Funding competition Establishing UK treatment centres for advanced therapies

UK organisations working with research organisations can apply for a share of up to £30 million to support the creation of a network of advanced therapies treatment centres.

Competition opens: Friday 29 September 2017
Competition closes: Wednesday 1 November 2017 12:00pm

This competition is now closed.

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Description

Innovate UK is to invest up to £30 million to establish a network of 3 advanced therapies treatment centres in the UK.

Proposals should:

increase patient access to advanced therapy medicinal products (ATMPs) on a national level
establish best practice for the safe and effective delivery of ATMPs to patients
establish best practice for the manufacturing and final preparation of ATMPs using Good Manufacturing Practice (GMP) within a clinical setting
establish robust connected supply chains for the manufacture and delivery of ATMPs
create systems to allow traceability and tracking of ATMPs. These must be compatible with current regulations and be suitable for applying across the NHS
establish best practice for patient follow up and data capture

All of the centres that receive funding will form a network. This will be co-ordinated through the Cell and Gene Therapy Catapult.

The 3 successful centres will eligible to apply for up to £6 million of additional funding in 2018 for network projects and related activities.

Funding type

Grant

Project size

Total project costs should be between £6 million and £9 million.

Find out if you are eligible to apply

To lead a project you must:

be a UK based business, an NHS trust, a hospital, an AHSN or a BRC
carry out your project in the UK
work in collaboration with others (businesses, Catapults, research base and third sector)
show a clear commitment and plan to grow a national network for ATMP delivery into the NHS

Any one business may be involved in up to 3 applications to this competition, but can only be the lead partner in one application. RTOs cannot lead applications but are not limited in the number of applications where they can be a collaborator.

Your project must be collaborative and include at least 3 grant-claiming organisations.

You must start your project by 1 February 2018 and you must complete your project within 3 years.

For all research organisations, the total level of project participation is set at a maximum of 50% of total eligible project costs. This limit applies if your consortium contains more than one research organisation.

Projects that we won't fund.

In this competition we are not funding projects covering:

the discovery of medicines or ATMPs
manufacture or development of medicines that are not ATMPs
process innovation using a non-human medicine as the product
stem cell treatments and transplants not covered by ATMP regulations
phase 1 clinical trials
treatment costs for patients in clinical trials

Funding and project details.

We have allocated up to £30 million to fund innovation projects in this competition.

Your project must focus on innovative methods to increase delivery of, and patient treatment with, ATMPs as outlined in the scope.

Your project must involve at least:

one NHS trust or hospital with an intensive care unit and a proven track record of treating patients with ATMPs. It must have the necessary infrastructure for running trials and delivering licensed ATMPs
one SME
one company developing commercial ATMPs
one supply chain company

If you are successful, you will be able to get grant funding towards your eligible project costs. The percentage we will pay towards your costs will vary depending on the type of organisation you are and the type of research you are carrying out.

Project types

Your project can focus on technical feasibility, industrial research or experimental development. This will depend on the challenge.

For technical feasibility studies and industrial research, you could get funding for your eligible project costs of:

up to 70% if you are a small business
up to 60% if you are a medium-sized business
up to 50% if you are a large business

For experimental development projects which are nearer to market, you could get:

up to 45% of your eligible project costs if you are a small business
up to 35% if you are a medium-sized business
up to 25% if you are a large business

Find out if your business fits the EU definition of an SME.

Competition scope

We aim to encourage the development and implementation of innovative methods or technologies that will scale up the delivery of ATMPs in hospitals. These therapies and their production will be disruptive to the current clinical treatment setting and systems. These can include, but are not limited to approaches that:

increase patient access to advanced therapy medicinal products (ATMPs) on a national level
develop best practice for the safe and effective delivery of ATMPs to patients
develop best practice for the manufacturing and final preparation of ATMPs using good manufacturing practice (GMP) within a clinical setting
establish robust connected supply chains for manufacture and delivery of ATMPs
develop systems that enable long term patient follow up
develop systems and processes that can be applied to other hospitals

You can only use ATMPs as examples.

Your proposal must improve business growth and productivity, or create export opportunities for at least one UK SME involved in the project.

Specific competition themes

We are particularly encouraging applications that:

work with more than one ATMP type
treat more than one organ, cell disease or disorder
accelerate the delivery of ATMP treatments and trials
are strategic collaborations involving clinicial teams , instrument suppliers, academia and companies developing innovative ATMPs
seek to develop processes that increase patient access to ATMPs
collaborate with commercial partners with manufacturing facilities external to the hospital or trust

29 September 2017: Competition opens
11 October 2017: Applicant briefing. Watch the recording
1 November 2017 12:00pm: Competition closes
17 November 2017: Applicants invited to interview.
27 November 2017: Panel interviews until 28 November 2017.
8 December 2017: Applicants notified

Before you start

To start an application you must create an account as the lead applicant. Once you have an account you can track the progress of your application.

