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Accelerated Development of Vaccine benefit-risk Collaboration in Europe

Objective

Aim: The ADVANCE vision is focused on Timely and Best Evidence on Vaccine Effects. Our mission is to establish a best practice framework to rapidly provide robust data on vaccine benefits and risks to support accelerated decision-making.

Approach: To achieve this vision through a public-private partnership, ADVANCE partners
1. establish common grounds and rules for collaboration between public and private stakeholders for best practice conduct of studies on the benefit-risk of vaccines.
2. map and promote synergies with pertinent other initiatives to maximize utilization of foreground and identification of gaps for program strengthening.
3. profile data sources that will yield rapid access to burden of disease, vaccine coverage, and benefits and risks of vaccines
4. adaptat and develop new methods for integrated benefit/risk assessment
5. create the ADVANCE phase I and phase II data platforms to evaluate a code of conduct, data sources, and methods developed in other WPs via a series of public-private co-operative studies proof-of-concept studies.

ADVANCE partners embrace the enormous potential to improve public health across European Member States by collaboratively utilizing the rich information generated in clinical routine care and captured in health care databases. While the ADVANCE Forum concept engages all stakeholder groups in a parliament-like structure, specific representative committees drive the innovative progress. Specific attention will be given to workflows depending on the level of urgency and on who is requesting utilization of the framework: regulatory authorities, vaccine manufacturers, public health organizations.

ADVANCE partners leverage their recent pioneering achievements in establishing operative technological platforms, developing pharmaco-epidemiological methods for burden of disease, coverage, effectiveness and risk. ADVANCE partners also build on a track record of delivering results of ground breaking international collaborative studies of unprecedented population size. ADVANCE capitalizes on these achievements and tailors structures and processes to the needs of collaborative public-private vaccine benefit-risk assessment. ADVANCE partners will provide access to data on more than 40 million subjects for testing of methods and immediate studies.

The existing technical platform boosted by the strong connection to the IMI EMIF project and many other synergistic initiatives will allow ADVANCE to focus on creating access modalities and accelerating exploitation of both underutilized and established rich data sources, to test innovative methods for integrated and vaccine specific benefit risk assessment, and to undertake real life studies from the outset of the project.

Consortium: The ADVANCE Consortium is designed to engage all stakeholders in Europe, while ensuring project feasibility by careful selection of a small group of 15 partners driving progress.. The ADVANCE consortium comprises partners in multiple domains that collectively will allow us to achieve the goals of the call. The first domain consists of European and national organizations responsible for vaccine product assessment and program evaluation. The second domain comprises renowned scientists at the forefront of providing innovative solutions for integrated vaccine outcome assessment. The third domain represents organizations with access to electronic health care records of large populations and with ample expertise in the statistical analysis of large observational data from a public health and pharmacoepidemiological perspective. Finally, a partner with specific expertise on management, dissemination and exploitation of large, complex biomedical research projects ensures outcome oriented interaction in the Consortium and efficient progress towards the attainment of its vision. Recognizing that all stakeholders need to be involved, ADVANCE has created the associate partner role allowing a wide array of int

Call for proposal

IMI-JU-07-2012
See other projects for this call

Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

P95 CVBA
Address
Koning Leopold Iii - Laan 1
3001 Leuven
Belgium
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 486 613
Principal investigator
Miriam Sturkenboom (-)
Administrative Contact
Thomas Verstraeten (MD)

Participants (28)

