Information systems for surrogate biomarkers.

Biopharmaceutical industry is incorporating biomarker concepts throughout the R&D processes, including the inclusion of biomarker-related data in the submission of new drug applications. In this paper we discuss the role of IT and information systems that support incorporation of surrogate biomarkers in the clinical development process, with emphasis on new molecular imaging technologies and associated IT requirements. In addition, we discuss how recently introduced FDA standards regarding submission data and FDA guidance documents related to genomic and imaging data can be accommodated in a solution architecture for (surrogate) biomarker-based clinical development.:

Text-based knowledge discovery: search and mining of life-sciences documents.

Text literature is playing an increasingly important role in biomedical discovery. The challenge is to manage the increasing volume, complexity and specialization of knowledge expressed in this literature. Although information retrieval or text searching is useful, it is not sufficient to find specific facts and relations. Information extraction methods are evolving to extract automatically specific, fine-grained terms corresponding to the names of entities referred to in the text, and the relationships that connect these terms. Information extraction is, in turn, a means to an end, and knowledge discovery methods are evolving for the discovery of still more-complex structures and connections among facts. These methods provide an interpretive context for understanding the meaning of biological data.