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Content archived on 2024-06-18

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes

Objective

Rationale
The inability of pre-clinical studies to predict clinical efficacy is a major bottleneck in drug development. In severe asthma this bottleneck results from: a lack of useful and validated biomarkers, underperforming pre-clinical models, inadequate and incomplete sub-phenotyping, and insufficient disease understanding.

Hypothesis
The use of biomarker profiles comprised of various types of high-dimensional data, integrated with an innovative systems biology approach into distinct phenotype handprints, will enable significantly better prediction of therapeutic efficacy than single or even clustered biomarkers of one data type and will identify novel targets.

Strategy
U-BIOPRED proposes a staged-strategy:
I)Generating an international consensus on diagnostic criteria for severe asthma.
II)Unbiased discovery of sub-phenotypes of severe asthma in adult and paediatric patient cohorts using biomarker profiles (“fingerprints”) and systems biology to define “phenotype/handprints”.
III)Validating the handprints for exacerbations, disease progression, and experimental challenges.
IV)Using the handprints to improve human/animal in vivo and ex vivo models.
V)Establishing the responsiveness and predictability of the handprints in gold standard and experimental therapeutic interventions.
VI)Refinement of the diagnostic criteria and definition of severe asthma sub-phenotypes by incorporating the handprints, thereby enabling more focused drug development and faster delivery proof of concept for novel drugs.
VII)Education, training and dissemination through a stakeholder platform and academic-industrial exchange, with potential for further growth as appropriate.

Innovative approach
We will use a novel systems biology approach to integrate high dimensional data from invasive, non-invasive and patient-reported outcomes. All studies will include academic and EFPIA partners as active contributors.

Call for proposal

IMI-JU-01-2008
See other projects for this call

Coordinator

NOVARTIS PHARMA AG
EU contribution
No data
Address
LICHTSTRASSE 35
4056 Basel
Switzerland

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Thomas Martin (Dr)
Administrative Contact
Barbara Stolz (Dr)
Links
Total cost
No data

Participants (41)