UNIVERSITAT BASEL
Switzerland
EU contribution
€ 381 074
Address
Petersplatz 1
4051 Basel
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Simone Casagrande (-)
THE EUROPEAN MEDICINES AGENCY
Netherlands
EU contribution
€ 219 246
Address
Domenico Scarlattilaan 6
1083 HS Amsterdam
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Peter Arlett (Mr)
European Centre for Disease Prevention and Control
Sweden
EU contribution
€ 313 394
Address
Tomtebodavägen
171 83 Stockholm
Administrative Contact
Rebecca Trott (Ms.)
UNIVERSITY OF SURREY
United Kingdom
EU contribution
€ 462 600
Address
Stag Hill
GU2 7XH Guildford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Sega-Buhalis (Mrs)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 546 123
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sander Woerdeman (Mr.)
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Spain
EU contribution
€ 700 949
Address
Calle Velazquez 94 Planta 1
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Natasha Yefimenko (Dr.)
THE OPEN UNIVERSITY
United Kingdom
EU contribution
€ 82 174
Address
Walton Hall
MK7 6AA Milton Keynes
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Monica Stainton (Mrs)
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
United Kingdom
EU contribution
€ 89 533
Address
Keppel Street
WC1E 7HT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michael Robinson (Mr.)
SOCIETA SERVIZI TELEMATICI SRL
Italy
EU contribution
€ 109 683
Address
Via Giacomo Medici
35138 Padova
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Luigi Comacchio (Mr.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 87 430
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Agneta Häggstöm (Ms)
ASL DELLA PROVINCIA DI CREMONA
Italy
EU contribution
€ 164 699
Address
Via Dei Toscani
46100 Mantova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Lorella Biancifiori (Dr)
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
EU contribution
€ 125 452
Address
C/ Campezo Edificio 8 1
28022 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
José Luis Alonso-Lebrero (Dr.)
AARHUS UNIVERSITETSHOSPITAL
Denmark
EU contribution
€ 155 764
Address
Palle Juul-jensens Boulevard 99
8200 Aarhus
Activity type
Research Organisations
Administrative Contact
Tove Nilsson (Dr)
TAMPEREEN YLIOPISTO
Finland
EU contribution
€ 161 195
Address
Kalevantie 4
33014 Tampere
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Susanna Airila (Ms.)
INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE
Belgium
EU contribution
€ 199 290
Address
Rue Juliette Wytsman 14
1050 Bruxelles
Activity type
Research Organisations
Administrative Contact
Aline Deworme (Ms.)
Medicines and Healthcare products Regulatory Agency
United Kingdom
EU contribution
€ 36 654
Address
Buckingham Palace Road
SW1W 9SZ London
Activity type
Research Organisations
Administrative Contact
Andrew Thomson (Dr.)
STATENS SERUM INSTITUT
Denmark
EU contribution
€ 220 419
Address
Artillerivej 5
2300 Kobenhavn S
Activity type
Research Organisations
Administrative Contact
Peter Nyborg Rasmussen (Mr.)
THE ROYAL COLLEGE OF GENERAL PRACTITIONERS
United Kingdom
EU contribution
€ 166 275
Address
Princes Gate - Hyde Park 14
SW7 1PU London
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Nina Spofforth (Ms)
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU contribution
€ 224 664
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
Administrative Contact
Marjon Hartwigsen (-)
GLAXOSMITHKLINE BIOLOGICALS SA
Belgium
Address
Rue De L Institut 89
1330 Rixensart
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Graham Somers (Dr)
SANOFI PASTEUR SA
France
Address
14 Espace Henry Vallee
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Remy Philibois (Manager R&D Controlling)
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Barbara Stolz (Dr.)
MERCK SHARP & DOHME CORP
United States
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Letitia Reyniers (Dr.)
JANSSEN VACCINES & PREVENTION BV
Netherlands
Address
Archimedesweg 4
2333 CN Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marc Ceuppens (Dr.)
PFIZER LIMITED
United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olga Krylova (Dr.)
TAKEDA PHARMACEUTICALS INTERNATIONAL AG
Switzerland
Address
Thurgauerstrasse 130
8152 Glattpark
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Astrid Borkowski (MD PhD)
AGENZIA REGIONALE DI SANITA
Italy
EU contribution
€ 33 290
Address
Via Pietro Dazzi 1
50141 Firenze
Activity type
Other
Administrative Contact
Daniele Lachi (Dr.)
FUNDACIO INSTITUT UNIVERSITARI PERA LA RECERCA A L'ATENCIO PRIMARIA DE SALUT JORDI GOL I GURINA
Spain
EU contribution
€ 33 290
Address
Gran Via De Les Corts Catalanes 587
08007 Barcelona
Activity type
Research Organisations
Administrative Contact
José Maria Gállego (M)