DIGIMED BAYERN Data-Driven Personalized Medicine DigiMed Bayern For implementation of innovative solutions in order to improve healthcare for the population, the generation, compilation, and analysis of health- care data is prerequisite. Big data analyses can significantly contribute to enhancing early detec- tion, diagnostics, and prevention, as well as to developing personalized and thus more efficient therapy solutions. This is especially relevant in the fight against chronic diseases such as diabetes, coronary heart diseases, cancer or rare diseases, which put major pressure on both the patients concerned and on the health system. DigiMed Bayern, a Lighthouse Project The so-called P4 medicine (predictive, preventive, personalized, participatory) allows for personal- ized prevention and individualized treatment for every patient, with greater and proactive involve- ment of the patients themselves. Based on high quantities and types of medically relevant data, the DigiMed Bayern project is investigating how molecular, environmental, and behavioral factors influence the development of diseases, and how prevention, detection and treatment can be per- sonalized and optimized. The lighthouse project began at the end of 2018 with a funding volume of EUR 22.5 million by the Bavarian State Ministry of Health and Care. It aims to implement and inte- grate P4 medicine into everyday clinical practice. DigiMed Bayern focuses on atherosclerosis, the deadliest disease worldwide. In Germany, cardiovascular diseases cause about 40% of all deaths. The five-year research project DigiMed Bayern combines comprehensive clinical and epidemiological data from patients diagnosed with, for example, coronary heart disease, stroke, or genetic risk factors. State-of-the-art molecular “multi-omics” characterization and health insur- ance data complement this data set. Thus, in this holistically configured project, data is both generated and analyzed from multiple perspec- tives, using custom-built IT-infrastructure. Where possible, the resulting findings are transferred to the health system as new state-of-the-art scientific understanding, as new diagnostic biomarkers and drug targets, as adaptations to medical guidelines and best practice, and as new tools. www.digimed-bayern.de and www.myvroni.de VRONI Study for Improvement in Hypercholesterolem An individual’s risk of heart attack and stroke is highly relevant for deci- sions on prevention and treatment. Familial hypercholesterolemia (FH) is the most common monogenic metabolic disease worldwide. Consider- ably elevated levels of LDL cholesterol in the blood significantly increase the risk of severe cardiovascular events, even from a young age. With early medication and lifestyle adaptions, however, the disease is treat- able. Nevertheless, only under 1% of approximately 270,000 FH carriers in Germany are diagnosed and thus adequately treated. As part of the DigiMed Bayern project, the VRONI study is a Bavaria-wide FH screening of children aged five to 14 years. The study was successfully launched in September 2020 in broad collaboration with pediatricians and cardiolo- gists. VRONI is led by Prof. Dr. med. Heribert Schunkert, Medical Director at the German Heart Centre Munich, and by Dr. med Veronika Sanin from the same leading cardiology clinic. The aim is to test up to 50,000 children by the end of 2023 for elevated LDL levels – integrated into their regular visits to pediatricians. If their LDL cholesterol levels are elevated, molecular genetic tests are carried out to identify known and novel causative mutations. Further known and yet unknown causative factors are analyzed. All children with hyper- cholesterolemia, with and without an identified genetic background, are offered therapy options by pediatricians and pediatric cardiologists, including lifestyle support with a novel psycho-educational training pro- gram for the family. Through partnership with a nationwide FH screening study and register, parents and other family members also affected by the hereditary disease can be identified and treated. To date, more than 370 pediatricians with over 5,700 children are participating in the VRONI study. In addition to direct benefits for patients, VRONI aims to provide medical education and serve as a model for FH screening and treatment implementation in the German and in international health systems. HerzFit App for Cardiovascular Risk Assessment and Management Health data are increasingly collected and used by patients themselves. The rapid development of mobile devices such as smartwatches, and software applications for health, including fitness, nutrition, and well-be- ing, allows people to take their health management more into their own hands. As an additional benefit, the associated collected “real-world data” have great potential for (applied) health research. In cooperation with the large patient organizations Deutsche Herzstiftung and Deutsche Hochdruckliga, plus support from the insurance company Techniker Krankenkasse, the app “HerzFit” is being developed in collabo- ration with DigiMed Bayern. Users receive a tool for risk assessment and are encouraged and guided toward positive behavioral changes. This includes fitness, nutrition, quitting smoking, and stress management. The toolbox enables the setting of personal goals, self-monitoring, indi- vidual coaching, and education. Lifestyle changes alone could prevent up to 80% of cardiovascular diseases. The public launch of HerzFit, which will be freely available in the common app stores, is currently planned for early 2022. Biotech in Bavaria - Report 2020/21 39