Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development.

Pharmaceutical research and development generates enormous amounts of nonclinical and clinical data related to safety and efficacy, and the ability to manage and utilize these data is critical for discovering and developing new drugs. Information systems exist that store and analyze relationships among seemingly disparate data sets (ie, data silos); however, to fully utilize the potential of these informatics systems, it is necessary to define basic parameters about the data and to develop concepts regarding "interconnectivity," or relationships among disparate data sets. To explore these issues, the Nonclinical Data Interconnectivity Sub-Group was chartered: a component of the Non-Clinical Road-Map and Impacts on Implementation Working Group associated with the US FDA-PhUSE (Pharmaceutical Users Software Exchange) Computational Sciences initiative. As a starting point, the group defined the meaning of data interconnectivity. Nonclinical data types were then identified and challenges and opportunities for interconnectivity explored. Specific-use cases were identified to provide examples of the value for interconnecting data across disciplines or silos.