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…