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Abundance of miscellaneous high performance computational platforms available across academia, healthcare industry, and in government organizations isn't doing much to close the gap between research and regulatory analytics. Extra iterations for drug, device and biologics approval process are causing a significant cost increase for medical product development. High-Performance Integrated Virtual Environment (HIVE) co-developed by FDA and GW presents a great opportunity for serving as a bridge. It is authorized as a regulatory NGS data analysis platform and provides unique capability for healthcare stakeholders to look into NGS data from regulatory perspective of FDA.
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, and more.