WORK PACKAGES

The GALAXY project is structured into 7 scientific work packages (WP) to meet the objectives of the project. All WPs are overseen by WP8: management, dissemination and exploitation.

Furthermore, a group of special managers have been appointed to set attention to areas of special interest in order to maximize impact of work.

Additional information can be found using the link to the individual WP:

Work package 1: Clinical studies

WP leader: Dr Maja Thiele, Odense University Hospital, Denmark

This work package will conduct four large clinical studies, two of which are randomised controlled trials. The studies will provide clinical data and tissue samples needed for phenotypical cohort characterisation and multi-omics analyses. Further, we will use the studies to investigate novel anti-fibrotic interventions and biomarker accuracy.

The objectives of WP1 are:

  1. To gather sample material and clinical data on well-phenotyped healthy controls and patients with the full spectrum of alcoholic liver fibrosis in an observational, prospective matter.

  2. To investigate new anti-fibrotic treatments with Rifaximin and Profermin in a randomised, controlled matter and concurrently to gather sample material and data before and after treatment.

Participating partner: Nordic Rebalance A/S

 

Work package 2: Multi-omics studies of host and gut microbiome

WP leader: Professor Peer Bork, European Molecular Biology Laboratory, Germany

The objective of this work package is to coordinate the extraction and sequencing of nucleic acids from human liver and faecal samples to characterize the role of the gut-liver axis in the understanding, diagnosis and treatment of chronic alcoholic liver disease. The data will be complemented by assaying blood samples for host DNA, RNA and extracellular matrix neo-epitopes. Taken together, this will result in a multi-tissue, multi-omics dataset that will be made accessible to the consortium partners for further analyses in work package 4.

WP2 will generate multi-omics data from host tissue samples and gut microbiome samples.

  1. Analysis of host tissue samples: genomics, transcriptomics, metabolomics (blood, liver).

  2. Analysis of gut microbiome: metagenomics and metatranscriptomics (faeces).

  3. Participating partner: University of Copenhagen, Denmark, Nordic Bioscience A/S, Denmark, Biomedical Research Foundation Academy of Athens, Greece

 

Work package 3: Metabolomics and biochemical assays

WP leader: Steno Diabetes Center A/S, Denmark

This work package will provide an in-depth metabolomic/biochemical profile of host metabolism, as measured by metabolomics in selected biochemical assays. The analyses will include liver as the target organ of the disease, as well as biofluids (serum, urine) and faecal samples.

The specific objectives of WP3 are:

  1. Metabolomic characterization of liver tissue

  2. Biochemical characterization of host tissue

Participating partner: University of Southern Denmark

 

Work package 4: Bioinformatics and systems modelling

WP leader: Professor Peer Bork, European Molecular Biology Laboratory, Germany

The main objective of work package 4 is to integrate the information collected in WP1, WP2 and WP3 with the goal to identify biomarkers for early diagnosis, risk stratification and efficacy of interventions in chronic liver diseases using multi-omics data. To reach this goal, gut microbial samples will first be analysed using current state of the art tools. Stratification by disease severity and differential disease progression and disease history, for example, will require the development of predictive algorithms based on heterogeneous input features, which will be integrated into a ‘systems medicine tool’.

WP4 has the following objectives:

  1. To analyse the gathered –omics data with current state of the art tools.

  2. To develop novel ground-breaking systems medicine tools for gut liver axis analysis.

  3. To analyse –omics data with in-house developed GALAXY systems medicine tools.

Participating partner: University of Copenhagen, Denmark, Nordic Bioscience A/S, Denmark, Biomedical Research Foundation Academy of Athens, Greece, Odense University Hospital, Denmark, Steno Diabetes Center A/S, Denmark

 

Work package 5: Animal studies and hepatic fibrogenesis

WP leader: Professor Jonel Trebicka, University of Bonn, Germany

 

This work package will confirm the role of the potential identified targets from the findings of the WP 1-4. Using animal models this WP will on the one side confirm the role of possible effectors and elucidate further the mechanisms and test therapeutic approaches in these animal models to improve fibrosis and portal hypertension linked to bacterial translocation and gut-liver-axis.

 

Work package 6: Biomarker development: evaluation and validation

WP leader: Professor, CEO Morten Karsdal, Nordic Bioscience A/S, Denmark

In work package 6, biomarker development and measurement will provide 4 key objectives:

  1. Evaluation of biomarkers in an FDA approved lab under GLP/CLIA conditions enabling FDA submission and commercialisation.

  2. Selection of biomarkers from Omics data, and development of simple in vitro diagnostic tools for worldwide use.

  3. Validation of selected biomarkers in clinical trials compared to gold standard markers.

  4. Selection of a biomarker, generating the FDA package as part of commercialisation efforts. This is crucial to provide a selected, developed and produced marker to laboratories worldwide.

Participating partner: University of Copenhagen, Denmark, European Molecular Biology Laboratory, Germany, Odense University Hospital, Denmark

 

Work package 7: Socio-economic evaluations

WP leader: Professor Hans Olav Melberg, Oslo University, Norway

 

The main objective of this work package is to provide information on economic costs and benefits, which is relevant to decisions about how to commercialise the diagnostic assay, the system medicine tools and the treatments. This includes:

  1. Estimating the costs of the treatments.

  2. Estimating the medical benefits (quality adjusted life years).

  3. Estimating the larger social and economic costs and benefits.

  4. Comparing costs to benefits.

  5. Quantifying the results for different sub-groups (gender, age).

The end result will be an analysis allowing decision makers to compare overall social gains relative to cost for interventions against liver fibrosis/cirrhosis. Such an analysis is an essential prerequisite for commercialisation since a favourable ratio of gains to costs would justify further investments by both the private and the public sector.

 

Work package 8: Project management, dissemination and communication

WP leader: Coordinator Professor Aleksander Krag, and Project Manager Dr. Linda Sevelsted Møller, University of Southern Denmark

     

The main objective of this work package is to ensure the day-to-day operational project management and dissemination and exploitation of the project results via various communication tools.

The work package aim will be achieved by pursuing the following objectives:

  1. To run an effective management framework for the GALAXY consortium in order to ensure progress of the project towards its planned objectives and respect of contractual commitments.

  2. To make research results available to the external stakeholders throughout the world.

  3. To promote and exploit the GALAXY project results and associated European research and technology development efforts.

 

Special managers

 

Dissemination manager: Professor Jonel Trebicka, University of Bonn, Germany

 
Primary task: broadcast results to stakeholders identified as health care providers, industry, policy makers, patients and scientific community.

Risk manager: Professor Torben Hansen, University of Copenhagen 


 
Primary task: assisting WP leaders in identification and resolution of critical risks, conflict resolution.

Innovation manager: Professor Peer Bork, European Molecular Biology Laboratory, Germany


 
Primary task: support to WP leaders in innovative tasks. 

Exploitation manager: Professor, CEO Morten Karsdal, Nordic Bioscience A/S, Denmark

 
Primary task: development of exploitation strategy.

Ethics manager: Dr Bjørn Stæhr Madsen, Odense University Hospital, Denmark

 
Primary task: overseeing ethical standards.