1. Introduction and definitions M. Wehling 2. Target identification and validation M. Plebani, M. Zaninotto, G. Lippi, E. Marrer, F. Dieterle, J. Vonderscher, D. Stroncek, P. Jin, E. Wang, J. Ren, F. M. Marincola, J. Kirchheiner, W. Peeters, W. J. M. Derksen, D. P. V. de Kleijn, G. Pasterkamp and M. Grasso 3. Biomarkers M. Wehling, D. Bernardi, M. Plebani, L. Lind, F. Azam, R. Midgley, D. J. Kerr, L. Johansson, A. Meyer-Lindenberg and H. Tost 4. Early clinical trial design F. Azam, R. Midgley, D. J. Kerr and C. Karlsson 5. Pharmaceutical toxicology S. Ernst, S. Boyer and S. Platz 6. Translational science biostatistics G. Ferber and E. Glimm 7. Learning by experience: examples of translational processes in the cardiovascular field M. Wehling.