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Tuberculosis
History, Now, and Why the Future Depends on NewVaccines
J2J Lung Health Media TrainingOctober 31, 2013
Kari Stoever
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Aeras: Background
Founded in 2003
Fully integrated, nonprofitbiotechnology organization within-house capabilities in finance,portfolio management, GMP pilotmanufacturing, translational productdevelopment and policy,advocacy and resource mobilization
501(c)(3) organization registeredin Washington DC
Offices
Rockville, MD (headquarters)
Cape Town, South Africa
Beijing, China
Governed by a Board of Directors
5 technical advisory groups incorporating expertise from around the world
Executive leadership team with decades of experience developing andcommercializing new vaccines/biologics
~ 160 employees with annual budget of approx. USD $55 million
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Mother Nature is
a Serial Killer
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The Scale of the Problem
4
Source: Nature/ World Tuberculosis Report,
2012
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TB decline in the pre-antibiotic era
5
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R i dd i h TB id i h
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Recent progress in addressing the TB epidemic hasbeen enabled through enhanced global coordination
and large investments
0
50
100
150
200
250
300
1990 1995 2000 2005 2010 2015
Year
Mortality
HIV co -infect ion
incidence
Incidence
Prevalence
TB rates per 100,000 population
DOTSDOTS-Plus
Launch of global partnerships and new control tools in the 1990s contributed to decreasing TB rates
Source: Global Tuberculosis Report 2012, WHO (2012), Nature Vol 502, No. 7470 Suppl, S2 (2013)
Stop TB Partnership
WHO/IUTLD GlobalProject on MDR-TBSurveillance
UN Millennium Development Goals
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Incidence of TB is falling so slowly
that it will take a millennium to end TB
Vaccines needed to turn the tide
Source: Christopher Dye, WHO
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Underinvestmentin new drugs, diagnostics and
vaccines has led to growth of drug-resistant TB.
TB evolving with some strains
becoming virtually untreatable
New, novel TB vaccines will aim to
prevent all strains of TB.
Failure to innovate has ledto drug resistance strains
> 500,000 MDR-TB cases in 2011
92 countries have reported XDR-TB
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Extensively Drug-Resistant TB: 92 Countries
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Source: WHO Global TB Report, 2013
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The problem of microbes becoming increasinglyresistant to the most powerful drugs should be
ranked alongside terrorism and climate change onthe list of critical risks to the nation.
Sally Davies, UK Government Chief MedicalOfficer
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Full implementation of Global Plan: 2015 MDG target reached
but TB will not be eliminated by 2050
Current rate of decline-2%/yr (globally)
W Europe after WWII
-10%/yr (Historical
example)
China, Cambodia
-4%/yr (the best
observed nowadays)
Elimination target:100x higherthan elimination
target in 2050
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What are the challenges if we target elimination
1. Still only two-thirds of the estimated total of 8.6 million people whofell ill with TB in 2012 were notified.
2. Despite a reduction of 45% since 1990, still over a million people diedof TB out of the estimated 8.6 million new cases in 2012.
3. Currently, only one in five of the notified patients estimated to have
MDR-TB is being diagnosed and treated.
4. The BCG vaccine does not have efficacy in preventing transmissionand there is no global strategy to protect against development ofdiseases in those who are infected with M. tuberculosis.
5. Insufficient tools to detect, treat or prevent TB,R&D underfunded, and even when tools areavailable, inefficient transfer of tools/technology.