As a lead applicant:

you are responsible for collecting the information for your funding application
you can invite other organisations who will participate in the project as collaborators if your application is successful
you can invite colleagues to contribute to the application
your organisation will lead the project if your application is successful

Partner organisations can be other businesses, research organisations, public sector organisations or charities.

Please read the general guidance for applicants it will help your chances of submitting a quality application.

Research organisations

Research organisations may participate in applications as collaborators.

There are specific rules for research partners which limit the amount of involvement a research organisation may have in your project. The participation rule will be set out in the eligibility criteria for the competition.

You will not be able to submit your application if your research participation is over the stated percentage for the competition.

What we ask you

The application is split into 3 sections:

Project details
Application questions
Finances

1. Project details

In this section you will provide the details of your project. This section is not scored, but our assessors will use it to decide whether the project fits with the scope of the competition. If it doesn’t fit the scope then it will be immediately rejected. Within project details you will need to complete:

Application details

The title of your project, the start date and project length. This section will also list you as the lead organisation and any partner organisations you have named as collaborators. The lead applicant must complete this section.

Project summary

Describe your project and what is innovative about it. We use this section to assign experts to assess your application so we need a summary of the innovation in your project.

Public description

Describe your project in a way that you are happy to see published. Please do not include any commercially sensitive information. If your project is successful and awarded funding, Innovate UK will publish this description.

Project scope

Describe how your project fits the scope of the competition. If your project is not in scope it will not be eligible for funding and will not be sent for assessment. Innovate UK will provide feedback if we decide that your project is not in scope.

2. Application questions

In this section, answers to these questions are scored by the assessors. Following assessment, you will receive feedback from the assessors for each question.

Question 1: Need or challenge

What is the business need, citizen challenge, technological challenge or market opportunity behind your innovation?

describe the main motivation for the project; the business need, the citizen-centric challenge (for Urban Living proposals), technological challenge or market opportunity
describe the nearest current state-of-the-art (including those near-market or in development) and its limitations
describe any work you have already done to respond to this need. For example is the project focused on developing an existing capability or building a new one?
identify the wider economic, social, environmental, cultural and/or political challenges which are influential in creating the opportunity for example, incoming regulations. Our Horizons tool can help here.

Question 2: Approach and innovation

What approach will you take and where will the focus of the innovation be?

explain how you propose to respond to the need, challenge or opportunity identified
explain how it will improve on the nearest current state-of-the-art identified
indicate where the focus of the innovation will be in the project (application of existing technologies in new areas, development of new technologies for existing areas or a totally disruptive approach) and the freedom you have to operate
explain how this project fits with your current product/service lines/offerings
explain how it will make you more competitive
describe the nature of the outputs you expect from the project for example, report, demonstrator, know-how, new process, product or service design. How will these will take you closer to targeting the need, challenge or opportunity identified?

You may submit a single appendix as a PDF no more than 1MB in size to support your answer.

Question 3: Team and resources

Who is in the project team and what are their roles?

describe the roles, skills and relevant experience of all members of the project team in relation to the approach you will be taking
describe the resources, equipment and facilities required for the project and how you will access them
provide details of any vital external parties, including sub-contractors, who you will need to work with to successfully carry out the project
(if collaborative) describe the current relationships between the project partners and how these will change as a result of the project
highlight any gaps in the team that will need to be filled

You may submit a single appendix as a PDF no more than 1MB in size.to support your answer.

Question 4: Market awareness

What does the market you are targeting look like?

Specify the markets (domestic and/or international) you will be targeting in the project and any other potential markets.

For the target markets, describe:

the size of the target markets for the project outcomes, backed up by appropriate references where available
the structure and dynamics of the market such as customer segmentation, together with predicted growth rates within clear timeframes
the main supply/value chains and business models in operation and any barriers to entry
the current UK position in targeting this market
aspects that may be relevant to the delivery of other advanced therapies, to allow the centre to expand the treatment range offered, or applied to the development of additional treatment centres

For highly innovative projects, where the market may be unexplored, explain:

what the route to market could or might be
what its size might be
how the project will seek to explore the market potential

For other markets, briefly describe the size and main features

Question 5: Outcomes and route to market

How do you propose to grow your business and increase your productivity into the long term as a result of the project?

describe your current position in the markets and supply/value chains outlined for example, if you will be extending or establishing your market position
describe your target customers and/or end-users, and the value proposition to them (why would they use/buy it?)
describe your route to market
tell us how you are going to profit from the innovation (increased revenues or cost reduction)
explain how the innovation will impact your productivity and growth in the short and long-term
describe how you will protect and exploit the outputs of the project for example, through know-how, patenting, designs, changes to business model
describe how you will share lessons from business models and operational models with the clinical and commercial sectors
outline your strategy for targeting the other markets identified during or after the project
for any research organisation activity in the project, outline your plans to disseminate project research outputs over a reasonable timescale
if you expect to use the results generated from the project in further research activities, describe how you will do this

Question 6: Wider impacts

What impact might this project have outside the project team?

