Individualized medicine within the GANI_MED project

Abstract

In 2009 the University Medicine Greifswald, Germany, has launched the “Greifswald Approach to Individualized Medicine” (GANI_MED) project to address major challenges of Individualized Medicine. The major goals of Individualized Medicine require excellent clinical stratification of patients as well as the availability of genomic data and biomarkers as prerequisites for the development of novel diagnostic tools and therapeutic strategies. In this chapter, we describe the implementation of the scientific and clinical infrastructure. Patient cohorts with an emphasis on metabolic and cardiovascular diseases are being established aiming at the inclusion of more than 5,000 patients. Standardized protocols for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking have been developed. A multi-omics based biomarker assessment is applied to identify new biomarkers or biomarker-signatures that complement disease-specific biomarkers at an individual or stratified level. A central data management structure has been implemented to integrate all relevant clinical data for research and translational purposes. Ethical research projects on informed consent procedures and the reporting of incidental findings were initiated as well as health economic evaluations.