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Controlling and reducing TB incidence requires
the application of transformational interventions
Infected ind ividu als
Preventing
transmission and
infection
Blocking progression
to infectious TB
Treating and
sterilizing active TB
A
B
C
Infect ious
TB
Transmissi
on
A2B
C
Transmission
cycle
breakpoints
A1Breakpoints
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Ill-equipped for this Complex Epidemic
We are beginning to see the winds of change, but
what we really need is a storm. It is imperative thatwe transform the way we diagnose, treat, prevent,
and control TBthrough biomedical research andpublic health measures
Anthony Fauci, Director of NIAID
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EXPOSED: The Race Against Tuberculosis
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A Global Problem
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Source: Nature/ World Tuberculosis Report,
2012
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A U.S. Problem: Recent Outbreaks
Nearly 10,000 cases in 2012
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A U.K. Problem: Outbreaks in London
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A European Problem
Economic burden of TB in Europe: >5billion/year
Lost productivity and treatment costs
>80,000 cases/year of MDR-TB in Europe
Highest in Eastern Europe and Central Asia
UK: Cost to treat drug-resistant TB>50,000/patient
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South Africa
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He that will not apply newremedies must expect newevils; for time is the greatest
innovator.Sir Francis Bacon
Russia: Drug Resistance
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India: Healthcare Workers at Risk & TDR-TB
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China: Biggest Disease Burden &Urbanization
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Photo: NPR/Ng Han Guan/AP New York Times, June 15, 2013
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Vaccines: The Future
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Vaccines: The Future
Nature will continue to evolve infectiousdisease threatsboth endemic andpandemic
Rather than resigning ourselves tocatastrophic outbreaks, we have thepower to disrupt historical trend lines
through the use of new vaccines tocombat these threats
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Vaccines: The Future
In the same way that during my Microsoft
career I talked about the magic of software, Inow spend my time talking about the magic
of vaccines. Vaccines have taken us to thethreshold of eradicating polio. They are themost effective and cost-effective health toolever invented. I like to say vaccines are a
miracle.Bill Gates
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Vaccine Success: Smallpox, Measles & More
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Vaccine Success: Polio
Source: WHO/IVB Database, July, 2013
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1908 2013
TB and Progress?
90-year-old BCG vaccine is the mostwidely used vaccine in the world
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The Need for New Vaccines
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A century of neglect followed by a decade ofprogress
2000 2002 2009 2012
No new
preventive TB
vaccines in
clinical trials
1st preventive
vaccine enters
clinical
trials (MVA85A)
Phase IIb proof-of-
concept trials of
preventive
vaccines initiated
16 vaccines have
entered clinical
trials, 12 currently
in clinical trials
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The Global Pipeline of TB Vaccine Candidates
Ad5 Ag85A
McMaster CanSino
VPM 1002
Max Planck, VPM, TBVI, SII
MVA85A/AERAS-485
Oxford, Aeras
M. Vaccae
Anhui Zhifei Longcon, China
MTBVAC
TBVI, Zaragoza, Biofabri
H1 + IC31
SSI, TBVI, EDCTP, Intercell
M72 + AS01E
GSK, Aeras
ID93 + GLA-SEIDRI, Aeras
RUTIArchivel Farma, S.L
Crucell Ad35/MVA85A
Crucell, Oxford, Aeras
H4/AERAS-404 + IC31
SSI, Sanofi-Pasteur, Aeras, Intercell
H56/AERAS-456 + IC31
SSI, Aeras, Intercell
Crucell Ad35/AERAS-402
Crucell, Aeras
VIRAL VECTOR
rBCG
PROTEIN/ADJUVANT
ATTENUATED M.Tb
IMMUNOTHERAPEUTIC:
MycobacterialWhole Cell orExtract
AERAS SPONSORED
PHASE I PHASE IIa PHASE IIb PHASE III
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Global partners for epidemiological studies and clinical trials
Clinical Studies
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Public Health Impact of a TB Vaccine
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Investing in prevention is the
greatest austerity measure
At a global level, an estimated US $1-3trillion over the next 10 years
X/MDR TB can be 200-1000 x more
expensive to treat than drug-sensitive
cases
MDR-TB utilizes 33% of South Africas
TB control budget (2% of all TB cases)
Control and treatment would cost us~$80 billion over the next decade.
Yet it could take $800 million over 10-15
years to develop new vaccines.
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Deciphering the Tower of Babble?
If we had an AIDS
vaccine we wouldnt
have to worry aboutTB
We will have a TBvaccine in the next
decade
The vaccine science isnt
there, Ill believe it when I
see it.
We should be investing indrugs and diagnosticsinstead of vaccines
2ndleading cause of deathfrom a single infectiousdisease
Zero deaths, zero infections,
zero suffering
SUPERBUG
TB is a disease of poverty
London is the TB capital of the
EuropeTB outbreak in Los An eles
TB is preventable, treatable and
cost effective.
Cost of XDR treatment up to 1000xmore expensive
Control efforts are working,40% reduction in deaths over
the past 20 years
More absolute cases of TB inthe world today than in 1990
Drug-resistant cases on the rise
New vaccines would be the single-most cost-effective tool in our fightagainst TB.
I was vaccinated against TB
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Communications
Compelling stories from many angles
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A Woman's Drug-Resistant TB Echoes Around the WorldBy GEETA ANANDUpdated Sept. 8, 2012 9:03 a.m. ET Dangerous TB Patient Detained on U.S. BorderByBETSY MCKAY
March 1, 2013
Action Urged Against Fake Tuberculosis DrugsPoor-Quality Medications Are Contributing to Treatment Resistance, Researchers Say
ByBETSY MCKAYJuly 4, 2013
Winners of the 2013 Daniel Pearl award for theworlds best cross-border investigative reporting
Source: wsj.com
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A four-part series of 9-13 minute films about the deadly global epidemic of tuberculosis.
By telling the stories of four inspiring individuals, interspersed with expert commentaryfrom some of the worlds top TB physicians, scientists, advocates and policymakers,
EXPOSED brings viewers to the forefront of the fight against TB.
1: The Global Epidemic
Natalie Skipper, an MDR-TB
survivor from the United
States, and medical experts
give a sense of the global TB
epidemic.
2: The Rise of a Superbug
Dr. Jayant Banavaliker, a
leading TB doctor in Delhi,
chronicles his daily struggle to
save patients using todays
limited tools. Plus, Phumeza
Tisile fights XDR-TB in South
Africa.
3: The Innovation Movement
A profile of Unathi Gwintsa, a
passionate participant in a TB
vaccine clinical trial in South
Africa, who is driven by her
desire to protect her daughter
from TB.
4: The Last Mile
Prof Helen McShane, who
has spent the last 12 years
developing new TB vaccines
in the UK, explores why now
is a pivotal moment in history
to save millions from TB.
EXPOSED: The Race Against Tuberculosis
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EXPOSED: The Race Against Tuberculosis
~ 80,000 views, either on Facebook, Vimeo,YouTube, or the Aeras website, with about 1,500new views in the last month 1000 non-English views; seen in 135 different countries
Screened for >1,350 government decision-makers,biotech and pharmaceutical leaders, TB vaccinedevelopers, national treatment program managers,research advisors, and more at >20 global events
Won PR Dailys Digital PR Award for Best Cause-
Related Video and received an honorable mentionfor Best Digital PR Campaign in the Nonprofit Sector
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Building momentum
through the
development of microcampaigns
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Engage new audiences by focusing on key issue areas and communities connected to the TB issue. In additionto helping us reach new audiences and constituencies, these issues have been selected because they arepriority areas for target funders as well as the media.
Key Issues
TB & MiningTB & Health
WorkersHuman & Animal TB
Launch mid-Nov. 2013 April - June 2014 Launch TBD
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TB vaccine R&D is a long-term, high-risk endeavor. There are no major scientificmilestones on the horizon in 2014.
Therefore, we need to engage in key current issues in the broader field of TB to growand sustain interest and support for TB vaccine R&D on the global health agenda.
The key issues identified provide a potential for increased scientific and/or advocacycollaborations.
With a focus on key issues in the broader field of TB, Aeras will build new partnershipswith stakeholder groups and expand our audience. New constituencies will help
increase demand for TB vaccine R&D prioritization.
Why Focus on these Key Issues?
