Aim
Toxicity issues with advanced therapies (ATs) include, but are not limited to, immune reactions, off-target gene effects, and tumourigenesis. The long-term safety of many advanced therapies remains uncertain, with potential for unexpected toxic effects over time.
Therefore, advancing our understanding of how these therapies can be safely and effectively delivered to patients holds significant potential for breakthroughs, particularly in treating complex and previously untreatable conditions.
This funding opportunity aims to establish core resources and capabilities in advanced therapy toxicology for the UK, fostering connectivity among business, academia, and regulatory bodies, and gaining insights into the biological processes through which ATs can cause harm.
Research into the toxicity of advanced therapies, including the advanced therapy medicinal product (ATMP) classification of cell and gene therapies, regenerative medicine and nucleic acid therapies such as oligonucleotide base therapies and base or gene editing techniques, are all in scope.
Aims include modelling short and long-term adverse effects and translating research evidence into harmonised standards and definitions of future regulatory pathways. Additionally, this initiative aims to influence policy and standards in the AT sector and support skills and training in toxicology and regulatory science.
Prosperity partnerships should aim to address at least one of the following challenge areas in at least one area of advanced therapies:
- mechanisms governing safety and toxicology of ATs
- persistence, localisation and distribution of ATs in vivo
- translation of mechanistic insights into tools and assays, and development of a standardised approach to assessment of safety and toxicology of ATs
For more information on these three challenge areas see the Additional information section.
Prosperity partnerships funded through this initiative will be co-developed with academia and business addressing significant challenge areas in safety and toxicology. These partnerships will form a UK-wide network that goes beyond the individual partnerships, coalescing the field and providing both connectivity and critical mass.
The strategic partnership can be newly established or based on existing, long-term relationships. It should be recognised by both parties and have a clear path for future collaboration, possibly formalised by a memorandum of understanding (MoU) or a collaboration agreement.
The research programme must be co-created, driving shared research challenges, with both business and academic researchers making distinct intellectual contributions.
This is an expression of interest stage, and the information about the full application stage may change. You can only apply for the full funding opportunity if we have invited you to do so following a successful expression of Interest.
The full funding opportunity will open in November 2024. More information will be available on this page then.
Scope
Applications should articulate co-developed research programmes addressing clear challenges in safety and toxicology of advanced therapies, and clearly described business-academic partnerships.
Academic and business partner project leads should ensure that:
- the business and academic partners have a demonstrable emerging or established research-based relationship
- there are clear plans to evolve this relationship via shared research challenges and the prosperity partnership is a key component of the plans to evolve and strengthen this relationship
- partners are committed to the co-creation of a jointly delivered large scale research programme addressing a clearly defined key challenge area within the funding opportunity remit
- the business partners can commit to matching funding for the prosperity partnership with at least a matched contribution. This must consist of at least 50% in cash with a maximum of 50% of the matched contribution being in-kind
- a definitive list of eligible cash contributions is set out in the ‘Definitive list of eligible cash contributions for business leads and partners’ section
- no UKRI, public, or government funding will be used as co-investment, and the partners are able to clearly demonstrate an auditable transfer during the grant duration
- the lead business partner must be:from a business in the private sector driven by profit or from an organisation with a commercial arm which generates independent revenue
- the lead business partner must be in a position to contribute to the nation’s prosperity through increasing their investment in UK based research and development activities and subsequent product development in the UK
The following is the definitive list of eligible cash contributions by business partners.
We expect the time of researchers, research and innovation associates, technicians, and grant managers to be fully costed onto projects depending on how much time a person would spend on it.
In the application, it is expected that the role and responsibilities of costed persons are detailed, and it is demonstrated clearly how their experience and skills are linked to work packages and outcomes. The appropriateness of the time devoted to the project will be assessed at the full application stage.
Gross salary can be claimed as matched funding (that is, including indirect costs such as pension, National Insurance, and taxes) but not business overheads or profits. The salary of a single member of staff (researcher, research and innovation associate or grant manager) can be covered in partnership by the business partner and Medical Research Council (MRC) funds in a ratio that best suits the project.
