ALL LIVES HAVE EQUAL VALUE

Transcription

1 ALL LIVES HAVE EQUAL VALUE Global Health Product Development Challenges and Opportunities IQ Symposium, Oct 5, 2016 Niya Bowers Senior Program Officer, CMC, Integrated Development 2015 Bill & Melinda Gates Foundation

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3 OUR HISTORY 1994 Bill Gates Sr. starts a small philanthropic foundation at his son s request Bill and Melinda read an article about rotavirus and are inspired to act The Bill & Melinda Gates Foundation is created, with a focus on health, education, and libraries Our Washington, D.C., office is established with a focus on governmentfunded partnerships We launch a branch office devoted to HIV/AIDS prevention initiative in India Warren Buffett pledges Berkshire Hathaway stock valued at $31 billion The foundation opens a Beijing office to focus on global health issues in Asia Bill joins Melinda full-time at the foundation A team is established in London to work closely with European and African governments, partners and grantees The foundation moves to its new permanent home in Seattle Our offices in Addis Ababa, Johannesburg, Abuja, and New Delhi bring local perspectives to global work Dr. Sue Desmond- Hellmann becomes our new CEO. Bill & Melinda Gates Foundation 3

4 OUR GLOBAL REACH AND PRESENCE $40B Trust endowment 1, active grantees Seattle Europe and Middle East Office Washington, D.C. Nigeria Ethiopia India China $4.2B 2015 grant payments South Africa 1, employees worldwide Bill & Melinda Gates Foundation 4

5 WHAT WE DO: AN INTEGRATED APPROACH TO IMPROVING PEOPLE S LIVES GLOBAL HEALTH GLOBAL DEVELOPMENT UNITED STATES PROGRAM GLOBAL POLICY & ADVOCACY COMMUNICATIONS Bill & Melinda Gates Foundation 5

6 GLOBAL DEVELOPMENT Delivering health and development solutions that help people lift themselves out of poverty. Programs: Agricultural Development Water, Sanitation & Hygiene Nutrition Family Planning Maternal, Neonatal & Child Health Polio Financial Services for the Poor Global Libraries Emergency Response

7 GLOBAL HEALTH Discovering and developing affordable vaccines, drugs, and diagnostics for people in the developing world. Programs: Enteric and Diarrheal Diseases Pneumonia Neglected Tropical Diseases Malaria HIV Tuberculosis

8 WHAT WE FOCUS ON Areas of greatest need Where we can have the greatest impact Making science happen for people Bill & Melinda Gates Foundation 8

9 FOUNDATION GRANTS SUMMARY In 2014, the foundation invested US$3.9 billion in these areas. Numbers include grants and direct charitable expenses (DCE), but do not include PRIs Global Development Program $1.923B Communications $41M Other Charitable Programs $69M Global Health Program $1.114B United States Program $513M Global Policy & Advocacy $200M Bill & Melinda Gates Foundation 9

10 Where we work

11 MISMATCH BETWEEN DISEASE BURDEN Malaria deaths TB cases HIV prevalence Early neonate mortality Source: Bill & Melinda Gates Foundation 11

12 AND AVAILABLE MEDICAL CARE Physicians Source: Bill & Melinda Gates Foundation 12

13 or biomedical research 13

14 THE CHALLENGE NO NEW INFECTIOUS DISEASES DRUGS Developing countries Worldwide infectious disease 90% Global R&D 10% 1,500 medicines since 1975 < medicines Bill & Melinda Gates Foundation 14

15 ADDITIONAL GAPS FOR GH PRODUCT DEVELOPERS Healthcare provider access Healthcare facility access Transportation barriers Infrastructure to support healthcare system Supply chain challenges Often develop more complex products to compensate for deficiencies in healthcare systems and infrastructure but must be cost effective and affordable Bill & Melinda Gates Foundation 15

