Notice

Digitalisation of medicines manufacturing: Challenge Fund

Published 20 August 2018

1. Dates and deadlines

Competition opens	10 September 2018
Competition briefing event	11 September 2018
Competition engagement event	21 September 2018
Final date for registration	Midday 3 October 2018
Deadline for submission of the full application (including finance forms, appendices and Je-S forms)	Midday 10 October 2018
Decision to applicants by end of:	2 November 2018

Please read the full competition scope before you make your application.

2. Funding

Innovate UK is to invest up to £8 million to support the growth of the UK’s commercial capacity to manufacture medicinal products through the application of digital technology. The investment is for enhancements to the manufacturing and distribution operations for small-molecule, biological and advanced therapies for the treatment of human disease and disorders.

Your total project costs may be between £2 million and £4 million.

Your application must show that the project will be compliant with all relevant general state aid regulations.

3. Competition process

Application:

• make sure you use the correct application form or your submission will not be eligible
• if your submission has incomplete or missing finance forms, it will not be eligible
• you must provide all submission documents in the file formats specified later in this guidance. If you provide any document in the incorrect format, your application will not be assessed

For this competition, the process will follow these steps:

• we will review submitted applications to make sure that they are both eligible and in scope for the competition
• we will send applications for assessment only if they meet the eligibility and scope requirements of the competition
• up to 5 external experts in the innovation area identified in your application will assess each in-scope application
• assessors will score applications consistently and in line with scoring matrices. They will provide written feedback for each marked question
• we will rank applications in descending order
• we will notify the lead applicant of the funding decision
• all eligible and in scope applications for the competition will receive assessor feedback

4. How to apply

Register: You will receive an email acknowledging your registration, followed by a second email up to 48 hours later. The second email will contain a username and password for our secure upload facility, along with a unique application number and form.

Application: Once you have received your unique username and password, you can sign in to the secure website. You are then able to access the finance form for this competition from the public download area.

Finance form: We will accept only finance forms named ‘Project Finance Form – capital projects.xls’ into this competition. Previous versions of the project finance form will be ineligible.

Submit your documents: You or your lead partner must submit to your FTP site:

• your application form with your unique application number for this competition (mandatory)
• project finance forms for every partner (including the lead organisation) in your project (mandatory)
• project appendices as PDF documents, labelled as per the appendices guidance below

Scope check: We will send your application for assessment only if it meets the eligibility criteria and scope of the competition. We will notify you if your application is out of scope and explain why. Innovate UK reserves the right to declare applications as out of scope.

Assessment: Once we have completed the scope and eligibility checks, we will send all applications that are eligible and in scope for assessment.

Feedback: We will give feedback to all applications that have been assessed. The lead applicant can access and download the feedback by signing in to the secure FTP site where you uploaded your application documents. It is the responsibility of the lead to communicate the feedback with the rest of the consortium, if applicable.

Notification: We will notify the lead organisation of the outcome of the application by the date stated in the timeline, using the email address provided in the application form.

5. The application form

This section explains the structure of the application form and offers guidance on what to answer in each question.

The structure is as follows:

• application details
• summary of proposed project
• public description of the project
• gateway question: scope
• question 1: need or challenge
• question 2: approach and innovation
• question 3: team and resources
• question 4: market awareness
• question 5: outcomes and route to market
• question 6: wider impacts
• question 7: project management
• question 8: risks
• question 9: added value
• question 10: costs and value for money
• other funding from public sector bodies
• finance summary table

Please make sure that you upload the final version of your application by the deadline. It is the lead organisation’s responsibility to ensure that you do not upload a blank or incomplete application form. You should also follow these steps:

• you can only use the application form provided. It contains specific information including a unique reference number for your project
• the application form contains specific fields. It is important that you complete each field and submit a fully completed form. We will consider incomplete forms ineligible and won’t send them for assessment
• you must not alter, convert or save the application form as a different version of Microsoft Word
• the space provided in each field of the form is fixed. You must restrict your responses in each of the fields to the space provided. The typeface, font size and colour are set and you cannot change them. You cannot include illustrations, graphics and hyperlinks in the application form
• the light grey shaded fields are completed automatically from other information entered on the form, such as the total columns of a table. You cannot overwrite these
• you should be able to see your total answer to the question when looking at the application form in print view. Any text that cannot be seen in this view or when the form is printed will not be assessed
• your answer to each question should be no longer than 1 side of A4 using the font Calibri 11

As part of our objective to stimulate and support UK innovation, we have established a close network of affinity partners. This list is made up of organisations that can help Innovate UK fund and support innovative businesses. Our joint aim is to speed up sustainable economic growth for the UK.

