Business Plan 2019 2022 - CEPI
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Business Plan 2019 - 2022
CEPI’S VISION CONTENTS
A world in which epidemics are
no longer a threat to humanity
CEPI’s mission - to accelerate the development of vaccines against Introduction 4
emerging infectious diseases and enable equitable access to these The challenge 7
vaccines for affected populations during outbreaks -
Scope and initial priorities 7
is supported by three strategic objectives:
The vaccine ecosystem 13
Vision, Mission and Strategic Objectives 14
Strategic objective 1: Preparedness 15
Strategic objective 2: Response 16
Strategic objective 3: Sustainability 18
Implementation 20
Preparedness 1 2 Response
Advance access to safe and Accelerate the research, Governance 20
effective vaccines against development and use of
emerging infectious diseases vaccines during outbreaks
Portfolio management 21
Management of funds 22
3 CEPI policies, procedures, and risk mitigation 22
Appendix: Results Framework 22
Sustainability
Create durable and equitable
solutions for outbreak
response capacity
2 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 3INTRODUCTION
The Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative
global partnership where we envision a world where epidemics are no
longer a threat to humanity. The global need for CEPI emerged after the
devastating West Africa Ebola crisis in 2014–16 that caused over 11,000
deaths. The collective response to Ebola had fallen short, and it was
evident that we needed a better system to produce vaccines—one of
our most powerful public health tools—against known epidemic threats.
In response, following extensive technologies with the potential to In the discussions that led to
public deliberation and accelerate the development and the creation of CEPI, hundreds
consultation, CEPI was launched manufacture of vaccines against of experts from around the
at Davos in January 2017 to speed previously unknown pathogens, world advised on the key issues
up the development of vaccines commonly referred to as Disease that CEPI should address. Their
against the most pressing X– ‘just in time’. recommendations culminated in
known pathogens with epidemic our Preliminary Business Plan,
Third, CEPI will support and
potential and advance innovative which served as the roadmap for
coordinate activities to improve
technological platforms to develop CEPI’s start-up phase. Now in
our collective response to
vaccines rapidly in response to our growth phase, a number of
epidemics, strengthen capacity
newly emerging infectious disease strategic documents have been
in countries at risk, and advance
threats. developed, including a Programme
regulatory science that governs
Document and Annual Plans
CEPI’s mission is to accelerate the
Founded by the governments product development.
of Norway and India, the Bill
to reflect a renewed approach. development of vaccines against emerging
Currently1 focussed on the Together with this Business Plan,
& Melinda Gates Foundation,
pathogens which cause Lassa
infectious diseases and enable access to
these documents incorporate
Wellcome, and the World
Economic Forum, CEPI is now a
fever, Middle East Respiratory decisions made by CEPI’s Interim these vaccines for people during outbreaks
Syndrome (MERS), Nipah, and now Permanent Board and
broad coalition of governments,
Chikungunya and Rift Valley fever, reflect lessons learned from the
international organisations ,
CEPI has already committed to first two years of operations.
philanthropies, civil society
investing up to $413 million to
partners, and the private sector. Three strategic objectives—
support the development of 18
preparedness, response, and
While many organisations vaccine candidates (Figure 1). The
sustainability—drive our efforts
operate within the end-to-end WHO R&D Blueprint for Action to
to accelerate the development
space of vaccine funding and Prevent Epidemics was the point of
of vaccines against emerging
R&D implementation, CEPI was departure for CEPI when selecting
infectious diseases and enable
designed to fill a number of priority diseases. Through our
equitable access to these vaccines
gaps. First, CEPI will advance second Call for Proposals, we
for affected populations during
vaccines against known threats are also funding innovative
outbreaks. This document provides
through proof-of-concept and platform technologies to speed the
details about these strategic
safety testing in humans and will development and manufacture of
objectives and outlines CEPI’s
establish investigational vaccine vaccines against newly emerging
approach to implementation.
stockpiles before epidemics begin pathogens – commonly referred to
– ‘just in case’. Second, CEPI as Disease X.
will support innovative platform Richard Hatchett, CEO
1 Correct at time of publication.
4 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 5THE CHALLENGE
Figure 1: CEPI’s progress since inception leading up to the revision of the Business Plan
Jan 2017 Jan 2017 Apr 2017
CEPI is officially launched at the World
Economic Forum’s annual meeting in Davos.
Launch of CEPI’s first Call for Proposals to
develop vaccine candidates against MERS-
Richard Hatchett starts his
position as CEO of CEPI
Scope and initial priorities
Oslo HQ established CoV, Nipah and Lassa viruses
The tragic West Africa Ebola outbreak in 2014-16—the largest and longest
outbreak of Ebola in history to date—galvanised global leaders behind
Nov 2017 Oct 2017 Sep 2017
CEPI established office in CEPI established office in London, UK Launch of CEPI’s second Call for Proposals
a goal of developing systems and tools to fight future outbreaks of Ebola
Washington D.C., USA for platform technologies to enable rapid and other severe infectious pathogens.
vaccine development against unknown
pathogens
Feb 2018 Feb 2018 Mar 2018
CEPI announces new permanent board CEPI held a first-of-its-kind workshop CEPI announces its first partnership with
looking at the challenges, opportunities and Themis Bioscience worth up to US$ 37,5
possiblilities of developing vaccines against million to advance vaccine candidates
In addition to the devasting human To better prepare for future For the diseases highlighted in the
Chikungunya in Delhi, India against Lassa fever and MERS-CoV costs, the socioeconomic burden outbreaks, the World Health WHO R&D Blueprint, development
caused by this outbreak was in Assembly endorsed the World of vaccines is an especially
excess of $53 billion.2 It created Health Organization (WHO) R&D important and complex endeavour
May 2018 May 2018 Apr 2018 severe shocks to investment, Blueprint for Action to Prevent (Box 1). Market forces have proved
CEPI announces partnership with Profectus CEPI announces partnership with IAVI worth CEPI announces partnership with Inovio
Biosciences and Emergent Biosolutions up to US$ 54,9 million to advance Lassa fever worth up to US$ 56 million to advance
production, and consumption Epidemics5, a global strategy and insufficient to bring such products
worth up to US$ 25 million to advance the vaccine development vaccine development and manufacturing throughout the region, coupled preparedness plan to reduce the forward and other incentives for
development and manufacture of a vaccine against Lassa fever and MERS-CoV with commodity price shocks in time between the declaration advancing the development of
against Nipah virus
affected countries.3 Healthcare of a public health emergency of medical countermeasures against
systems in affected countries international concern and the emerging infectious diseases
Aug 2018 Aug 2018 Sep 2018 were also weakened, resulting availability of effective diagnostics, (EIDs) were poorly coordinated
in a significant decline in most therapeutics, and vaccines that can or lacking altogether.
