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Applied Public-Private Research enabling OsteoArthritis Clinical Headway

Objective


The problem: finding the right patient for the right treatment
Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have de-emphasized or even abandoned OA drug development due to perceived hurdles. Crucial in this is the lack of appropriate outcome measures that can robustly identify patient benefit from a specific therapy. The lack of specific and sensitive endpoints to differentiate between responders and non-responders both at the level of pain and tissue structure modification (disease modifying OA drug: DMOAD) has led to trials that included hundreds of patients in each arm with at least 3-years follow-up. Even despite these enormous trials, EMA and FDA have not approved any DMOAD yet. There is a general lack of understanding OA pathogenesis, which appears rather variable and likely reflecting different phenotypes with fundamental differences in disease aetiology, tissue alterations, clinical manifestations (pain/mobility) and disease progression. Although the current mind-set for drug treatment in the field is moving to a more personalized medicine and patient stratification approach, there are no accepted methods or guidelines to classify patients according to their prognosis and differentiate between subsets in terms of diagnosis methodology and treatment plan. The APPROACH consortium brings together a competent and multidisciplinary group of stakeholders that will setup – for the first time – a longitudinal cohort based on highly innovative stratification methods that identifies different OA phenotypes and subsequently develop guidelines for differentially diagnosing the right patient for the right treatment.

The stratified medicine APPROACH
The APPROACH consortium brings together a unique complimentary set of skills to develop, validate and link biomarkers with biological processes and clinical end points in OA patient subsets. This will support future regulatory qualification and guide clinical trials for relevant endpoint validation, thereby paving the road for stratified or personalized medicine. This leads to the following overall objectives of the consortium:
- Implement and establish a new, integrated and comprehensive database platform of existing data from partners that will be extended with newly collected longitudinal data, incorporating novel high quality biomarkers.
- Define subsets of (phenotypically) different patients in both the existing cohorts as well as (later) in the new longitudinal extension cohorts and subsequently identify the “right patient” to treat for each subset/phenotype via innovative stratification techniques.
- Optimize, introduce and validate the next generation imaging methodologies (modality + post-processing), human motion analysis and biochemical assays to enable more efficient and reliable diagnoses and treatment of OA patients.
- Identify mechanistic targets for patient subsets, create prediction models and establish guidelines for a DMOAD development that forms the roadmap for OA.

APPROACH: a tri-partite partnership between relevant stakeholders
The ambitious objectives of the APPROACH consortium require the mobilization of a broad set of skills and extensive expertise, from academics, clinicians and the private sector. The APPROACH consortium brings together a strong tri-partite team from European clinical centers (cohorts), basic research institutes (state-of-the-art tools) and SME/Industry (certified tool analyses and logistics) which also collaborate with large US-based OAI and MOST cohorts. This group is engaged with end users in hospitals and patient advocacy groups actively involved in OA awareness, fundraising and research support. The consortium crosses barriers and enables inter-sectorial collaborations that bring together all the expertise and knowledge in one place, where the information can be seamlessly integrated and, as such, contributes to innovative stratification and personalized diagnostic methods

Call for proposal

IMI-JU-11-2013
See other projects for this call

Funding Scheme

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinator

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
Address
Great West Road 980
TW89GS Brentford
United Kingdom
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Jonathan Larkin (-)
Administrative Contact
Sally Miles (Ms)

Participants (24)

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 2 919 900
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Antoinette van der Linden-Gruntjes (Mrs.)
STICHTING LYGATURE
Netherlands
EU contribution
€ 695 000
Address
Jaarbeursplein 6
3521 AL Utrecht
Activity type
Other
Administrative Contact
Leonie Hussaarts (Dr.)
MAX IV Laboratory, Lund University
Sweden
EU contribution
€ 162 500
Address
Paradisgatan 5C
22100 Lund
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Susanne Bauer (PhD)
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 190 000
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Christian Herold (O. Univ.-Prof., Dr.)
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
EU contribution
€ 550 000
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
Activity type
Higher or Secondary Education Establishments
Administrative Contact
FIONA AIREY (MRS)
FRIEDRICH-ALEXANDER-UNIVERSITAET ERLANGEN-NUERNBERG
Germany
EU contribution
€ 75 000
Address
Schlossplatz 4
91054 Erlangen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Franziska Müller (Ms.)
UNIVERSITATSKLINIKUM ERLANGEN
Germany
EU contribution
€ 35 000
Address
Maximiliansplatz 2
91054 Erlangen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katrin Faber (Dr.)
Artialis SA
Belgium
EU contribution
€ 250 000
Address
Avenue De L'hôpital
4000 Liège (Sart-tilman)
Administrative Contact
Jeannette Chignesse (Management assistant)
HEMICS BV
Netherlands
EU contribution
€ 200 000
Address
Torenallee 20 Unit 7034
5617 BC Eindhoven
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Wouter Rensen (Dr)
UNIVERSITY OF LEEDS
United Kingdom
EU contribution
€ 150 000
Address
Woodhouse Lane
LS2 9JT Leeds
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Martin Hamilton (Mr)
STICHTING NATIONAAL REUMAFONDS
Netherlands
EU contribution
€ 112 500
Address
Dr J Van Breemenstraat 4
1056 AB Amsterdam
Activity type
Other
Administrative Contact
Wilma Kop (N/A)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 701 010
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marieke Bax (Dr.)
UNIVERSITY OF SURREY
United Kingdom
EU contribution
€ 400 000
Address
Stag Hill
GU2 7XH Guildford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Sega-Buhalis (Mrs)
SERVIZO GALEGO DE SAUDE
Spain
EU contribution
€ 458 000
Address
Edificio Administrativo San Lázaro
15703 Santiago De Compostela
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
SANTIAGO PEREZ CACHAFEIRO (MD)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 178 050
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Patrica Schott (Madame)
Diakonhjemmet Hospital
Norway
EU contribution
€ 163 040
Address
Diakonveien
0319 Oslo
Administrative Contact
Ida Kristin Haugen (Md, PhD)
Immunodiagnostic Systems Holdings PLC
United Kingdom
Address
Boldon Business Park
NE35 9PD Boldon
Administrative Contact
Dagmar Kasper (Dr)
European Technology for Business Ltd
United Kingdom
EU contribution
€ 185 000
Address
Rothesay Rd
LU1 1QZ Luton
Administrative Contact
Denis Hodgins (Mr)
Arthritis Research UK
United Kingdom
Address
St Mary's Gate
ST41 7TD Chesterfield
Administrative Contact
Sarah Rudkin (Dr)
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS
France
Address
Rue Carnot 50
92284 Courbevoie
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marie DUVICQ (Mme)
Merck KGaA
Germany
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ninog Peresse (Scientific Innovation and Partnerships)
NORDIC BIOSCIENCE COMPOUND DEVELOPMENT A/S
Denmark
Address
Herlev Hovedgade 207
2730 Helev
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Kristina Adrian König (Legal Counsel)
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU contribution
€ 75 000
Address
Rue Michel Ange 3
75794 Paris
Activity type
Research Organisations
Administrative Contact
Patrick Mounaud (Mr)
ABBVIE INC
United States
Address
North Waukegan Road 1
60064 North Chicago Il
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Samantha Zappia (M.S.)