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Autism Innovative Medicine Studies – 2 – Trials

Objective

Autism Spectrum Disorder (ASD) is a heterogeneous neurodevelopmental condition affecting over five million people in the European Union. The combination of core symptoms (deficits in social-communication and repetitive and restricted behaviours and interests) and common comorbidities (e.g. epilepsy and depression) significantly reduces the quality of life and life-span of affected individuals. Currently there are no effective drug treatments for the core symptoms. Key factors that have hampered progress include; 1) limited understanding of the underlying pathophysiolog(ies); 2) lack of successful translation from animal models to humans; 3) testing of drugs with specific actions in biologically heterogeneous populations; 4) limited expertise of many European ASD centres in running large-scale clinical trials; and 5) trial designs (e.g. placebo effects).

Our vision, therefore, is to apply a precision medicine approach to ASD and improve patient outcomes by tailoring treatments to a patient’s biological profile. Our efforts will build on the achievements of 5 other IMI initiatives, 4 Horizon 2020 networks, and 6 SMEs for the first time to; 1) align global resources to validate and qualify stratification biomarkers from infancy to adulthood; 2) develop objective outcome measures that can be used in trials; 3) create a European-wide clinical trials network that reliably carries out studies able to support filings to the EMA/FDA; 4) carry out better targeted clinical trials linked to other international efforts – including quick wins or “fast fails” of ineffective agents; 5) translate molecular mechanisms and drug effects between preclinical models and particular subtypes of ASD.

Together we will bring Europe to the forefront of clinical research in ASD. Also we will provide a sustainable legacy that is accessible by others across the world, attracts industry into ASD, and helps transform healthcare.

Coordinator

KING'S COLLEGE LONDON
Net EU contribution
€ 20 141 917,04
Address
Strand
WC2R 2LS London
United Kingdom

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
Other funding
€ 1 002 981,26

Participants (56)

F. HOFFMANN-LA ROCHE AG
Switzerland
Net EU contribution
€ 0,00
Address
Grenzacherstrasse 124
4070 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 435 000,00
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE
United Kingdom
Net EU contribution
€ 2 797 032,50
Address
Trinity Lane The Old Schools
CB2 1TN Cambridge

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Region
East of England East Anglia Cambridgeshire CC
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
STICHTING RADBOUD UNIVERSITEIT
Netherlands
Net EU contribution
€ 4 268 059,35
Address
Houtlaan 4
6525 XZ Nijmegen

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
SERVICIO MADRILENO DE SALUD
Spain
Net EU contribution
€ 5 542 309,11
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
INSTITUT PASTEUR
France
Net EU contribution
€ 2 661 580,75
Address
Rue Du Docteur Roux 25-28
75724 Paris Cedex 15

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 1 200 000,00
UNIVERSITAT BASEL
Switzerland
Net EU contribution
€ 1 199 928,75
Address
Petersplatz 1
4051 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT
Germany
Net EU contribution
€ 920 245,00
Address
Square J 5
68159 Mannheim

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Region
Baden-Württemberg Karlsruhe Mannheim, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
BIOSCI CONSULTING BVBA
Belgium
Net EU contribution
€ 192 343,75
Address
Weg Naar Geneuth 95
3631 Maasmechelen

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Vlaams Gewest Prov. Limburg (BE) Arr. Tongeren
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
RIJKSUNIVERSITEIT GRONINGEN
Netherlands
Net EU contribution
€ 833 975,00
Address
Broerstraat 5
9712CP Groningen

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Region
Noord-Nederland Groningen Overig Groningen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 751 011,25
Address
Wellington Square University Offices
OX1 2JD Oxford

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 847 916,25
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
THE UNIVERSITY OF EDINBURGH
United Kingdom
Net EU contribution
€ 7 850,86
Address
Old College, South Bridge
EH8 9YL Edinburgh

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Region
Scotland Eastern Scotland Edinburgh
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

LOTHIAN HEALTH BOARD
United Kingdom
Net EU contribution
€ 29 274,06
Address
Waterloo Place 2-4 Waverley Gate
EH1 3EG Edinburgh

