#MIGlobal

Total humanitarian funding toward Ebola

Response plan

funding, $1.42 billion

Other funding,

$1.8 billion

Pledges, not yet

received, $618 million

Source: United Nations.

Total committed or

contributed funding :

$3.22 billion

Outstanding pledges:

$618 million

#MIGlobal

Ebola response plans face a funding gap of almost US$1 billion

0.0 0.1 0.3 0.4 0.5 1.1 6.9

20.9

36.1

48.2

55.0 58.5

61.7

0

10

20

30

40

50

60

70

Mar-2014 May-2014 Jul-2014 Sep-2014 Nov-2014 Jan-2015 Mar-2015

Source: United Nations.

Percent of funding requirements met

#MIGlobal

Ebola could cost the West African economy up to $32.6 billion

2.2 1.6

7.4

25.2

0

10

20

30

Short-term impact Medium-term impact

$ billions

High Ebola estimate (disease spreading)

Low Ebola estimate (disease containment)

Source: World Bank.

#MIGlobal

Ebola dramatically reduced 2014 growth compared with

projections

4.5

5.9

11.3

0.5

2.2

4.0

0

4

8

12

Guinea Liberia Sierra Leone

Percent

Actual

Projected

Source: World Bank.

#MIGlobal

Reductions in 2015 growth rates lead to a projected

$1.6 billion in forgone GDP due to Ebola

Source: World Bank.

540

180

920

0

200

400

600

800

1000

Guinea Liberia Sierra Leone

$ millions

#MIGlobal

Other diseases, 813 products

registered Neglected diseases, 37

products registered

Source: The Lancet.

Treatments targeted at neglected diseases represented less

than 5% of 850 new therapeutic products registered in 2000-11

* Neglected diseases were defined as malaria, tuberculosis, diarrheal

diseases, neglected tropical diseases, and other diseases of poverty.

#MIGlobal

U.S. government funding for emerging infectious diseases

45 58 47

230

45 55 46

211

46 73

n/a

260

46 50

n/a

257

0

50

100

150

200

250

300

CDC Global DiseaseDetection and

Emergency Response

USAID/State Dept.Pandemic Influenza andOther Emerging Threats

DoD Global EmergingInfections Surveillance

and Response

DoD CoorperativeBiological Engagement

$ millions 2012 2013 2014 2015

Sources: U.S. Foreign Assistance Dashboard, Kaiser Family Foundation.

#MIGlobal

Sources of funds for R&D on neglected diseases

Public (high-income governments),

62.6%

Public (multilaterals), 0.2%

Public (low- and middle-income

governments), 2.1%

Philanthropic, 18.5%

Private (multinational

pharmaceutical companies), 14.4%

Private (small pharmaceutical and biotech companies),

2.0%

Source: World Health Organization.

#MIGlobal

Allocations of R&D for neglected diseases, 2010

HIV/AIDS, 35.0%

TB, 18.8%

Malaria, 17.9%

Dengue, 5.8%

Diarrheal diseases, 5.2%

Kinetoplastids, 4.8%

Bacterial pneumonia and meningitis, 3.0%

Helminths, 2.4% Salmonella

infections, 1.4% Other, 5.7%

Source: World Health Organization.

#MIGlobal

Despite progress in treatment, tuberculosis still costs billions

to global economy

Each year, TB results in:

• 8.4 million patients

• A 30% decline in average productivity loss of US$1 billion

• Two million deaths deficit of US$11 billion

The TB death rate dropped 45% between 1990 and 2013.

• 37 million lives saved through effective diagnosis and treatment, 2000-

2013

• US$2 billion needed to fill resource gap to implement existing TB

interventions

Sources: World Health Organization, Science and Society.

#MIGlobal

Investment in AIDS treatment generates $19.8 billion in returns Cohort of 3.5 million, cumulative 2011-2020

-14.2

31.8

0.8 1.4

19.8

-20

-10

0

10

20

30

40

Program cost Labor productivity Orphan care costsaverted

End-of-life costsaverted

Net benefit

$ billion

Source: PLOS One.

#MIGlobal

Malaria costs Africa $12 billion every year

• Countries with endemic malaria had income levels that were only

33% of those in countries that do not suffer from malaria.

• Countries with a severe malaria burden grew 1.3% less than those

without each year.

• Aggregate loss owing to the disease in 25 countries was more than

15% of GDP.

Sources: Science and Society, Gallup.

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Ebola is a blip on the historical perspective Tuberculosis: Biggest infectious disease killer in human history

Source: Nature / World Health Organization World Tuberculosis Report 2013.

0.0

0.5

1.0

1.5

Ebola Tuberculosis

1.5 million deaths

7,905 deaths

2014: Deaths Ebola vs. Tuberculosis Millions

#MIGlobal

Extensively Drug-Resistant Tuberculosis (XDR-TB) “XDR-TB: Ebola with wings.” Coming to a country near you?

• Airborne transmission with mortality similar to Ebola (30-70%)

• Found in 100+ countries

• At least 2x as many cases (43,200) last year as the total number of cases

of Ebola (20,206)

Source: World Health Organization, 2015.

#MIGlobal

Vaccines: An Extraordinary Track Record

“Among the most cost-effective health interventions ever developed”

– The Bill & Melinda Gates Foundation

Source: Aeras.