CEPI announces partnership with Profectus CEPI announces partnership with IDT worth CEPI announces partnership with Oxford
Biosciences and Emergent Biosolutions up to US$ 36 million to advance MERS-CoV University and Janssen Vaccines worth up indicators of maternal and child be used to respond to such a crisis.
worth up to US$ 36 million to advance the vaccine development to US$ 19 million to develop MERS, Lassa health as well as many other health
development and manufacture of a vaccine and Nipah vaccines
system outputs.4
against Lassa virus
Jan 2019 Jan 2019 Dec 2018
CEPI announces partnership with the CEPI launches its third Call for Proposals CEPI announces partnership with Imperial
University of Queensland worth up to to develop vaccines against Rift Valley fever College London worth up to US$ 8,4 million
US$ 10,6 million to develop a “molecular and Chikungunya virus to develop a transformative rapid-response
clamp” platform technology technology to create vaccines against
unknown pathogens
Feb 2019 Feb 2019 June 2019
CEPI awards contract worth up to US$ 31 CEPI awards US$ 34 million contract to CEPI awards up to US$ 21 million to
million to The University of Tokyo to develop CureVac to advance The RNA PrinterTM - a Themis Bioscience for Phase 3 Chikungunya
vaccine against Nipah virus mRNA vaccine platform that can rapidly vaccine development
combat multiple diseases
July 2019 July 2019 July 2019
CEPI awards up to US$ 23,4 million to CEPI awards funding agreement worth up to CEPI awards contract worth up to US$ 12,5
Valneva for late-stage development of a US$ 9,5 million to Colorado State University million to consortium lef by Wageningen
single-dose Chikungunya vaccine to develop a human vaccine against Rift Bioveterinary Research to develop a human
Valley fever vaccine against Rift Valley fever
Business Plan published
2 https://academic.oup.com/jid/article-abstract/218/suppl_5/S698/5129071
3 http://www.worldbank.org/en/topic/macroeconomics/publication/2014-2015-west-africa-ebola-crisis-impact-update
4 https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30078-5/fulltext
5 www.who.int/blueprint
6 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 7Box 1: Market deficiencies in vaccine development
Vaccine development for EIDs have predominantly affected Of the 259 treatments7 that are The WHO R&D Blueprint was the of platform technologies that can
emerging infectious diseases low- and middle-income countries being developed for use against point of departure for CEPI when rapidly be adapted to such threats,
(EIDs) is challenging for many and are much more likely to evolve WHO R&D Blueprint pathogens, selecting priority diseases (Box we seek to further strengthen the
reasons, including the difficulty into large epidemics in such most are in early phases of 2). Criteria including the risk of world’s ability to respond to the
of demonstrating vaccine settings. These countries have development and are not ready an outbreak occurring, burden of broadest set of challenges in the
effectiveness, the unpredictability limited means to finance or drive for use during outbreaks. This disease, and feasibility of vaccine realm of EIDs (Boxes 3 and 4).
of epidemics, the substantial vaccine development on their own. paucity of available treatments development were also applied. In
CEPI has a focussed funding scope
complexity of conducting As a consequence of these factors, underscores how unprepared addition to the known pathogens
to invest in vaccine candidates and
clinical trials in the midst of an the development of commercial the world is for future outbreaks - where a threat has been
innovative platform technologies
outbreak, and the substantial vaccines against epidemic threat of EIDs. identified - there are numerous
against emerging epidemic
costs associated with development pathogens happens infrequently, other pathogens that also have the
diseases, and use “enabling
efforts.6 For a variety of reasons, if at all. potential to cause epidemics and
science” to support their
extensive human suffering and
advancement (Box 2).
distress: the so-called “Disease X”.
The figure below shows the stage of development for vaccine candidates against 11
By supporting the advancement
epidemic infectious diseases, from preclinical through to Phase III7
MERS-CoV
Rift Valley fever
Ebola Zika Box 2: Prioritised areas for funding
Chikungunya
Ebola
MERS-CoV Development of vaccine candidates against Lassa, Nipah, and MERS-CoV for stockpiling prior
CCHF
Marburg to large-scale efficacy testing (through Phase II).
Zika
Ebola Chikungunya
Chikungunya Development of vaccine platform technologies tested against several pathogens (through Phase I).
CCHF
Development of vaccine candidates for Chikununya and Rift Valley fever.
Phase I; 22 Phase II; 7
Zika Enabling science and technologies that support the advancement of such vaccines.
Phase III; 2
Ebola Finishing the job of developing vaccines against Ebola.
SFTS
SARS
By the end of 2022, we aim to have CEPI will need to secure $1 billion
completed Phase II clinical trials to accomplish the strategic
Preclinical; 228 and established investigational objectives we have set for our first
stockpiles for four candidates 5 years of operation9. Our success
Rift Valley fever against at least two of our priority will not only improve our collective
pathogens. These investigational ability to prepare for and respond
vaccines will then be ready for to epidemics but will prevent the
large-scale efficacy testing in devastation they can cause and
Lassa fever
the event of future outbreaks. To reap societal, public health, and
achieve this ambitious target, economic benefits for everyone.
