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ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Objective

Current anti-tuberculosis (TB) drug regimens face serious limitations at times of increasing antimicrobial drug resistance. Fortunately, for the first time for centuries, several novel anti-TB compounds are available for clinical evaluation. As the traditional approach to testing these in multiple combination regimens is too slow and inefficient new approaches of clinical phase 2 study designs are required if we are to meet the targets of the WHO EndTB strategy to save the lives of millions into the near future. Our consortium brings together a unique group of European and international leaders in TB research and leading industry partners. Together we will provide the necessary comprehensive range of expertise to meet the demands of the UNITE4TB scientific research agenda. Specifically, we will develop a new global standard for phase 2 TB clinical trial designs, utilising simulation tools to identify optimal doses in phase 2A trials and apply a multi-arm multi-stage adaptive randomised controlled 2B/C trial design capable of rapid and simultaneous evaluation of the best candidate regimens. Our innovative phase 2 trials will be performed to the highest regulatory standards, incorporating state-of-the-art microbiology, biomarker investigation and clinical pharmacology. We will take advantage of existing global TB clinical trial networks with the capacity to enrol patients at an unprecedented pace and number across four continents. Artificial intelligence/machine learning technologies will be applied to validate state-of-the art molecular and imaging tools as treatment decision biomarkers with the aim of establishing new, real-time outcome measures. Our consortium will evaluate 3-5 new chemical entities (NCEs) at phase 2A and up to 17 novel combination regimens in phase 2B/C. Our objective is to identify those that have the greatest chance of success in subsequent definitive phase 3 clinical trials and of becoming the global gold-standard TB regimens of the future.

Call for proposal

H2020-JTI-IMI2-2020-20-two-stage
See other projects for this call

Coordinator

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Address
Geert Grooteplein 10 Zuid
6525 GA Nijmegen
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 64 968 756,75

Participants (29)

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
United Kingdom
EU contribution
€ 794 947,50
Address
Keppel Street
WC1E 7HT London
Activity type
Higher or Secondary Education Establishments
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 1 499 568,75
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
FORSCHUNGSZENTRUM BORSTEL
Germany
EU contribution
€ 3 312 102,50
Address
Parkallee 1-40
23845 Borstel
Activity type
Research Organisations
STICHTING LYGATURE
Netherlands
EU contribution
€ 2 274 497,50
Address
Jaarbeursplein 6
3521 AL Utrecht
Activity type
Other
UNIVERSITY OF LANCASTER
United Kingdom
EU contribution
€ 253 347,50
Address
Bailrigg
LA1 4YW Lancaster
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 2 994 251,25
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
TASK FOUNDATION NPC
South Africa
EU contribution
€ 869 670
Address
M2 Karl Bremer Hospital Mike Pienaar Boulevard Belleville
7530 Cape Town
Activity type
Other
UNIVERSITA VITA-SALUTE SAN RAFFAELE
Italy
EU contribution
€ 713 000
Address
Via Olgettina 58
20132 Milano
Activity type
Higher or Secondary Education Establishments
HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Germany
EU contribution
€ 1 775 000
Address
Ingolstadter Landstrasse 1
85764 Neuherberg
Activity type
Research Organisations
KONINKLIJKE NEDERLANDSE CENTRALE VERENIGING TOT BESTRIJDING DER TUBERCULOSE (KNCV)
Netherlands
EU contribution
€ 1 573 523,75
Address
Maanweg 174
2516 AB 'S Gravenhage
Activity type
Other
CRITICAL PATH INSTITUTE, LIMITED
Ireland
EU contribution
€ 2 387 091,25
Address
33 Sir John Rogerson's
2 Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN LUNG FOUNDATION
United Kingdom
EU contribution
€ 270 375
Address
Glossop Road 442
S10 2PX Sheffield
Activity type
Other
INSTITUTO DE SAUDE PUBLICA DA UNIVERSIDADE DO PORTO
Portugal
EU contribution
€ 616 040
Address
Praca Gomes Teixeira - Edificio Gomes Teixeira
4050 290 Porto
Activity type
Research Organisations
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 1 630 442,50
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT
France
EU contribution
€ 144 995
Address
Boulevard De Dunkerque 44 Cs 90009
13572 Marseille
Activity type
Research Organisations
UNIVERSITAET HAMBURG
Germany
EU contribution
€ 436 250
Address
Mittelweg 177
20148 Hamburg
Activity type
Higher or Secondary Education Establishments
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
United States
EU contribution
€ 1 500 100
Address
Franklin Street 1111, 12 Floor
94607 Oakland Ca
Activity type
Higher or Secondary Education Establishments
GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON PROFIT ORGANISATION
United States
EU contribution
€ 1 393 765
Address
Wall Street 40 24Th Floor
10005 New York
Activity type
Research Organisations
FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS
Switzerland
EU contribution
€ 1 135 539,50
Address
Campus Biotech, Chemin Des Mines 9
1202 Geneve
Activity type
Other
UNIVERSITA DEGLI STUDI DI MILANO
Italy
EU contribution
€ 402 652,50
Address
Via Festa Del Perdono 7
20122 Milano
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY COURT OF THE UNIVERSITY OF ST ANDREWS
United Kingdom
EU contribution
€ 633 985
Address
North Street 66 College Gate
KY16 9AJ St Andrews
Activity type
Higher or Secondary Education Establishments
UPPSALA UNIVERSITET
Sweden
EU contribution
€ 446 286,25
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
EUROPEAN RESPIRATORY SOCIETY
Switzerland
EU contribution
€ 223 375
Address
Avenue Sainte Luce 4
1003 Lausanne
Activity type
Other
TUBERCULOSIS NETWORK EUROPEAN TRIALSGROUP EV
Germany
EU contribution
€ 250 437,50
Address
Armenberg 6
23843 Bad Oldesloe
Activity type
Research Organisations
GLAXOSMITHKLINE INVESTIGACION Y DESARROLLO SL
Spain
EU contribution
€ 0
Address
C/ Severo Ochoa Numero 2 Parque Tecnologico De Mad
28760 Tres Cantos Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
JANSSEN PHARMACEUTICA NV
Belgium
EU contribution
€ 0
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
OTSUKA NOVEL PRODUCTS GMBH
Germany
EU contribution
€ 0
Address
Erika Mann Strasse 21
80636 Munchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
DEUTSCHES ZENTRUM FUR INFEKTIONSFORSCHUNG (DZIF) EV
Germany
EU contribution
€ 0
Address
Inhoffenstrasse 7
38124 Braunschweig
Activity type
Research Organisations
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany
EU contribution
€ 0
Address
Geschwister Scholl Platz 1
80539 Muenchen
Activity type
Higher or Secondary Education Establishments