ALL LIVES HAVE EQUAL VALUE
Global Health Product Development – Challenges and Opportunities
Niya Bowers Senior Program Officer, CMC, Integrated Development
© 2015 Bill & Melinda Gates Foundation
IQ Symposium, Oct 5, 2016
© Bill & Melinda Gates Foundation | 3
OUR HISTORY
1994 Bill Gates Sr. starts a small philanthropic foundation at his son’s request.
2007 The foundation opens a Beijing office to focus on global health issues in Asia.
1997 Bill and Melinda read an article about rotavirus and are inspired to act.
2008 Bill joins Melinda full-time at the foundation.
2000 The Bill & Melinda Gates Foundation is created, with a focus on health, education, and libraries.
2010 A team is established in London to work closely with European and African governments, partners and grantees.
2001 Our Washington, D.C., office is established with a focus on government-funded partnerships.
2011 The foundation moves to its new permanent home in Seattle.
2003 We launch a branch office devoted to HIV/AIDS prevention initiative in India.
2012 Our offices in Addis Ababa, Johannesburg, Abuja, and New Delhi bring local perspectives to global work.
2006 Warren Buffett pledges Berkshire Hathaway stock valued at $31 billion.
2014 Dr. Sue Desmond-Hellmann becomes our new CEO.
© Bill & Melinda Gates Foundation | 4
OUR GLOBAL REACH AND PRESENCE
1,500+ 2015 active grantees
1,300+ 2015 employees worldwide
$4.2B 2015 grant payments Ethiopia
Europe and Middle East Office
China Washington, D.C.
India
Nigeria
South Africa
Seattle
$40B Trust endowment
© Bill & Melinda Gates Foundation | 5
WHAT WE DO: AN INTEGRATED APPROACH TO IMPROVING PEOPLE’S LIVES
GLOBAL HEALTH GLOBAL DEVELOPMENT UNITED STATES PROGRAM
GLOBAL POLICY & ADVOCACY COMMUNICATIONS
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
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
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WHAT WE FOCUS ON
Areas of greatest
need
Where we can have
the greatest impact
Making science happen for people
Bill & Melinda Gates Foundation |
In 2014, the foundation invested US$3.9 billion in these areas.
© Bill & Melinda Gates Foundation | 9
FOUNDATION GRANTS SUMMARY
Global Health Program $1.114B
Global Policy & Advocacy $200M
United States Program $513M
Global Development Program $1.923B
Other Charitable Programs $69M
Communications $41M
Numbers include grants and direct charitable expenses (DCE), but do not include PRIs
Where we work
Malaria deaths
© Bill & Melinda Gates Foundation | 11
MISMATCH BETWEEN DISEASE BURDEN…
HIV prevalence
TB cases
Early neonate mortality
Source: http://www.worldmapper.org/
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Source: http://www.worldmapper.org/
Physicians
…AND AVAILABLE MEDICAL CARE…
…or biomedical research
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THE CHALLENGE – NO NEW INFECTIOUS DISEASES DRUGS
Global R&D
Worldwide infectious
disease
Developing countries
10%
90%
1,500 medicines
since 1975 100 medicines <20
Often develop more complex products to compensate for deficiencies in healthcare systems and infrastructure – but must
be cost effective and affordable 15
ADDITIONAL GAPS FOR GH PRODUCT DEVELOPERS
• Healthcare provider access • Healthcare facility access • Transportation barriers • Infrastructure to support healthcare system • Supply chain challenges
© Bill & Melinda Gates Foundation |
62%
38%
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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
Portfolio by therapeutic area
Portfolio summary1
Portfolio by technology
Discovery Preclinical Phase 1 Phase 2 Phase 3 Registration
10
13
25 1 32 33
34
37
66
45 51
52 47
24 3
4
Post-launch
27
26
28
29
17 54
30 35
53 11 14 18
19
22
23
36 44
48
49
63
64
65
38
67
57
Malaria HIV NTD Family Planning TB EDD Discovery Polio Pneumonia Key:
Portfolio highlights
Standard solid orals
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
NCE’s versus new dosage forms
Reformulation or new process
NCE’s Malaria
Other2
NTD
TB
Family Planning
HIV
Complex solid orals
Long-acting injectables
& implantables
Other complex drug delivery
68
69
71 72
5
20
27%
40%
22%
11%
29%
17% 16%
13%
14%
13%
43
58 40 42
62
16
59
THE FOUNDATION’S THERAPEUTICS PORTFOLIO IS DIVERSE WITH ~$1B IN ACTIVE INVESTMENTS
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SUCCESSFUL PILOT OF LOW-COST API MANUFACTURING PROCESS
Novel Chemistry Transfer to API Manufacturers
Track Price Reductions 1 2 3
Substitute lower cost materials
Simplify operations
Reduce solvent use and waste
Transfer process to manufacturers
Track commercial API prices
• 21 Unit operations
• 50% Isolated yield • Starting material cost:
$100/kg
• 4 Solvent exchanges
• 11 Unit operations
• 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
Commercial Process
TAF/TDF (tenofovir) grant in place and chemistry development in progress
RESULTS: ≥30% lower COGs
NEVIRAPINE PROGRESS
Increase yields
© Bill & Melinda Gates Foundation |
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
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FLASH NANOPRECIPITATION (FNP)
© Bill & Melinda Gates Foundation | 19
SAYANA PRESS
Description and History • Lower dose, subQ formulation of DMPA
in a prefilled, single-dose, non-resusable Uniject™ injection system
• Approved in EMA and over 25 countries including several in sub-Saharan Africa
• 2015 approval by MHRA for self-administration
Benefits • Three months of contraceptive protection in easy-to-
administer 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
• 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
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PRIVATE AND PUBLIC SECTOR COLLABORATION IN GLOBAL HEALTH – BENEFITS FOR MULTI-NATIONAL CORPORATIONS
http://www.viewsoftheworld.net/wp-content/uploads/2011/10/WorldPopulationAnimation.gif
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AFRICA IS THE FASTEST GROWTH CONTINENT
Population 2010 Population 2080
http://www.viewsoftheworld.net/wp-content/uploads/2011/10/WorldPopulationAnimation.gif
• 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
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MODELS FOR POSITIVE SOCIETAL IMPACT
ABBVIE – A CASE STUDY BY HARVARD KENNEDY SCHOOL
Source: Nelson, Jane. “Supporting Research in Neglected Tropical Diseases – Lessons Learned from Abbvie’s Neglected Diseases Initiative” Harvard Kennedy School: Corporate Responsibility Initiative http://community.businessfightspoverty.org/profiles/blogs/jane-nelson-supporting-research-in-neglected-tropical-diseases-le
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
• 2015 - 17,148 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
THANK YOU
