Project description DEENESFRITPL New clinical trial design for tuberculosis drugs As with many bacterial diseases, tuberculosis has been hit by drug resistance, threatening the efficacy of existing treatments. Although there are new drugs for clinical evaluation, testing the different combinations is time-consuming and requires a concerted effort. The EU-funded UNITE4TB project brings together experts in the field to design and set new standards for tuberculosis Phase II clinical trials. The team will take advantage of existing networks across continents to recruit patients in trials and introduce state-of-the-art microbiology methods and machine learning technologies. Data on biomarkers and clinical pharmacology will accompany the validation of the new drugs to ensure their subsequent success down the drug discovery pipeline. Show the project objective Hide the project objective 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. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug resistancemedical and health sciencesclinical medicinepneumologytuberculosisnatural sciencescomputer and information sciencesartificial intelligencemachine learningnatural sciencesbiological sciencesmicrobiologynatural sciencescomputer and information sciencessoftwaresoftware applicationssimulation software Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2020-20-03 - Academia and industry united innovation and treatment for tuberculosis (UNITE4TB) Call for proposal H2020-JTI-IMI2-2020-20-two-stage See other projects for this call Funding Scheme RIA - Research and Innovation action Coordinator STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM Net EU contribution € 64 968 756,75 Address Geert grooteplein 10 zuid 6525 GA Nijmegen Netherlands See on map Region Oost-Nederland Gelderland Arnhem/Nijmegen Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (31) Sort alphabetically Sort by Net EU contribution Expand all Collapse all LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER United Kingdom Net EU contribution € 794 947,50 Address Keppel street WC1E 7HT London See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD United Kingdom Net EU contribution € 1 499 568,75 Address Wellington square university offices OX1 2JD Oxford See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FORSCHUNGSZENTRUM BORSTEL LEIBNIZ LUNGENZENTRUM Germany Net EU contribution € 3 312 102,50 Address Parkallee 1-40 23845 Borstel See on map Region Schleswig-Holstein Schleswig-Holstein Segeberg Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STICHTING LYGATURE Netherlands Net EU contribution € 2 274 497,50 Address Jaarbeursplein 6 3521 AL Utrecht See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region West-Nederland Utrecht Utrecht Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY OF LANCASTER United Kingdom Net EU contribution € 253 347,50 Address Bailrigg LA1 4YW Lancaster See on map Region North West (England) Lancashire Lancaster and Wyre Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY COLLEGE LONDON United Kingdom Net EU contribution € 2 994 251,25 Address Gower street WC1E 6BT London See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 TASK FOUNDATION NPC South Africa Net EU contribution € 869 670,00 Address M2 karl bremer hospital mike pienaar boulevard belleville 7530 Cape town See on map Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITA VITA-SALUTE SAN RAFFAELE Italy Net EU contribution € 713 000,00 Address Via olgettina 58 20132 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH Germany Net EU contribution € 1 775 000,00 Address Ingolstadter landstrasse 1 85764 Neuherberg See on map Region Bayern Oberbayern München, Landkreis Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 KONINKLIJKE NEDERLANDSE CENTRALE VERENIGING TOT BESTRIJDING DER TUBERCULOSE (KNCV) Netherlands Net EU contribution € 1 573 523,75 Address Maanweg 174 2516 AB 's-gravenhage (den haag) See on map Region West-Nederland Zuid-Holland Agglomeratie ’s-Gravenhage Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CRITICAL PATH INSTITUTE, LIMITED Ireland Net EU contribution € 2 387 091,25 Address 33 sir john rogerson's 2 Dublin See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Northern and Western Border Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EUROPEAN LUNG FOUNDATION United Kingdom Net EU contribution € 230 375,00 Address Glossop road 442 S10 2PX Sheffield See on map Region Yorkshire and the Humber South Yorkshire Sheffield Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. LUNGS EUROPE Belgium Net EU contribution € 40 000,00 Address Rue de treves 49-51 1040 Brussels / bruxelles See on map 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 Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 INSTITUTO DE SAUDE PUBLICA DA UNIVERSIDADE DO PORTO Portugal Net EU contribution € 616 040,00 Address Praca gomes teixeira - edificio gomes teixeira 4050 290 Porto See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Continente Norte Área Metropolitana do Porto Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE UNIVERSITY OF LIVERPOOL United Kingdom Net EU contribution € 1 630 442,50 Address Brownlow hill 765 foundation building L69 7ZX Liverpool See on map Region North West (England) Merseyside Liverpool Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT France Net EU contribution € 144 995,00 Address Boulevard de dunkerque 44 cs 90009 13572 Marseille See on map Region Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITAET HAMBURG Germany Net EU contribution € 436 250,00 Address Mittelweg 177 20148 Hamburg See on map Region Hamburg Hamburg Hamburg Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE REGENTS OF THE UNIVERSITY OF CALIFORNIA United States Net EU contribution € 1 500 100,00 Address Franklin street 1111 12 floor 94607 Oakland ca See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON PROFIT ORGANISATION United States Net EU contribution € 1 393 765,00 Address Wall street 40 24th floor 10005 New york See on map Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS Switzerland Net EU contribution € 1 135 539,50 Address Campus biotech, chemin des mines 9 1202 Geneve See on map Region Schweiz/Suisse/Svizzera Région lémanique Genève Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITA DEGLI STUDI DI MILANO Italy Net EU contribution € 402 652,50 Address Via festa del perdono 7 20122 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE UNIVERSITY COURT OF THE UNIVERSITY OF ST ANDREWS United Kingdom Net EU contribution € 633 985,00 Address North street 66 college gate KY16 9AJ St andrews See on map Region Scotland Eastern Scotland Clackmannanshire and Fife Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UPPSALA UNIVERSITET Sweden Net EU contribution € 446 286,25 Address Von kraemers alle 4 751 05 Uppsala See on map Region Östra Sverige Östra Mellansverige Uppsala län Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EUROPEAN RESPIRATORY SOCIETY Switzerland Net EU contribution € 223 375,00 Address Avenue sainte luce 4 1003 Lausanne See on map Region Schweiz/Suisse/Svizzera Région lémanique Vaud Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 TUBERCULOSIS NETWORK EUROPEAN TRIALSGROUP EV Germany Net EU contribution € 250 437,50 Address Armenberg 6 23843 Bad oldesloe See on map Region Schleswig-Holstein Schleswig-Holstein Stormarn Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 GLAXOSMITHKLINE INVESTIGACION Y DESARROLLO SL Spain Net EU contribution € 0,00 Address C/ severo ochoa numero 2 parque tecnologico de mad 28760 Tres cantos madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 20 000 000,00 JANSSEN PHARMACEUTICA NV Belgium Net EU contribution € 0,00 Address Turnhoutseweg 30 2340 Beerse See on map Region Vlaams Gewest Prov. Antwerpen Arr. Turnhout Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 20 246 175,00 OTSUKA NOVEL PRODUCTS GMBH Germany Net EU contribution € 0,00 Address Erika mann strasse 21 80636 Munchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 22 118 569,00 DEUTSCHES ZENTRUM FUR INFEKTIONSFORSCHUNG (DZIF) EV Germany Net EU contribution € 0,00 Address Inhoffenstrasse 7 38124 Braunschweig See on map Region Niedersachsen Braunschweig Braunschweig, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 350 000,00 LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN Germany Net EU contribution € 0,00 Address Geschwister scholl platz 1 80539 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window 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. KLINIKUM DER UNIVERSITAT MUNCHEN Germany Net EU contribution € 0,00 Address Marchioninistrasse 15 81377 Munchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 29 785 256,00