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MRC/AstraZeneca: Mechanisms of Disease call for proposals

Please note this opportunity is now CLOSED.
View all OPEN opportunities

  • Status: Closed
  • Open date: 6 Dec 2011
  • Closing date: 1 Jun 2012 16:00 GMT+1
  • Type: Calls,

As part of the MRC strategy to better understand human disease and to develop and foster partnerships with industry, the MRC and AstraZeneca have worked together to provide access for UK academic researchers to a high-quality collection of AstraZeneca compounds. These compounds can be used to support studies to investigate human mechanisms of disease and the development of potential therapeutic interventions.

This unique initiative will support MRC’s Translational Research Strategy and drive towards its mission of supporting research that can be applied to improve healthcare and benefit for patients. It will also provide AstraZeneca the opportunity to engage with a larger section of the academic community across a range of disease areas that may fall outside its core focus.

Scope of the Initiative

The Initiative will support two principal types of study:

(1) Pre-clinical studies to enable and inform further clinical insight to disease. Applicants must demonstrate clear “line of sight” to clinical benefit and enable investigation of mechanisms of human disease. For example, providing in vitro or in vivo evidence that a specific pathway is involved in disease pathology; validating models of human disease; informing patient selection hypotheses; etc.

Or

(2) Clinical research studies, using compounds in new disease areas, which build upon evidence that the specific pathway plays a role in disease pathology.

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 AstraZeneca development plans, and do not replicate previous or existing studies. Projects which are considered by MRC and AstraZeneca to fall within current development pathways for the company will not be eligible for MRC funding. In such cases, applicants may discuss with AstraZeneca the possibility of direct funding. MRC will inform applicants as soon as possible after submission of an outline proposal if AstraZeneca 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:

  • ophthalmology and dermatology
  • using multiple compounds for screening

Asset Pool

AstraZeneca 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. Further details of compounds, including relevant preclinical and clinical safety and efficacy data generated to date, will be shared by AstraZeneca under a confidentiality agreement with researchers after successful submission of an outline application. This information sharing will allow full applications to be made in partnership with AstraZeneca to MRC, and studies to be conducted appropriately.

Who can apply?

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 AstraZeneca as the collaborative partner.

Funding available

MRC has allocated up to £10m to fund projects of up to 3 years duration.

AstraZeneca may offer to fund a project in its entirety if, based on the outline proposal, 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 AstraZeneca without any further MRC involvement. Applicants who do not wish to accept this offer may continue to seek MRC support through the Call, if successful at outline.

Call Process

The call process will be in three stages:

  • Outline Application
  • Investigators workshop
  • Full Application

Application process

Outline Applications

You must first submit an outline application via Je-S. Successful outline applicants will then be invited to submit a full application.

The purpose of the outline application 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 AstraZeneca
  • 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

Outline assessment 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 outline proposals received.

To submit an outline application, the applicant must first complete the Outline Application form and then submit this as a PDF via the Je-S website. The following guidance will walk you through completing the Outline Application and the Je-S submission. Outlines must be received by MRC by 4pm on 2 February 2012.

The Outline Application must address the following headings:

Project title - This title should be the same as the project title of your Je-S submission.

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.

Project plan

  • 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.
  • 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. The Je-S system form will calculate the expected total project duration, cost and estimate the MRC contribution, based on 80% of the requested costs.

All Outline applications must be completed using the Outline Application form using Arial 11pt typeface. Please refer to the Guidance document for this call when completing your application.

Investigator workshop

Lead applicants from successful outline applications will be expected to attend an investigator workshop in March/April 2012. The workshop will be an opportunity to bring clarity to the process of a full application, share understanding about IP, and bring together lead applicants with the relevant contact from AstraZeneca to fully share compound information and to plan the full applications. It is expected that lead investigators will work closely with AstraZeneca counterparts during the preparation of the full proposals.

Full applications

Full applications should follow the standard MRC research grant application form and headings. As the applications will be collaborative research proposals between academics and AstraZeneca, all applicants are advised to refer to the guidance on MRC Industry Collaboration Agreement (MICA) and must submit a MICA form with their application.

Guidance for the full application will be made available to successful Outline applicants following the investigator workshop.

How to apply

Proposals submitted against this call must be costed with Full Economic Costing. You should submit your proposal using the Research Councils’ Joint electronic Submission (Je-S) System. Guidance on setting up a Je-S account and on filling out the Je-S forms can be found here.

When adding a new proposal to Je-S, you should select:

  • Select New Document
  • Under ‘Select Council’ select MRC
  • Under ‘Select Document Type’ select Outline Proposal
  • Under ‘Select Scheme’ select Standard Outline
  • Under ‘Call Type’ select MRC/AstraZeneca Mechanisms of Disease

Note that clicking ‘submit document’ on your proposal form in Je-S initially submits the proposal to your host organisation’s administration, not to MRC. Please ensure you allow sufficient time for your organisation’s submission process between submitting your proposal to them and the call closing date. MRC must receive your application by 4pm on 2nd February 2012.

Assessment Processes

This call will be overseen by a Joint Steering Group (JSG) comprised of senior independent academics, and representatives of MRC and AstraZeneca. The JSG will also assess the outline applications according to the criteria stated above, seeking additional advice if necessary.

Please note that MRC reserves the right to amend the review process in the case of high demand.

Full proposals will be sent out for international peer review and assessed by an independent review panel convened by the MRC. This panel will make the final funding decisions. Full proposals will be assessed on the standard criteria for an MRC research grantThere will be no AstraZeneca involvement in the review of the full proposals or decision on funding.

Key Dates

The Je-S system will be accepting outline applications from 6th December 2011

The closing date for outline applications is 2nd February 2012

Deadline for full applications will be in June 2012

Final Panel meeting will take place in October 2012

Issues

Collaborative Projects

All projects funded under this Call will be collaborative studies between academic researchers and AstraZeneca. The investigators will work under a collaborative research agreement, jointly signed by the HEI and AstraZeneca, based closely on the model Industry Collaborative Research Agreement. Release of funds will be contingent on receipt of the signed agreement by MRC.

Sponsorship

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

Liability and indemnity responsibilities for clinical studies will follow those outlined in the model Industry Collaborative Research Agreements. Briefly, it is expected that the responsibilities for the conduct of the study will lie with the Sponsor of the research, and the responsibility for the quality of the compounds will lie with AstraZeneca.

Frequently Asked Questions

Questions and answers on this funding scheme regarding eligibility, funding, preparing an application, assessment, intellectual property, ethics and governance can be found under frequently asked questions.

Contacts

If you have enquiries regarding the scheme please contact the programme manager:

Dr Joanna Latimer

Email: joanna.latimer@headoffice.mrc.ac.uk

Telephone: 0207 395 2219