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TB and Mining
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Source: Dharmadhikari et. Al., 2013
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Human and Animal TB
TB in animals and humanscontinues to be an enormouspublic health problem and aneconomic burden on agriculturaland health budgets UK: In 2012, >37,000 cattle
slaughtered at a cost of 100Mto the taxpayer
DEFRA estimates >1 billionwill be spent over the nextdecade for bovine TB control
We can inform vaccinedevelopment in both animal andhuman TB by combiningexpertise, learning & resources
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Source: Department for Environment, Food and Rural Affairs, 2013
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TB and Healthcare Workers
Increased risk ofTB infection
Short, mediumand long-term
activities canhelp protect at-risk populations We can
educate, andmotivate aglobalpreventionresearch
agenda 48
C t t t t
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Content strategy
We are building a robust and integrated communications, resource mobilizationand advocacy strategy and process that drives efficiency and scale up in
content development and distribution. Every time we publish a fact sheet,report or press release, every time someone speaks on a panel or writes ablog, every time we hold a briefing, we will seek to distribute our contentthrough as many relevant channels as possiblebuilding new audiences andsupport along the way.
Content
Web
Feature
Fact
Sheet
Email Social
MediaEvent /
Conf. CallPress
Stakeholder
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Activities/Message Vehicles
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Conferences and Events
Leverage national, regional and global fora on key issues platform to place vaccine R&D onthe agenda
Microsite and multimedia
Maximize reach of new website capabilities and deepen our social media presence tostrengthen Aeras voice in global dialogue on key issues
Fact sheets
Build issue-specific messaging to reach new audience, engage new constituencies, andcreate TB vaccine R&D advocates
Outreach avenues
Blogs
Social media
Traditional media
Email
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Introduction to the TB Vaccine Investment
Case
A dynamic model was developed to address four key objectives:
1. To identify a product development strategy that maximized thepublic health impact of new TB vaccines;
2. To conduct a strategic market analysis to assess the
commercial viability of new TB vaccines;3. To evaluate portfolio development costs in order to inform on
investment strategies by phase of development over time, tosupport the successful commercialization of at least one newTB vaccine;
4. To demonstrate the cost efficiencies of implementing a portfoliomanagement approach.
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TB vaccines are our best hopeto end the TB epidemic
Shared public and privatesector investment at keystages will offset risk
Even partially effective TBvaccines for adults and
adolescents will have asignificant public health impact
A viable market for TBvaccines exists
Greater diversification needed
in TB vaccine portfolio A disciplined portfolio
management approach isnecessary
Business Case Key Messages
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53
Countries in analysis 197 countries included in the Applied Strategy Model
14 countries excluded (no TB and/or birth data 2009)
183 countries included for analysis
183 countries geographic segmentation
Economies are divided according to 2011 GNI per capita, calculatedusing the World Bank Atlas method
low income - $1,025 or less;
middle income - $1,026 - $12,475
lower middle income, $1,026 - $4,035;
upper middle income, $4,036 - $12,475
high income - $12,476 or more
Global TB Market Segmentation
TB Vaccines Target Product Profiles
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TB Vaccines Target Product Profiles
Adolescents & Adults
Vaccine
To prevent active disease
10yo
without known active TB
2 doses
Routine vaccination of 10yo, andMass campaigns in 11yo, every
10 yrs
HPV coverage rate proxy for 10yo
60% improvementin relative efficacy compared
to the control arm
No safety concerns
Indication
Target Population
# Doses
Vaccination
Strategy
Vaccination
Coverage Rate
Proxy
Expected Efficacy
Expected Safety
Infant Vaccine
To prevent active disease
Newbornsindependent of
HIV status
1 dose
Routine vaccinationof newborns
BCG
60% improvementin relative efficacy compared to
current BCG
As safe ascurrent BCG
Portfolio Evolution 2014-2027 using
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55
$0
$20,000
$40,000
$60,000
$80,000
$100,000
$120,000
Projected Annual Development Costs by Stage
Discovery / Pre-Clinical 1 Pre-Clinical 2 Phase 1 / 2A
Phase 2B Phase 3 Pre-Commerce
Total Development C osts
$846,786
0
5
10
15
20
25
NumberofVaccines
Number of Vaccines in Portfolio by Development Stage Over Time
Discovery / Pre-Clinical 1 Pre-Clinical 2 Phase 1 / 2APhase 2B Phase 3 Pre-CommercePost-Commerce
Portfolio Evolution 2014 2027 using
Monte Carlo Simulations
Portfolio Development Probability of
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Portfolio Development Probability of
Success The key outputs of the portfolio development analysis are:
Probability of successful commercialization of a vaccine by year
Costs to develop the portfolio to commercialization
Given that there are numerous potential outcomes related to the various probabilitiesof success, the model incorporates Monte Carlo simulation to analyze the variouspotential outcomes.
