EVERY PERSON DESERVES THE CHANCE TO LIVE A HEALTHY, PRODUCTIVE LIFE. January 27, 2012 2010 Bill & Melinda Gates Foundation 1
Our Areas of Focus US Education Global Health Global Development
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
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 2010 Bill & Melinda Gates Foundation 4
Vaccine Markets Our approach in vaccine markets is based on the following strategies Engage with all parties willing to work for global health goals 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) Invest in specific product development projects 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 Seek novel and potentially transformative opportunities Pioneering academic research Development of early proofs-of-concept Funding to support other development work that has insufficient potential payback to justify commercial risks January 27, 2012 2011 Bill & Melinda Gates Foundation 5
Polio Vaccine Markets BMGF Role Role Support UNICEF SD Enhance information Partner with manufacturers Key Activities UNICEF is lead on supplying OPV Provide funds for OPV Input into procurement approaches 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 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 January 27, 2012 2011 Bill & Melinda Gates Foundation 6
Market Insights: Key Areas of Work Partnership with Oliver Wyman IPV Product Landscape: Economics & Time-to-Market IPV Demand & Supply Dynamics OPV Demand & Supply Dynamics High-Level Objectives Examined IPV supply, estimating: Overall time-to-market Potential capacity Manufacturing COGS ranges Done for the full range of products currently under development 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 Examined how the new polio Endgame and potential use of IPV will impact demand and supply for OPV going forward Sample of Findings Sabin development is occurring at a healthy pace and achieving several milestones Demand scenarios still preliminary, but drafts indicate a fairly wide range of doses could be required Work is just starting on this initiative findings will be shared in the future However, uncertainty still remains the exact economics and time-tomarket Still discussing target population, dosing, & route of administration January 27, 2012 2012 Bill & Melinda Gates Foundation 7
Market Insights: Overview of OPV Work Sample of Key Areas of Analysis New Endgame Impact on OPV Demand Transition from Supplying topv bopv Impact of topv bopv on Self-Producing Countries What are demand implications of global transition from topv bopv? What will demand look like at the country level to achieve the transition? 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? Oliver Wyman looks forward to engaging with manufacturers to get perspectives on these and other topics 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? January 27, 2012 2012 Bill & Melinda Gates Foundation 8
CHAI adopts a holistic approach to market innovation, built on a strong understanding of the dynamics of public health markets CHAI market shaping activities support six pillars of healthy marketplaces 1 2 3 Rapid access Affordable to the best & products sustainable prices Stringent quality standards 4 5 6 Broad supplier base Robust procurement practices Information transparency and focus on a range of priority products with varying market dynamics Vaccines Access Work TB Diagnostics 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Malaria ACTs Second Line ARV s Pediatric ARV s HIV Diagnostics First Line ARV s
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 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 Close coordination to integrate deals into procurement and financing systems 10
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 scaleup. We are interested in enhancing availability of affordable IPV, new IPV strains and also in IPVcontaining hexavalent vaccines January 27, 2012 2011 Bill & Melinda Gates Foundation 11
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. 2012 2013 2014 2015 2016 2017 2018 2019 2020 Rationale topv Timeframe ( Pre-Switch ) Preparation for topv bopv transition Potential Goals Exact transition date to be determined Speeding cvdpv type 2 elimination Reducing transmission of WPV and speeding overall eradication bopv Timeframe ( Switch ) Rationale Transition from topv bopv Potential Goals Protecting against cvdpv type 2 reemergence Also speeding eradication of WPV Exact transition date to be determined Post-OPV Timeframe ( Cessation ) 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) January 27, 2012 2012 Bill & Melinda Gates Foundation 12