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Expression of interest: Prosperity partnerships: advanced therapies safety and toxicity

UK Research and Innovation

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.

Specialties

Biomedical Engineering

Immunology

Nuclear Medicine

Pharmacology

Tissue Engineering

Genetics & Genomics

Molecular Biology

Pharmaceuticals

Regenerative Medicine

Eligibility Requirements

Research organisations can act as the academic lead if they are eligible to receive UKRI funding.

Businesses can act as the lead project partner if they are:

a UK-based business or have UK-based research activity
a business in the private sector driven by profit, or from an organisation with a commercial arm which generates independent revenue
able to contribute to the UK national prosperity through increasing their investment in research and development activities and subsequent product, service, or technology development in the UK

Businesses may be a contributor to other applications as a project partner. Other businesses can collaborate in the partnership as project partners, but the majority of the matched contribution is expected from the lead business partner.

Before applying for funding, check the Eligibility of your organisation.

UKRI has introduced new role types for funding opportunities being run on the new Funding Service.

For full details, visit Eligibility as an individual.

A research organisation may lead or partner on more than one application and applications may comprise more than one research organisation.

For applicants who do not have a contract of employment for the duration of the proposed programme, by submitting an application the research organisation is confirming, if it is successful:

contracts will be extended beyond the end date of the programme
all necessary support for the programme and the applicants will be provided, including mentorship and career development for early career researchers

Who is not eligible to apply

You are not eligible to apply for this opportunity as academic lead if you are based at an international research organisation. This does not include MRC Unit The Gambia or MRC/UVRI Uganda Research Unit at the London School of Hygiene and Tropical Medicine that are eligible to apply as project lead. Before applying for funding, check the Eligibility of your organisation.

International applicants

You can include international applicants as project co-leads (international), where they will make a major intellectual contribution to the design or conduct of the programme. The contribution and added value to the research collaboration should be clearly explained and justified in the application.

Equality, diversity and inclusion

We are committed to achieving equality of opportunity for all funding applicants. We encourage applications from a diverse range of researchers.

We support people to work in a way that suits their personal circumstances. This includes: