The development and production of medicines is a trial & error based activity characterized by the long development times (12-14 yrs), low success rate and moderate product performance (efficacy-to-safety ratio). In addition many diseases still have to be covered after 50 years of practicing. Not an extremely effective health care strategy. Yet the advances in neuroscience, molecular medicine, diagnostic radiology, robotic surgery, pharmacology, and many other areas - as well as their funding - have exploded since the initial sequence and analysis of the human genome was published in 2001.

Translational medicine research (TMR) is the research approach to bridge this move “from bench to bedside” or from laboratory experiments through clinical trials to actual point-of-care patient applications. TMR in combination with the Quality by Design (QbD) approach for the development and manufacture of new medicines form a ring of structured events that starts and ends at the patient.