In some cases, we may share the public description of your project with other potential funding bodies, for example Local Enterprise Partnerships (LEP’s), agencies of Scotland, Wales and Northern Ireland. These bodies may wish to contact you about providing funding or other support for your proposal.

Field	Guidance
Competition name	This field will show the full name of the Innovate UK competition to which the form applies. You do not need to enter anything here.
Document ID	This field is completed automatically.
Applicant number	This field is completed automatically and is the reference that you should use on all correspondence (this is the 6 digit number after the dash).
Application details
Project title	Enter the full title of the project.
Project timescales	Enter the estimated start date and its planned duration. These are indicative at this stage and are not guaranteed.
(Lead ) organisation name	Enter the full registered name of the (lead) organisation for the project. If you are not in a consortium application, these will be your organisation details. Please note that the lead organisation will be the main point of contact between Innovate UK and the project team.
(Lead) organisation contact details	Enter the full name, postcode, email address and telephone number of the main point of contact between Innovate UK and the project.

Summary of proposed project (not scored)

Please provide a short summary of the content and objectives of the project including what is innovative about it.

This summary is not scored, but provides an introduction to your proposal for the benefit of Innovate UK staff and assessors only. We will not disseminate it publicly. It should cover, in brief:

• the business need, technological challenge or market opportunity you will target
• the approach you will take and how this will improve on current state-of-the-art
• the difference the project will make to UK competitiveness and productivity

Public description of the project (not scored)

To comply with government practice on openness and transparency of public-funded activities, Innovate UK has to publish information relating to funded projects. Please provide a short description of your proposal in a way that will be understandable to the general public. Do not include any commercially-confidential information, for example intellectual property or patent details. Describe your project. We will not provide funding to successful projects without this.

Gateway question: scope

How does this application align with the specific competition scope?

• all applications must align with the specific competition scope criteria as described in the relevant competition brief
• to demonstrate alignment, you need to show that a clear majority of the project’s objectives and activities are aligned with the specific competition

6. Competition questions

All questions apply to all project partners and are scored out of 10 marks.

Question 1. Need or challenge

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

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 focus of your project is on developing an existing capability or building a new one
• any links to existing projects funded by Innovate UK, such as for the Advanced Therapy Treatment Centres or the Medicines Manufacturing Collaborative R&D competitions
• any alignment to regional initiatives such as those started through Local Enterprise Partnerships
• the wider economic, social, environmental, cultural 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

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

You can submit a single appendix as a PDF no larger than 1MB and up to 2 pages long to support your answer. The font must be legible at 100% zoom.

Question 3. Team and resources

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

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 you will need to fill

You can submit a single appendix as a PDF no larger than 1MB and up to 4 pages long to support your answer. The font must be legible at 100% zoom.

Question 4. Market awareness

What does the market you are targeting look like?

Describe or explain:

• the markets (domestic, international or both) 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 to 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 into the long term as a result of the project?

Describe or explain:

• 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 or end users, and the value to them, for example, why they would use or buy your product
• your route to market
• how you are going to profit from the innovation, including 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 this project have outside the project team?

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, especially those promoted through the Industrial Strategy Challenge Fund
• 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

How will you manage the project effectively?

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 you will use 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 can upload a project plan or Gantt chart as an appendix in PDF format no larger than 1MB and up to 2 pages long. The font must be legible at 100% zoom.

