Working groups

WG1. IN-DEPTH PHENOTYPING IN DILI
Leader: Prof. Helena Cortez-Pinto. University of Lisboa (Portugal) 

Deputy Leader: Dr. Michael Manns. Hannover Medical School (Germany)
Co-Leader: Jane Grove (PhD.) (UK)
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
DELIVERABLES
  • Standardized approach to diagnosis and SOPs for data/samples collection (year 1)
  • Pre-funded database of DILI patients (year 1-4)
  • Review: DILI diagnosis & management (year 2)
  • Classification system for HDS (year 3)
  • Consensus on nomenclature, diagnosis, classification, assessment & treatment of DILI (year 3-4)

 

Deliverables WG1 2018 2019 2020 2021 2022
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)
Co- Leader as sustitute: Dr. Dean Naisbitt. Biosketch University of Liverpool (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
DELIVERABLES
  • EU Framework translational research plan for biomarker development (year 1-2)
  • Scientific publication on the current knowledge DILI risk modifiers (year 2)
  • Written input to commercial enterprises for Future Market Exploitation of biomarkers (year 3)
  • Publication on predictive models of drug hepatotoxicity (year 4)

 

Deliverables WG2 2018 2019 2020 2021 2022
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.
DELIVERABLES
  • Review: Realistic in vitro/in silico models in hepatotoxicity; non-invasive optical/ chemical imaging techniques (year 2)
  • List appropriate control compounds for testing new in vitro models (year 3-4)
  • Roadmap for the development of preclinical models of DILI (year 3-4)

 

Deliverables WG3 2018 2019 2020 2021 2022
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
AND TRIALS
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.
Co- Leader: Dr Judith Sanabria Cabrera, 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
DELIVERABLES
  • Design of clinical trials to assess the effect of an intervention on DILI course or outcomes (year 1-4)
  • SOPs to facilitate the conduct of a multicentre clinical trial in DILI (year 2-4)
  • Study design for biomarkers evaluation & robust statistical methods (year 2-3)

 

Deliverables WG4 2018 2019 2020 2021 2022
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.
DELIVERABLES
  • Website setup, social media & updates (year 1-4)
  • Quality plan and good practice policies (year 1)
  • Mobile application development & update (year 2-4)
  • Mid-term review of the COST Action proposal (year 2)
  • Preparation of large-scale European projects (year 2-4)
  • RoadMap to DILI research in Europe (year 4)

 

Deliverables WG5 2018 2019 2020 2021 2022
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