Identify, and where possible measure, the economic benefits from the project to those outside the project (customers, others in the supply chain, broader industry and the UK economy) such as productivity increases and import substitution.

Identify, and where possible measure, any expected social impacts, either positive or negative, for example:

quality of life
social inclusion/exclusion
jobs (safeguarded, created, changed, displaced)
education
public empowerment
health and safety
regulations
diversity
any expected impact on government priorities

Identify, and where possible measure, any expected environmental impacts, either positive or negative.

Identify any expected regional impacts of the project.

Question 7: Project management

How will you manage the project effectively?

outline the main work packages of the project, indicating the relevant research category and lead partner assigned to each, and the total cost of each one
describe your approach to project management, identifying any major tools and mechanisms that will be used to ensure a successful project outcome. Highlight your approach to managing the most innovative aspects of the project
outline the management reporting lines
outline your project plan in sufficient detail to identify any links or dependencies between work packages or milestones

You may upload a project plan or Gantt chart as an appendix in PDF format no more than 1MB in size.

Question 8: Risks

What are the main risks for this project?

identify the main risks and uncertainties of the project, including the technical, commercial, managerial and environmental risks. Highlight the most significant ones, providing a risk register if appropriate
explain how these risks will be mitigated
list any project inputs on the critical route to completion such as resources, expertise or data sets
is the output likely to be subject to regulatory requirements, certification, ethical or other similar issues? If so how will you manage this?

You may upload a risk register as an appendix in PDF format no more than 1MB in size.

Question 9: Additionality

Describe the impact that an injection of public funding would have on this project.

tell us if this project could go ahead in any form without public funding and if so, the difference the public funding would make such as faster to market, more partners, reduced risk
describe the likely impact of the project on the business of the partners involved
tell us why you are not able to wholly fund the project from your own resources or other forms of private-sector funding (what would happen if the application is unsuccessful)
explain how this project would change the nature of research and development activity the partners would undertake, and related spend

Question 10: Costs and value for money

How much will the project cost and how does it represent value for money for the team and the taxpayer?

justify the total project cost and the grant being requested in terms of the project goals
explain how the partners will finance their contributions to the project
explain how this project represents value for money for you and the taxpayer. How does it compare to what you would spend your money on otherwise?
justify the balance of costs and grant across the project partners
justify any sub-contractor costs and why they are critical to the project

3. Finances

The finances section asks each organisation to complete project costs, organisational details and funding details for each organisation in your project. Academics will need to complete and upload a Je-S form. For full details on what costs you can claim please see our project costs guidance.

Background and further information

Advanced therapy medicinal products (ATMP) are new and emerging medicines based on genes (gene therapy), cells (cell therapy), and tissues (tissue engineering). These new treatment options will be particularly important in areas of unmet clinical need where conventional approaches have not yielded viable options. These include some common conditions, such as forms of blindness, cancer, heart failure, liver disease, and neurological conditions, but also rare and paediatric diseases.

By their nature, advanced therapies are very different from traditional pharmaceuticals and biopharmaceuticals and require distinct and complex production. Many of the therapies being developed represent the most personalised form of medicine, as the starting material used for the production of the therapeutic agent is the patient’s own cells. As such, these therapies and their production will be disruptive to the current clinical treatment setting and systems.

A near?term opportunity exists for the UK to lead with these disruptive technologies. Once established, with attendant supply chains, the unique and complex manufacturing and clinical interfaces will help speed products to market. They will also anchor jobs and economic activity in the UK, and form a strong base for the export of goods and services globally.

The UK advanced therapy sector is growing, with both standalone advanced therapy companies (and supply chains) and established pharmaceutical companies. The most recent data from the Office for Life Sciences show that there are 62 ATMP manufacturers in the UK, with turnover of £156 million and approximately 840 employees. These companies have seen approximately 35% growth in annual turnover and 6% employment growth between 2011 and 2015.

While HMG has supported investment in the development of Advanced Therapies, the centres would fill a strategic gap by establishing a viable business model for hospitals to support commercially viable production in “in-hospital settings”. It will also address a number of market failures relating to the scale-up and commercialisation of the highly innovative cell and gene therapies currently being developed in this emerging and highly competitive cell commercial sector.

If you want help to find a project partner, contact the Knowledge Transfer Network.

If you need more information, contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.

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