Question 8. Risks

Identify the main risks and uncertainties you will face in trying to deliver quality research and development, and ultimately new products and services, from this investment. In your answer:

• include commercial, managerial and environmental risks, highlighting the most significant ones
• highlight issues that might prevent you and your consortium (if you are working with one) from spending and claiming the grant by 31 March 2018
• explain how you will mitigate these risks

In a separate appendix you can submit a risk register of up to 2 sides of A4 in length in PDF format.

Question 9. Added value

Describe the impact that public funding would have on this project. Tell us:

• whether this programme could go ahead in any form without public funding, and if so, the difference the public funding would make (such as faster routes to market, more partners or reduced risk)
• the likely impact of the investment on the organisations involved
• why you are not able to wholly fund this from your own resources or other forms of private-sector funding (in other words, what would happen if the application is unsuccessful)
• explain how this investment would change the nature of your R&D and manufacturing activity

Question 10. Costs and value for money

How much grant are you requesting, and how does it represent value for money for the team and the taxpayer?

To give evidence for this:

• justify the grant you are requesting by explaining the potential impact on the production of medicines
• as a business, explain how you will match (50:50) the grant requested and what you would spend this money on otherwise
• explain how this investment represents value for money for you and the taxpayer

Other funding from public sector bodies

If you have included one or more entries in column 7 of the finance summary table (below), please provide:

• the names of the bodies
• the name of the programme or scheme from which the funds are provided
• the fund amounts

7. Finance summary

This table lists the total eligible project costs by organisation. Please note that only certain project costs are eligible for grant funding under UK state aid rules. See our project costs guidance for information on eligible project costs and how to complete the project finance form.

Column 1 Organisation name	Provide the full names of the lead organisation followed by any other organisations in the project consortium (organisation names as noted in Companies House).
Column 2 Organisation registration number	Organisations should provide the Company Registration Number (as noted in Companies House). Universities and higher education institutions should enter their RC number, charitable status or legal entity registration number.
Column 3 Enterprise category	Select your enterprise category. SME definition is based on the EU definition Medium sized: Headcount less than 250: Turnover less than 50 million euros or balance sheet total less than 43 million euros Small: Headcount less than 50: Turnover less than 10 million euros or balance sheet total less than 10 million euros Micro: Headcount less than 10: Turnover less than 2 million euros or balance sheet total less than 2 million euros
Column 4 Postcode where majority of work will be done	Provide the postcode where the majority of work will take place for each organisation participating in the project.
Column 5 Contribution to the project by each organisation (£)	List the total contribution each organisation will make to the project.
Column 6 Funding sought from Innovate UK	Enter the funding sought from Innovate UK for each contributing organisation for this competition.
Column 7 Other funding from public sector bodies	Include any funding applied for separately for the project from any other public sector bodies and not as part of this competition. Funding from other public sector bodies might include other applications to research councils, other government departments, devolved administrations, other public sector organisations and some charities. The purpose of this column is to provide Innovate UK with information on the total public funding for the project.
Column 8 Total (£)	The total cost of the project for each contributor. This is the sum of columns 5, 6 and 7 and will be calculated automatically.
Bottom Row Total (£)	The total of each column will be calculated automatically.

Please ensure that you click out of each cell after entering your figures.

8. Finance form

Each non-academic organisation in your project must provide a project finance form using the template ‘Project finance form – capital projects.xls’, which is available on the FTP site. In this competition we will only fund costs which fall under the ‘capital’ tabs in the form. The lead applicant must submit this in Excel format with the application form.

Each finance form provides a detailed breakdown of each organisation’s total eligible project costs. Please ensure that all total figures listed in your finance summary table match those stated in the ‘Form status’ tab within the project finance form.

9. Project appendices

You can only include appendices in support of questions 2, 3, 7 and 8 as described in the guidance for those questions.

We will consider your application ineligible if you submit appendices:

• in support of any other questions
• that do not use the correct naming convention
• that have the wrong content

In order that assessors can open and read the appendices, each appendix must:

• conform to the maximum length specifications stated for each question
• be in portable document format (PDF)
• be legible at 100% zoom
• display prominently the ‘application number’ as in the filename of the application form, for example ‘AppendixQ4-(application number eg.123456)’