ACADEMIA AND INDUSTRY UNITED INNOVATION AND TREATMENT FOR TUBERCULOSIS

Deliverables

Report of kickoff meeting

Target product profile for stage-specific biomarkers - submitted to WHO and EMA

Target product profile for stage-specific biomarkers – submitted to WHO and EMA

Report of third annual consortium meeting
Communication and dissemination plan
Report of second annual consortium meeting
Annual report on status of posting results for phase 2B/C (1)
Establish CAG
Establish SAB and RAB
Annual report on status of posting results for phase 2A (1)
DAT training module developed
Report of first annual consortium meeting
Establish EAB
Code for pharmacodynamic models applicable phase 2A and 2B/C data (1)

Code for pharmacodynamic models applicable phase 2A and 2B/C data (1)

Inaugural meeting with communication professionals of the partners in the consortium
Establish Young Investigators Group

Visual identity and communication toolkit, including project website

Visual identity and communication toolkit including project website

Publications

Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin

Author(s): Keutzer L, You H, Farnoud A, Nyberg J, Wicha SG, Maher-Edwards G, Vlasakakis G, Moghaddam GK, Svensson EM, Menden MP, Simonsson USH, On Behalf Of The UNITE4TB Consortium
Published in: Pharmaceutics, 2022, ISSN 1999-4923
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics14081530

A flexible multi‐metric Bayesian framework for decision‐making in Phase II multi‐arm multi‐stage studies

Author(s): Suzanne M. Dufault; Angela M. Crook; Katie Rolfe; Patrick P. J. Phillips
Published in: Statistics in Medicine , 43 (3) pp. 501-513. (2024), Issue 17, 2024, Page(s) 501-513, ISSN 0277-6715
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/sim.9961

Treatment-shortening regimens for tuberculosis: updates and future priorities

Author(s): Francesca Saluzzo, Victor Abiola Adepoju, Raquel Duarte, Christoph Lange, Patrick P.J. Phillips
Published in: Breathe, Issue 19 (3), October, 2023, ISSN 1810-6838
Publisher: European Respiratory Society
DOI: 10.1183/20734735.0028-2023

Tuberculosis: current challenges and beyond

Author(s): Raquel Villar-Hernández, Arash Ghodousi, Olha Konstantynovska, Raquel Duarte, Christoph Lange, Mario Raviglione on behalf of the UNITE4TB Consortium
Published in: Breath, 2023, ISSN 2073-4735
Publisher: European Respiratory Society
DOI: 10.1183/20734735.0166-2022

Towards comprehensive clinical trials for new tuberculosis drug regimens: policy recommendations from a stakeholder analysis

Author(s): Simone Villa, Pierpaolo de Colombani, Lucia Dall’Olio, Giuliano Gargioni, Mario Raviglione
Published in: BMJ Global Health, Issue 2024;9: e014630, 2024, Page(s) 1-9, ISSN 2059-7908
Publisher: BMJ Journals
DOI: 10.1136/bmjgh-2023-014630

Tuberculosis Treatment Monitoring and Outcome Measures: New Interest and New Strategies

Author(s): Heyckendorf J, Georghiou SB, Frahm N, Heinrich N, Kontsevaya I, Reimann M, Holtzman D, Imperial M, Cirillo DM, Gillespie SH, Ruhwald M, Consortium UNITE4TB
Published in: Clinical Microbiology Reviews, Issue 21 March 2022, 2022, Page(s) n/a, ISSN 1098-6618
Publisher: American Society for Microbiology
DOI: 10.1128/cmr.00227-21

Developing biomarker assays to accelerate tuberculosis drug development: defining target product profiles 

Author(s): Stephen H Gillespie , Andrew R DiNardo, Sophia B Georghiou, Wilber Sabiiti , Mikashmi Kohli, Ursula Panzner , Irina Kontsevaya6, Norbert Hittel, Lieven J Stuyver, Jia Bin Tan, Reinout van Crevel, Christoph Lange, Thuong Nguyen Thuy Thuong, Jan Heyckendorf, Morten Ruhwald, Norbert Heinrich
Published in: Lancet Microbe, 2024, Page(s) 1-11, ISSN 2666-5247
Publisher: Elsevier ltd.
DOI: 10.1016/s2666-5247(24)00085-5

Implementing molecular tuberculosis diagnostic methods in limited-resource and high-burden countries

Author(s): Anca Vasiliu, Antonia Morita Iswari Saktiawati, Raquel Duarte, Christoph Lange, Daniela Maria Cirillo on behalf of the UNITE4TB Consortium
Published in: Breath, 2023, ISSN 2073-4735
Publisher: European Respiratory Society
DOI: 10.1183/20734735.0226-2022

Rolling out new anti-tuberculosis drugs without diagnostic capacity

Author(s): Tara Ness, Le Hong Van, Ilze Petermane, Raquel Duarte, Christoph Lange, Dick Menzies, Daniela Maria Cirillo
Published in: Breathe, Issue 19(2), July, 2023, ISSN 1810-6838
Publisher: European Respiratory Society
DOI: 10.1183/20734735.0084-2023

Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development

Author(s): Mockeliunas L, Faraj A, van Wijk RC, Upton CM, van den Hoogen G, Diacon AH, Simonsson USH
Published in: Front. Pharmacol., 2023, ISSN 1663-9812
Publisher: Frontiers Media S.A.
DOI: 10.3389/fphar.2023.1150243

UNITE4TB: a new consortium for clinical drug and regimen development for TB

Author(s): Boeree, M. J.; Lange, C.; Thwaites, G; Paton, N ; de Vrueh, R.; Barros, D.; Hoelscher, M.; on behalf of the UNITE4TB Consortium
Published in: International Union Against Tuberculosis and Lung Disease, Issue Volume 25, Number 11, 1 November 2021, 2021, Page(s) 886-889, ISSN 1027-3719
Publisher: International Union Against Tuberculosis And Lung Disease/Union Internationale Contre la Tuberculose et les Maladies Respiratories
DOI: 10.5588/ijtld.21.0515

Deliverables

Publications

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