R&D Financing by the Bill & Melinda Gates Foundation PRESENTED BY Neil McDonnell, Pharm.D. January 12, 2009 WHO Expert Working Group on R&D Financing

Gates Foundation Mission To ensure that life-saving advances in health are developed & shared with those who need them the most. (Photo, chart, or graph here) © 2009 Bill & Melinda Gates Foundation | ‹2›

How We Prioritize Our Work Greatest burden The areas that cause widespread illness and death: infectious diseases, undernutrition, and reproductive maternal, neonatal, and child health Widest imbalance Problems that disproportionately affect poor countries Gaps in attention Fill in areas receiving inadequate attention and resources Benefit the most people Prevention has the greatest impact – focus on vaccines and other prevention strategies, micronutrient deficiencies Be willing to take risks Innovation requires accepting risks © 2009 Bill & Melinda Gates Foundation | ‹3›

DALYs by Cause, Low Income Countries Non-Foundation Priorities: 43% Foundation Priorities: 57% © 2009 Bill & Melinda Gates Foundation | ‹4›

How We Prioritize Our Work Greatest burden The areas that cause widespread illness and death: infectious diseases, undernutrition, and reproductive maternal, neonatal, and child health Widest imbalance Problems that disproportionately affect poor countries Gaps in attention Fill in areas receiving inadequate attention and resources Benefit the most people Prevention has the greatest impact – focus on vaccines and other prevention strategies, micronutrient deficiencies Be willing to take risks Innovation requires accepting risks © 2009 Bill & Melinda Gates Foundation | ‹5›

Foundation Support for Discovery, Development, and Delivery Global Health Impact Appropriate Uptake and Use © 2009 Bill & Melinda Gates Foundation | ‹6›

Gates Foundation Support for Drugs and Vaccines in Late-Stage Preclinical or Clinical Development Product Class Candidates HIV (Vaccines) 13 HIV (Non-Vaccine Prevention) 9 TB (Vaccines) 6 TB (drugs) 2 Malaria (vaccines) 10 Malaria (drugs) Pneumonia (vaccines) 5 Diarrhea (vaccines) 11 Diarrhea (drugs) 1 Dengue Fever Visceral Leishmaniasis 3 Human African Trypanosomiasis Hookworm Japanese Encephalitis Human Papillomavirus Product/Platform Candidates 4 Total 77 © 2009 Bill & Melinda Gates Foundation | ‹7›

Product Development Partnerships Supported by the Gates Foundation Diarrhea International Vaccine Institute Enteric Vaccine Initiative Advancing Rotavirus Vaccine Development HIV/AIDS International AIDS Vaccine Initiative International Partnership for Microbicides Malaria Medicines for Malaria Venture Malaria Vaccine Initiative NTD Dengue: Pediatric Dengue Vaccine Initiative Hookworm: Human Hookworm Vaccine Initiative Leishmaniasis: Infectious Disease Research Institute Trypanosomiasis: UNC Consortium for Parasitic Drug Development Multiple: Drugs for Neglected Diseases Initiative Respiratory Infection Influenza Vaccine Development Program Meningitis Vaccine Project Pneumococcal Vaccine Development Program TB Aeras Global TB Vaccine Foundation Global Alliance for TB Drug Development Cross-Cutting Foundation for Innovative New Diagnostics Innovative Vector Control Consortium Institute for One World Health © 2009 Bill & Melinda Gates Foundation | ‹8›

Global Health Program Payout © 2008 Bill & Melinda Gates Foundation

The Need for R&D in Global Health Guaranteed obsolescence in infectious diseases We need for newer, better methods of prevention Many disease for which no effective treatment or prevention is available Innovation is required to meet these challenges Financing innovation requires a willingness to make extremely risky investments © 2008 Bill & Melinda Gates Foundation

Providing Access to Medicines and Vaccines for the Poor – Focus on R & D Governments Support for basic research Support innovative finance mechanisms designed to stimulate R&D Support for funds such as the Global Fund, GAVI, UNITAID, etc. Industry Research, development, and manufacturing to addresses global disease burden and neglected diseases Access Plans © 2008 Bill & Melinda Gates Foundation

Providing Access to Medicines and Vaccines for the Poor – Focus on R & D Foundations Work in defined niches Support innovation and development of new health solutions Operating at the interface between governments, the private sector, and other interested parties De-risking subsequent investments by the public and private sectors © 2008 Bill & Melinda Gates Foundation

Many players to incentivize in R&D, final common pathway through industry Pharma Biotech Govern-ment Lab Academic Lab Academic Lab ResearchInstitute ResearchInstitute Discovery Development Product Approval Introduction Govern-ment Lab Pharma Biotech Govern-ment Lab Biotech Company Pharma Biotech Company Pharma Pharma Biotech © 2008 Bill & Melinda Gates Foundation

Stimulating Global Health R&D We need incentives for governments, foundations, and a broad cross section of industries to participate in the R&D effort We need to identify novel mechanisms to fund global health R&D and new policies that encourage more R&D. We have to be willing to take risks © 2008 Bill & Melinda Gates Foundation