NATA programme
The NATA is a £30 million investment awarded by the UK’s Strategic Priority Fund to support and accelerate the development of NAT. The NATA programme works in partnership with international industry and academic organisations and is being delivered by the Medical Research Council, part of UKRI.
The NATA programme consists of two main offerings to the UK R&I community:
- the NATA Hub which offers world-leading, state-of-the-art NAT research infrastructure at the Harwell Research Campus, Oxfordshire
- substantive programme grants to address a number of focused Research Challenges to tackle major barriers to NAT development.
The NATA programme is led by an Executive Group, chaired by Professor Fiona Watt who is the Programme SRO and Executive Chair of MRC, and supported by a world-leading Strategic Advisory Group (NATA Hub) that advise on strategic opportunities for the initiative.
NATA Hub
NATA Hub is a brand-new UK research centre based on the Harwell Research Campus offering end-to-end platform technology across the pre-clinical pathway, from oligo design, synthesis and characterisation, through to targeted delivery, in vitro screening and in vivo assessment. NATA Hub comprises state-of-the-art chemistry and biology capability to collaboratively address bottlenecks in NAT development.
The hub is disease agnostic with an initial focus on short oligonucleotide therapeutics (ASOs and siRNAs).
NATA Hub’s toolbox and techniques will help answer the main questions about translational development:
- target identification
- oligonucleotides design and synthesis
- off-target or safety prediction
- precision targeting
- ligand conjugation
- efficacy in vitro or in vivo
- distribution and uptake
- quantification
- drug metabolism and pharmacokinetics (DMPK).
NATA Hub’s initial areas of interest include tissue specific targeting, endosomal escape, novel manufacture methodologies and new advanced conjugate modalities.
NATA Research Challenges
NATA’s Research Challenge programme grants will enable and accelerate early stage innovation for nucleic acid therapy development, developing and disseminating platform technologies that will clear the way for the next generation of precision medicines.
Funding will support two consortia of academic and industry experts. One consortium will address barriers to the manufacture of synthetic nucleic acid therapeutics and one consortium will address barriers to precision delivery. Up to £6 million of UKRI funding will be available to each consortium.
NATA’s second Research Challenge funding opportunity will launch later this year, supporting systemic targeting and intracellular delivery of nucleic acid therapeutics.
Industry involvement and available funding
MRC is keen for industry to be actively involved in consortia and, whilst we expect that large companies would support their own costs in participating in the consortia, we are willing to consider requests for funding from small/medium companies involved in the consortia.
These requests will be reviewed on a case-by-case basis and will need to be accompanied by an explanation at the full application stage as to:
- why the involvement of the company is essential to the success of the consortia
- how the funding to the company will be used to support the objectives of the consortia
- why the company is not able to support the costs themselves.
We may also undertake financial checks on companies requesting funding to ensure that the company is not in financial difficulty. MRC reserves the right to adapt the funding model available to companies to comply with future UK subsidy control rules. If this is necessary, MRC will communicate with applicants during the application process.
Intellectual property guidance
MRC recognises that intellectual property (IP) considerations will vary across each individual consortium and we support the formation of appropriate governance structures that principally facilitates the delivery of a programme’s science, while managing background and arising IP for the benefit of the consortium and the UK.
As such, MRC will expect each consortium to put in place a collaboration agreement before MRC provides funding to the successful consortium.
Whilst the exact provisions included in the agreement will require discussion by the consortium, MRC has some principles in relation to the management of IP which it expects to be taken into consideration. These principles can be discussed in more detail during the application process.
To summarise, the collaboration agreement should ensure that each partner has the rights to use any background and arising IP to deliver the research planned by the consortium.
MRC would expect the consortium to jointly agree and co-ordinate the protection and commercialisation of arising IP, taking into consideration how access to background IP may be achieved if needed for commercialisation and ensuring that academic consortium members and the wider academic community are and remain able to use arising IP.
Dependent on contributions made, it may be appropriate for industry consortium members to be granted rights to use arising IP for internal research purposes and an option mechanism to take licences for commercial purposes.
However, MRC would expect that any arising IP that is of general applicability and utility would only be licensed non-exclusively for commercial purposes to ensure the widest possible impact.
Additional conditions
Supplementary to the standard UKRI grant conditions, additional conditions will be added to this call. These will include, but are not limited to the following conditions.
Milestones
This award is contingent upon meeting the progression milestones set out at the full application stage. Failure to meet progression milestones may result in termination of the award at the discretion of MRC. Spending on the grant should be limited to work detailed within the programme plans for the active milestone.
Without specific prior written approval, MRC will not reimburse the host institution for the costs of any work contributing to a later milestone should it be decided that the criteria of an active milestone have not been met and the programme is terminated.
Changes to programme plan
If issues or problems arise prior to or during the course of the funded programme that could potentially result in the inability to achieve the programme objectives or milestone, the issue, as well as proposed solutions, should be promptly communicated to MRC.
MRC requires that the programme team provide advance notification of any proposed change to the programme plan, including significant changes in milestone criteria, grant length or cost, in writing. Requests may be sent to challenges@natahub.org.
Changes must be approved by the MRC prior to them being implemented. Please note, due to the milestone driven nature of the project, the process for change requests differs from other MRC schemes. Please do not submit your request through Je-S.
Expenditure against grants
The duration of the grant should be between two and five years. Expenditure profiles will be agreed before the programme commences.
Reporting and expenditure profiles
The awarded consortium must provide quarterly progress reports reporting the programme’s delivery against objectives, success criteria and milestones. Financial reporting on to-date and forecast expenditure, in addition to risks to delivery, will also be captured in quarterly reports.
It is the responsibility of the host organisation to ensure the research programme remains on the expected profile. Research organisations must inform MRC of material slippage or cost savings as soon as possible. MRC reserves the right to suspend or reprofile a grant if spend does not closely match allocation.
External advisory board
Grant holders must establish an external advisory board, or equivalent body, to act as a ‘critical friend’ and provide advice on the running of the project, its research and related activities. This board must meet with grant holders at least annually, with the grant holders providing the external advisory board with an annual written report before the meeting detailing the project’s:
- progress against programme objectives and milestones
- risks and mitigation strategy
- outputs and training
- outreach and professional development activities.
Each advisory board meeting will include UKRI observers and will be chaired by the NATA Executive Director when in post. NATA or MRC will provide secretariat for the external advisory board.
Commercialisation committee
Grant holders must establish a commercialisation committee with representation from all consortium members and NATA to coordinate the protection and commercialisation of arising IP, including approval of commercialisation agreements.
Final expenditure statement
It is the responsibility of the principal investigator to submit a final expenditure statement and a Project End Report at the end of the grant. The final payment will be withheld until the final expenditure statement and the Project End report are received and failure to submit may result in financial sanctions.
Evaluation requirements
This funding opportunity is part of the wider NATA programme, funded by the Strategic Priorities Fund (SPF). In line with the SPF’s business case, the NATA programme and grant holders funded by the programme must adhere to the evaluation requirements set by the SPF.