE) hardware and software at the FDA presents a great opportunity for exploring new ways of analyzing vast amounts of data and deriving more comprehensive evidence to characterize a medical product. As a distributed storage and computation environment and a multicomponent cloud infrastructure, HIVE provides secure web access for authorized users to deposit, retrieve, annotate, and compute on biomedical big data, and to analyze the outcomes using web interface visual environments appropriately built in collaboration with internal and external end users. In addition to the initial HIVE applications to next generation sequencing, the current universe of HIVE projects covers tailor-made applications involving dimensionality analysis, federated and integrated data mapping, modeling and simulations that are applicable to basic research, biostatistics, epidemiology, clinical studies, post-market evaluation, manufacturing consistency, environmental metagenomics, outbreak detection, etc.

In this forum, we will:

• Describe challenges faced by the industry and FDA with relation to a size and complexity of the information pertaining to regulatory research and submissions
• Describe the HIVE end-to-end solution platform developed by FDA and George Washington University in order to bridge modern computational paradigms into the clinical and regulatory settings
• Briefly describe the major capabilities provided by a wide arsenal of visualization and predictive analytics tools
• Provide a few examples of successful biomedical research projects involving large data integration and computation
• Invite the MDEpiNet auditorium to propose HIVE-based collaborative research pilots providing the bioinformatics solutions for the challenges pertaining to medical devices

Instructors

Vahan Simonyan, PhD – US Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

Yelizaveta (Lisa) Torosyan MD, PhD – US Food and Drug Administration

Center for Devices and Radiological Health (CDRH)

Danica Marinac-Dabic, MD, PhD – US Food and Drug Administration

Center for Devices and Radiological Health (CDRH)

Join the webcast meeting (link) (https://dukemed.webex.com/dukemed/j.php?MTID=mc81abb99903fbb2407291d3b52befe00)

Meeting number:  734 929 982 Meeting password:  mdepinet

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