Below we state the eligible cash contributions for business leads and partners.
Researcher salaries
All or part of the pro rata, gross salary cost associated with researchers employed by research organisations (including project co-leads).
Research and innovation associates’ salaries
All or part of the gross salary cost associated with research associates employed by research organisations to work exclusively on the prosperity partnership.
Research associates can also be employed directly by the businesses in the partnership and the appropriately costed gross salary can be claimed as a cash contribution depending on how much time the person spends on the prosperity partnership.
Professional grant manager salaries
Pro rata gross salary cost of a professional grant manager.
Technician salaries
Pro rata gross salary cost of technicians.
Software licences
New software licences needed for the project and their maintenance cost for the duration of the project. Software licences or intellectual property (IP) owned by the business which are already accessible by the partners will apply at marginal cost, not at market rate.
New equipment
Equipment essential for the successful delivery of the proposed research.
Items of multiple-use equipment (where the equipment is necessary for the pursuit of the proposed research but will not be fully occupied on it) may also be included.
The application must explain the other proposed uses and the overall benefit to MRC research of the equipment.
Equipment produced by the business
Equipment produced by the business is only claimable at the cost of manufacture (not market) rate.
Access to equipment and facilities
Access to specific equipment and facilities critical to achieve the outcomes of the project. If the facility is based at the academic or business partner’s facility, the cash contribution will be valued at cost.
Facilities development
Facilities development can be an eligible business cash contribution if the upgrade will increase the capability of the facilities with specific benefit to the proposed work. This contribution must be justified in addition to any estate costs already factored in. Any facilities development contributions require discussion with us prior to submission.
Business cash contribution
Business cash contributions which will be provided to the academic partners, for the academic partners to manage in line with the project objectives.
Skills and talent training
Skills and training activities such as higher apprenticeships, continuing professional development of the project’s research and innovation team, exchanges, and secondments.
For more information on the background of this funding opportunity, go to the Additional information section.
Duration
The duration of this award is up to a maximum of five years.
Funding available
The full funding amount of £10.5 million will be delivered in a single funding opportunity with programmes being up to five years. The academic full economic cost (FEC) of your programme can be between £2 million and £4 million.
MRC will fund 80% of the FEC and 100% of permitted exceptions
Find out more about full economic costing.
The business partner(s) must provide at least a matched (financial and in-kind) contribution to the programme.
What we will fund
MRC will fund the academic partner’s costs which can include:
- staff costs
- equipment and other items required to carry out the programme
- costs related to impact
- travel and subsistence
- skills and talent training costs
You can also request costs for work to be undertaken at international organisations by international project co-leads. We will fund 100% of the full economic cost.
The total of such costs requested for international applicants from high income countries (those not on the OECD DAC List of ODA Recipients), India and China must not exceed 30% of the total resources requested.
There is no cap on costs requested for international applicants from DAC list countries.
For more information on international costs and what we will and will not fund see costs we fund overseas and the Collaborate with Researchers in Norway guidance.
Supporting skills and talent
We encourage you to follow the principles of the Concordat to Support the Career Development of Researchers and the Technician Commitment.
Trusted Research and Innovation (TR&I)
UKRI is committed in ensuring that effective international collaboration in research and innovation takes place with integrity and within strong ethical frameworks. Trusted Research and Innovation (TR&I) is a UKRI work programme designed to help protect all those working in our thriving and collaborative international sector by enabling partnerships to be as open as possible, and as secure as necessary. Our TR&I Principles set out UKRI’s expectations of organisations funded by UKRI in relation to due diligence for international collaboration.
As such, applicants for UKRI funding may be asked to demonstrate how their proposed projects will comply with our approach and expectation towards TR&I, identifying potential risks and the relevant controls you will put in place to help proportionately reduce these risks.
Further guidance and information about TR&I, including where you can find additional support.
