© 2010 Bill & Melinda Gates Foundation |

EVERY PERSON DESERVES THE CHANCE TO LIVE A HEALTHY, PRODUCTIVE LIFE.

1 January 27, 2012

US Education Global Health Global Development

Our Areas of Focus

© 2010 Bill & Melinda Gates Foundation |

Polio Eradication is our #1 Priority

• There is no acceptable alternative

• The money saved far exceeds what we are spending • Net benefits between

US$ 40-50B

• Success will energize the field of global health • Enabling us to more dramatically

improve lives of children

© 2010 Bill & Melinda Gates Foundation | 4 January 27, 2012

BMGF Areas of Focus on Polio Eradication

Funding

• ≈ $1.5 billion to date

• Grants to WHO, UNICEF, Rotary

• Support OPV, ops, staff, surveillance

Advocacy

• Political leaders in affected countries

• Donors

• Partners

Strategic /

technical input

• 40+ staff with broad expertise

• Involved in strategic direction of GPEI at global, regional, country levels

January 27, 2012 © 2011 Bill & Melinda Gates Foundation | 5

Vaccine Markets Our approach in vaccine markets is based on the following strategies

Make public our interest in collaboration and remain open to offers

Seek new manufacturers that have potential to serve international

markets

Keep open lines of communication with manufacturers

Invest in information and dissemination of it (e.g., demand forecasts)

Engage with all parties

willing to work for global

health goals

Invest in product development and clinical trials in areas

of critical interest

Technical assistance to manufacturers to achieve WHO

pre-qualification

Capital and other help to scale up manufacturing, reduce

commercial risks and achieve lower COGS

Invest in specific product

development projects

Pioneering academic research

Development of early proofs-of-concept

Funding to support other development work

that has insufficient potential payback to

justify commercial risks

Seek novel and

potentially transformative

opportunities

January 27, 2012 © 2011 Bill & Melinda Gates Foundation | 6

Polio Vaccine Markets BMGF Role

Role Key Activities

Support UNICEF SD • UNICEF is lead on supplying OPV

• Provide funds for OPV

• Input into procurement approaches

Enhance information

• Invest in market analysis of supply and demand

• Utilize information to expand knowledge of partners

(including manufacturers) and inform procurement

approaches

• Partnership with Oliver Wyman

Partner with

manufacturers

• Identify opportunities to help achieve global health goals

• Focus on individually tailored solutions

• Partnership with CHAI

Prepare for long-term • Ensure right vaccines are available at sufficient quantities

and appropriate price

• Invest now to minimize long-term risks

Market Insights: Key Areas of Work Partnership with Oliver Wyman

January 27, 2012 © 2012 Bill & Melinda Gates Foundation | 7

High-Level

Objectives

Sample of

Findings

Examined IPV supply,

estimating:

– Overall time-to-market

– Potential capacity

– Manufacturing COGS

ranges

Done for the full range of

products currently under

development

IPV Product Landscape:

Economics & Time-to-Market

Synthesized the latest

thinking on potential IPV

demand in the tOPV, bOPV,

and – to a more limited

extent – post-OPV

timeframes

Identify implications for

supply & vice versa

IPV Demand & Supply

Dynamics

Examined how the new

polio ‘Endgame’ and

potential use of IPV will

impact demand and supply

for OPV going forward

OPV Demand & Supply

Dynamics

Sabin development is

occurring at a healthy pace

and achieving several

milestones

– However, uncertainty

still remains the exact

economics and time-to-

market

Demand scenarios still

preliminary, but drafts

indicate a fairly wide range

of doses could be required

– Still discussing target

population, dosing, &

route of administration

Work is just starting on this

initiative – findings will be

shared in the future

Market Insights: Overview of OPV Work Sample of Key Areas of Analysis

What are demand

implications of global

transition from tOPV

bOPV?

– What will demand look

like at the country level

to achieve the

transition?

New ‘Endgame’ Impact on

OPV Demand

January 27, 2012 8 © 2012 Bill & Melinda Gates Foundation |

What will be required for

manufacturers to ramp

down tOPV production

and increase bOPV

production?

