At this workshop, systems biology, (toxico) genomic, functional genomic, proteomic and metabonomic data related to biomarker development will be presented and discussed among academia, industry and regulators. The synergistic path of discovery and development of biomarkers during the drug development process will be presented and discussed.
Presentations will also include examples of organ specific safety biomarkers: challenges in discovery, development and registration, as well as for clinical efficacy biomarkers in different biological fluids. A special presentation has been added on the latest developments in the use of epigenetic for cancer therapy.
In the workshop an update will be provided on the US C-Path Initiative (www.c-path.org) and on the European Innovative Medicines Initiative (www.imi-europe.org). The US and European regulatory view on acceptance of novel biomarkers will be presented and discussed by a panel.