Funding competition Medicines manufacturing round 1: challenge fund

UK businesses can apply for a share of up to £15 million for innovative projects in medicines manufacturing solutions.

This competition is now closed.

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Competition sections

Description

Innovate UK is to invest up to £15 million in innovation projects in medicines manufacturing to be funded through the Industrial Strategy Challenge Fund. Projects should focus on identified technical or commercial challenges. There are 2 parts to this competition:

1.Feasibility projects.

2.Industrial research and experimental development projects.

You must start your projects by 1 February 2018.

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

Funding type

Grant

Project size

Feasibility: total project costs of £50,000 to £100,000. Industrial research and experimental development: total project costs of up to £2 million.

Find out if you are eligible to apply

To lead a project you must be UK based and carry out your project in the UK.

Feasibility study projects must be led by an SME working alone or in collaboration.

Industrial research and experimental development projects must be collaborative and work with at least one other grant-claiming partner (businesses, RTO, Catapult, research base and/or third sector).

Both 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 be collaborative with other partners. This must include a site that holds an appropriate full Manufacture of Investigational Medicinal Product licence in the UK for the manufacture of medicines.

Making more than one application and resubmissions

  • any one business may be involved in up to 3 applications to this competition, but can only be the lead partner in one application
  • if an application is unsuccessful, you can use the feedback received to reapply for the same project into either another round of this competition or another competition. A project proposal can only be submitted twice

For all research organisations, the total level of project participation is set at a maximum of 30% of total eligible project costs. If your consortium contains more than one research organisation, they must share this maximum between them.

Projects that we won’t fund

In this competition we will not fund:

  • medicines discovery
  • manufacturing process innovation using a non-human medicine as the product
  • manufacturing process innovation using a marketed medicine as the product example
  • 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

Funding and project details

We have allocated up to £15 million to fund innovation projects in this competition. This is divided up as:

  • up to £1 million for projects lasting up to one year
  • up to £14 million for projects lasting up to 3 years

Projects must focus on innovative medicines manufacturing challenges outlined in the scope.

Feasibility studies:

  • total project costs must range in size from £50,000 to £100,000
  • projects can be from a single SME or you can work with other businesses or research organisations
  • you must complete your project within one year

Industrial research and experimental development:

  • total project costs must must be up to £2 million
  • projects must be collaborative and include at least 2 grant-claiming organisations.
  • you must complete your project within 3 years

We can consider projects outside this range but you must contact us at least 10 days before the submission deadline to discuss.

You must start your project by 1 February 2018.

If you are successful, you can get grant funding towards your eligible project costs. The percentage of costs that we pay varies. This depends 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.

For technical feasibility studies and industrial research, you could get:

  • up to 70% of your eligible project costs 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 or work packages which are nearer to market, you could get:

  • up to 45% of your eligible project costs 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.

Competition scope

This competition aims to stimulate the development and implementation of innovative methods/technologies to improve the manufacture of novel medicines for human use. Proposals must offer innovative approaches to medicines manufacturing challenges. These can include, but are not limited to, approaches that 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 this competition medicines that are in scope and must be used as examples 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

For feasibility projects, the grant enables the exploration and evaluation of the commercial potential of an early-stage concept. The 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. Proposals must demonstrate:

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

We will fund a portfolio of projects. These can include technical feasibility, industrial research or experimental development. Projects must show significant innovation in one of our priority areas (described in the specific competition themes section). Proposals must also improve business growth, productivity and/or create export opportunities for at least one UK SME involved in the project.

Specific competition themes

Projects should deliver solutions in the following themes:

  • in-process monitoring, control and release testing
  • maintenance of 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 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
4 September 2017
Competition opens
13 September 2017
1 November 2017 12:00pm
Competition closes
8 December 2017 8:35am
Applicants notified

Before you start

To start an application you must create an account as the lead applicant, or sign in as a representative of your organisation. 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 take part 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 successful application.

Research organisations

Research organisations may participate in applications as collaborators.

The level of total research participation is a maximum of 30% of total eligible project costs.

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:

1. Project details.2. Application questions.3. 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 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 we will not send it 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 healthcare and business need, technological challenge or market opportunity behind your innovation?

  • describe the main motivation for the project; the healthcare and business need, 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 evidence of freedom 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 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
  • 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 you will need to fill

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

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
  • 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 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 R&D activity that you (and any partners) would undertake. How would it impact on your R&D spending?

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. This is 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

The manufacturing of medicines is a significant industrial opportunity for the UK. Global pharmaceutical revenues exceeded $1 trillion in 2014 and are expected to grow beyond $1.7 trillion by 2025. The UK medicines industry is a leading manufacturing sector. UK exports in 2014 exceeded £24bn and the gross added value (GVA) per employee for pharmaceutical manufacture was double that of any other manufacturing sector (£206,000 in 2010).

The global medicines industry is in a period of dramatic change. Ageing populations, chronic/lifestyle diseases, emerging-market expansion, treatment and technology advances are expected to increase sector growth. Healthcare systems around the world are demanding access to cost-effective, innovative medicines with improved patient outcomes. Improved disease understanding is proving an incentive for patient classification and precision medicine. This is resulting in matching smaller pools of patients with effective medicines. A number of new, more complex, types of medicines are being developed. These present unique manufacturing challenges that need to be solved if they are to be scaled and delivered to large numbers of patients. These factors are forcing a fundamental shift in how medicines are developed and manufactured.

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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