The Innovative Medicines Initiative (IMI) has approved the five-year project TRISTAN focusing on validation of translational imaging methods as potential imaging biomarkers.
TRISTAN (Translational Imaging in Drug Safety Assessment) is a partnership involving 21 organisations, including academics centres, research organisations, small and medium-size enterprises (SMEs), and imaging and pharmaceutical companies.
The objective of the project is to validate or qualify translational imaging methods as potential imaging biomarkers. The imaging biomarker qualification will specifically address three areas with a high unmet medical need: the assessment of liver toxicity, lung toxicity and the bio-distribution of biologics.
The contributions to the project of around €12m by the industrial partners are complemented by IMI funding in a total budget of €24m.
TRISTAN is led by Bayer and co-ordinated by the European Organisation for Research and Treatment of Cancer (EORTC).
The use of biomarkers has become commonplace in preclinical and clinical research. However, imaging biomarkers are not widely used in the drug discovery process, although they could advance drug safety evaluation, both for preclinical and clinical development. Imaging biomarkers have the potential to improve translatability of preclinical data to healthy volunteers and patients and thus could help avoid late stage attrition of development programmes.
Data relevant for validation of methods addressed in the project and aggregated data will be made publicly available in compliance with data privacy laws. Significant interactions with existing imaging biomarker initiatives as well as with regulatory authorities will have a strong impact on the future value of imaging biomarker procedures. To sustainably offer access to the validated imaging biomarkers, the three project SME partners are planning to offer respective biomarker imaging