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Lead Discovery for Infectious Tropical Diseases ANNUAL REPORT 2008 Lead discovery for infectious tropical diseases TDR BUSINESS LINE 3 For research on diseases of poverty LEad DISCOVERY FOR INFECTIOUS TrOPICAL DISEASES Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009 All rights reserved. The use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organiza- tion Special Programme for Research and Training in Tropical Diseases. The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner whatsoever. The designations employed and the presentation of material in this health information product, including maps and other illustrative materi- als, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders. Mention or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, includ- ing TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or depicted. The views expressed in this health information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product. Design: Lisa Schwarb • Layout: Simon Fenwick Cover picture: WHO/TDR/Craggs Printed by the WHO Document Production Services, Geneva, Switzerland LEad DISCOVERY FOR INFECTIOUS TrOPICAL DISEASES BL3 TDR/BL3.08 Table of contents Overview and highlights .....................................................................................................................5 Contributions to leverage, empowerment and stewardship ....................................................................... 7 Implications of progress/delays on 2008-2013 plans ................................................................................. 8 1. Context, strategic objectives and framework ...................................................................9 1.1. Context and rationale ...................................................................................................................... 9 1.2. Strategic objectives .......................................................................................................................... 9 1.3. Strategic framework/operational approach .................................................................................... 10 2. Key stakeholders and partnerships: roles and responsibilities .............................15 3. Implementation plan 2008–2013 and progress .............................................................17 3.1. Plan, progress and key milestones ................................................................................................... 17 3.2. Implications of progress/delays and global context changes on 2008–2013 plans ........................... 24 3.3. Specific activities for 2009 ............................................................................................................... 24 4. BL leverage, contributions to empowerment and stewardship and synergies with TDR business lines .........................................................................................25 4.1. Leverage .......................................................................................................................................... 25 4.2. Contributions to overall empowerment and stewardship and synergy with TDR business lines ....... 26 4.3. Elements enhancing sustainability of BL outcomes .......................................................................... 26 4.4. Synergies with work of TDR BLs ..................................................................................................... 26 5. Critical issues and suggested solutions ...............................................................................27 Issues identified through STAC and EDAC reviews addressed .................................................................. 27 6. Annexes ..................................................................................................................................................29 Annex 1. List of publications, meetings, conferences or invited lectures attended by BL3 in 2008 and planned for 2009 .......................................................................................................... 29 Annex 2. Membership of EDAC (Expert Drug Discovery Advisory Committee) and Helminth Drug Initiative Task Force ........................................................................................................ 31 Annex 3. Summary of BL3 activities and end-products for 2009 ............................................................ 32 Annex 4. Details of revision of business plan .......................................................................................... 35 Annex 5. Responses to specific JCB and STAC requests on BL3 .............................................................. 35 Annex 6. Report of EDAC (BL3 SAC) ..................................................................................................... 38 TDR BL3 • 2008 Report 3 BL3 LEad DISCOVERY FOR INFECTIOUS TrOPICAL DISEASES LEad DISCOVERY FOR INFECTIOUS TrOPICAL DISEASES List of abbreviations ADME Absorption, Distribution, Metabolism IP Intellectual property and Excretion LMPH Laboratory of Microbiology, AiBST African Institute for Biomedical Science Parasitology and Hygiene and Technology LSHTM London School of Hygiene and Tropical ANDI African Network for Drugs and Medicine Diagnostics Innovation MMV Medicines for Malaria Venture ASTMH American Society for Tropical Medicine MTS Medium-Throughput Screening and Hygiene NCDS National Centre for Drug Screening BL Business Line NIH-USA National Institutes of Health - United BMGF Bill and Melinda Gates Foundation States of America CDRI Central Drug Research Institute NPIMR Northwick Park Institute for Medical CRO Contract Research Organization Research CYP Cytochrome P NIPRD National Institute for Pharmaceutical DEC Disease-Endemic Country Research DMPK Drug Metabolism and PK Pharmacokinetics Pharmacokinetics PPP Public-Private Partnerships EU European Union QC Quality Control EDAC Expert Drug Discovery Advisory R&D Research and Development Committee SAC Scientific Advisory Committee DNDi Drugs for Neglected Diseases Initiative SOP Standard Operating Procedures GIBEX Global Institute for Bioexploration STI Swiss Tropical Institute HAT Human African Trypanosomiasis TB Tuberculosis HDI Helminth Drug Initiative TBRI Theodor Bilharz Research Institute HEOS Hit Explorer Operating System TDR Special Programme for Research and HIV Human Immunodeficiency Virus Training in Tropical Diseases HTS High-Throughput Screening UB University of Buea IC Inhibitory Concentration UK United Kingdom ICGEB International Centre for Genetic UNAIDS United Nations Joint Programme on Engineering and Biotechnology HIV/AIDS ICS-UNIDO International Centre for Science UW University of Washington and High Technology - United Nations WHA World Health Assembly Industrial Development Organization WHO World Health Organization IFPMA International Federation of Pharmaceutical Manufacturers and Associations IGWG Inter-Governmental Working Group (on Public Health, Innovation and Intellectual Property) 4 TDR BL3 • 2008 Report LEad DISCOVERY FOR LINFECTIOUSEad DISCOVE TrRYOPIC FORA ILNFECTIOUS DISEASES TrOPICAL DISEASES BL3 Overview and highlights The gap in the availability of drug leads and compound evaluation through parasite screens in candidates to sustain the development pipeline vitro and in animal models in vivo; and iterative for infectious tropical diseases is well documented medicinal chemistry linked to drug metabolism/ through the work of TDR and others (Fig. 1). pharmacokinetics. The primary objective of the Lead Discovery The major strengths of this North-South
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