16 THE FOUNDATION S THERAPEUTICS PORTFOLIO IS DIVERSE WITH ~$1B IN ACTIVE INVESTMENTS Portfolio summary 1 Key: Discovery Preclinical Phase 1 Phase 2 Phase 3 Registration Portfolio by therapeutic area TB Family Planning 67 Malaria HIV NTD Other 2 14% 13% 13% NTD 16% 29% 17% Malaria HIV Family Planning Portfolio by technology Long-acting injectables & implantables Post-launch TB EDD Discovery Polio Pneumonia Other complex drug delivery 22% 11% 27% 40% Complex solid orals Standard solid orals Portfolio highlights Approximately 60 programs across all stages of development Over 25 partners with wide range of technologies and experience Funded by 9 disease areas across the Foundation NCE s versus new dosage forms Reformulation or new process 38% 62% NCE s 1 Product candidate bubble position represents only candidate stage of development and not progress within each respective stage; portfolio includes only therapeutics candidates (except Livestock) and excludes devices, diagnostics, and vector control candidates 2 Other therapeutic areas are Discovery, EDD, Polio, Pneumonia Bill & Melinda Gates Foundation 16

17 SUCCESSFUL PILOT OF LOW-COST API MANUFACTURING PROCESS Transfer to API 1 Novel Chemistry 2 3 Manufacturers Track Price Reductions Substitute lower cost materials Track commercial API prices Commercial Process Simplify operations Increase yields Reduce solvent use and waste Transfer process to manufacturers NEVIRAPINE PROGRESS 21 Unit operations 11 Unit operations 50% Isolated yield Starting material cost: $100/kg 4 Solvent exchanges 87% Isolated yield Starting material cost: $60/kg Single solvent New process transferred to CHAI Multiple generic manufacturers interested Process established to monitor market price change Anticipate 15-25% market price reduction RESULTS: 30% lower COGs TAF/TDF (tenofovir) grant in place and chemistry development in progress Bill & Melinda Gates Foundation 17

18 FLASH NANOPRECIPITATION (FNP) Maximizes kinetic solubility A cheaper alternative Applicable for wide range of brick dust Recent study achieved 3x in-vivo bioavailability Flexibility in scale (3.5kg/day 1000kg/day) Used to produce β-carotene feed for salmon. Applied in formulation of small molecules, peptides and biologics Bill & Melinda Gates Foundation 18

19 SAYANA PRESS Description and History Lower dose, subq formulation of DMPA in a prefilled, single-dose, nonresusable Uniject injection system Approved in EMA and over 25 countries including several in sub-saharan Africa 2015 approval by MHRA for selfadministration Benefits Three months of contraceptive protection in easy-toadminister format Enables administration by any level of provider, as well the user Lower shipping costs and storage volumes Eliminates need for injection supplies Suitable for remote areas or areas with limited supply of trained providers Accessible outside health clinics Current Status Novel pricing agreement co-funded by BMGF and CIFF* enables access at $1/dose Building evidence on user acceptance for self-injection Testing demand at $1/dose * Children s Investment Fund Foundation Bill & Melinda Gates Foundation 19

20 PRIVATE AND PUBLIC SECTOR COLLABORATION IN GLOBAL HEALTH BENEFITS FOR MULTI-NATIONAL CORPORATIONS Corporate philanthropy and/or social responsibility Risk sharing New drugs for developed world market with applications in low resource settings New technologies for low resource settings -- with potential application for mature markets Utilize excess manufacturing capacity Diversify learning and development opportunities for scientists Resonates with millennials and future work force Bill & Melinda Gates Foundation 20

21 AFRICA IS THE FASTEST GROWTH CONTINENT Population 2010 Population Bill & Melinda Gates Foundation 21

22 MODELS FOR POSITIVE SOCIETAL IMPACT Philanthropy Donate cash or products Merck, J&J, GSK, etc. Corporate Social Responsibility Use resources and competencies of a company to accomplish social good TB Accelerator Shared Value Creation Address unmet societal needs in a manner that also provides a business opportunity Novartis, Sanofi, GSK AbbVie Model Bill & Melinda Gates Foundation 22

23 ABBVIE A CASE STUDY BY HARVARD KENNEDY SCHOOL Approaches: Retiree volunteers Internship Staff volunteer Equipment excess Sr. Leadership commitment AbbVie s scientists work with PDPs AbbVie Foundation s philanthropic support Results: 167 of AbbVie s scientists engaged ,148 hours or 9 FTEs >120,000 compounds shared with PDPs, Hundreds of tests conducted 2 molecules in development Malaria NCE in Phase II by MMV, and Tekada Source: Nelson, Jane. Supporting Research in Neglected Tropical Diseases Lessons Learned from Abbvie s Neglected Diseases Initiative Harvard Kennedy School: Corporate Responsibility Initiative

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26 THANK YOU