This document provides information about an upcoming SBRI (Small Business Research Initiative) competition focused on vaccines for epidemic diseases. It summarizes the agenda for an information session on the competition, including welcome remarks, an overview of the UK Vaccine Network and competition aims, and details about the call and timelines. The competition will provide up to £10 million in funding across multiple projects to enhance clinical and regulatory preparedness of vaccines for UKVN priority pathogens or "Disease X". Applications will be accepted from October 11-November 10, 2021 and contracts are expected to be awarded starting April 1, 2022.
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Introduction to the SBRI Competition: Vaccines for Epidemic Diseases
1. www.ktn-uk.org
Dr Gabriela Juárez Martínez
Health Team
gabriela.juarezmartinez@ktn-uk.org
SBRI - Vaccines for epidemic diseases:
Readiness for clinical development.
12 Oct 2021
2. Agenda
15.00 Welcome and introduction to KTN, Gabriela Juarez Martinez.
15.05 Update on the UKVN and the aims of the SBRI – Vaccines for
epidemic diseases: Readiness for clinical development call, Sarah
Legrand, DHSC.
15.25 Details of the Call and Timelines, Phil Packer, Innovate UK.
15.45 Q&A.
16.00 Close.
House keeping
• Microphones will be muted.
• The event will be recorded.
• If you have any questions,
please type them in the Q&A
box.
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Gabriela Juarez Martinez
gabriela.juarezmartinez@ktn-uk.org
Karen Wilkinson
karen.wilkinson@ktn-uk.org
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6. UK Vaccine Network Funding
12 October 2021
Sarah Legrand,
Head of UK Vaccine Network Project
Global Health Security Programme,
DHSC
7. 1. UK Vaccine Network: Our Background
• The West African Ebola outbreak in 2014-2016 illustrated a serious
market failure in the development of vaccines against diseases that
cause epidemics in low- and middle-income countries (LMICs).
• The UK Vaccine Network (UKVN) Project aims to address this by
supporting the development of vaccines and vaccine technologies to
combat priority diseases with epidemic potential in LMICs, awarding
over £110m in funding from 2016-2021.
• The UKVN has an Expert Group who identified 12 priority pathogens
as the focus of investment.
• The UKVN Project is 100% Official Development Assistance (ODA),
so all funding is for research which is of primary benefit to LMICs.
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UKVN Priority
Pathogens:
• Chikungunya
• Crimean Congo
Haemorrhagic
Fever
• Ebola
• Hantavirus
• Lassa
• Marburg
• Middle East
Respiratory
Syndrome
(MERS)
• Nipah
• Plague
• Q fever
• Rift Valley Fever
• Zika
8. Overview
• The UKVN sits within the Global Health Security Programme (GHS), which is part of DHSC's
International Directorate
• Since 2016, the GHS Programme has supported low and middle income countries to:
o prevent and reduce the likelihood of public emergencies such as disease outbreaks and
antimicrobial resistance (AMR)
o detect health threats early to save lives
o provide rapid and effective response to health threats
• The GHS Programme supports five projects: the Fleming Fund, the UK Vaccine Network, the
Global Antimicrobial Resistance Innovation Fund (GAMRIF), the International Health
Regulations Strengthening Project and the UK Public Health Rapid Support Team
Global Health Security Programme
9. 2. UKVN Project 2016 – 2022 Priorities
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• Supporting vaccines through the first ‘valley of death’ between late stage pre-clinical and early clinical trials
• Research to improve vaccine manufacturing and effective vaccine deployment
• Support the Coalition for Epidemic Preparedness Innovations (CEPI), to fund later stages of vaccine development
10. 3. UKVN Project Funding
2016- 2022 funding distribution by pathogen / research area
The 78 funded projects are
delivered by academic institutions
and Small and medium-sized
enterprises (SMEs), and managed
by our delivery partners:
Over 40 projects are now complete
with the remainder on track to
complete spending this financial
year.
11. 4. Successes
UKVN funded research has already seen success. Highlights include:
• UKVN-funded Middle Eastern Respiratory Syndrome (MERS) vaccine
technology was repurposed (by National Institute for Health Research, UK
Research and Innovation, the Lemann Foundation and Gates Foundation)
to develop the Oxford- AstraZeneca COVID-19 vaccine. This vaccine has
been distributed to 178 countries with over 1.3 billion doses deployed.
• New MERS vaccine developed (Phase 1 trials underway)
• Epidemic data capture kit developed, with significant real-world impact
already achieved e.g. saved 15 million pieces of paper in the 2019
Democratic Republic of Congo Ebola outbreak
• Successful clinical testing of a ChAdOx1 platform Rift Valley fever
veterinary vaccine; findings indicate 100% efficacy against both infection
and disease. This vaccine has also successfully completed Phase 1
clinical trials in humans.
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12. 4. Successes
• Developed a computational tool for vaccine demand and a
mathematical model for vaccine supply
• UKVN-funded self-amplifying RNA vaccine technology was used
to develop Imperial’s COVID-19 vaccine candidate
• Completed a phase 1 clinical trial for a mosquito-borne diseases
vaccine
• Developed a novel Crimean-Congo Haemorrhagic fever (CCHF)
virus vaccine using a proprietary insect cell line.
• Undertaking two first in human clinical trials for a CCHF
vaccine using the ChAdOx1 platform
• Successful clinical development of a Plague vaccine, with Phase
1 trials underway
• Multiple projects received significant follow-on funding
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13. 7. New Research Competition
• Today the UKVN are launching a new research
competition, to be run by Innovate UK
• The competition will grant up to £10 million* of funding
across multiple projects
• The competition will run for one year, between April 2022-
April 2023
• The competition is open to existing and new projects, to
enhance clinical and regulatory preparedness of vaccines
and vaccine technologies for use against diseases in the
UKVN priority pathogen list, or "Disease X"
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*Subject to SR outcomes
14. SBRI - Vaccines for epidemic diseases:
Readiness for clinical development
Details of the Call and Timelines
Dr Phil Packer
Innovation Lead AMR & Vaccines
Innovate UK
15. A structured process enabling the public sector to engage
with innovative suppliers.
• Helping public sector achieve objectives:
Using innovation to achieve step function improvements
• Accelerating commercialisation of ideas:
SBRI Provide a route to market
• Supporting the development of innovative companies:
Provide a lead customer, funding and credibility for fund raising
Helping government, helping businesses
SBRI: the small business research initiative
16. A structured process enabling the public sector to engage
with innovative suppliers
• Development contracts:100% funded R&D services procurement contracts
UK implementation of EU Pre-Commercial Procurement.
• Contract with a single organisation:
Who may choose to sub contract parts of the work.
• IP ownership rest with supplier organisation:
Certain usage rights with the pubic sector – suppliers are encouraged
to exploit the IP.
Helping government, helping businesses
SBRI: the small business research initiative
17. SBRI:
the small
business
research initiative
Helping government, helping
businesses:
Open to all organisations
§ There is no limit on the size or type
of organisation.
Open to organisations not currently
engaged in the sector.
§ Research organisations may also
apply, however all organisations must
demonstrate a route to market
Helping government, helping
businesses:
Open to all organisations
§ There is no limit on the size or type of
organisation.
Open to organisations not currently
engaged in the sector.
§ Research organisations may also
apply, however all organisations must
demonstrate a route to market
18. Technical Requirements
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Project can address any part of the pre-clinical, non-clinical, manufacturing, or
clinical pathway. Vaccine candidates can be for human use or for animal use
where there is an animal reservoir of the target diseases, target Disease X or
human diseases with epidemic potential identified by the UK Vaccine Network:
• Middle East respiratory syndrome
• Nipah
• Plague
• Q fever
• Rift valley fever
• Zika
• Disease X
Projects must complete within a 1-year time frame, making technology ready to be
progressed further along the developmental pathway.
