Avijit Chatterjee

IT solutions for imaging biomarkers in biopharmaceutical research and development

Biomarkers are indicators of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention. The biopharmaceutical industry is building significant molecular-imaging capabilities and in this context is incorporating biomarker concepts throughout its research. In this paper, we discuss and propose information technology (IT) standards and architectures that support incorporation of imaging biomarkers into the drug discovery and clinical development process. In particular, we cover various uses of emerging imaging technologies in biopharmaceutical research and development, examples of imaging biomarkers in therapeutic areas, IT requirements related to the use of imaging technologies, challenges related to the integration of imaging biomarker data with clinical and genotypic data, and the need to integrate external public data sources. We discuss IT standards and architectures associated with the inclusion of biomarker-related data in the submission of new drug applications, with emphasis on imaging technologies. We suggest extensions to the Study Data Tabulation Model of the Clinical Data Interchange Standards Consortium and the JANUS Data Model of the Food and Drug Administration with data elements based on imaging biomarkers.

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.: