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Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Information systems for surrogate biomarkers
Michael Hehenberger1, Avijit Chatterjee1, Jörg Sprengel2
1IBM, Route 100, Bldg 3, MD 3125, Somers, NY 10589, USA.
Abstract:
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.:

