Funding competition Medicines manufacturing round 2: challenge fund

UK businesses can apply for a share of £10 million from the Industrial Strategy Challenge Fund for innovative projects in medicines manufacturing.

Competition opens: Monday 12 March 2018
Competition closes: Wednesday 9 May 2018 12:00pm

This competition is now closed.

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Description

Innovate UK as part of UK Research and Innovation will invest up to £10 million in innovation projects in medicines manufacturing to be funded through the Industrial Strategy Challenge Fund. Projects should focus on specific technical or commercial challenges.

You must show how your project will improve the productivity, competitiveness and growth of at least one UK micro, small or medium-sized enterprise (SME) involved in the project.

A business must lead the project.

If you are a business, you can carry out the project on your own or you can collaborate with others.

If your project size falls outside of our scope, contact us before you apply.

Funding type

Grant

Project size

Your project’s total costs should be between £50,000 and £1.5 million. Projects should start by 1 September 2018 and must be completed before April 2021. It should last between 6 months and 30 months.

Who can apply

To be eligible for funding you must:

be a UK-based business, academic organisation, charity, public sector organisation or research and technology organisation (RTO)
carry out your project work in the UK
intend to exploit the results from the UK

You must be a business to lead an application.

All projects must involve at least one SME, working alone or in collaboration with other organisations. Projects longer than 12 months or with costs of £100,000 or more must:

collaborate with other organisations but can be led by a business of any size
include a site that holds a full manufacturing and importation authorisation (MIA licence) or a manufacture of investigational medicinal products (MIA IMP) licence in the UK for the manufacture of the appropriate type of medicine

The lead organisation must claim funding through this competition. If the project is collaborative, at least one other organisation in the consortium must also claim funding.

Any one business may lead on one application and partner in a further 2 applications.

RTOs cannot lead on an application but can be a collaborator in any number of applications.

Academics cannot lead on an application but can be a collaborator in any number of applications.

The research organisations collaborating as part of a consortium may share up to 30% of the total eligible project costs. If your consortium contains more than one research organisation, this maximum will be shared between them.

Projects may include partners that don’t receive any funding (for example, non-UK businesses). Their costs will count towards the total project costs but they will not count as collaborators.

If you applied to a previous competition as the lead or sole company and were awarded funding by Innovate UK, but did not make a substantial effort to exploit that award, we will award no more funding to you, in this or any other competition. You will not be able to contest our decision. We will:

assess your efforts in the previous competition against your exploitation plan for that project
review the monitoring officers’ reports and any other relevant sources for evidence
document our decision, which will be made by 3 team members
communicate our decision to you in writing

Resubmissions

If Innovate UK judges that your proposal is not materially different from your previous proposal, it will be classed as a resubmission.

If your application is unsuccessful, you may reapply with the same proposal once more, taking into account the feedback received from the assessors. This can be into another competition. In other words, you can make a maximum of 2 applications in total with any proposal.

Funding

We have allocated up to £10 million to fund innovation projects in this competition.

Up to £1 million is available to fund projects with eligible costs of up to £100,000 and 6 to 12 months in duration.

Up to £9 million is available to fund projects with eligible costs of up to £1.5 million and between 12 and 30 months in duration.

Project costs of up to £100,000

If you are a micro or SME and your eligible project costs are up to £100,000, you can run the project on your own. You can also work with other businesses or research organisations.

Project costs of £100,000 or above

If your eligible project costs are more than £100,000 you must work with other organisations who are claiming grant as part of the project. At least one member of the consortium must be a micro or SME.

Your proposal

This competition aims to stimulate the development of innovative methods or technologies to improve the manufacture of novel medicines for human use.

‘Novel’ medicines are those that have not yet been commercially launched on the market but may have been applied as part of clinical trials or under exemptions from the UK Human Medicines Regulations.

Your proposals can include, but are not limited to, approaches that have the potential to deliver:

improved commercially viable manufacturing processes
methods for the reliable and robust scale-up of production of novel medicines
increased yield of active ingredient
lower cost of production and goods

In each case there must be reason to expect an improvement in excess of 25%. Small incremental improvements will be deemed to be outside scope.

In this competition medicines that are in scope and can be used as examplar products are limited to:

advanced therapy medicinal products
natural product medicines
nucleic acid-based drugs
prophylactic vaccines
protein or peptide biopharmaceuticals
small molecular weight pharmaceuticals
virus and phage therapeutics

We are looking to fund a portfolio of projects, across a variety of technologies, markets, medicine classes, and technological maturities. These may include feasibility studies, industrial research projects or experimental development projects.

Specific themes

We are particularly encouraging applications that address:

in-process monitoring, control and release testing
maintaining product-critical quality parameters such as purity, potency and viability
formulation processes
packaging and storage processes
product characterisation
process challenges for increasing the scale of production
process development and effective site-to-site transfer for novel medicines
transfer of technology from small-scale manufacturing to a good manufacturing practice (GMP) manufacturing facility
lowering of the cost of goods
increase in yield of active ingredient
increase in speed of production cycle
methods to increase the flexibility of established manufacturing facilities
adaptation of processes from batch to continuous production

Project types

Your project can focus on technical feasibility, industrial research or experimental development.

For feasibility projects, the grant enables the exploration and evaluation of the commercial potential of an early-stage concept. Your project must deliver:

assessment of the business opportunity
validation of the initial concept
potential conceptualisation
scoping for further development

For industrial research and experimental development, the grant enables the development of new and innovative solutions to medicines manufacturing challenges. Your proposal must demonstrate:

the current challenge and value proposition
a clear understanding of the market potential, routes to market and commercialisation strategies

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

up to 70% if you are a micro or 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 funding for your eligible project costs of:

up to 45% if you are a micro or 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.

Projects we won’t fund

We will not fund projects that cover:

small incremental improvement to an existing process
medicines discovery
manufacturing process innovation using a non-human medicine as the product
manufacturing process innovation using a marketed medicine as the product
product or prototype development where the main innovation, challenge or risk is not in the manufacturing process
projects that apply existing and well-known manufacturing processes, without significant innovation challenges, to develop a new product
manufacturing process innovation that does not apply to the list of medicines detailed in the scope section

12 March 2018: Competition opens
20 March 2018: Online applicant briefing event. Register now. Password: medman.
9 May 2018 12:00pm: Competition closes
29 June 2018 1:59pm: Applicants notified

Before you start

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

When you start an application you will be prompted to create an account as the lead applicant or sign in as a representative of your organisation. You will need an account to track the progress of your application.

As the lead applicant you will be responsible for:

collecting the information for your application
representing your organisation in leading the project if your application is successful

You will be able to invite:

colleagues to contribute to the application
other organisations to participate in the project as collaborators if your application is successful

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

What we will ask you

The application is split into 3 sections:

Project details
Application questions
Finances

1. Project details

Explain your project. This section is not scored, but we will use it to decide whether the project fits with the scope of the competition. If it doesn’t, it will be immediately rejected.

Application details

The lead applicant must complete this section. Give your project’s title, start date and length. List any partner organisations you have named as collaborators.

Project summary

Describe your project briefly, and be clear about what makes it innovative. We use this section to assign experts to assess your application.

Public description

Describe your project in detail, and in a way that you are happy to see published. Please do not include any commercially sensitive information. If we award your project funding, we will publish this description. This could be before you start your project.

Project scope

Describe how your project fits the scope of the competition. If your project is not in scope it will be immediately rejected and will not be sent for assessment. We will give you feedback on why.

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.

Your answer to each question can be up to 400 words long.

Question 1: Need or challenge

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

You should describe or explain:

the main motivation for the project
the business need, technological challenge or market opportunity
the nearest current state-of-the-art, including those near market or in development, and its limitations
any work you have already done to respond to this need, for example if the project is focused on developing an existing capability or building a new one
any background research by you or other researchers that gives you confidence in achieving the desired manufacturing improvement
the wider economic, social, environmental, cultural and/or political challenges which are influential in creating the opportunity, such as incoming regulations. Our Horizons tool can help with this

Question 2: Approach and innovation

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

You should describe or explain:

how you will respond to the need, challenge or opportunity identified
how you will improve on the nearest current state-of-the-art identified
whether the innovation will focus on the application of existing technologies in new areas, the development of new technologies for existing areas or a totally disruptive approach
the freedom you have to operate
how this project fits with your current product, service lines or offerings
how it will make you more competitive
the nature of the outputs you expect from the project (for example, report, demonstrator, know-how, new process, product or service design) and how these will help you to target the need, challenge or opportunity identified
how the results may impact manufacture in the wider medicines manufacturing sector

You may submit a single appendix as a PDF no larger than 1MB and up to 2 pages in size to support your answer.

