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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
•
•
Widest imbalance
•
•
Fill in areas receiving inadequate attention and resources
Benefit the most people
•
•
Problems that disproportionately affect poor countries
Gaps in attention
•
•
The areas that cause widespread illness and death: infectious diseases, undernutrition,
and reproductive maternal, neonatal, and child health
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
Oral diseases
Congenital abnormalities
Musculoskeletal diseases
Diseases of the GU system
Skin diseases
Digestive diseases
Infectious and
parasitic diseases
Cardiovascular
diseases
.
Non-Foundation
Priorities: 43%
Nutritional/endocrine disorders
Diabetes mellitus
Other neoplasms
Other malignant neoplasms
Foundation
Priorities: 57%
Cervical, Liver, Gastric CA © 2009 Bill & Melinda Gates Foundation
| ‹4›
How We Prioritize Our Work
•
Greatest burden
•
•
Widest imbalance
•
•
Fill in areas receiving inadequate attention and resources
Benefit the most people
•
•
Problems that disproportionately affect poor countries
Gaps in attention
•
•
The areas that cause widespread illness and death: infectious diseases, undernutrition,
and reproductive maternal, neonatal, and child health
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
Discovery
Development
Delivery
Appropriate
Uptake and Use
Global
Health
Impact
© 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)
TB (Vaccines)
9
TB (drugs)
Malaria (vaccines)
Malaria (drugs)
6
2
10
Pneumonia (vaccines)
Diarrhea (vaccines)
Diarrhea (drugs)
Dengue Fever
Visceral Leishmaniasis
Human African Trypanosomiasis
6
5
11
1
1
3
2
Hookworm
2
Japanese Encephalitis
1
Human Papillomavirus
1
Product/Platform Candidates
Total
4
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
Respiratory Infection
Influenza Vaccine Development Program
Meningitis Vaccine Project
Pneumococcal Vaccine Development Program
HIV/AIDS
International AIDS Vaccine Initiative
International Partnership for Microbicides
TB
Aeras Global TB Vaccine Foundation
Global Alliance for TB Drug Development
Malaria
Medicines for Malaria Venture
Malaria Vaccine Initiative
Cross-Cutting
Foundation for Innovative New Diagnostics
Innovative Vector Control Consortium
Institute for One World Health
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
© 2009 Bill & Melinda Gates Foundation | ‹8›
Global Health Program Payout
2,000
1,800
1,600
Payout (USD, Millions)
1,400
1,200
1,000
800
600
400
200
2000
2001
2002
2003
2004
2005
2006
2007
2008
© 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
Government Lab
Academic
Lab
Research
Institute
Research
Institute
Government Lab
Academic
Lab
Discovery
Pharma
Biotech
Biotech
Company
Government Lab
Development
Pharma
Biotech
Company
Pharma
Product Approval
Pharma
Biotech
Introduction
© 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