Based on the base assumptions and the initial portfolio, there is a 55%probability of having one vaccine commercialized by 2024 and greater than 80%chance of having one vaccine commercialized by 2030
16% 16%
55% 56%
70%
77%79% 82%
83%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
By Year2022
By Year2023
By Year2024
By Year2025
By Year2026
By Year2027
By Year2028
By Year2029
By Year2030
Probability of 1 Vaccine Reaching Commercialization
O ll P tf li D l t C t
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Overall Portfolio Development Costs
As highlighted in the histogram above (based on Monte Carlo simulation of the variouspotential outcomes), the estimated cost range for developing one vaccines throughcommercialization can range from $435m to $1,050m, with and average development costof $630m.
0
1020
30
40
50
60
70
80
90100
$250 -$300
$300 -$350
$350 -$400
$400 -$450
$450 -$500
$500 -$550
$550 -$600
$600 -$650
$650 -$700
$700 -$750
$750 -$800
$800 -$850
$850 -$900
$900 -$950
$950 -$1,000
$1,000 -$1,050
Total Portfolio Development Costs - 1 Vaccine Commercialized
Std. Deviation - 97,254
630,592Average -
Min -
Max - 1,050,286
435,250
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Portfolio Development Funding Analysis
The financial model also analyzes various funding alternatives for the
development of the current TB vaccine portfolio This component of the model leverages the first two components of
the model
Total development costs required to develop the portfolio - i.e.what amount of funding is going to be needed?
Potential royalty stream that can be realized uponcommercializationi.e. how is the funding going to be repaid?
The model allows for analysis of various non-traditional fundingalternatives to facilitate the development of the portfolio, including bothdebt like investments and equity investments (in addition to grants)
The key outputs of this component of the model include: Analysis of the financial returns to the funding sources
The optimal funding sources and security structures will ultimately be determined by
the composition of the portfolio and associated risks of development
P bli d P i t S t Ri k Sh i
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Public and Private Sector Risk-SharingA blended-capital financing structure will enable appropriate risk-sharing betweenprivate and public sectors:
With governments strong economic and public health interest in new TB vaccines,public funding will be required to support the earlier phases of vaccine
development, where the scientific risk is the greatest
In return, industrial partners will be expected to cost-share in the later, moreexpensive phases of development
I iti l T k f A l i T D t
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Initial Takeaways from our Analysis To-Date
There is a significant market potential for commercialized
TB vaccines, particularly an adult/adolescent vaccine The overall market potential of a successful
adult/adolescent vaccine seems sufficient enough tosupport meaningful financial returns to industry and potential
niche public/private investors in the development of thevaccine portfolio.
Having a robust and diverse pipeline of vaccine
candidates in early development stages is critical to
attracting investment capital as the portfolio approachincreases the likelihood of successful commercialization andthus financial returns.
There might be poss ible RSFF direct and /or ind irectf inancing opportunities in late stage R&D phases
Global Portfolio Management
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Global Portfolio Management
Principles
Optimizat ion: The framework will utilize existing technical expertise, scientific advisorycommittees and governance structures of key parties and build new capacity whereneeded in order to enhance portfolio decision-making and maximize organizationalsynergies and knowledge sharing.
Transparency: Procedures and decision-making will be clear and objective based on
objective gating and priority setting criteria that disclose and avoid any conflict ofinterest.
Sound Financ ial Management: Funds will be managed in a rational manner withsufficient control over the use of those resources to ensure that stage gate decisionprocesses are adopted and utilized.
Diversi f icat ion: The portfolio will be global and diverse to minimize financial risks andcreate the best opportunity for success; similarly, funding sources should include abroad array of different types of financing to increase the pool of available resources asmuch as possible.