Nipah
Marburg
MERS-CoV
9 CEPI Preliminary Business Plan 2017-2021
6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5518734/
7 Gouglas et al (2018) Lancet Global Health and Secretariat analysis
8 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 9Box 3: CEPI priority diseases
Lassa Nipah MERS Chikungunya Rift Valley fever Disease X
Lassa virus belongs to the Nipah virus belongs to the MERS-CoV is the virus that causes WHO has highlighted Chikungunya Rift Valley fever has been listed in Disease X represents the
Arenaviridae family and causes Paramyxoviridae family of viruses, Middle East Respiratory Syndrome as a major public health risk and the WHO R&D Blueprint of priority knowledge that a serious
Lassa fever, also known as Lassa genus Henipavirus, alongside (MERS). It is a coronavirus, part has stated that further research pathogens in view of its epidemic international epidemic could be
haemorrhagic fever (LHF). It Hendra virus. of the same family of viruses and development is needed to potential. Most human infections caused by a pathogen currently
is a haemorrhagic illness that that causes the common cold and mitigate the risk it poses. result from contact with the blood unknown to cause human disease.
The natural hosts of the virus are
occurs between one and three SARS (Severe Acute Respiratory or organs of infected animals but In February 2018, Disease X was
fruit bats (also known as flying It causes fever, severe joint pain,
weeks after infection. The Syndrome). It is thought that can also result from the bites of included in the updated WHO
foxes) of the genus Pteropus. Nipah muscle pain, headache, nausea,
natural host of Lassa virus is camels are a major source of infected mosquitoes. The virus R&D Blueprint list of priority
virus can be spread to people from fatigue and rash. Joint pain is
the rodent Mastomys natalensis, infection in people. Raising camels, was first identified in 1931 during diseases.
infected bats, infected pigs, or often debilitating and can vary
otherwise known as the Natal eating undercooked camel meat, an investigation into an epidemic
infected people. in duration. What we do know is that new
multimammate mouse or rat. and drinking raw camel milk among sheep on a farm in the Rift
diseases emerge all the time,
or urine are risk factors for the The disease shares some clinical Valley of Kenya. Multiple outbreaks
Lassa virus can pass from person from locations all around the
disease in humans. MERS-CoV signs with Dengue and Zika viruses have been reported across the
to person via bodily fluids, and world. Developing countries,
can spread from person to person, and can be misdiagnosed in areas African continent and in Saudi
can spread in healthcare settings particularly those with high rates
usually through close contact. where they commonly occur. Arabia and Yemen.
if suitable precautions are not of biodiversity, are at heightened
taken. Most human cases are mild but in a risk because of the increased
small proportion of patients severe risk of outbreaks and the limited
forms of the disease can develop, capacity for surveillance and
which can include ocular disease, response in these countries.
encephalitis, or haemorhagic fever,
which can be lethal.
MERS
Chikungunya
Rift Valley fever
Nipah
Lassa
Nipah/MERS
The map to the left shows all the
MERS / Rift Valley fever countries that have been affected
by CEPI’s priority diseases, either
Chikungunya / Rift Valley fever by local disease transmission or
importation of cases. It serves as
Chikungunya/ Nipah
a reflection of global spread of the
Chikungunya/MERS diseases rather than their relative
severity across countries.
Source: WHO
10 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 11Box 4: Vaccine development explained Box 5: Platform technologies explained
The R&D process for developing and pharmacological parameters. emergence and re-emergence. Platform technologies can be understood as building materials (“platforms”) that can be
vaccines consists of preclinical Phase I studies are primarily Phase II tested vaccines therefore applied for developing a multitude of vaccines against different pathogens. Vaccines based on
and clinical phases. concerned with safety. Phase II have the potential of stopping different platform technologies induce different types of immune responses, and the immune
studies involve larger numbers the spread of disease during response required for protection against a certain disease varies. As such, one does not need to
Preclinical research and
of subjects and are intended to outbreaks, as well as being ready know the exact disease a platform is being developed for, allowing it to be potentially used for
development is carried out in
provide preliminary information for Phase III testing. Depending novel, as well as known pathogens.
laboratories and based on both in
about a vaccine’s ability to on the study design, one may
vitro (e.g. microorganisms, cells The WHO R&D Blueprint process has identified several platform technology proposals for
produce its desired effect (usually choose to conduct a “Phase IIb”
and biological molecules) and, human vaccine development that have the potential to rapidly develop vaccines against known
immunogenicity) in the target trial between Phase IIa and Phase
when necessary, in vivo (e.g. mice or unknown pathogens in the event of an epidemic. CEPI is developing promising platform
population and its general safety. III. The purpose of this trial is to
and non-human primates) studies. technologies through to the end of Phase I studies. Successful development of these platform
Together, Phase I and II trials essentially conduct a small-scale
The data from the preclinical technologies could reduce vaccine development time significantly, thereby increasing the
establish “proof-of-concept”. To efficacy trial. For many EIDs this
studies provide details of the number and types of vaccine platforms that can be quickly adapted against EIDs.
fully assess the protective efficacy may be the most realistic trial to
development and production of a
and safety of a vaccine, extensive consider prior to some form of
vaccine which need to be adequate
Phase III trials are required. emergency use listing.
to justify subsequent clinical
studies in humans.
The Phase III clinical trial is
traditionally the pivotal study on
The figure below depicts these The vaccine ecosystem
different stages of development.
Clinical trials are classified into which the decision on whether Development and delivery of vaccines is a costly and complex process
The end of every phase is
three phases: Phase I, Phase to grant a licence is based and
II and Phase III. The Phase I sufficient data have to be obtained
depicted by the average success that involves many steps and numerous partners. The vaccines CEPI
rate, ranging from low to high.
clinical studies carry out initial to demonstrate that a new
Depending on the success rate
helps develop are therefore not CEPI vaccines, but the World’s vaccines.
testing of a vaccine in small product is safe and effective for
applied, it is expected that 3-5 CEPI thus also assesses both resources for the greater good. To be responsive and effective in
numbers (e.g. 20) of healthy the purpose intended. For many
preclinial candidates are needed to opportunities and challenges/ Acknowledging the important our mission, we forge partnerships
adults, to test the properties of EIDs, Phase III trials cannot be
have 1 successful Phase II outcome. bottlenecks that other work of other stakeholders, CEPI with local and regional institutions
a vaccine, its tolerability, and, if conducted in advance of outbreaks
appropriate, clinical laboratory due to the sporadic nature of their organisations face in the discovery approaches all of its investments and involve the scientific
and delivery – either those that by taking an end-to-end approach, community in affected countries.
hinder a health pipeline of early acting as either a facilitator or This is also an integral part of
candidates or those that impede funder as required to drive change our organisational model and our
delivery and access to vaccines. and help fill the critical gaps that governance structure, whereby the
CEPI coordinates its efforts with still exist (Figure 2). broadest set of experts, funders
Number of candidates
WHO and other major institutional and institutions working in the
partners, and works closely with field are consulted and take part
like-minded funders to allocate in decision-making.
41%
Figure 2: CEPI’s funding and facilitating role
CEPI role as a facilitator
67-90% Proof of Regulatory
concept approval
Pre-clinical CEPI role as a funder
31-54%
1 2 3 4 5
Phase 1 DISCOVERY DEVELOPMENT/ MANUFACTURE DELIVERY/ LAST MILE
Phase 2 LIECENSURE STOCKPILIING
Phase 3
Academia Industry Industry GAVI Countries
Laboratory and In human studies Large scale/post-
animal studies outbreak Time Governments Governments BARDA UNICEF WHO
Wellcome Trust Regulators CMOs PAHO UNICEF
NIH Wellcome Trust Regulators Governments Responding
IMI NIH Governments WHO Organisations
GLOPID-R EC WHO Industry (eg. MSF)
Sources: 1) WHO Technical Report, Series No. 924, 2004. Annex 1 Guidelines on clinical evaluation
Industry IMI GHIF Pandemic Emergency
of vaccines: regulatory expectations. 2) Pronker, Plos One 2013 3) Hay, Nature biotechnology 2014 4) Regulators BMGF Facility (World Bank)
Wong, Biostatistics 2019 Biotech BARDA/DTRA etc. WHO Contingency
WHO Fund
Biotech
PDPs
12 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 13VISION, MISSION Strategic objective 1: Preparedness
AND STRATEGIC OBJECTIVES Advance access to safe and effective
vaccines against emerging infectious diseases
CEPI’s vision is a world in which epidemics are no longer a threat to Our ability to advance vaccine candidates against our priority
humanity. Our mission is to accelerate the development of vaccines against pathogens is the ultimate test of our ability to deliver on our mission.
emerging infectious diseases and enable equitable access to these vaccines
for affected populations during outbreaks.
To achieve this mission, CEPI equitable access to epidemic principle that once a vaccine is However, vaccine development is • I nvesting in promising deployment of vaccines during
has three strategic objectives: vaccines in the context of an licensed, price should not limit a lengthy process. Advancement candidates targeting EIDs to outbreaks.
preparedness, response, and outbreak means; necessary access to a vaccine it of vaccines—especially epidemic drive development of vaccines
•P
roviding expert assistance
sustainability. To measure has funded while at the same time diseases—is a complex endeavour where markets incentives are
that appropriate vaccines are and funds enabling science and
progress and success towards ensuring the sustainability of vaccine requiring active involvement by insufficient.
available when and where they technologies to enhance vaccine
these objectives, CEPI has manufacturing and distribution. industry, academic and public
are needed to end an outbreak or •F
acilitating the establishment development efforts.
developed a results framework health experts.
curtail an epidemic, and that they Accordingly, equitable access is and maintenance of
(see Appendix).
are accessible to all populations a commitment that drives every To support preparedness against investigational stockpiles and
All our strategic objectives that need them, without financial aspect of our work and is key to EIDs, CEPI engages in the development of robust plans
encompass the principle of constraints, to achieve that objective. our success as a global health following areas of work: to allow for trials and eventual
equitable access – our most Moreover, as part of its funding organisation.
important priority. To CEPI, agreements, CEPI will pursue the
Plans and targets (see Appendix)
•Advance 3 candidates each against Lassa, Nipah, and MERS through Phase II testing by end of 2022.
• Have 4 vaccine candidates against at least 2 pathogens in investigational stockpiles by end of 2022.
• Ensure that development partners seek early engagement with regulators and agree to terms that
are consistent with CEPI’s Equitable Access policy.
Investing in promising assess the performance of be added to CEPI’s portfolio
candidates targeting EIDs to our vaccine portfolio and add in response to reassessments
drive development of vaccines additional investments based of existing threats and new
where markets incentives are on its progress. As part of our emerging diseases. Depending on
insufficient investments, we work with our the success rate of our vaccine
development partners to develop portfolio, CEPI might also choose
CEPI supports the development
domestic clinical-trial capacity to invest in additional vaccine
of vaccines against priority
in countries where we will deploy candidates for existing priority
Price should not limit necessary access to a pathogens and works with
our vaccines. diseases or co-invest in large-
partners to ensure that promising
vaccine CEPI has funded while at the same vaccine candidates are ready for While initial investments have
scale efficacy trials when a vaccine
candidate is ready.
time ensuring the sustainability of vaccine large-scale field trials when an been made in vaccines against
outbreak occurs. CEPI carefully Lassa, Nipah, MERS, Chikungunya
manufacturing and distribution. manages its portfolio of vaccine and Rift Valley fever as priority
candidates. We continuously diseases, new diseases may
14 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 15Facilitating the establishment and more doses are needed. These of clinical trials suitable for
maintenance of investigational manufacturing capabilities will testing candidate vaccines during Plans and targets (see Appendix)
stockpiles and developing robust also be required to replenish public health emergencies, and
unused stockpiles of vaccines that a great deal of preparatory work • Have at least 2 vaccine platform technologies by end of 2022 that can be rapidly
plans to allow for trials and
have expired. will be required if vaccine trials adapted to develop vaccines against unknown pathogens for use in humans.
eventual deployment of vaccines
are to be conducted under such • Have at least 8 candidates through preclinical by 2020 and 6 vaccine candidates
during outbreaks Providing expert assistance
circumstances.
and funds enabling science and through Phase I by end of 2022.
CEPI will facilitate the
technologies to enhance vaccine CEPI staff, external experts, and
establishment of investigational • Ensure that development partners have necessary agreements in place for
development efforts members of its Scientific Advisory
stockpiles of successful vaccine vaccines to be deployed and tested during an outbreak.
Committee (SAC) contribute
candidates. This activity is
CEPI provides substantial subject-matter expertise in
designed to enable a response to
technical support to its partners support of partners. CEPI also
an outbreak and the fast-tracked
and serves as a liaison with promotes and funds enabling
execution of large-scale efficacy
WHO, other institutional science. Examples of enabling
trials (Phase III clinical studies) Investing in platforms to speed vaccines in a variety of storage These may include ensuring
partners, and countries at-risk, science include the validation
during the initial stages of an the development and manufacture conditions, needleless injection that development partners have
to increase the likelihood of of animal models required for
outbreak. of vaccines devices, and other vaccine delivery necessary agreements in place
success and expedite clinical vaccine proof-of-concept, the
testing. CEPI’s partners face an systems that can make it easier for for vaccines to be deployed and
If a vaccine is deemed to be safe development of correlates of CEPI invests in platform
and effective, trials must be array of challenges in developing healthcare workers to administer tested during an outbreak. CEPI
protection, providing support for technologies that can be rapidly
followed by regulatory approval vaccines against epidemic vaccines. also works with WHO and other
diagnostics, and the preparation adapted to new and unknown
and licensure. Manufacturing diseases. The epidemiology of biological standards and partners as needed to coordinate
pathogens, to reduce the time Engaging end-to-end partners
plans will also need to be devised of CEPI’s target diseases has assays critical for the evaluation its response activities.
required for vaccine development to plan for the testing and
to allow for eventual large-scale not been well characterised. of vaccine candidates. CEPI also to as little as 16 weeks. deployment of vaccines during
deployment. In view of these Preclinical models for these works closely with regulators and
In addition to expediting vaccine outbreaks
manufacturing needs, all vaccine diseases are underdeveloped authorities in developed countries
and the international standards development, our platform
candidates supported by CEPI and developing countries to CEPI proactively coordinates with
will have manufacturing plans and assays needed for vaccine technologies will be adaptable for
promote regulatory harmonisation a range of end-to-end partners
and associated quality controls development have not been and to ensure that regulatory use across different viral families.
that enable testing and delivery of
in place to increase production established. Much work remains requirements are addressed. The goal of CEPI’s investments in vaccines to affected populations
capacity of these vaccines if to be done to optimise the design
vaccine platforms is to accumulate during an outbreak situation.
data on the performance of these
This means working with
platforms in a variety of settings,
partners to design and implement
to characterise the human
clinical trials, engaging relevant
immune response to vaccines
Strategic objective 2: Response
regulators and ethics review
developed on these platforms
boards prospectively, ensuring
to the greatest extent possible,
the security and reliability of
and to work with regulators to
Accelerate the research, development streamline pathways for the
the supply chain (including any
needed cold-chain logistics), and
approval of vaccines emerging
and use of vaccines during outbreaks from these platforms in the event
of an emergency.
preparing for potential large-scale
administration of vaccines once
trials are complete and the vaccine
Response to an unknown pathogen requires the necessary tools to expedite Supporting the development of has been shown to be safe and
technologies to facilitate field use effective.
vaccine development, and innovative technologies can make uptake and and rapid response
Our Joint Coordination Group
delivery of the vaccine more effective. Where appropriate, and often in (JCG)—composed of normative
conjunction with other partners, bodies, regulators, funders,
CEPI will support the development stockpilers, and first responders—
Importantly, history has shown • Investing in platforms to • Engaging end-to-end partners
of technologies that enable plays a key role in this effort.
us that the R&D and delivery speed up the development and to plan for the deployment of
rapid testing and delivery of Under their guidance, CEPI
response will not be effective manufacture of vaccines. vaccines during outbreaks.
vaccines in the field. Examples maps roles and responsibilities
unless it has been tested and
• Supporting the development of of these technologies we could in relation to the vaccines it is
planned for in preparedness mode.
technologies to facilitate use of support in the future include funding, identifies potential gaps
To support the epidemic response,
vaccines in the field and rapid thermostabilisation technologies in preparedness, and develops
CEPI is:
response to epidemics. to enhance the stability of plans to address these gaps.
16 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 17Strategic objective 3: Sustainability
Create durable solutions and equitable
for outbreak response capacity
While preparedness and response are key priorities for an organisation
working on EIDs, sustainability is a key component within all priorities and
investments will ultimately ensure that the products we help develop stand
the test of time.
This means that CEPI will priorities of other organisations. • Driving efficiencies in vaccine Driving efficiencies to reduce Developing contingency plans
organise and prioritise such that To ensure that CEPI’s approach is development to reduce costs. costs across the end-to-end to reduce risk so that successful
the investments we make are sustainable, CEPI is: spectrum of vaccine development products are available to support
• Developing contingency plans
robust to tackle the unpredictable outbreak response
• Improving the predictability to reduce risk so that successful CEPI constantly strives for cost
nature of epidemics, and that they
of financing for vaccine vaccines are available during reductions and streamlining in CEPI establishes contingency
can help drive systemic changes
development to address end-to- outbreaks. all areas: from R&D and vaccine plans with our partners for key
in vaccine R&D for EIDs through
end market failures. manufacturing to regulatory aspects of epidemic responses,
innovation and alignment with
process and stockpiling, and including those related to
even through to deployment of manufacturing and delivery of
vaccines. CEPI also supports the vaccines.