• Chikungunya
• Crimean-Congo haemorrhagic fever
• Ebola
• Hantavirus
• Lassa
• Marburg
19. Projects can include, but are not restricted to, any
elements of the following:
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• work to create a regulatory package suitable for endorsement by the appropriate
regulatory or ethical authority, for example the MHRA and ethics committees, to allow
future work packages to start as soon as funding is available
• completion of work on pre-clinical, non-clinical and supportive assays and technologies
packages to aid the transition from the laboratory to clinical trial-enabling activities
• distinct packages of work to enable drug substance and drug product manufacture
development
• distinct packages of work to enable clinical development, including assay development,
clinical design, and production of regulatory documents
• ideas to increase technical and economic utility or acceptance of vaccines and therefore
likely availability or use in low- and middle-income countries (LMICs)
• can include social impacts of diseases, such as vaccine hesitancy
20. Proposals must:
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• demonstrate your experience in vaccine development
• show you have the required expertise to complete pre-clinical, clinical and manufacturing
work packages to the appropriate time, cost and GxP standards
• have a vaccine technology addressing one of the 12 priority diseases described by the UK
Vaccine Network or Disease X
• describe the candidate vaccine, vaccine platform technology or manufacturing technology
you intend to develop, explaining its relevance to epidemic disease threats, anticipated
clinical application and medical value
• demonstrate that the vaccine candidates, platform technologies and manufacturing
technologies primarily impact and are beneficial to populations in LMICs.
• describe how the product or capability would be used, where and by whom
• give evidence that the technologies and models are appropriate and fit for purpose
• have a defined and justified intended use
• be Official Development Assistance (ODA) compliant, meaning your project can be carried
out in high-income countries, but the primary aim of the research must be to improve the
health, welfare or economic development of countries on the Organisation for Economic
Co-operation and Development’s ‘ Development Assistance Committee (DAC) list’ of ODA
recipients.
21. Applicants should consider:
8
• ease and speed of manufacture
• ease of use in low to middle income countries (LMIC) settings, for example,
needle free and other modes of administration
• temperature stability
• single dose or a low number of boosts
• length of protection
• vaccine platforms that can be rapidly adapted for new or re-emerging diseases.
• vaccines that protect against several strains of a single pathogen, or against
several pathogens.
22. Projects will not be funded that:
9
• do not include complete pre-clinical, clinical, regulatory or manufacturing work
packages delivered to the appropriate time, cost and GxP standards
• do not have industrial expertise and commercial insight in project design
• cannot be undertaken within the working restrictions of coronavirus (COVID 19)
• directly duplicate other UK government work you have already been funded to
deliver
• duplicate existing innovation, or work in progress by others
• are not Official Development Assistance (ODA) compliant
• have total eligible project costs over the amount allowed
• are dependent on export performance
23. Applications
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- A total of up to £10 million, inclusive of VAT, is allocated for this competition.
- The total funding available for the competition will be subject to government approval of funds in the spending review
for 2021-2022.
- Projects can range in size up to total costs of £500,000, inclusive of VAT and up to 12 months duration.
- IUK expect to fund up to 50 projects.
Applicants can:
• be an organisation of any size
• work alone or with others from business, research organisations, research and technology organisations or the third sector as
subcontractors
- Contracts will be awarded only to a single legal entity.
- IUK are looking for proposals that involve industrial or academic institutions as the lead and subcontractors. This work will still be the
responsibility of the main contractor.
- Applications must have at least 50% of the contract value attributed directly and exclusively to R&D services, including solution
exploration and design. R&D can also include prototyping and field-testing the product or service.
R&D does not include:
• commercial development activities such as quantity production
• supply to establish commercial viability or to recover R&D costs
• integration, customisation or incremental adaptations and improvements to existing products or processes
24. |Dates
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Publication date 20 September 2021
Open date 11 October 2021
Close date 10 November
Online event: register to attend 12 October 2021
Online application event briefing event: register to attend https://ukri.zoom.us/j/96646724375
Oct 13, 2021 11:30 London
contracts awarded 1April 2022
Feedback 31 December 2021