Principles of Translational Science in Medicine From Bench to Bedside

A state-of-the-art survey of translational medicine, with emphasis on its emerging scientific backbone, its strengths, and its weaknesses.

Despite advancements in the cloning of the human genome, biomedical innovations at patient level are rare events. Translational medicine is, however, a burgeoning science that shows potential to reverse the trend. This textbook provides a survey of translational medicine, emphasising its emerging scientific backbone, its strengths and weaknesses. It explores all aspects of preclinical and clinical issues relevant to the success of translational pharmaceutical or medical device or diagnostic innovations, including target risk assessment, biomarker evaluation, and predictivity grading for both efficacy and toxicity; early human trial designs, adequate to guide stop or go decisions on the grounds of biomarker panels; and biostatistical methods to analyze multiple readout situations and quantify risk projections. Translational Science in Medicine provides guidance to design profiling strategies for new approaches to the field. By generating dialogue about translational science Wehling explores the implications of this field on the future of patient care.

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.

A state-of-the-art survey of translational medicine, emphasising its emerging scientific backbone, its strengths, and weaknesses. This textbook explores all aspects of preclinical and clinical issues relevant to the success of translational pharmaceutical or medical device or diagnostic innovations guiding readers in designing profiling strategies for new approaches to the field.

Professor Mark Wehling is an internist, cardiologist, and full professor of clinical pharmacology at the University of Heidelberg, Germany. He has authored more than 200 scientific publications and several books and has been recipient of the Heisenberg Scholarship from Deutsche Forschungsgemeinschaft. After working as Director of Discovery Medicine at AstraZeneca, he returned to his academic position in 2007. In his return to academia, his aim is to further translational medicine by aligning academic and private activities to support biomedical innovation. His main tools are connecting distant players in the translational process; bridging gaps between preclinical and clinical stages; assembling, developing, and profiling biomarkers with particular assessment of their predictive value; and developing smart translational plans to reliably and swiftly promote translatable projects.