Modern medicine seeks to personalize diagnosis and treatment to the needs of individual patients. Personalized medicine approaches use non-invasive imaging to detect and characterize disease. While anatomical and molecular imaging systems have become a commodity, these systems have also grown complex. Complexity is further increased by the introduction of combined (hybrid) imaging systems, such as PET/CT, SPECT/CT or PET/MR. Within the context of hybrid imaging, these systems provide multi-parametric image information that has proven promising in rendering diagnoses and subsequent therapeutic management of patients more effective. The growing complexity of diagnostic and therapeutic regimens in light of the drive to integrate multiple layers of biomarker information no longer supports the operation of hybrid imaging modalities by singular specialists, but instead requires a new generation of open-minded, technology-fluent and applications-oriented experts. HYBRID will help educate future imaging experts in adopting and disseminating such a cross-specialty approach. Our idea for this innovative training network is built on our personal experience and understanding of the importance of quantitative multi-parametric biomarkers in the years to come. We propose a consortium of world-leading imaging experts and partners that present with extended experience in advanced biomarker utilization, from the development of multi-parametric imaging methods and the design and construction of hybrid imaging systems to sourcing non-image based biomarker information. We are supported by vendors of diagnostic hardware and software systems who engage in this multi-disciplinary and cross-specialty effort, as well as by scientific associations and non-governmental entities. Thus, HYBRID provides an exceptional platform to young, ambitious and talented researchers who like to engage in supporting the concept of personalized medicine through multi-parametric data.

Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA. Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a “Safety Biomarker Factory”, regularly qualifying new markers, with an associated “Safety Biomarker Warehouse”, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.