Obiettivo
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.
Campo scientifico
Argomento(i)
Invito a presentare proposte
IMI-JU-01-2008
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Meccanismo di finanziamento
JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)Coordinatore
4056 Basel
Svizzera
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Partecipanti (41)
1105AZ Amsterdam
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SO17 1BJ Southampton
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SW7 2AZ LONDON
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95131 Catania
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00133 Roma
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2650 Hvidovre
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31-007 Krakow
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3012 Bern
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1085 Budapest
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M13 9PL Manchester
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13284 Marseille
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80686 Munchen
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901 87 Umea
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9000 Gent
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75794 Paris
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20123 Milano
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1165 Kobenhavn
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17177 Stockholm
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NG7 2RD Nottingham
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5020 Bergen
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3831PE Leusden
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S10 2PX Sheffield
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E1 8AA LONDON
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1000 BRUXELLES
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95127 Catania
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EH2 4JN Edinburgh
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5656 AG Eindhoven
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S0166YD SOUTHAMPTON
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75450 UPPSALA
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3631 Maasmechelen
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08022 Barcelona
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151 85 Sodertaelje
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55218 Ingelheim
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43122 Parma
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TW89GS Brentford
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Partecipazione conclusa
CT13 9NJ Sandwich
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4070 Basel
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1070 Bruxelles / Brussel
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2300AG Leiden
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1831 Diegem
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08889 Whitehouse Station Nj
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