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.

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

© 2009 Bill & Melinda Gates Foundation | ‹4›

Non-FoundationPriorities: 43%

FoundationPriorities: 57%

Infectious and parasitic diseases

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Cervical, Liver, Gastric CA

Other neoplasmsDiabetes mellitus

Cardiovasculardiseases

Digestive diseasesSkin diseases

Oral diseases

Other malignant neoplasms

Nutritional/endocrine disorders

Congenital abnormalitiesMusculoskeletal diseases

Diseases of the GU system

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

© 2009 Bill & Melinda Gates Foundation | ‹6›

GlobalHealthImpact

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) 6 Pneumonia (vaccines) 5 Diarrhea (vaccines) 11 Diarrhea (drugs) 1 Dengue Fever 1 Visceral Leishmaniasis 3 Human African Trypanosomiasis 2

Hookworm 2

Japanese Encephalitis 1

Human Papillomavirus 1

Product/Platform Candidates 4 Total 77

© 2009 Bill & Melinda Gates Foundation | ‹7›

Product Development Partnerships Supported by the Gates Foundation

© 2009 Bill & Melinda Gates Foundation | ‹8›

DiarrheaInternational Vaccine InstituteEnteric Vaccine InitiativeAdvancing Rotavirus Vaccine Development

HIV/AIDSInternational AIDS Vaccine InitiativeInternational Partnership for Microbicides

MalariaMedicines for Malaria VentureMalaria Vaccine Initiative

NTDDengue: Pediatric Dengue Vaccine InitiativeHookworm: Human Hookworm Vaccine InitiativeLeishmaniasis: Infectious Disease Research InstituteTrypanosomiasis: UNC Consortium for Parasitic Drug DevelopmentMultiple: Drugs for Neglected Diseases Initiative

Respiratory InfectionInfluenza Vaccine Development ProgramMeningitis Vaccine ProjectPneumococcal Vaccine Development Program

TBAeras Global TB Vaccine FoundationGlobal Alliance for TB Drug Development

Cross-CuttingFoundation for Innovative New DiagnosticsInnovative Vector Control ConsortiumInstitute for One World Health

Global Health Program Payout

© 2008 Bill & Melinda Gates Foundation

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200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2000 2001 2002 2003 2004 2005 2006 2007 2008

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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

© 2008 Bill & Melinda Gates Foundation

Discovery

Development

Product Approval

Introduction

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