WP5: Translational Development of Patient-Stratification Processes




WP5 aims to establish a link between biomarker profiling and treatment options. This will be achieved by building on use cases presented by investigators having developed animal, organoid, cellular, or in-silico models.

Description of work:

This WP is two-fold, involving the 1) development of translational strategies in the industry for the pre-clinical development of patient-targeted therapies, and 2) translational research to assign the best appropriate treatment options for each patient cluster.

For the first major task, a survey will be prepared and distributed to representatives of pharmaceutical and diagnostic industries; the aim here is to map out the different strategies to address challenges limiting the productivity and success of clinical trials. The results of the survey will enable a better understanding of the challenges and opportunities in the translational development phase of personalised medicine clinical trials.

Moreover, a workshop will be organised with key representatives from the pharmaceutical industry to discuss and exchange experiences on the adoption of specific processes at the pre-clinical level that guide successful and efficient drug discovery and development. The workshop will lead to recommendations for the establishment of industry-based translational strategies.

For the purpose of the second main task, a workshop will be organised on translational models coupling stratification and treatment options, leading to a report. A special focus will be given to the relevance of pre-clinical methods in light of subsequent clinical trial approval by competent authorities, ethics committees, and regulatory authorities and HTAs.