Question 3: Team and resources

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

You should describe or explain:

the roles, skills and experience of all members of the project team that are relevant to the approach you will be taking
the resources, equipment and facilities needed for the project and how you will access them
the details of any vital external parties, including sub-contractors, who you will need to work with to successfully carry out the project
(if your project is collaborative) the current relationships between project partners and how these will change as a result of the project
any gaps in the team that will need to be filled
how the proposed work fits into the business development activity of the lead organisation and any collaborators

You may submit a single appendix as a PDF no larger than 1MB and up to 4 pages long to support your answer.

Question 4: Market awareness

What does the market you are targeting look like?

You should describe or explain (for the manufacturing technology, rather than for the exemplar medicine(s)):

the markets (domestic, international or both) that you will be targeting in the project and any other potential markets
the size of the target markets for the project outcomes, backed up by references where available
the structure and dynamics of the target markets, including customer segmentation, together with predicted growth rates within clear timeframes
the target markets’ main supply or value chains and business models, and any barriers to entry that exist
the current UK position in targeting these markets
the size and main features of any other markets not already listed

If your project is highly innovative, where the market may be unexplored, describe or explain:

what the market’s size might be
how your project will try to explore the market’s potential

Question 5: Outcomes and route to market

How are you going to grow your business and increase your productivity in the long term as a result of the project?

You should describe or explain (for the manufacturing technology, rather than for the exemplar medicine(s)):

your current position in the markets and supply or value chains outlined, and whether you will be extending or establishing your market position
your target customers and/or end users, and the value to them, for example, why would they use or buy it?
your route to market
how you are going to profit from the innovation (increased revenues or cost reduction)
how the innovation will affect your productivity and growth, in both the short and the long term
how you will protect and exploit the outputs of the project, for example through know-how, patenting, designs or changes to your business model
your strategy for targeting the other markets you have identified during or after the project

If there is any research organisation activity in the project, describe:

your plans to spread the project’s research outputs over a reasonable timescale
how you expect to use the results generated from the project in further research activities

Question 6: Wider impacts

What impact might the manufacturing improvements from this project have outside the project team?

You should describe, and where possible measure:

the economic benefits from the project to external parties, including customers, others in the supply chain, broader industry and the UK economy, such as productivity increases and import substitution
any expected impact on government priorities
any expected environmental impacts, either positive or negative
any expected regional impacts of the project

Describe any expected social impacts, either positive or negative on, for example:

quality of life
social inclusion or exclusion
jobs, such as safeguarding, creating, changing or displacing them
education
public empowerment
health and safety
regulations
diversity

Question 7: Project management

You should describe or explain:

the main work packages of the project, indicating the relevant research category, the lead partner assigned to each and the total cost of each one
your approach to project management, identifying any major tools and mechanisms that will be used for a successful and innovative project outcome.
the management reporting lines
your project plan in enough 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 larger than 1MB and up to 2 pages long.

Question 8: Risks

What are the main risks for this project?

You should describe or explain:

the main risks and uncertainties of the project, including the technical, commercial, managerial and environmental risks, providing a risk register if appropriate
how these risks will be mitigated
any project inputs that are critical to completion, such as resources, expertise, data sets
any output likely to be subject to regulatory requirements, certification, ethical issues and so on, and how will you manage this?

You may upload a risk register as an appendix in PDF format no larger than 1MB and up to 2 pages long.

Question 9: Additionality

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

You should describe or explain:

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 and reduced risk
the likely impact of the project on the business of the partners involved
why you are not able to wholly fund the project from your own resources or other forms of private-sector funding, and what would happen if the application is unsuccessful
how this project would change the nature of R&D activity the partners would undertake, and the 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?

You should describe or explain:

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

3. Finances

The finances section asks each organisation in your project to complete their own project costs, organisational details and funding details. 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.

Before you start

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

To apply:

register online using the green button
read the guidance for applicants <add link> for this competition
consider attending one of the briefing events listed in ‘Dates’
complete and upload your online application to our secure server

We will not accept late submissions. Your application is confidential.

External, independent experts will assess the quality your application. We will then select the projects to fund, building a portfolio of projects that:

are high quality
address the range of themes as described in the scope
represent the potential for return on investment for the company and the UK

Subject to meeting the quality threshold, we reserve the right to manage the portfolio to achieve the correct balance of projects and funding.

Please use Microsoft Word. If you use Google Docs or any other open source software your application will be ineligible.

Background and further information

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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