MRC-Industry Asset Sharing Initiative 2016
Building on the world-leading MRC/AstraZeneca Mechanisms of Disease Call in which 15 high quality experimental medicine grants were awarded, the MRC is now working with 6 industry partners (AstraZeneca, GSK, J&J, Pfizer, Takeda and UCB) to provide researchers access to their deprioritised compounds.
This unique initiative will support MRC’s strategic priority in understanding mechanisms of human disease through discovery science and drive towards its mission of supporting research that can be applied to improve healthcare and benefit for patients. It will also provide the pharma partners the opportunity to engage with the academic community across a range of disease areas that may fall outside their core focus.
The aim is for this to be a long standing initiative with a ‘virtual library’ of assets that applicants can use in their experimental medicine research studies. The initiative is open to new industry partners joining and existing partners adding more assets to the ‘virtual library’.
The potential outputs of research may include:
- Pre-clinical and clinical data on the relevance of the selected mechanisms and compounds in new disease areas.
- Pre-clinical and clinical data to support patient stratification (selection of responder vs. non-responder populations) strategies in clinical development.
- Data to support the validation of translational models (in vitro and in vivo).
It is envisaged that the proposals will focus on new, previously unexplored areas of clinical research that lie outside the scope of current core of participating company development plans, and do not replicate previous or existing studies. Projects which are considered by MRC and the companies to fall within current development pathways for the company will not be eligible for MRC funding. In such cases, applicants may discuss with the company the possibility of direct funding. MRC will inform applicants as soon as possible after submission of an outline proposal if the relevant company is already conducting such studies.
All disease areas within the MRC portfolio will be considered. However, the following areas are outside of the remit of the call:
- using multiple compounds for screening
- head to head compound comparisons (with the exception where one compound is CNS penetrant and the other not)
The participating companies are making available a defined pool of assets which will include compounds that are good tools to test the importance of the relevant mechanism of action in preclinical models. A selection of these compounds will also have sufficient clinical data to enable the exploration of clinical hypotheses.
The full list of assets available can be found here, together with limited non-confidential information on each compound, sufficient to allow potential applicants to determine whether they could be used in planned research projects (View the information on individual compounds). Further details of compounds will be shared as appropriate, by the companies under a confidentiality agreement with researchers after successful submission of an Expression of Interest application. This information sharing will allow full applications to be made with the relevant company to MRC, and studies to be conducted appropriately.
This call follows standard RCUK eligibility criteria and is open to UK-based researchers who can show they will direct the proposed research and be actively engaged in carrying it through. Eligible institutions include UK higher education institutions, Research Council Units and Institutes, and eligible Independent Research Organisations (IROs). All IROs listed on the RCUK web page are eligible to apply.
Research proposals that are led by commercial entities are not eligible. However applications may include collaborations with third commercial parties under the relevant agreements.
All full proposals will be considered by MRC as industry collaborative research proposals, with the relevant company as the collaborative partner.
Up to £5M is available under this initiative. All full proposals will be assessed in open competition with other research grants submitted to the MRC-Industry Asset Sharing Initiative Panel.
A participating company may offer to fund a project in its entirety if, based on the Expression of Interest, it considers that route to be the most appropriate funding mechanism for that individual study. In such cases, these will be taken forward through direct collaboration with the company without any further MRC involvement. Applicants who do not wish to accept this offer may continue to seek MRC support through the initiative, if successful at the Expression of Interest stage.
The call process will be in two stages:
- Expression of Interest
- Full Application
Applicants will need to first submit an Expression of Interest using the Expression of Interest form. These will be assessed by MRC and companies will comment on the feasibility and novelty of the Expression of Interests. Successful applicants will then be invited to submit a full application.
The purpose of the Expression of Interest is to ascertain the following:
- Fit to remit
- Strength of scientific rationale
- Feasibility of proposal - with regards to asset availability and supply
- Novelty - whether such studies are already on-going within the company whose compound an applicant wishes to use
- Design of any clinical trial proposed (length, subject numbers, endpoints)
- Appropriateness of risk-benefit for patients enrolled in any proposed clinical studies, based on known safety & tolerability profiles of the compound & mechanism
Assessment of Expressions of Interest will also take into account the MRC funding portfolio and current strategic priorities.
MRC reserves the right to modify the process in the light of the actual number of Expressions of Interest received.
Expressions of Interest must be use the Expression of Interest form and address the following:
- Project title
- Summary of the project
Please provide a summary of the project, including scientific rationale, fit to the scheme and management.
- Details of Lead Applicant and co-applicants
- Track record of research and/or funding
- Team and centre capabilities e.g. cohorts, infrastructure that will contribute to the project.
- Case for Support
- Clearly identify the compound/s you are interested in using, the indication to be investigated.
- Clearly describe the patient population to be studied for any clinical proposal and duration of proposed treatment.
- Brief evidence of why this pathway may be important in the disease area under investigation.
- Brief description of research plans including progression milestones.
- Approximate estimation, to the extent possible at this time, of how much compound you will need, formulation, route of administration, etc.
- The proposed resourcing and timescale.
- For clinical studies, details of the proposed endpoints and any statistical analysis, where relevant.
Please include estimates of costs you anticipate will be required for the project.
Expressions of Interest should be submitted to firstname.lastname@example.org
If successful at EOI stage, applicants will submit full proposals which will be sent out for international peer review and assessed by an independent review panel convened by MRC. This panel will make the final funding decisions. Full proposals will be assessed on the standard criteria for an MRC research grant. As the applications will be collaborative research proposals between academics and a company, all applicants are advised to refer to the guidance on MRC Industrial Collaboration Awards (MICA) and must submit a MICA form with their application.
Please note that MRC reserves the right to amend the review process in the case of high demand.
There will be no participating company involvement in the review of the full proposals or decision on funding.
All projects funded under this Initiative will be collaborative studies between academic researchers and a participating company. The investigators will work under a collaborative research agreement, jointly signed by the HEI and the participating company, based closely on either the Lambert Agreements for preclinical studies or the model Industry Collaborative Research Agreement for clinical studies. Release of funds will be contingent on receipt of the signed agreement by MRC.
As outlined in MRC’s Terms & Conditions it is expected that the Research Organisation will identify itself as the sponsor (or one of a group of individuals/organisations that accepts the sponsor’s responsibilities) as described under the Research Governance Framework for clinical studies.
Liability and indemnity responsibilities for clinical studies will follow those outlined in the Collaborative Research Agreements as appropriate. Briefly, it is expected that the responsibilities for the conduct of the study will lie with the Sponsor of the research.
For Scientific queries please contact Dr Jo Latimer at email@example.com
View the full compound list