streamlining of processes related
Plans and targets (see Appendix) In practice, this means that if
to vaccine development and
there is a failure of “plan A”
• Raise $1bn as multi-year contributions to CEPI. regulatory approval that could
(i.e. a vaccine manufacturing
reduce R&D timelines or extend
• Have agreements in place with downstream partners on life-cycle financing partner goes out of business),
the shelf life of vaccines, thereby
a of CEPI-funded products. we have “plan B”, which will
reducing the frequency of costly
enable continued vaccine
stockpile replenishments.
manufacturing and
CEPI is committed to developing distribution.
and deploying vaccines
against EIDs in a manner that
Improving the predictability of CEPI collaborates with These contributions allow us
demonstrates it is a responsible
financing to address end-to-end organisations, whose missions to operate flexibly in uncertain
steward of public resources. CEPI
market failures intersect with our own, to environments, such as during
must therefore guarantee that the
proactively identify and fill outbreak situations, and to
We work closely with public- financial resources, bestowed to
funding gaps for vaccine increase financial predictability
sector and private-sector partners CEPI by our investors, are invested
R&D. Such collaboration for our vaccine development
to coordinate the development in a way that provides value for
could manifest as funding partners. This approach requires
and procurement of our vaccine money.
candidates. By improving the
opportunities for large-scale CEPI to work closely with other CEPI is committed to developing
vaccine efficacy studies or support actors and funders to align
predictability of such financing,
for development of financial organisational priorities.
and deploying vaccines
and establishing long-term
mechanisms for the maintenance
incentives such as prizes, against EIDs in a manner that
advance purchase commitments,
of stockpiles, we can ensure that
or vouchers. We continue our
demonstrates it is a responsible
successful vaccines can reach
affected populations during an
efforts to secure multi-year steward of public resources.
financial contributions for vaccine
outbreak.
research and development.
18 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 19IMPLEMENTATION Portfolio management
10
Governance Research shows that to
successfully move one vaccine
CEPI’s PSMB, with advice from its
SAC and external experts, defines
periodic “stage-gate” reviews for
partners seeking the next tranche
candidate from preclinical the target portfolio of vaccine of funding to advance to the next
assessment to Phase II, one will candidate, platform technology stage of development.
CEPI’s governance structure • The Board is composed of 8 • The Scientific Advisory involve at least three product and enabling sciences projects,
has been developed to embed independent members and four Committee (SAC) provides A Joint Monitoring and Advisory
failures.11 As the development and manages delivery of the
sound scientific assessment, and representatives of the Investors technical advice to the Group (JMAG) consisting
of our portfolio progresses, we portfolio according to a standard
evidence based decision-making Council — a body composed Secretariat on disease of key Secretariat staff and
anticipate that there will be a portfolio management cycle
as well as ensure the highest of all Investors in CEPI. While prioritisation, vaccine candidate representatives of vaccine
high rate of attrition. Therefore, (Figure 4). The ultimate funding
operational standards and rigour the Board is CEPI’s ultimate selection, portfolio management, development partners continually
to meet our strategic objectives, decisions are then made by the
in awarding of funds (Figure 3). decision-making authority, and vaccine science. assess progress of individual
we require an appropriately sized Board. In advance of entering into
three sub-committees of the projects, approve plans, and make
• The Joint Coordination Group portfolio of vaccine candidates, partnership agreements, CEPI
Board gives the Secretariat recommendations to the PSMB
(JCG) is composed of normative with a robust framework for performs financial, technical, and
• The members’ meeting is CEPI’s guidance on issues critical concerning project continuation
and regulatory agencies, portfolio management. legal and business due diligence
highest body, equivalent to a for the progress of CEPI, but and the extension of additional
funders, procurers and delivery to ensure that development
general assembly. This meeting which do not require full Board Rigorous investment decisions funding through the formal stage-
institutions. The JCG addresses partners possess the necessary
includes all independent Board approval. and trade-offs will need to be gate review process.
barriers to advancing and scientific, financial, and overall
members and all Investors and made on an ongoing basis to reach
• The Investors Council also delivering vaccines and works to management expertise to advance At the portfolio level, CEPI uses
is responsible for adopting the our ambitious targets, as outlined
provides oversight and guidance align priorities between member products and are able to manage a range of analytical approaches
annual accounts and approving through our Strategic Objectives.
to the Secretariat in areas institutions. It can also establish significant sums of money. The as part of our annual strategic
revisions to the CEPI’s Articles of Therefore, CEPI employs a
relevant for management. working groups for issues partnership agreements also reviews to monitor risk and the
Association. consistent portfolio management
requiring dedicated attention. provide a mechanism for ensuring value of our portfolio. Following
system in place that includes the
compliance with our Equitable close evaluation of our portfolio’s
following aspects:
Access policy, and the Secretariat progress, and of other unmet
Figure 3: CEPI’s governance model •A
common portfolio regularly publishes reports on the needs for vaccine R&D for EIDs,
management cycle to enable implementation of the policy. CEPI plans for future additional
disciplined identification, investments. This is informed by
CEPI manages projects through
Members meeting selection, management and
active engagement and routine
screening of new potential areas
evaluation of vaccine candidate for funding, including analyses of
monitoring and reviews. Approval
and platform projects in line vaccine research.