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Region
Scotland Eastern Scotland Edinburgh
Activity type
Research Organisations
Other funding
€ 0,00
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 997 102,33
Address
55 Boulevard Diderot
75012 Paris

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Region
Ile-de-France Ile-de-France Val-de-Marne
Activity type
Research Organisations
Other funding
€ 0,00
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD, OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
Net EU contribution
€ 390 695,00
Address
College Green Trinity College
D02 CX56 Dublin 2

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Region
Ireland Eastern and Midland Dublin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
BIRKBECK COLLEGE - UNIVERSITY OF LONDON
United Kingdom
Net EU contribution
€ 3 039 130,90
Address
Malet Street
WC1E 7HX London

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Other funding
€ 147 250,00
STICHTING BURO ECNP
Netherlands
Net EU contribution
€ 187 498,75
Address
Daltonlaan 400
3584 BK Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Other
Other funding
€ 0,00
NOLDUS INFORMATION TECHNOLOGY BV
Netherlands
Net EU contribution
€ 271 352,50
Address
Nieuwe Kanaal 5
6709 PA Wageningen

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Oost-Nederland Gelderland Veluwe
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
ARTTIC
France
Net EU contribution
€ 479 589,35
Address
39 Rue Des Mathurins
75008 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ARTTIC INNOVATION GMBH
Germany
Net EU contribution
€ 80 426,00
Address
Oskar-von-miller-ring 29
80333 Munchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
DEMCON LIFE SCIENCES & HEALTH ENSCHEDE BV
Netherlands
Net EU contribution
€ 224 218,75
Address
Institutenweg 25
7521 PH Enschede

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Region
Oost-Nederland Overijssel Twente
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DEMCON PRODUCTION BV
Netherlands
Net EU contribution
€ 2 500,00
Address
Institutenweg 25
7521 PH Enschede

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Region
Oost-Nederland Overijssel Twente
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DEMCON ADVANCED MECHATRONICS BESTB.V.
Netherlands
Net EU contribution
€ 98 750,00
Address
Kanaaldijk 29
5683 CR Best

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Region
Zuid-Nederland Noord-Brabant Zuidoost-Noord-Brabant
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DEMCON FLEX CENTER BV
Netherlands
Net EU contribution
€ 6 959,20
Address
Institutenweg 25
7521PH Enschede

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Region
Oost-Nederland Overijssel Twente
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DEMCON MACAWI RESPIRATORY SYSTEMS BV
Netherlands
Net EU contribution
€ 135 540,80
Address
Institutenweg 25
7521 PH Enschede

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Region
Oost-Nederland Overijssel Twente
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DEMCON INNOVATION & TECHNOLOGY B.V.
Netherlands
Net EU contribution
€ 12 500,00
Address
Institutenweg 25
7521PH Enschede

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Region
Oost-Nederland Overijssel Twente
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
KAROLINSKA INSTITUTET
Sweden
Net EU contribution
€ 1 199 067,35
Address
Nobels Vag 5
17177 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN
Germany
Net EU contribution
€ 780 202,50
Address
Theodor W Adorno Platz 1
60323 Frankfurt Am Main

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
Net EU contribution
€ 1 059 870,00
Address
Heidelberglaan 100
3584 CX Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITEIT GENT
Belgium
Net EU contribution
€ 954 428,60
Address
Sint Pietersnieuwstraat 25
9000 Gent

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Region
Vlaams Gewest Prov. Oost-Vlaanderen Arr. Gent
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
Net EU contribution
€ 183 968,75
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne

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Region
North East (England) Northumberland and Tyne and Wear Tyneside
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITAET ULM
Germany
Net EU contribution
€ 802 187,50
Address
Helmholtzstrasse 16
89081 Ulm

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Region
Baden-Württemberg Tübingen Ulm, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS
France
Net EU contribution
€ 24 125,00
Address
Boulevard Tonelle 2
37044 Tours Cedex 9

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Region
Centre — Val de Loire Centre — Val de Loire Indre-et-Loire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
Germany
Net EU contribution
€ 208 750,00
Address
Ismaninger Strasse 22
81675 Muenchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
Fondazione Stella Maris
Italy
Net EU contribution
€ 68 125,00
Address
Viale Del Tirreno 331
56118 Pisa

