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Anti-Biopharmaceutical Immunization:Prediction and analysis of clinical relevance to minimize the risk

Objective

The ABIRISK project provides an integrated approach to the study of immunization against biopharmaceuticals, bringing together a unique panel of experts from different disciplines.
ABIRISK will involve many of the European leaders in rheumatology, gastroenterology, hemophilia and multiple sclerosis, caring for ~30,000 patients treated with biopharmaceuticals, with ~10,000 additional patients recruited per year. This should lead to the constitution of the largest possible cohort in Europe for the study of immunogenicity, a condition critical for the success of the program. ABIRISK will also benefit from the unique expertise of immunologist partners in the development of innovative strategies for predicting the immunogenicity of biopharmaceuticals and for defining its mechanisms. The large number of patients enrolled in the ABIRISK cohorts should make it possible to study the genetic basis of immunogenicity in a new way.
We will standardize all clinical and biological information before its integration into a large database for evaluation of the clinical relevance of immunization against biopharmaceuticals and stratification of the risk to patients as a function of factors linked to treatment or to the individual. Computational biology and biostatistical modeling will be used to develop models for predicting immunogenicity that will be validated with the ABIRISK database.
The complementarity between the clinical partners from different disciplines, immunologists, methodologists and biostatisticians will create a unique task force for studies of biopharmaceutical immunogenicity. The direct outcomes of the proposed work will be greater understanding of the mechanisms involved in the emergence of anti-drug antibodies, the development of new methods for predicting immunogenicity and a comprehensive view of the respective value of predictive tools, and guidelines for the development of new biopharmaceuticals and patient care.

Call for proposal

IMI-JU-03-2010
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Coordinator

NOVARTIS PHARMA AG
Address
Lichtstrasse 35
4056 Basel
Switzerland

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Sebastian Spindeldreher (Dr.)
Administrative Contact
Barbara Stolz (Dr.)

Participants (37)

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 3 807 426
Address
Rue De Tolbiac 101
75654 Paris

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Activity type
Research Organisations
Administrative Contact
Laurence PARMANTIER (Ms.)
UNIVERSITA DEGLI STUDI DI FIRENZE
Italy
EU contribution
€ 610 139
Address
Piazza San Marco 4
50121 Florence

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
CRISTINA DOLFI (Dr.)
FONDAZIONE PER L'ISTITUTO DI RICERCA IN BIOMEDICINA
Switzerland
EU contribution
€ 729 599
Address
Via Francesco Chiesa 5
6500 Bellinzona

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Activity type
Research Organisations
Administrative Contact
Giorgio Noseda (Prof.)
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
France
EU contribution
€ 739 970
Address
Rue Leblanc 25
75015 Paris 15

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Activity type
Research Organisations
Administrative Contact
ELIANE DECK-CHAUMONT (Ms.)
Biomonitor A/S
Denmark
EU contribution
€ 627 000
Address
Fruebjergvej
DK-2100 Copenhagen

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Administrative Contact
Marie Holde-Jensen (Ms.)
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 1 683 976
Address
Gower Street
WC1E 6BT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 555 396
Address
Albinusdreef 2
2333 ZA Leiden

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
J. J. (John) Van Roozendaal (Dr)
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 799 973
Address
Meibergdreef 15
1105AZ Amsterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Erwin J. Van der Meijden (Dr)
ISTITUTO GIANNINA GASLINI
Italy
EU contribution
€ 422 175
Address
Via Gerolamo Gaslini 5
16147 Genova

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Gabriella Marinari (Dr.)
GROUPE D'ETUDES THERAPEUTIQUES DES AFFECTIONS INFLAMMATOIRES DIGESTIVES ASSOCIATION
France
EU contribution
€ 494 079
Address
2 Rue Ambroise Pare
75010 Paris

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Activity type
Research Organisations
Administrative Contact
JULIE DEMOLIN (Mme.)
THE HEALTH CORPORATION - RAMBAM
Israel
EU contribution
€ 151 883
Address
Haaliya 8
31096 Haifa