criteria are applied to support
with strategic objectives
Formal relationship Board •E
ffective portfolio governance Figure 4: Porfolio management
enabling timely and high quality
Informal relationship decision-making, overseen by Strategic Objectives
Executive & Compensation
Audit & risk a dedicated Portfolio Strategy
investment & nomination
& Management Board (PSMB),
consisting of senior members Opportunity
of the CEPI leadership team and identification
internal technical and subject (new and existing)
Joint matter experts
Secretariat Investors
Coordination •S
tandardised project and
Council portfolio management practices
Group
CEO Office to drive harmonisation, R&D Project
consistency and comparability Project review prioritisation
across the portfolio and evaluation
Portfolio
Vaccine Business Management and selection
Vaccine Science Scientific •C
lear and consistent
Working groups Development Development
Advisory Cycle
management of project and
People, Policy Comms, Finance and Committee portfolio information and
and Planning Advocacy & RM analyses to enable effective
Operations
decision-making in terms of
portfolio value, cost, time, risk Project execution
and diversity and monitoring
10 More details on CEPI’s operating model is provided in CEPI’s Programme Doccument and can be found on www.cepi.net 11 Gouglas D, Tung TL, Henderson K, et al. Estimating the cost of vaccine development against epidemic infectious diseases. The Lancet Global Health. (in press)
20 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 21Management of funds IMPACT OUTCOMES OUTPUTS ACTIVITIES
The funds received by CEPI of its funds in US dollars and capital preservation and liquidity.
support outbreak
plans developed
from its investors are usually currently makes all grants in
Contingency
CEPI’s annual reporting is
available to
Successful
response
products
received and kept in a Financial this currency. The Secretariat
informed by progress reports
for sustainable development (SDG 17)
Intermediary Fund managed has commercial bank accounts
Revitalised the global partnership
Create durable and equitable solutions
from our development partners.
3.3.1
by the World Bank, with some for disbursement to CEPI’s
3.3
for outbreak response capacity
This information enables CEPI
Improved Sustainability
investors having chosen to development partners or
to measure progress towards our
transfer funds directly to CEPI’s operating expenses. Funds
strategic objectives and financial
Sustainability
to end spectrum
improvements
across the end
Costs reduced
bank accounts. held for either contingency or
development
Efficiency
of vaccine
targets.
made
cash-management purposes are
The Secretariat maintains most
conservatively invested to ensure
3.2.1
3.2
• Investment in promising candidates. platforms targeting EIDs, and enabling science
market failures
Predictability
End-to-end
CEPI policies, procedures, and risk mitigation
of financing
addressed
improved
• Partnership building and engagement of stakeholders and scientific community
3.1.1
0.3
3.1
3
CEPI is guided by a commitment mitigation measures, policies, and i) Legal, ethical, and regulatory
Access to EID vaccines for affected populations during outbreaks
A world in which epidemics are no longer a threat to humanity
to effective, ethical operations procedures are critical, especially requirements including those
and investment practices. For in view of CEPI’s fiduciary, required by global regulatory
during outbreaks
each vaccine development project, operational, and indirect agencies and authorities in
for testing and
Plans in place
deployment
End to end
the CEPI Secretariat creates a development responsibilities. the geographies in which CEPI
partners
engaged
“Risk and Follow-up Report”. These measures are also operates.
and sustainable growth (SDG 8)
Accelerate the research, development
and use of vaccines during outbreaks
2.3.1
Risks are described in detail in important because the projects
Promote sustained, inclusive
2.3
ii) Industry standards and best
funding applications, integrated we fund might involve testing
practice for conducting R&D
Improved Response
product development plans, new vaccines in vulnerable
and ensuring that it is ethical,
Facilitated field
Development of
and by CEPI during technical, populations during an outbreak.
use and rapid
technologies
Response
effective, and transparent.
response
financial, legal, and integrity To ensure compliance with all
• Strategy development and gap analysis
due diligence. Significant risks relevant regulations and the iii) Operational and financial
• Advocacy and resource mobilisation
2.2.1
requirements investors have
2.2
are included in the CEPI Risk highest ethical and quality
Register, which is shared with the standards, CEPI’s policies12 asked CEPI to follow.
Board on a quarterly basis. Risk reflect:
• Governance and operations
and manufacture
specific vaccines
Through Phase I
and unknown
development
on platforms
progressing
of vaccines
pathogens
for known
Preclinical
Expedited
Pathogen
Through
• Expert assistance
2.1.1
0.2
2.1
2
APPENDIX: RESULTS FRAMEWORK
Advance access to safe and effective vaccines against
Vaccine development
manufacture in place
Plans for trials and
efforts enhanced
This Appendix provides an provides more detail on how of achievements towards our
wellbeing for all at all ages (SDG 3)
Ensure healthy lives and promote
overview of all the indicators each indicator is monitored and strategic objectives. This is
emerging infectious diseases
and their targets. A Theory of measured. To complement this deemed particularly important for
Improved Preparedness
Change outlines how elements Framework, CEPI will continue the Theory of Change levels 2.2,
Preparedness
within our Strategic Objectives to develop its monitoring plan 2.3.1, 3.2 and 3.3 which currently
1.2.1
1.2
respond to the results hierarchy. by the end of 2019 to support do not have dedicated indicators.
CEPI’s Programme Document timely and accurate follow-up
Investigational stockpiles
Vaccines candidates
Through Preclinical
established
developed
Through Phase II
Through Phase I
0.1
1.1.1
1.1
1
12 See www.cepi.net/about/governance for an up-to-date list of CEPI policies
22 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 23Indicator TOC Baseline Target Target Target Target Target Indicator TOC Baseline Target Target Target Target Target
Indicators Indicators
number number YO 2018 2019 2020 2021 2022 number number YO 2018 2019 2020 2021 2022
Progress Progress
3.B.2 Development assistance
Number of vaccine candidates towards towards
1 0,1 to medical research & basic N/A N/A N/A N/A N/A N/A 8 1,1,1 c MERS: 0 MERS: 1 MERS: 1 MERS: 3
advanced through PII trials targets targets
healthcare
reported reported
3.D.1 Health emergency At least one
2 0,1 N/A N/A N/A N/A N/A N/A Number of available biological 1 biological
preparedness validated
standards and validated assays Progress Progress Progress standards
assay
(including standard operating towards towards towards developed
3 0,2 8.1.1 GDP per capita growth rate N/A N/A N/A N/A N/A N/A 9 1,2,1 0 available
procedures) for evaluation of targets targets targets for each
each of
vaccine candidates against reported reported reported of priority
17.6.1 Science and technology priority
4 0,3 N/A N/A N/A N/A N/A N/A CEPI’s priority pathogens pathogens
cooperation pathogens
Number of vaccine candidates Percent of vaccine candidates
4 candidates
in investigational stockpile in clinical development (e.g.
