Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK (ABIRISK)
Research Areas
At a Glance
- Status: Active Consortium
- Year Launched: 2012
- Initiating Organization: Innovative Medicines Initiative
- Initiator Type: Government
- Rare disease
- Disease focus:
Hemophilia A, Inflammatory Diseases, Multiple Sclerosis - Location: Europe
Abstract
Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK (ABIRISK) is a consortium managed by the Innovative Medicines Initiative (IMI). ABIRISK seeks to provide an integrated approach to anti-drug immunization by evaluating immunogenicity in hemophilia A, multiple sclerosis, and inflammatory diseases, and by exploring new tools for protein drug immunogenicity. By examining the correlation between patient and clinical factors and the incidence of immunogenicity, ABIRISK hopes to reduce the regulatory and resource burdens of immunogenicity testing.
Mission
ABIRISK aims to develop an integrated approach to anti-drug immunization through examination of immunogenicity in three other conditions: hemophilia A, multiple sclerosis, and inflammatory diseases. The data collected will be pooled in a single immunogenicity databank and will be standardized and used to develop models of anti-drug antibodies.
The objectives of the consortium are as follows:
Consortium History
2012: ABIRISK was started as a 60-month project.
Structure & Governance
ABIRISK is grouped into five working projects, which communicate with one another and provide each other with results and data for analysis. The five working projects are ADA assay development and validation and cohort management; cellular characterization and mechanisms of the AD immune response; evaluation and development of technologies for predicting immunogenicity; establishment of database, data analyses and integration; and project management and communication. Each working project has three to four team leaders.
As with other IMI-managed consortia, ABRISK project teams are managed by an IMI project manager, who reports to the IMI executive director.
Financing
ABIRISK received total funding of £34.9 million, which was broken down into IMI funding (£18.2 million), in-kind funding contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA; £11.2 million), and £5.5 million from other sources.
Intellectual Property
All IMI projects, such as ABIRISK, operate under the same intellectual property (IP) umbrella. Any IP discovered as a result of work in the collaboration is owned by the participating institution that made the discovery (or if the discovery was made jointly, by both institutions). Other participants have access rights to the generated IP during and after the project for research use, and participant owners have the right to license their IP and associated obligations to other parties, including to affiliated entities. Third parties may request access rights, which do not involve the ability to sublicense without receiving authorization from the IP-owning participant.
Patient Engagement
ABIRISK recruits both retrospective study patients (after patients suffering from the three disease groups have undergone immunotherapy treatment) and prospective patients into dedicated studies. Uniform protocols were established to facilitate standardized data collection from both sets of patients.
Data Sharing
Uniform protocols were established to facilitate standardized data collection from both sets of patients. The intent of ABIRISK is to share its data as quickly as possible through its immunogenicity databank. In keeping with IMI policy, the project has up to one year after completion to disseminate IP or data created by the project.
Impact/Accomplishment
To date, nine publications have been released from groups associated with the ABIRISK project.
Links/Social Media Feed
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https://www.linkedin.com/groups/Innovative-Medicines-Initiative-1126077 |
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Homepage |
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Other website |
Points of Contact
Project Coordinator:
Daniel Sikkema
GlaxoSmithKline Research & Development Ltd
980 Great West Road, Brentford
Middlesex, TW8 9GS
United Kingdom
phone: (610) 270-6054
email: dan.x.sikkema@gsk.com
Managing Entity for EU funds:
Marc Pallardy
Institut National de la Santé et de la Recherche Médicale
UMR 996, University Paris-Sud
32 rue des Carnets
92140 Clamart
France
phone: 33-1-46-83-54-92
email: marc.pallardy@upsud.fr
Sponsors & Partners
Academisch Medisch Centrum |
ALTA Ricerca e Sviluppo in Biotecnologie Srlu |
Bayer Pharma AG |
Biomonitor A/S |
Centre National de la Recherche Scientifique |
Commissariat a L’Energie Atomique et aux Energies Alternatives |
DRK-Blutspendedienst Baden-Württemberg– Hessen gemeinnützige GmbH |
Fondazione per I’Istituto di Ricera in Biomedicina |
Fundació Institut de Recerca de L'hospital Universitari Vall D’hebron |
GlaxoSmithKline |
Groupe d’Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif |
Höpitaux de Paris |
Inserm |
IPSEN Innovation SAS |
Istituto Giannina Gaslini |
Johann Wolfgang Goethe Universität |
Karolinska Institutet |
Klinikum rechts der Isar der Technischen Universität München |
Leiden University Medical Center |
Medizinische Universität Innsbruck |
Merck KGaA |
Novartis Pharma AG |
Novo Nordisk A/S |
Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel |
Pfizer Limited |
Queen Mary and Westfield, University of London |
Rambam Medical Center |
Region Hovedstaden |
Sanofi-Aventis |
UCB Pharma SA |
Universita di Firenze |
Universitätsklinikum Bonn |
Universitätsklinikum Düsseldorf |
University College London |
University Hospital Basel |
Univerzita Karlova v Praze |