Will bOPV need to be

registered in any

countries? If so, which

countries and what is the

process and timeline?

Transition from Supplying

tOPV bOPV

Which self-producers

have an interest in

transitioning from tOPV

bOPV production?

– Do producers currently

have the capabilities

required to produce

bOPV?

– What is the process and

overall timing of such a

transition?

– How will sufficient supply

of tOPV be ensured if

production must be

stopped to prepare for

bOPV?

Impact of tOPV bOPV on

Self-Producing Countries

Oliver Wyman looks forward to engaging with manufacturers to get perspectives on these and other topics

CHAI adopts a holistic approach to market innovation, built on a strong understanding of the dynamics of public health markets

Information

transparency

Robust

procurement

practices

Broad

supplier

base

Rapid access

to the best

products

Affordable

&

sustainable

prices

Stringent

quality

standards

1 2 3

4 5 6

CHAI market shaping activities support six pillars of healthy marketplaces…

…and focus on a range of priority products with varying market dynamics

Access Work

First Line ARV’s

Second Line ARV’s

Pediatric ARV’s

2004 2003 2006 2005 2012 2010 2011 2008 2007 2009

HIV Diagnostics

Malaria ACTs

TB Diagnostics

Vaccines

10

BMGF has engaged CHAI to represent it in constructing optimal deals with suppliers to sustainably improve market dynamics for vaccines

Supplier Partners

• Determines strategy and generates key data and analysis (eg, demand forecasts)

• Provides potential assets to support deals (eg, capital, balance sheet, etc.)

• Conduct negotiations to reach the final deal

• Approves and ensures execution of final deal

Close coordination to integrate

deals into procurement and

financing systems

• Analyze business economics , market dynamics

• Leads discussions with suppliers on deal framework and options; analyzes deal impact on access goals

• Conduct negotiations to reach the final deal

• Discuss options and terms needed to improve global access

• Provides data to support deal terms

January 27, 2012 © 2011 Bill & Melinda Gates Foundation | 11

Partnership with CNBG In November 2011, the foundation made an investment in CNBG for development and supply of OPV in support of GPEI

The China National Biotech Group (CNBG) approached the foundation in spring 2011 with an offer to

produce OPV for supply to UNICEF in return for assistance to scale up its capacity to meet potential

demand

The foundation signed a Memorandum of Understanding with CNBG in June 2011 to collaborate on

global health goals. As a first project within this MoU, in November 2011, the foundation made an

investment in CNBG’s Tiantan Bio subsidiary:

- The investment is a grant and loan to enable CNBG to supply OPV to UNICEF for use by GPEI

- This investment reduces the costs to GPEI of OPV, helps secure OPV supply, and brings a large

Chinese manufacturer to the international market with potential to manufacture other vaccines of

global health interest

It is likely that the foundation will make further investments in polio vaccine development and scale-

up. We are interested in enhancing availability of affordable IPV, new IPV strains and also in IPV-

containing hexavalent vaccines

Post-OPV Timeframe (“Cessation”)

Potential IPV Role in Polio Endgame Recently, a new polio 'Endgame'1 was announced defining three key OPV use time periods, each of which has different opportunities for IPV use.

Rationale

‒ Preparation for tOPV

bOPV transition

Potential Goals

‒ Speeding cVDPV type 2

elimination

‒ Reducing transmission

of WPV and speeding

overall eradication

Rationale

‒ Transition from tOPV

bOPV

Potential Goals

‒ Protecting against

cVDPV type 2 re-

emergence

‒ Also speeding

eradication of WPV

Rationale

‒ Total OPV cessation

Potential Goals

‒ Prevent cVDPV type 1,

2, or 3 re-emergence

‒ Protect in event of polio

re-emergence (e.g.,

breach in containment)

tOPV Timeframe (“Pre-Switch”)

January 27, 2012 12 © 2012 Bill & Melinda Gates Foundation |

2012 2013 2014 2017 2018 2020

bOPV Timeframe (“Switch”)

2019 2016 2015

Exact transition date to be determined

Exact transition date to be determined