Forschung

Despite tremendous efforts, despite the cloning of the total human genome, innovations at the patient level are becoming rare events, and insufficiencies in predicting human efficacy/safety from early discovery and development work is blamed to underlie many failures. It has become a fashionable phrase, but this is just not enough. Translational medicine is a complex science which is still in its infancy, and needs careful development both as generic science, and in concrete projects. As a generic science, the principles of translational activities need to further explored, standardized and developed. A very important milestone in the development of translational science is the classification of biomarkers in regard to their predictive value for cross-species efficacy and safety extrapolations. The institutionalization of translational science and integration into large networking structures at sites of prime research and clinical facilities seems to be a timely investment. In the US, an increasing number of universities has undertaken those efforts and build up institutes of translational medicine, governmental and regulatory (e.g. FDA) bodies have called for increased activities under those auspices (Critical Path Initiative), and the time for phrases and fashionable titles without true translational content should end as soon as possible. This textbook will address the scientific aspects of translational medicine and teach the essential components of a complex network of activities which should lead to successful and reliable translation of preclinical into clinical results.
It will deal with all aspects of preclinical and clinical issues which are relevant to the translational success of pharmaceutical or medical device/diagnostic innovations; this includes target risk assessment, biomarker evaluation and predictivity grading both for efficacy and toxicity, early human trial design adequate to guide stop/go decisions on grounds of biomarker panels, biostatistical methods to analyze multiple readout situations and quantify risk projections. The book will provide guidance to design smart profiling strategies for new approaches aiming at cutting timelines, compare and concentrate on quality issues early on in developmental processes. Translational efforts will always be benchmarked against patients` needs and integrative strategies to optimize yield and cost ratios.
The textbook will comprise state-of-the-art knowledge in translational medicine, with emphasis on its scientific backbone, its strengths, but weaknesses of a young discipline as well. Under didactic auspices, it should further the substantiation of this emerging science, create awareness about its urgently needed potential to promote innovations into clinical practice, but also for the threat implied by the empty phraseology inherent to the present hype in this area.
Lit.:
Wehling, M.
Translational medicine: can it really facilitate the transition of research "from bench to bedside"? Eur J Clin Pharmacol 62, 91-95, 2006

Wehling, M.
Translational Science in Medicine-Implications for the Pharmaceutical Industry.
Int J Pharm Med 20, 1-8, 2006”