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Activity type
Research Organisations
Administrative Contact
Ronya Rubinstein (Dr.)
UNIVERSITATSKLINIKUM BONN
Germany
EU contribution
€ 536 309
Address
Venusberg-campus 1
53127 Bonn

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Beate Becker (Ms.)
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
Germany
EU contribution
€ 633 868
Address
Paul-ehrlich-strasse 51-59
63225 Langen

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Stefanie Larisch (Ms.)
JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN
Germany
EU contribution
€ 526 630
Address
Theodor W Adorno Platz 1
60323 Frankfurt Am Main

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Christoph Königs (Dr.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 570 619
Address
Nobels Vag 5
17177 Stockholm

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johan Forsslöf (Dr.)
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 714 470
Address
Christoph Probst Platz 1
6020 Innsbruck

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Florian Deisenhammer (Prof.)
HEINRICH-HEINE-UNIVERSITAET DUESSELDORF
Germany
EU contribution
€ 536 525
Address
Universitaetsstrasse 1
40225 Dusseldorf

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Thomas Dehmel (Dr.)
REGION HOVEDSTADEN
Denmark
EU contribution
€ 306 812
Address
Kongens Vaenge 2
3400 Hillerod

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Per Soelberg Sorensen (PROF.)
UNIVERSITATSSPITAL BASEL
Switzerland
EU contribution
€ 229 481
Address
Hebelstrasse 32
4031 Basel

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Ludwig Kappos (MD)
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
EU contribution
€ 353 678
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona

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Activity type
Research Organisations
Administrative Contact
Lluis Masso (Mr.)
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 261 905
Address
327 Mile End Road
E1 4NS London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
TANYA SZENDEFFY (Ms.)
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
Germany
EU contribution
€ 658 000
Address
Ismaninger Strasse 22
81675 Muenchen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Renate Rädlein (Dr.)
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU contribution
€ 411 157
Address
Rue Michel Ange 3
75794 Paris

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Activity type
Research Organisations
Administrative Contact
Camille SEZE-GOIMIER (Ms)
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU
Italy
EU contribution
€ 438 672
Address
Via Fiorentina 151
53100 Siena

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Natascia Cannella (Dr.)
DRK-BLUTSPENDEDIENST BADEN-WURTTEMBERG-HESSEN GGMBH
Germany
EU contribution
€ 268 372
Address
Friedrich Ebert Strasse 107
68167 Mannheim

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Activity type
Research Organisations
Administrative Contact
Jörg Schüttrumpf (Dr.med.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 307 839
Address
Ovocny Trh 560/5
116 36 Praha 1

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kristyna Matejkova (Dr.)
PFIZER LIMITED
United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olga Krylova (Dr)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sally Miles (-)
UCB Biopharma SPRL
Belgium
Address
Allée De La Recherche
1070 Brussels

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon Dresse (Mr.)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Nathalie PITON (Dr.)
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
Address
Frankfurter Strasse 250
64293 Darmstadt

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ninog Péresse (Mrs.)
NOVO NORDISK A/S
Denmark
Address
Novo Alle 1
2880 Bagsvaerd

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jørgen Dirach (Dr.)
Bayer Pharma AG
Germany
Address
Muellerstrasse 178
13353 Berlin

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Petra Freitag (Ms)
IPSEN INNOVATION SAS
France
Address
Avenue Du Canada - Zone Industrielle De Courtaboeuf 5
91940 Les Ulis

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Philippe Bardin (Mr.)
MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER
Israel
EU contribution
€ 12 680
Address
Tel Hashomer Sheba Medical Center
52621 Ramat Gan

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Activity type
Research Organisations
Administrative Contact
Eve Keret (Ms)
SciCross AB
Sweden
EU contribution
€ 345 958
Address
Gothia Science Park
54123 Skovde

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Administrative Contact
Pierre Dönnes (PhD)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 435 626
Address
3 Avenue Victoria
75000 Paris

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Activity type
Research Organisations
Administrative Contact
Alix PILLOT (Mrs)