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Background Paper 6.8 Tuberculosis Priority Medicines for Europe and the World "A Public Health Approach to Innovation" Update on 2004 Background Paper Written by Dr Mary Moran Background Paper 6.8 Tuberculosis By Laurien Rook, MSc 01 March 2013 Update on 2004 Background Paper, BP 6.8 Tuberculosis Table of Contents Glossary ................................................................................................................................................................ 4 Executive Summary ............................................................................................................................................ 6 What is new since 2004: .................................................................................................................................. 7 1. Introduction ................................................................................................................................................. 8 1.1 TB burden of disease .......................................................................................................................... 8 1.1.1 Global burden of disease ............................................................................................................. 8 1.1.2 EU/EEA burden of disease ........................................................................................................... 9 1.2 TB Control Strategy .......................................................................................................................... 11 1.2.1 Diagnostics ................................................................................................................................... 11 1.2.2 Treatment ...................................................................................................................................... 12 1.2.3 Vaccines ........................................................................................................................................ 13 1.3 Summary ............................................................................................................................................ 13 2. Developments in TB Tools; Past and Present ..................................................................................... 13 2.1 Basic research .................................................................................................................................... 13 2.2 Pharmaceuticals ................................................................................................................................ 14 2.2.1 Public and Not-for-Profit Private Sector ................................................................................. 14 2.2.2 Industry ......................................................................................................................................... 17 2.3 Diagnostics ........................................................................................................................................ 18 2.3.1 Current Research & Development ........................................................................................... 21 2.4 Vaccines ............................................................................................................................................. 22 2.4.1 Public and Not-for-Profit Sector ............................................................................................... 22 2.5 TB tools; future needs....................................................................................................................... 23 3. Existing resource flows for TB R&D ..................................................................................................... 24 3.1 Basic Research ................................................................................................................................... 26 3.2 Pharmaceuticals ................................................................................................................................ 26 3.3 Diagnostics ........................................................................................................................................ 28 3.4 Vaccines ............................................................................................................................................. 28 4. Research gaps ............................................................................................................................................ 29 4.1 Basic Research ................................................................................................................................... 29 4.2 Pharmaceuticals ................................................................................................................................ 30 4.3 Diagnostics ........................................................................................................................................ 31 4.4 Vaccines ............................................................................................................................................. 32 5. Conclusion ................................................................................................................................................. 33 References ........................................................................................................................................................... 33 6.8-2 Update on 2004 Background Paper, BP 6.8 Tuberculosis Annexes ............................................................................................................................................................... 39 Annex 6.8.1A TB Burden in the EU/EEA Region in 2010 ................................................................... 40 Annex 6.8.1B MDR-TB burden in the EU/EEA in 2010 ...................................................................... 41 Annex 6.8.2 PreDiCT-TB Partners ........................................................................................................... 42 Annex 6.8.3 EC Sixth and Seventh Framework Programmes focused on TB ................................... 44 Annex 6.8.4 Redirected Pharmaceuticals and Novel Regimens for TB ............................................. 48 Annex 6.8.5 EDCTP Funded TB Projects ............................................................................................... 52 Annex 6.8.6 CPTR Initiative Founders and Partners ............................................................................ 53 Annex 6.8.7 TB Drug Accelerator Participants ...................................................................................... 54 Annex 6.8.8 Tuberculosis Diagnostics currently in Use and under Development ......................... 55 Annex 6.8.9 Global TB Vaccine Pipeline ................................................................................................ 58 6.8-3 Update on 2004 Background Paper, BP 6.8 Tuberculosis Glossary Terms and acronyms Definitions AIDS Acquired Immunodeficiency Syndrome ARVs Antiretroviral drugs BCG Bacille-Calmette-Guérin vaccin Bill & Melinda Gates Philanthropic organization with a large global health program. Foundation BMBF German Federal Ministry of Education and Research Case notification rate Notified TB cases for each given year per 100 000 population CDC United States Centers for Disease Control and Prevention CPTR Critical Path to TB Drug Regimens CRO Contract Research Organization DOTS Directly Observed Treatment, Short-course DST Drug sensitivity testing EDCTP European and Developing Countries Clinical Trials Partnership EMA European Medicines Agency FDA United States Food and Drug Administration FDC Fixed Dose Combination FIND Foundation for Innovative New Diagnostics FP6 European Commission’s Sixth Framework Programme HIV Human Immunodeficiency Virus Institut Pasteur Private non-profit foundation with a focus on infectious disease. It provides education, supports biology research and provides public health services through its medical centre. IUATLD International Union against Tuberculosis and Lung Disease. Non-governmental organization. Janssen Johnson & Johnson, a multinational pharmaceutical company. LED Light emitting diode LMIC Low and Middle Income Countries LTBI Latent Tuberculosis Infection MDR-TB Multi Drug Resistant Tuberculosis. Resistant to at least isoniazid and rifampicin. NDWG Stop TB Partnership’s New Diagnostics Working Group NGO Non-governmental Organization NIAID United States National Institute of Allergy and Infectious Diseases. Part of the NIH. NIH United States National Institutes of Health PDP Product Development Partnership. A form of Public Private Partnerships (PPPs) focused on development of a specific (group of) product(s). 6.8-4 Update on 2004 Background Paper, BP 6.8 Tuberculosis Terms and acronyms Definitions PPP Public Private Partnership. A long-term collaboration between the public-sector and one or more private sector companies. SMEs Small and Medium Enterprises SSI Statens Serum Institute. A public enterprise under the Danish government STAG-TB WHO Strategic and Technical Advisory Group for Tuberculosis STBVAC Stop TB Partnership’s Working Group on New TB Vaccines Stop TB Partnership Network of international organizations, countries, financial donors from the public and private sectors, governmental or non-governmental organizations and other entities, housed within WHO. It contains seven Working Groups that all focus on different aspects of tuberculosis. TAACF Tuberculosis
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