Work packages
The project activities are managed in so-called work packages. ImmUniverse is set up around six such work packages. Different partners, academic and industrial, take the lead on achieving different tasks within a particular work package while ensuring close collaboration with other institutions and across the different work packages.
For more information, please click on the graphic below
WP1: Project management and dissemination
Lead/ Co-Lead: European Research and Project Office GmbH (EURICE)/ Humanitas University (HUNIMED), Sanofi-Aventis Deutschland GmbH (Sanofi)
WP1 is in charge of the overall project management providing optimal guidance, ensuring a smooth project workflow, the timely fulfilment of all contractual commitments and support to all partners through effective management and communication structures. It ensures proper documentation of project activities and transparent communication between all partners and the IMI JU. In addition, WP1 is responsible for external outreach and communication activities aiming to create visibility for ImmUniverse and accelerating the uptake and exploitation of results by reaching out to relevant stakeholders.
WP2: Identification and characterisation of tissue-specific signatures using new and existing technologies
Lead/ Co-Lead: Christian Albrechts-Universität zu Kiel (CAU)/ Sanofi-Aventis Deutschland GmbH (Sanofi)
In this WP, centralised state-of-the-art profiling technologies for relevant Multi-omics analysis forms the basis for selection of biomarkers that may predict disease progression and stratification with tailored treatment. Firstly, an analysis of transcriptome, methylome, tissue-adherent microbiome and serum metabolome/exosomal miRNAome is done in a larger study of retrospective samples in order to generate a first longitudinal “tissue signature” of disease in ulcerative colitis and atopic dermatitis. Secondly, Deep Personal Profiling (DPP) data sets in samples from the prospective observational cohorts in WP3 and WP6 are produced comprising nine parallel data layers at two time points from lesional and non-lesional tissue and blood.
WP3: Utilisation and validation of disruptive liquid biopsy methodology
Lead/ Co-Lead: Humanitas University (HUNIMED)/ GlaxoSmithKline Research and Development Ltd (GSK), Ludwig-Maximilians-Universität München (LMU)
In WP3 liquid biopsies collected using disruptive technologies are evaluated for the identification of signatures for ulcerative colitis and atopic dermatitis. To that end, preclinical studies and clinical studies are conducted for Low-Intensity Pulsed Ultrasound Stimulation (LIPUS)-enabled gut liquid biopsy in ulcerative colitis patients as well as clinical studies for dermal Open Flow Microperfusion (dOFM) in atopic dermatitis patients.
The execution of the clinical translation of the LIPUS technology is being supported though a collaboration of SSSA with BAC Technologies.
WP3: Utilisation and validation of disruptive liquid biopsy methodology
Lead/ Co-Lead: Humanitas University (HUNIMED)/ GlaxoSmithKline Research and Development Ltd (GSK), Ludwig-Maximilians-Universität München (LMU)
In WP3 liquid biopsies collected using disruptive technologies are evaluated for the identification of signatures for ulcerative colitis and atopic dermatitis. To that end, preclinical studies and clinical studies are conducted for Low-Intensity Pulsed Ultrasound Stimulation (LIPUS)-enabled gut liquid biopsy in ulcerative colitis patients as well as clinical studies for dermal Open Flow Microperfusion (dOFM) in atopic dermatitis patients.
The execution of the clinical translation of the LIPUS technology is being supported though a collaboration of SSSA with BAC Technologies.
WP4: Bioinformatics approach
Lead/ Co-Lead: Luxembourg Centre for Systems Biomedicine (LCSB), Université du Luxembourg (UNILU)/ Pfizer Limited (PFE), GlaxoSmithKline Research and Development Ltd (GSK)
In WP4, bioinformatics platforms will be built to analyse and correlate the data from work packages 2, 3, 5 and 6. Strategies for data analysis will be developed in close collaboration with these WPs. These platforms and strategies will facilitate the efficient management of raw data and derived data with access for all consortium partners. It also includes the development of software and bioinformatics packages for full data integration and analysis, and the design and implementation of a database and IT infrastructure to allow for query of data sets and long-term housing of data within the consortium.
WP5: Verification of identified signatures
Lead/ Co-Lead: Austrian Institute of Technology (AIT)/ Novartis Pharma AG (NVS)
Following a tiered signature verification and prioritisation process, this WP is to produce a streamlined set of disease state/severity and treatment associated signatures. These signatures are then verified in a large cohort of WP6-derived longitudinal tissue and liquid biopsy samples using assays which eventually only cover a couple of selected omics layers as well as a very limited set of targets feasible for the clinical setting. This WP is closely aligned with WP2, WP3 and WP6 regarding profiling activities, and the type, quantity, preservation and timing of bio-sampling respectively.
WP6: ImmUniverse bioclinical hub
Lead/ Co-Lead: Christian Albrechts-Universität zu Kiel (CAU)/ Eli Lilly and Company Limited (Lilly)
WP6, working seamlessly with WP5, WP2 and WP3, designs and delivers a non-interventional, open label, observational study to validate the identified signatures to better understand therapy response and disease progression. This is done through a registry-like design, with physician choice of targeted therapies and will recruit more than 500 ulcerative colitis and atopic dermatitis patients including a clinical follow-up over at least 12 months. Furthermore, WP6 will serve as the project’s bioclinical hub through providing accurately annotated and harmonised clinical data and biospecimen resources of patients and healthy controls.