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Region
Centro (IT) Toscana Pisa
Activity type
Research Organisations
Other funding
€ 0,00
UNIVERSIDAD DE SALAMANCA
Spain
Net EU contribution
€ 234 231,25
Address
Calle Patio De Escuelas 1
37008 Salamanca

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Region
Centro (ES) Castilla y León Salamanca
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITY OF GLASGOW
United Kingdom
Net EU contribution
€ 108 968,75
Address
University Avenue
G12 8QQ Glasgow

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Region
Scotland West Central Scotland Glasgow City
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

GREATER GLASGOW HEALTH BOARD
United Kingdom
Net EU contribution
€ 75 000,00
Address
Great Western Road 1055 J B Russell
G12 0XH Glasgow

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Region
Scotland West Central Scotland Glasgow City
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
France
Net EU contribution
€ 1 056 713,75
Address
Rue Leblanc 25
75015 Paris 15

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Germany
Net EU contribution
€ 68 125,00
Address
Robert-koch-strasse 40
37075 Goettingen

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Region
Niedersachsen Braunschweig Göttingen
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
STELLENBOSCH UNIVERSITY
South Africa
Net EU contribution
€ 417 777,50
Address
Victoria Street Administration B Building
7600 Stellenbosch

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Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UPPSALA UNIVERSITET
Sweden
Net EU contribution
€ 149 995,00
Address
Von Kraemers Alle 4
751 05 Uppsala

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Region
Östra Sverige Östra Mellansverige Uppsala län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSIDADE DE COIMBRA
Portugal
Net EU contribution
€ 777 016,05
Address
Paco Das Escolas
3004-531 Coimbra

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Region
Continente Centro (PT) Região de Coimbra
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
FUNDAZIOA POLICLINICA GIPUZKOA FUNDACION
Spain
Net EU contribution
€ 68 125,00
Address
Paseo Miramon 174
20014 San Sebastian

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Region
Noreste País Vasco Gipuzkoa
Activity type
Other
Other funding
€ 0,00
FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
Spain
Net EU contribution
€ 66 832,50
Address
Carrer Rossello 149
08036 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

HOSPITAL CLINIC DE BARCELONA
Spain
Net EU contribution
€ 135 000,00
Address
Calle Villarroel 170
08036 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Other funding
€ 0,00
JANSSEN PHARMACEUTICA NV
Belgium
Net EU contribution
€ 0,00
Address
Turnhoutseweg 30
2340 Beerse

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Region
Vlaams Gewest Prov. Antwerpen Arr. Turnhout
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 250 000,00
NOVARTIS PHARMA AG
Switzerland
Net EU contribution
€ 0,00
Address
Lichtstrasse 35
4056 Basel

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 203 856,00
UCB BIOPHARMA
Belgium
Net EU contribution
€ 0,00
Address
Allee De La Recherche 60
1070 Bruxelles

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 564 000,00
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Israel
Net EU contribution
€ 0,00
Address
5 Basel St
49131 Petach Tivka

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 110 400,00
AUTISM SPEAKS INC. NON PROFIT CORPORATION
United States
Net EU contribution
€ 0,00
Other funding
€ 4 262 700,00
THE SIMONS FOUNDATION, INC
United States
Net EU contribution
€ 0,00
Address
160 Fifth Avenue, 7th Floor
10010 New York

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Activity type
Research Organisations
Other funding
€ 50 887 750,00
AUTISTICA
United Kingdom
Net EU contribution
€ 0,00
Address
St Saviour's House 39-41 Union Street
SE1 1SD London

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Region
London Inner London — East Lewisham and Southwark
Activity type
Other
Other funding
€ 322 360,00
AUTISME-EUROPE AISBL
Belgium
Net EU contribution
€ 267 469,50
Address
Rue Montoyer 39
1000 Bruxelles

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Other funding
€ 55 288,31
UNIVERSITY OF BRISTOL
United Kingdom
Net EU contribution
€ 51 812,50
Address
Beacon House Queens Road
BS8 1QU Bristol

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bristol, City of
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
STARLAB BARCELONA SL
Spain
Net EU contribution
€ 122 500,00
Address
Avenida Tibidabo 47 Bis
08035 Barcelona

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00