for at least
5 1,1 for outbreak situations and 0 0 0 0 0 being tested in humans), with Subject to Subject to Subject to Subject to Subject to
2 priority
ready for efficacy studies and relevant engagement from successful successful successful successful successful
pathogens
emergency use 10 1,2,1 a national authorities—including 0 completion completion completion completion completion
regulators—in at-risk countries of preclinical: of preclinical: of preclinical: of preclinical: of preclinical:
Percent of vaccine partnership (End preclinical/move to Phase 100% 100% 100% 100% 100%
agreements that have I (Stage Gate 1): Scientific advice
6 1,2 manufacturing plans in place N/A 100% 100% 100% 100% 100% for CTA/Pre-IND package)
to enable vaccine production in
response to an outbreak Percent of vaccine candidates
in clinical development (e.g.
Percent of vaccine development being tested in humans), with Subject to Subject to Subject to Subject to Subject to
partners agreeing to terms that relevant engagement from successful successful successful successful successful
10 1,2,1 b 0
7 1,2 are fully consistent with CEPI’S N/A 100% 100% 100% 100% 100% national authorities—including completion completion completion completion completion
Equitable Access Policy and regulators—in at-risk countries of PI 100% of PI 1 100% of PI 100% of PI 100% of PI 100%
implementation guidance (End of Phase I, type C meeting/
scientific advice)
Number of vaccine candidates
8 1,1,1 a advanced through preclinical Lassa: 0 Lassa: 1 Lassa: 3 Lassa: 4 Lassa: 4 Percent of vaccine candidates
trials in clinical development (e.g.
being tested in humans),
Subject to Subject to Subject to Subject to Subject to
Number of vaccine candidates with relevant engagement
successful successful successful successful successful
8 1,1,1 a advanced through preclinical Nipah: 1 Nipah: 1 Nipah: 3 Nipah: 4 Nipah: 4 10 1,2,1 c from national authorities— 0
completion completion completion completion completion
trials including regulators—in
of PII 100% of PII 100% of PII 100% of PII 100% of PII 100%
at-risk countries. (for Phase II,
Number of vaccine candidates submission of CTA to NRAs in
8 1,1,1 a advanced through preclinical MERS: 1 MERS: 1 MERS: 2 MERS: 3 MERS: 4 affected countries)
trials
2 or greater,
Progress including
Number of vaccine candidates towards at least
8 1,1,1 b Lassa: 0 Lassa: 2 Lassa: 3 Lassa: 3 Number of vaccine platform
advanced through PI trials targets Progress Progress Progress Progress one novel
technologies that can be rapidly
reported towards towards towards towards (innovative)
11 2,1 adapted to develop vaccines 0
targets targets targets targets platform, i.e.,
against unknown pathogens for
Progress reported reported reported reported that has no
use in humans
Number of vaccine candidates towards prototyped
8 1,1,1 b Nipah: 0 Nipah: 0 Nipah: 3 Nipah: 3 licensed
advanced through PI trials targets
reported vaccine
Progress Percent of vaccine development
Number of vaccine candidates towards partners with necessary
8 1,1,1 b Nipah: 0 Nipah: 0 Nipah: 3 Nipah: 3 12 2,3 agreements in place for vaccines 0 100% 100% 100% 100% 100%
advanced through PI trials targets
reported to be deployed and tested during
an outbreak
Progress
Number of vaccine candidates towards Percent of vaccine development
8 1,1,1 b MERS: 0 MERS: 1 MERS: 2 MERS: 3 partners with plans in place for
advanced through PI trials targets
reported 13 2,3 equitable access fully consistent 0 100% 100% 100% 100% 100%
with CEPI’s Equitable Access
Progress Progress Policy
Number of vaccine candidates towards towards
8 1,1,1 c Lassa: 0 Lassa: 0 Lassa: 2 Lassa: 3 Progress Progress
advanced through PII trials targets targets
reported reported Number CfP2 vaccine candidates towards towards
14 2,1,1 a 0 8 candidates
progressing through preclinical targets targets
Progress Progress reported reported
Number of vaccine candidates towards towards
8 1,1,1 c Nipah: 0 Nipah: 0 Nipah:1 Nipah:3
advanced through PII trials targets targets
reported reported
24 Coalition for Epidemic Preparedness Innovations Business Plan 2019 - 2022 25Indicator TOC Baseline Target Target Target Target Target
Indicators
number number YO 2018 2019 2020 2021 2022
Progress Progress
Number of CfP2 vaccine towards towards
14 2,1,1 a 0 8 candidates
candidates targets targets
reported reported
Progress Progress Progress
Number of CfP2 vaccine
towards towards towards
14 2,1,1 b candidates progressing through 0 6 candidates
targets targets targets
preclinical
reported reported reported
Number of CfP2 vaccine
Annual Annual Annual Annual Annual
15 2,2,1 candidates progressing through N/A
update update update update update
preclinical
Agreements in place with
downstream partners on 3 agreements
16 3,1 0
life-cycle financing a of CEPI- in place
funded products, by disease area
Progress Progress Progress Progress
$1bn raised as multi-year towards towards towards towards
17 3,1 $630 m $1 bn
contributions to CEPI targets targets targets targets
reported reported reported reported
Percent of priority actions taken
18 3,2,1 0 0 50% 50% 50% 50%
to achieve efficiencies
Percent of vaccine partnership
agreements in place that
19 3,3,1 N/A 100% 100% 100% 100% 100%
contain contingency plans for
manufacturing
Epidemics affect us all. They do not respect borders.
A virulent respiratory virus spreading as fast as flu
can reach all major global capitals within 60 days.
Vaccines are one of our most powerful tools
in the fight to outsmart epidemics.
26 Coalition for Epidemic Preparedness Innovationswww.cepi.net
#OutsmartEpidemics
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