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Analysis of Research and Development Priorities for Malaria – Working Paper Global Malaria Programme Analysis of research and development priorities for malaria – working paper In collaboration with the WHO Global Observatory on Health R&D Framework for a national insecticide resistance monitoring and management plan for malaria vectors Global Malaria Programme World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Prepared in collaboration with the Barcelona Institute for Global Health, the Malaria Eradication Scientific Alliance and WHO Global Malaria Programme August 2018 © World Health Organization 2018 All rights reserved. The content of this document is not final, and the text may be subject to revisions before publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. CONTENTS LIST OF FIGURES AND TABLES ................................................................................................................................................................. 3 ACKNOWLEDGMENTS ................................................................................................................................................................................... 4 ABBREVIATIONS ................................................................................................................................................................................................ 5 EXECUTIVE SUMMARY ................................................................................................................................................................................. 7 1 INTRODUCTION ...................................................................................................................................................................................... 9 2 MALARIA TODAY ................................................................................................................................................................................ 10 2.1 .. Malaria and the Sustainable Development Agenda 10 2.2 .. Global trends in malaria 10 2.3 .. Impact of effective treatment and control 11 2.4 .. Investing in malaria 12 3 GLOBAL TECHNICAL STRATEGY FOR MALARIA 2016–2030 .................................................................................. 14 4 RESEARCH NEEDED UP- AND DOWN-STREAM OF PRODUCT DEVELOPMENT........................................ 16 4.1 Basic science 16 4.2 Implementation science 18 4.3 Health policy and systems research 20 5 R&D ANALYSIS FOR MALARIA: OBJECTIVES AND METHODS .............................................................................. 21 5.1 Objectives 21 5.2 Consultation process 21 5.3 Methodology 22 5.4 Considerations for priority setting and updates 24 6 CHALLENGES TO THE ACHIEVING THE GTS GOALS: LIMITATIONS OF EXISTING TOOLS AND APPROACHES ........................................................................................................................................................................................ 26 6.1 Biological adaptation (resistance) 27 6.2 Addressing transmission 30 6.3 Transforming surveillance 31 6.4 Achieving universal access 32 6.5 P. vivax and non-falciparum species 34 7 POTENTIAL HEALTH PRODUCT SOLUTIONS TO ADDRESS THE CHALLENGES ........................................... 36 8 INTEGRATED GAP ANALYSIS OF THE CURRENT PIPELINE AGAINST R&D NEEDS .................................. 38 8.1 Health products in the pipeline 38 8.2 Current status of health product R&D and gap analysis 38 9 PRIORITIZATION OF R&D NEEDS VERSUS THE CURRENT DEVELOPMENT PIPELINE........................... 45 9.1 Changing priorities 46 9.2 Attrition 46 9.3 Insufficient evidence of product attributes 46 9.4 Vector control 48 Analysis of research and priorities for malaria – working paper | 1 9.5 Diagnostics 48 9.6 Drugs 49 9.7 Vaccines 50 10 POLICY AND REGULATORY PATHWAY OF NEW PRODUCTS BY CLASS ......................................................... 51 10.1 Vector control 51 10.2 Diagnostics 52 10.3 Drugs 53 10.4 Vaccines 54 11 OVERVIEW OF MALARIA R&D FUNDING ........................................................................................................................... 55 11.1 Global Technical Strategy for Malaria 2016–2030 funding targets and forecasts 55 11.2 Trends in malaria R&D funding (G-FINDER) 55 12 MARKET STRUCTURE FOR R&D................................................................................................................................................ 57 12.1 Vector control 58 12.2 Diagnostics 59 12.3 Drugs 60 12.4 Vaccines 61 13 CONCLUSIONS ...................................................................................................................................................................................... 63 REFERENCES ...................................................................................................................................................................................................... 64 ANNEX 1: POTENTIAL HEALTH PRODUCTS IDENTIFIED AS STRATEGICALLY IMPORTANT MAPPED TO OPERATIONAL CONSTRAINTS TO THE CHALLENGES IMPEDING ACHIEVEMENT OF THE GTS GOALS ............................................................................................................................................................................ 80 ANNEX 2: MALARIA HEALTH PRODUCT PIPELINE LISTED IN THE GLOBAL OBSERVATORY FOR HEALTH R&D AND UPDATED ONLINE .................................................................................................................................. 85 Vector control 85 Diagnostics 89 Drugs 94 Vaccines (information collected March 2018) 95 ANNEX 3: HEAT MAPS FOR MALARIA HEALTH PRODUCTS IN THE PIPELINE AGAINST POTENTIAL TARGET INDICATIONS ..................................................................................................................................................................... 97 Vector control 97 Diagnostics 99 Drugs 101 Vaccines 103 ANNEX 4: SCORING OF POTENTIAL HEALTH PRODUCT SOLUTIONS AGAINST THE PRIORITIZATION CRITERIA ............................................................................................................................................. 104 ANNEX 5: HEALTH PRODUCT R&D PRIORITIES VERSUS THE CURRENT PIPELINE IN MALARIA ........... 105 Analysis of research and priorities for malaria – working paper | 2 LIST OF FIGURES AND TABLES Table i: Prioritization of malaria health product R&D and strength of the pipeline (last updated March 2018)............................................................................................................................... 8 Figure 2.1 Estimated malaria cases by WHO region, 2016. ............................................................... 11 Figure 2.2 Predicted cumulative number of malaria cases averted by interventions in sub-Saharan Africa 2000−2015.12, 13 .............................................................................................................. 12 Table 3.1 Goals, milestones and targets for the Global Technical Strategy for Malaria 2016–2030.6 . 14 Figure 3.1 Strategic framework for the Global Technical Strategy for Malaria 2016–2030.6 .............. 15 Figure 4.1 The role of modelling directed against programmatic aims. [Adapted from malERA refresh.20]................................................................................................................................. 20 Figure 5.1 Summary of the methodology for the R&D analysis of malaria. ....................................... 23 Table 6.1: Challenges and problems that drive the R&D framework ................................................. 26 Table 7.1: Anticipated impact of potential health products relative to the challenges for achieving GTS goals. ................................................................................................................................ 37 Table 8.1 Summary of the current status of potential health products compared to the status of products in the pipeline. .......................................................................................................... 40 Table 9.1 Matrix of how R&D of novel tools can impact upon the key challenges. ............................ 45 Table 9.2 Prioritization of malaria health product R&D and strength of the pipeline. ....................... 47 Figure 10.1 The inter-relationships between the two target product profiles and the individual target candidate profiles (reproduced with permission from MMV). .................................................. 50 Table 11.1. Regulatory challenges to antimalarial drug approval.98, 99 ............................................... 53 Table 12.1 Cost of implementing the Global Technical Strategy 2016–2030.5, 6 ................................ 55 Figure 12.1 Malaria R&D funding by recipient and by research area 2010−2015 (in US$ million).10 .. 56 Analysis of research and priorities for malaria – working paper | 3 ACKNOWLEDGMENTS This document was prepared by Naomi Richardson of Magenta Communications Ltd who was funded by the Barcelona Institute for Global Health, in partnership with Kate Whitfield and Regina Rabinovich (ISGlobal/MESA); David Schellenberg (WHO GMP) and Taghreed Adam (WHO IER). Members of the Malaria Policy Advisory Committee (MPAC) reviewed and commented on the report, particular thanks go to Larry Slutsker, Caroline Jones, Gabriel Carrasquilla for their
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