Non-Alcoholic Fatty Liver Disease (NAFLD), including its more pathologic consequence, non-alcoholic steatohepatitis (NASH), is believed to be the most common chronic liver disease worldwide, affecting between 6 to 37% of the population. NAFLD is a so called ‘silent killer’, as clinical symptoms only surface at late stages of the disease, when it is no longer treatable: untreated, NAFLD/NASH can lead to cirrhosis and hepatocellular carcinoma, culminating in liver failure. Currently the best method of diagnosing and staging the disease is liver biopsy, a costly, invasive and somewhat risky procedure, not to mention unfit for routine assessment. Besides, no therapeutic consensus exists for NAFLD/NASH treatment. mtFOIE GRAS (Foie Gras being French for "fat liver") proposes to address the pressing need for non-invasive, accurate, rapid assessment of NAFLD/NASH stages, before and after intervention, through the development of biomarkers and innovative tools to follow mitochondrial (mt) dysfunction, a central mediator of fatty liver disease pathogenesis. This promising R&D strategy will also bring new knowledge about the disease mechanisms and improved understanding of the pathogenic process and disease drivers. To that end, mtFOIE GRAS envisages a training-through-work plan that brings together an intersectoral, multidisciplinary team of researchers and technicians experts in their fields, from basic to translational research, clinical practice, technology commercialization and public advocacy. Together with several PhD students, the team will share expertises and work synergistically along the value creation chain to address the unmet medical need of more informative NAFLD assessment. In the process, mtFOIE GRAS will endow the involved staff with excellent scientific knowledge and transferable skills while building and strengthening intersectoral cooperation among partners, thus contributing to EU RD&I excellence.

Sepsis is a complex, systemic and inflammatory host reaction on an infection and with worldwide 1.5 million cases per year a health challenge. There is a strong need for a reliable biomarker like progranulin. Preliminary data prove that progranulin allows a highly sensitive and specific detection of sepsis, a monitoring of infection without time delay, prognosis regarding disease course and a differentiation between the infectious agent inducing sepsis. Economic advantages of progranulin as biomarker are the reduction of the length of stay in the ICU (500-1000€ / day) and avoidance of unnecessary antibiotic therapy (10-500€ / day). Thus, the hospital can improve patient care and reduce therapeutic costs by a progranulin measurement for 5-10€. A mean incidence rate of 0.094% results in a 12 million euro market in the US and EU. Based on intellectual property this market is available only for Mediagnost. Successfully validated, progranulin measurement will be introduced in third level hospitals in the EU. The subsequent strategic product development includes point of care and multiplex test systems. Mediagnost already has a technically validated test system for this biomarker available, therefore the overall objectives of this study are the clinical validation of progranulin measurement in sepsis and its implementation in clinical routine. Specifically, in phase I the economic potential of this biomarker is evaluated. These objectives are addressed during phase I in a feasibility study including market and cost analysis. Key opinion leaders in the EU are interviewed by a structured questionnaire to evaluate scientific solidity and market potential. In direct contact to EU Notified Bodies the best regulatory strategy is evaluated. Further, literature research will complete the picture of the market and reimbursement requirements. Excellent infrastructure and highly qualified scientific and administrative employees guarantee the successful completion of this work.

PAS GRAS aims to prevent and reverse obesity and associated metabolic complications in four age groups: pre-pubertal children (3-9 yr), adolescents (10-18 yr), young adults (19-25 yr), and adults (25-55). PAS GRAS focuses on four main pillars. 1) Develop a personalized risk assessment tool (RAT): an algorithm that will anticipate obesity priming and development in the critical age groups, and identify risk factors for specific complications in subsequent years that will constitute new outcomes for interventional studies. 2) Develop and implement RAT-based personalized interventions by integrating non-pharmacological lifestyle modifications including Mediterranean Diet components alone or with rational pharmacological targeting metabolic and neuroendocrine mechanisms. 3) Inform and engage effectively target groups on obesity causes, risks and intervention by co-production of creative and interactive digital tools (including a simpler version of the RAT) and personalized diet and physical activity programs. 4) Expand and consolidate the PAS GRAS tailor-made campaign across Europe through developing joint programs for health and food/nutrition literacy and physical activity, with healthcare centres, schools, sports clubs, municipalities, and other relevant actors and public authorities. PAS GRAS outcomes will contribute to a long-term 15% decrease in overweight/obesity prevalence in adults and 30% in children/adolescents in the EU until 2050, contributing to a downstream reduction of obesity-associated complications, pharmaceutical and surgical interventions, and to promote Mediterranean Diet as tool for a more nutritious and sustainable future. PAS GRAS is a unique multi- and interdisciplinary research team from 8 countries, including 12 top-level Universities and Research Institutions. Non-academic partners include a civil organization, one company, one patient organization and one Pan-European research Society.