Unbiased BIOmarkers in PREDiction of respiratory disease outcomes

At a Glance
  • Status: Completed Consortium
  • Year Launched: 2009
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • Disease focus:
    Asthma
  • Location: Europe

Abstract

The Unbiased BIOmarkers in PREDiction of respiratory disease outcomes (U-BIOPRED) consortium will create and validate innovative testing methods to classify patients into distinct severe asthma types. Using a systems biology approach, the consortium will bring together genetic data from patients and results from tissue samples, blood tests, and breathing tests, as well as clinical findings and patient-reported symptoms. This will be linked to results of preclinical models, in order to facilitate future drug development.

The Unbiased BIOmarkers in PREDiction of respiratory disease outcomes (U-BIOPRED) consortium is part of the European Innovative Medicines Initiative with aims to advance the development of treatments for patients with severe asthma. Specifically, it aims to:

Consortium History

2009 – Project start date
2011 – U-BIOPRED recruits first adult into major asthma study (May)
2011 – U-BIOPRED announces the asthma art contest winner, Marije Kootstra (July)
2011 – U-BIOPRED project presents findings to press and patients (September)
2013 – U-BIOPRED hits patient recruitment target (April)
2013 – U-BIOPRED uses electronic nose to find differences between severe asthma patients, which represents a first step towards the project’s goal of identifying distinct subtypes of severe asthma based on the extensive biological characterization of patients (October)
2014 – U-BIOPRED wins best practice award at BIO-IT World (May)

Structure & Governance

The U-BIOPRED consortium includes representatives of all stakeholder groups by involving 20 academic institutions, 10 biopharma industry partners (EFPIA), 6 patient organizations, 3 small to medium enterprises, and 1 multinational industry, in 12 European countries.

The project is coordinated by the Academic Medical Centre, University of Amsterdam, The Netherlands. Professor Peter Sterk is the project leader.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) coordinator is Novartis Pharma AG.

Patients have been involved at all stages of the project: as members of the Ethics Board (EB) and Safety Monitoring Boards (SMB), in the Patient Involvement Platform (PIP), and as participants.

There are three advisory boards that oversee the project and tackle any issues that may arise. The boards ensure that the project is ethical and safe, and meets the needs of patients. Topics that require the boards' input can be submitted from any of the work packages in the project.

The boards are:
Ethics Board
Safety Monitoring Board
Patient Input Platform

The boards comprise of volunteers with a range of expertise from different countries. This ensures European-wide input to take into account different perspectives and expectations from different countries. All members of the board take part as individuals and do not represent an organization. As patient involvement is key to the U-BIOPRED project, patient representatives are included on all boards.

Financing

This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), resources of which are composed of financial contribution from the EU Seventh Framework Programme and EFPIA companies’ in-kind contribution. Large pharmaceutical companies participating in IMI projects do not receive IMI funding.

The IMI Intellectual Property (IP) Policy governs the IP regime of all projects funded by the IMI JU.  To assist with specific IP queries, IMI has set up a dedicated IP Helpdesk that can be contacted by e-mailing IMI-IP-Helpdesk@imi.europa.eu. The IMI IP policy can be accessed here

Data Sharing

According to IMI’s intellectual property policy, the participants undertake to disseminate the data as soon as reasonably practicable but not later than one (1) year after the termination or expiry of the project. The Project Agreement shall include a description of the material that must be disseminated in accordance with the IP Policy and referenced in the Grant Agreement. If the participants do not disseminate within such time periods without good reason, the Executive Office has the right to disseminate such results in a manner consistent with the Grant Agreement.

Sponsors & Partners

Novartis Pharma AG, Basel, Switzerland

Laboratorios Almirall S.A., Barcelona, Spain

AstraZeneca AB, Södertälje, Sweden

Boehringer Ingelheim International GmbH, Ingelheim, Germany

Chiesi Farmaceutici S.p.A, Parma, Italy

GlaxoSmithKline Research and Development LTD, Brentford, UK

F. Hoffmann-La Roche AG, Basel, Switzerland

UCB Pharma SA, Brussels, Belgium

Centocor, a J&J company

Amgen NV, Brussels, Belgium

Merck Sharp & Dohme Corp, Rahway, US

Academisch Medisch Centrum bij de Universiteit van Amsterdam, Amsterdam, Netherlands

The University of Southampton, Southampton, UK

Imperial College of Science, Technology and Medicine, London, UK

Università degli Studi di Catania, Catania, Italy

University of Rome ‘Tor Vergata’, Rome, Italy

Hvidovre Hospital, Hvidovre, Denmark

The Jagiellonian University Medical College, Krakow, Poland

Universität Bern, Bern, Switzerland

Semmelweis Egyetem, Budapest, Hungary

University of Manchester, Manchester, UK

Université de la Médietrranée, Aix-Marseille II, Marseille, France

Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., München, Germany

Umeå University, Umea, Sweden

Universiteit Gent, Gent, Belgium

Centre National de la Recherche Scientifique, Paris, France

Universita’ Cattolica Del Sacro Cuore, Milan, Italy

Københavns Universitet (University of Copenhagen), Copenhagen, Denmark

Karolinska Institutet, Stockholm, Sweden

University of Nottingham, Nottingham, UK

Universitetet i Bergen, Bergen, Norway

Astma Fonds Longstichting, Leusden, the Netherlands

European Lung Foundation, Lausanne, Switzerland

Asthma UK, London, UK

European Federation of Asthma and Allergy Associations, Brussels, Belgium

Lega Italiana Anti Fumo – ONLUS, Catania, Italy

International Primary Care Respiratory Group, Aberdeen, UK

Synairgen Research Limited, Southampton, UK

Aerocrine AB, Solna, Sweden

BioSci Consulting, Maasmechelen, Belgium

Philips Electronics Nederland B.V., Eindhoven, the Netherlands


Last Updated: 04/08/2016

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