Table of Contents External Review Committee ............................................................................................ 5 Executive Summary.......................................................................................................... 6 The Past........................................................................................................................... 7 TDR in a Radically Changed Landscape........................................................................ 7 TDR’s Strengths: The Basis for Its Existence ................................................................ 8 Proposals for the Future: Evolution and Growth ............................................................ 8 Re-orientation and Stakeholder Engagement Exercise................................................. 14 Governance, Management and Budget......................................................................... 15 The Director of TDR..................................................................................................... 16 Overall Conclusions...................................................................................................... 16 Summary of Major Recommendations......................................................................... 17 Chapter 1. Introduction.................................................................................................. 21 The Terms of Reference of the 4th External Review................................................ 21 Methodology ............................................................................................................ 22 Some of the Thinking Behind This Report .............................................................. 26 Chapter 2. Retrospective Review of TDR Achievements: 2000 - 2005 .................... 28 Actual Results in Terms of Meeting the Output and Performance Indicators for 2000-5 .......................................................................................................................... 29 Major Achievements in the Areas of Specific Diseases, Partnerships, Capacity Building and Technical Information............................................................................. 31 Drugs Developed by Industry with Input from TDR........................................ 34 Cases Illustrating Some of TDR’s Strengths and Weaknesses......................... 37 Overall Summary and Conclusions for Chapter 2 ........................................................ 43 Chapter 3. The Changed and Changing Landscape................................................... 44 Global Changes........................................................................................................ 44 Changing Relationships with WHO Regarding Research Plans............................... 45 Roles of Other Global Health Research Organizations ............................................ 46 Newer and Bigger Sources of Research Funding ..................................................... 46 Emergence of Product-Developing PPPs ................................................................. 46 Emergence of Other Players in Capacity Strengthening for Research ..................... 50 Emergence of Other Players in Intervention/Implementation Research .......... 51 Conclusion .................................................................................................................... 51 Chapter 4. Situation Analysis ....................................................................................... 53 Strengths ...................................................................................................................... 53 Weaknesses .................................................................................................................. 53 General Situation Analysis......................................................................................... 54 The Double Mandate of TDR .................................................................................. 54 Global Position and Relationships with Co-Sponsors and Countries ...................... 62 Conclusion: Implications for the Future ....................................................................... 66 Chapter 5. Research Advocacy, Coordination and Stewardship .............................. 69 Needs and expectations................................................................................................. 69 Implications................................................................................................................... 71 2 Conclusion .................................................................................................................... 74 Chapter 6. Research and Development for Physical Products.................................. 75 Drug Development Pipeline.......................................................................................... 75 TDR’s Role in Drug Development in the Old Landscape ............................................ 76 TDR’s Role in R&D for Physical Products in the New Landscape ............................. 77 TDR’s Strengths and Weaknesses in Product Development ........................................ 78 The Place of R&D for Physical Products in the ERC-Proposed Functional Areas...... 79 Conclusions and Recommendations ............................................................................. 79 Chapter 7. Expanded Intervention Research (E – IR) ......................................... 81 Implementation or Intervention Research?................................................................... 81 Clinical Trials: Also a Changing Scenario.................................................................... 82 Research for Action ...................................................................................................... 83 Health Research and the Bigger Picture ....................................................................... 84 Health Services or Health Systems Research?.............................................................. 85 Crossing Boundaries ..................................................................................................... 85 Implementing E-IR ....................................................................................................... 86 Chapter 8. Research Capability Strengthening for the Future (RSC-F).................. 88 New Concepts ............................................................................................................... 88 New Directions ............................................................................................................. 89 Potential New Partnerships........................................................................................... 91 New Foci for RCS-F ..................................................................................................... 93 New Opportunities........................................................................................................ 95 Organizational and Funding Needs for RCS-F............................................................. 96 Chapter 9. Governance, Management and Functioning of TDR .............................. 97 A. Governance .............................................................................................................. 97 Joint Coordinating Board (JCB) ................................................................................... 98 Standing Committee.................................................................................................... 100 WHO as the Executing Agency .................................................................................. 101 The Scientific and Technical Advisory Committee (STAC)...................................... 102 Relations with Scientific Working Groups and Steering Committees........................ 103 B. Management........................................................................................................... 104 The Management Review of 2003.......................................................................... 104 From Matrix to Strategy?........................................................................................ 105 The (Unclear) Strategic Process.............................................................................. 106 Human Resources and their Use at TDR ................................................................ 111 The Administrative Burden..................................................................................... 112 Chapter 10. Decentralization: Needs, Opportunities and a Practical Solution...... 115 Characteristics of the Proposed Teams................................................................... 115 Chapter 11. Africa: Needs and Opportunities .......................................................... 121 Greater Needs.............................................................................................................. 121 Greater Opportunities.................................................................................................. 121 Chapter 12. Financing ................................................................................................. 124 Situation Analysis....................................................................................................... 124 Resource Mobilization for the New TDR................................................................... 126 Notes on Some Potential Donor Sources...................................................................