title: Information systems for surrogate biomarkers.
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.:
authors: IBM, Route 100, Bldg 3, MD 3125, Somers, NY 10589, USA. Electronic address:hehenbem@us.ibm.com.
authors: Michael
authors: M
authors: Hehenberger
authors: IBM, Route 100, Bldg 3, MD 3125, Somers, NY 10589, USA.
authors: Avijit
authors: A
authors: Chatterjee
authors: IBM Basel, Schwarzwaldalle 215, Areal Rosental 1008, Basel 4010, Switzerland.
authors: Jörg
authors: J
authors: Sprengel
authors: InnovationXchange Network, P.O. Box 210106, San Francisco, CA 94121, USA.
authors: Christopher
authors: C
authors: Yoo