Hans-Juergen Loyda, Ph.D., MBA, is Director of Clinical Development and Education of Medical and Scientific Affairs at Roche Diagnostics in Indianapolis. He holds a Bachelor of Science in Biology, a Doctorate in Zoology from the Rheinisch-Friedrichs-Wilhelms University in Bonn/Germany and a Master of Business Administration from the Indiana Wesleyan University. He has been with Roche Diagnostics for 28 years with extensive experience in sales and marketing. The last 8 years he has focused on developing relevant and compelling clinical evidence for cardiac biomarker in Medical & Scientific Affairs. For this area he is also scientific resource internally and externally.

Personalized Medicine has been in discussion for many years. The main challenge for this area is to demonstrate its efficacy and safety in comparison to treatments for which the efficacy benefit has been demonstrated for specific target populations. But being effective in populations also includes that it might not work for an individual patient. Personalized Medicine can be applied on different levels – in a purely diagnostic mode to identify individual disease in a particular patient. It can help predict the patient’s response to a specific treatment, it might provide information about potential recurrence of disease and finally it provides information about the actual response of an individual to treatment with proven efficacy in populations. The complexity of the topic will be discussed with the example of “Therapy Guidance for Heart Failure Patients”. This example will specifically focus on the discussion of developing sufficient evidence to demonstrate efficacy – especially when it is not totally clear how to use biomarkers to demonstrate clinically relevant change in patients. But as for many years the main focus of research around therapy guidance was to define the exact conditions under which the approach could demonstrate that it is able to improve patient outcomes, we now are seeing further applications and expansion of biomarker usage beyond this field. The development of high sensitivity Troponins seem to provide us with an opportunity to identify patients with subclinical disease. In combination with natriuretic peptides we might have powerful tools available to identify patients with subclinical, but still progressing disease who might be potential target for new therapeutic approaches. And while this is being discussed we see first new examples of biomarker use in the field of new drug development in acute heart failure – both developments which demonstrate the fast growing field of biomarker use in Personalized Medicine in cardiovascular disease.