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PRINCIPLES OF VACCINE PORTFOLIO PRIORITIZATION AND MANAGEMENT © 2014 Bill & Melinda Gates Foundation Product Development Boot Camp November 5, 2015 New York, New York

PRINCIPLES OF VACCINE PORTFOLIO … OF VACCINE PORTFOLIO PRIORITIZATION AND MANAGEMENT © 2014 Bill & Melinda Gates Foundation Product Development Boot Camp November 5, 2015 New York,

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PRINCIPLES OF VACCINE PORTFOLIO PRIORITIZATION AND MANAGEMENT

© 2014 Bill & Melinda Gates Foundation

Product Development Boot Camp

November 5, 2015

New York, New York

Strategy, Planning & Management

Hugh Chang, Director

HIV

TB

Malaria

NTD

EDD

Global HealthFunctional Areas

Global Program Strategy Teams

Global DevelopmentFunctional Areas

Discovery & Translational

Sciences

Vaccine Development and Surveillance

Integrated Development

Vaccine Delivery

Integrated Delivery

FH1 Nutrition

Global Policy & Advocacy | Country Offices

Polio

WSH3

Ag

FSP4

Strategy, Planning & Management

Life Sciences PartnershipsKim Bush, Director

Mark Suzman, President

Orin Levine, Director

Trevor Mundel, President Chris Elias, President

Dan Hartman, Director

Toni Hoover, Director

Chris Wilson, Director

Penny Heaton, Director

Dana Hovig, Director

Emilio Emini, Director

Gilla Kaplan, Director

Roger Voorhies, Director

Jay Wenger, Director

Shawn Baker, Director

Trevor Mundel, Interim Director

Anita Zaidi, Director

Brain Arbogast, Director

Pamela Anderson, Director

Alan Magill, Director

1 Family Health 2 Maternal and Child Health3 Water, Sanitation & Hygiene

2

FP5 Kellie Sloan, Director

FH1 MCH2 Mariam Claeson, Director

4 Financial Services for the Poor5Family Planning

Pneumo Keith Klugman, Director

Global Program Organization

© 2014 Bill & Melinda Gates Foundation | 4

LIFE EXPECTANCY BY COUNTRY*

Source: GBD 2013, IHME

© Bill & Melinda Gates Foundation | 5

WHAT WE FOCUS ON

What are the areas

of greatest need?

Where can we have

the greatest impact?

© 2014 Bill & Melinda Gates Foundation | 6

Source: WHO (http://www.who.int/mediacentre/factsheets/fs310/en/index1.html)

© Bill & Melinda Gates Foundation | 7

CHILDHOOD DEATHS ARE DECLINING WORLDWIDE BUT NEED MORE PROGRESS, PARTICULARLY IN NEONATES

5M

10M

15M

20M

20121960 1965 1970 1980 1985 1990 1995 2000 20101975 2005

20 million

6.6 million

Source: The World Bank

© Bill & Melinda Gates Foundation | 81. Vaccine spend only. Excludes GAVI spend tied to VIS (e.g., Cholera Stockpile, YF Campaigns) as well as cash programs and business plan. Source: Under 5 mortality from GBD 2013 IHME; GAVI budget from GAVI Investment Opportunity 2015

Leading Causes of Mortality in Children Under 5

6.3M deaths per year (2013)

GAVI budget $6.5B (2016-2020) (1)

• Disease burden (disability-adjusted life years)

• Probability of success of vaccines as compared with other interventions

• Cost-effectiveness

• Co-Chair interests

© 2014 Bill & Melinda Gates Foundation | 9

SIMPLE RULES FOR VACCINE PORTFOLIO PRIORITIZATION

© Bill & Melinda Gates Foundation | 10

VACCINE DEVELOPMENT PRIORITIESLeading Causes of Mortality in Children Under 5

6.3M deaths per year (2013)

GAVI budget $6.5B (2016-2020)

Near-term

• Poliovirus vaccines

• Pneumococcal conjugate vaccines

• Rotavirus vaccines – oral; parenteral

• HPV

• RSV

Mid- and long-term

• Other enterics – ETEC, Shigella, Typhoid

• Malaria

• HIV

• TB

Sustain legacy vaccines

• Penta, MR, YF, BCG, JE, Cholera

Explore other maternal vaccines

• aP and Group B strep

© 2014 Bill & Melinda Gates Foundation | 11

• Requirement to address novel or unique hypotheses regarding immune

responses that may play a role in preventing or mitigating HIV infection

• Potential to be transformational

• Probability of success/robustness of data to date

• Orthogonal to what others are funding

• Of special interest

SIMPLE RULES FOR HIV VACCINE PORTFOLIO PRIORITIZATION

Burden of disease at a subnational level in regions of interest, key risk factors, 25 year projections, comorbidities

(e.g. HIV-TB), existing standards of care

Dynamic model of disease demonstrates relative impact of potential interventions, provides

key insights that motivate the strategy

No regret or essential interventions (e.g. malaria SE Asia

elimination, TB nutritional intervention)

Cost effectiveness analysis of potential interventions

Definition of high level intervention implementation plan (either key elements of product development plan or

delivery plan, including identification of decision points and associated decision criteria)

KEY ELEMENTS OF GH PROGRAM STRATEGY DEVELOPMENT

© 2014 Bill & Melinda Gates Foundation | 12