Effect iveness: The collaboration will offer donors and investors a highly efficientmechanism in order to show value for money, participate in risk-sharing and reduce timeto market.
Affordabi l i ty : Vaccines to be developed will have to be available worldwide at
affordable prices. 61
A streamlined decision-making framework in order to advance the global TBvaccine portfolio and realize overall R&D cost efficiencies through effective portfolio
management will follow the principles:
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Enhancing Portfolio Management Capabilities
Leverage Aeras and TBVI scientific expertise in the Global TB
vaccine partnership regarding decisions on development of projects
within the TB vaccines portfolio.
Link funding decisions to scientific decisions made by Global TB
Vaccine Partnership
Incorporates both preclinical and clinical portfolios to optimizediversity
Prioritizes around a set of predefined targeted product profiles(TPPs) that seeks to maximize the public health impact of new TBvaccines
Implements 1 universal and shared set of rigorous stage gatingcriteria and milestone based finance through contractualagreements
Shares information from all trials successful or failing to improveselection and design of future trials.
Consults outside expertise to review and offer expertise on the
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Funding priorities have lagged relative to the
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g p gg
morbidity and mortality of tuberculosis
1,000,000,000Tuberculosis death
Small pox
PlagueInfluenzaCholera
30,000,000HIV/AIDS death
Malaria
Tuberculosis has led to more deaths in the last200 years than any other infectious disease
Source: Global Tuberculosis Report 2012, WHO (2012), Nature Vol 502, No. 7470 Suppl, S2 (2013), Financing GlobalHealth 2012, IHME
but has received significantly less funding in the
last 10 years as compared to HIV and malaria1
Malaria
$43 billionHIV/AIDS global funding
1 Based on OECD and IHME Development Assistance for Health (DAH) funding data
HIV/AIDS
Tuberculosis
$7 billionglobal funding
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TB R&D funding overview
US $600 million was invested in TB vaccine R&D between 2005 and2011
5 institutions/agencies provided nearly 80% of funding (BMGF, NIH, EC,DFID, DGIS)
To date, EDCTP has invested approximately42 million towards site
preparedness and capacity building for TB vaccines in Africa, withadditional direct funding for specific clinical trials
PDPs across the board have seen cuts in the order of US $30-50million per year over the past three years.
Only 3 new G8 governments are exploring new or increased funding forPDPsGermany, Australia and Japan
Global trends show declining support for neglected disease R&D
overall
TB R&D has seen an 8.3% drop from 2010 The majority of funding is allocated to drugs (42.5%), followed by basic research
(26.8%), preventative vaccines (18.8%), diagnostics (9.1%) and therapeutic vaccines
(0.01%)
E j l i US f di f l b l h lth i i h d th k
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Every major scale-up in US funding for a global health crisis has occurred thanks
to strategically executed communications campaigns, constituency building and
active advocacy efforts.
US Malaria YOY Funding:
From $146 Million to $834 MillionUS Global HIV/AIDS YOY Funding:
From $614 Million to $5.5 Billion
US TB Funding Fails to Keep Pace
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$85.1 $92.0 $91.5$94.9
$163.2$176.6
$243.2$238.4
$254.4
$0.0
$50.0
$100.0
$150.0
$200.0
$250.0
$300.0
2004 2005 2006 2007 2008 2009 2010 2011 2012
US TB funding has failed to keep pace with that of malaria and HIV/AIDS which
increased 6x and 9x respectively in the past decade. Had TB funding kept pace with
these diseases, support would be between $500 million to $760 million per year.
US Global TB Funding:From $85 million to $254 million.
Source: Congressional Resource Service
In 2011 HIV vaccine R&D received ~9x ($845M) more funding
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In 2011, HIV vaccine R&D received ~9x ($845M) more fundingcompared to TB vaccine R&D ($95M). Public sector support was ~19xhigher.
Source: TAG, 2012Source: HIV Research Tracking, 201
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8/14/2019 TB and Vaccines
69/71
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8/14/2019 TB and Vaccines
70/71
We Must Increase Momentum
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8/14/2019 TB and Vaccines
71/71
Thank You.