#MIGlobal

Vaccine development: expensive and risky

• Risk at every step

• Major outlay of money

toward the end of the

process: Phase 3 and

manufacturing

• “The valley of Death”

• Raising manufacturing

standards and Regulatory

requirements

• Remaining targets are

scientifically challenging

Fact sheet

April 2009

#MIGlobal

Vaccine Development is a long process

EXPLORATORY PRECLINICAL CLINICAL DEVELOPMENT REGISTRATION LCM

Many years 1-2 years 4-8 years 3 years

Preclinical PoC File Launch

Phase III

• Large scale safety

+

• Lot to lot consistency

+

• Non inferiority (combos)

or

• Efficacy

Post-marketing

commitments

• Safety

• Effectiveness

Pharmacovigilance

Industrial Investment

done early and at risk

Done mostly outside of

the “Big Pharma”

#MIGlobal

Opportunities for improvements are

numerous

EXPLORATORY PRECLINICAL CLINICAL DEVELOPMENT REGISTRATION LCM

Many years 1-2 years 4-8 years 3 years

“Animal Rule” Post-Marketing

Commitments

Standardized CMC

Standardized and modular

manufacturing

Reverse Vaccinology

and other ‘omics

Synthetic Biology

Clinical Trials in a test tube

#MIGlobal

Te

chnic

al F

easib

ility

The many remaining vaccine targets are

scientifically challenging

Medical Value/Market Attractiveness

• GBS

Chikungunya

E. coli UTI

E. coli 0157

Enterovirus 71

H. pylori (ther)

Dental carries

S. paratyphi

Leishmaniasis

Norovirus

Otitis Media

Parvo B19

PIV

Schistosomiasis

Shigella (prot)

Rhinovirus

S. aureus

S. CoNS

RSV

Bocavirus

C. jejuni

Cholera

Epstein-Barr Virus

HHV-6

Legionella

M. pneumoniae

Hantavirus

Hep C (ther)

hMPV

HSV 2

hMPV-PIV Combo

CMV

P. acnes

Enterococcus

TB latency

A baumannii

Klebsiella

E. coli nosoc

P. aeruginosa

Periodontal

ETEC

GAS

• N.gonorrhea

• Tryposonomia

sis

Preferred but

empty quadrant

#MIGlobal

Is there a crisis in the making in the Industry?

• 2 Vaccine manufacturers have recently exited: Novartis and Baxter

• Another has reduced its product line: J&J

• Most GAVI vaccine are supply constrained, DTP supply crisis for

UNICEF

• Share of vaccine trials among all clinical trials decreasing

(clintrial.gov)

• Asymmetry in the Eco system: “R&D” and “non R&D” producers

• Compete through Innovation vs Compete through Low Cost

• Need for a balanced Ecosystem

#MIGlobal

Thanks to BMGF and other donors, HIV, Malaria and TB are

no longer neglected But is enough done for the others?

Source: clintrial.gov

#MIGlobal Source: BioCentury.

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#MIGlobal

Framework for health sector response & early recovery from

the Ebola crisis

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Confirmed cases of Ebola in Guinea, Liberia and Sierra

Leone

#MIGlobal

Decline of Ebola in Guinea and Sierra Leone

confirmed cases each week

#MIGlobal

Guinea, Liberia, Sierra Leone: most infection on West coast

#MIGlobal

West Africa epidemic curve

#MIGlobal

West Africa epidemic curve

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R&D

Vaccines

• Phase III vaccine trial of Canadian vaccine VSV-EBOV started in

communities in Coyah and Conakry on 23 March 2015

• The trial is sponsored by Guinea with WHO and MSF

• So far about 500 people have been vaccinated in 15 rings. More rings will

be set up as contact tracing continues, with the aim of vaccinating 10 000

people.

#MIGlobal

R&D

Drugs

• siRNA (Tekmira) RCT trial in Sierra Leone has enrolled 21 patients, of

which 11 were included in the treatment arm (n = 100)

Diagnostics

• Assessment of the ReEBOV Antigen Rapid Test Kit (Corgenix) by

Partners in Health on 25 blood samples found the test had 100%

sensitivity (cf 92% in the WHO study) and 92% specificity (cf 85% in

WHO study)

#MIGlobal

Getting to “zero”: Guinea, Liberia, Sierra Leone

Outbreak ended in any one of the above countries 42 days after last

confirmed case has tested negative twice for the virus

After 42 days, each country should maintain a system of heightened

surveillance for a further 90 days

End of the outbreak in the West African sub-region will be declared when the

42-day period has elapsed in the last affected country

#MIGlobal

WHO’s role in fighting Ebola

Information & Data

• Data to quantify the epidemic

• ≈60 technical documents and

guidelines

People

• Rapid deployment >2000 technical

experts, >500 through GOARN, staff

for 26 mobile laboratories, >100

logisticians, 58 foreign medical teams

Hospitals

• Built 5 Ebola Treatment Units (ETUs),

technical support for 70+ ETUs, 150+

community care & holding centres

Equipment

• Delivered > 1.4 million kits Personal

Protective Equipment

Research & Development

• Investigation of vaccines, drugs,

therapies, and diagnostics

Coordination & Partnership

• Coordinated health response to Ebola

across West Africa (3+4+)