GIVVISH is a proposed collaborative public service project that aims to design, develop, deploy, and maintain a socially-scaled, human relevant method validation platform and library. It will feature open-source data storage and processing for delivering super-computed algorithms for evaluation and regulatory review of emerging human-based assay methods and tools used in pre-clinical drug development. The platform will incorporate Big Data, user/enterprise level security and sharing settings, and a peer review process to streamline the validation pathway for these new technologies. In collaboration with industry, academia, and government entities, our goal is to provide the surface and structure to organize and review large volumes of multi-sourced, independent data to facilitate the bridge from last century's reliance on animal models to a 21st century solution- a predictive model based on human biology for assessing human clinical outcome. The GIVVISH platform will function in real-time, with deep machine learning for constant refreshing of algorithmic codes for predictive modeling, creating an organically-built validation engine and library of validated methods. By facilitating engagement of the scientific community and regulatory agencies with statistically-significant volumes of computed data in an organized manner, a validation process can take hold. The GIVVISH vision is a human-relevant predictive model that will help deliver safer, more efficacious therapies, spur innovation, reduce cost, and align with our highest scientific and ethical potential.
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