|WG1. IN-DEPTH PHENOTYPING IN DILI|
|Leader: Prof. Helena Cortez-Pinto. University of Lisboa (Portugal)
Deputy Leader: Dr. Michael Manns. Hannover Medical School (Germany)
|AIM||To support translational research in DILI and will integrate and collaborate closely with the remaining WGs.|
|TASK||DILI case definition, characterization and classification of phenotypic sub-groups|
|Standardized approach to diagnosis and SOPs for data/samples collection|
|Pre-funded database of DILI patients|
|Review: DILI diagnosis & management|
|Classification system for HDS|
|Consensus on nomenclature, diagnosis, classification, assessment & treatment of DILI|
|WG2. DILI RISK STRATIFICATION|
|Leader: Prof. Gerd A Kullak Ublick. University Hospital Zurich (Switzerland)
Deputy Leader: Dr. Michael Merz. University Hospital Zurich (Switzerland)
Co-leader: Prof. Ann Daly. Newcastle University (United Kingdom)
|AIM||To characterize drug’s potential for hepatotoxicity, individual susceptibility, and their interactions|
|TASK||Evaluate the risk of DILI, assess its severity and predict its outcomes|
|EU Framework translational research plan for biomarker development|
|Scientific publication on the current knowledge DILI risk modifiers|
|Written input to commercial enterprises for Future Market Exploitation of biomarkers|
|Publication on predictive models of drug hepatotoxicity|
|WG3. PRECLINICAL EVALUATION OF DILI|
|Leader: Prof. José Fernández Checa, Institute of Biomedical Research, Barcelona, Spain.
Co- Leader: Leonard J Nelson, PhD. Institute for Bioengineering
|AIM||To contribute to an improved regulatory decision-making concerning DILI.|
|TASK||To review the current knowledge and expertise on preclinical methods and technologies that assess the associated risk of DILI of a given drug.|
|Review: Realistic in vitro/in silico models in hepatotoxicity; non-invasive optical/ chemical imaging techniques|
|List appropriate control compounds for testing new in vitro models|
|Roadmap for the development of preclinical models of DILI|
|WG4. DESIGN AND ENDPOINTS IN CLINICAL DILI INVESTIGATIONS
|Leader: Prof. Einar Stefán Björnsson, Chiefof the Internal Medicine at the Landspitali University hospital Reykjavik Iceland.
Co- Leader: Dr Mercedes Robles Díaz, University Hospital Virgen de la Victoria , Málaga Spain.
|AIM||To set standards for clinical trials design and establish precise endpoints to assess the efficacy of novel interventions or for exploring novel biomarkers in DILI.
To share individual data from clinical trials from the drugs under development as wel as post-marketing where DILI has been identified as an issue.
|TASK||Define criteria and establish endpoints to measure efficacy on novel interventions in DILI|
|SOPs to facilitate the conduct of a multicentre clinical trial in DILI|
|Study design for biomarkers evaluation & robust statistical methods|
|Design of clinical trials to assess the effect of an intervention on DILI course or outcomes|
|WG5. KNOWLEDGE DISSEMINATION, COMMUNICATION,
TRAINING PLAN AND EXTERNAL RELATIONSHIPS WITH STAKEHOLDERS
|Leader: Dr Simona Stankevičiūtė, Hospital of Lithuanian University of Health Sciences (Lithuania).
Co-leader: Dr Thomas Hammond, Molecular and Systems Toxicology, University of Basel, Switzerland.
|AIM||Development of good practice models to disseminate the knowledge gained throughout the Action.|
|TASK||To monitor and evaluate the dissemination plan and advise the Core Group if the approach needs changing.|
|Website setup, social media & updates|
|Quality plan and good practice policies|
|Mobile application development & update|
|Mid-term review of the COST Action Proposal|
|Preparation of large-scale European projects|
|RoadMap to DILI research in Europe|