Molecular Pathology Nodes Call
Please note: The above detailed MRC Molecular Pathology Nodes Call is only open to applicants that have been invited to apply, following the successful submission of their Expression of Interest.
MRC and EPSRC invite proposals to establish high-quality molecular pathology nodes.
Each node will be a multidisciplinary centre of innovative molecular diagnostic test discovery and development bringing together the research base, pathology/genetic services and industry. Together the nodes will be expected to cooperate as a network, for the benefit of the UK by, for example, sharing best practice and assisting in the evaluation and diffusion of next generation tests.
The nodes and network will need to complement partner investments including the National Institute for Health Research Diagnostic Evidence Centres and the Technology Strategy Board Precision Medicine Catapult.
The development of novel molecular pathology diagnostic tools targeting identified clinical needs requires the input of biomedical, clinical, engineering and physical sciences researchers. To operate effectively, each node should either include or link to:
- Leading biomedical, clinical, engineering and physical sciences communities: to provide a pipeline of, for example, high-quality biomarkers and analytical technologies, including, where relevant mathematical algorithm development.
- Innovative clinical practice and pathology/genetic services:
- to assist in the design and delivery of validation studies, for instance, by advising on and providing access to appropriate study populations
- to provide access to skills and capabilities in, for example, sample collection, handling and processing, assay development and biobanking.
- to provide a local or regional environment for innovative tests to move into clinical care for further assessment and service use.
- Industry: engagement with industry to facilitate access to synergistic assets and skills and potentially provide commercialisation routes for newly developed tests.
We anticipate that applicants will have differing balances of existing strengths and that the available funding may be used to develop one or more area.
We anticipate that the nodes initial focus will be on the discovery and validation of novel molecular pathology approaches:
- Discovery and validation of biomarkers associated with disease strata.
- Development of novel sensing and analytical technologies for new diagnostic tools.
- Application of mathematical and statistical methodologies for the extraction of information from complex datasets.
Longer term, nodes will be expected to support test adoption and delivery, as tests under development mature.
Government and charity funders have made significant investments in the discovery of new diagnostic biomarkers and analytical technologies. These include a £60m MRC stratified medicine initiative and a £64m EPSRC investment in underpinning analytical science. If the UK is to benefit from these substantial commitments, it is crucial that there exists a robust pathway and capability for the development and adoption of new diagnostic tests.
To provide the necessary path and capability, the steering group of a recent MRC Molecular Pathology Review (PDF, 1.22MB) has recommended that:
- Path: a clear map of the diagnostic development path should be produced, including the evidence needs of the regulatory, evaluation and commissioning organisations along the path. Consideration should also be given to whether these organisations provide appropriate coverage and support.
- Proximity: the research base, pathology services and industry have become separated, to the detriment of all. These parties should be brought back into closer proximity.
- People: the skills base of the UK should be enhanced, by developing future research leaders in pathology, and increasing capacity in data analysis and health economics.
The node funding, by establishing multidisciplinary centres of excellence in molecular diagnostics discovery and innovation, represents the first phase of responding to these recommendations.
The MRC is contributing up to £15m and EPSRC up to £2.5m, to a joint £17.5m call. It is anticipated that this will support up to eight awards, with diverse research focus and structure, of three to four years duration.
Capital requests will be considered but we hope that some bids will build on recent capital awards, including those made by the MRC co-ordinated clinical research infrastructure initiative.
It is the intention that further funding will be made available to build on this initial call, recognising the need for long term investment in this area. This might provide an opportunity to enlarge and/or supplement the number of nodes supported through this call, but follow-on support cannot be guaranteed at this stage.
We expect applications to demonstrate partnership between Higher Education Institutions (HEIs) and local NHS hospital(s). We anticipate that proposals will be led by the HEI but have governance mechanisms that enable genuine partnership between these organisations.
Given that these awards are to align and co-ordinate local infrastructure and capabilities, we do not expect to receive more than one application per HEI. In addition, we would anticipate that proposals will be made with close linkage to medical schools, given their skills and training objectives.
Skills and training
Through providing an exciting and dynamic research environment with strong links to the clinic, the nodes will be well-placed to develop the next generation of leadership in the field and to upskill current practitioners.
Innovative proposals capturing this opportunity would be welcomed. Such proposals might include:
- Research intensive masters level courses, modules and/or taster fellowships of up to a year, to provide hands on experience.
- Opportunities for local specialists to develop their skill sets, perhaps through buying out clinical time.
- Intermediate to senior research focused posts (clinical and non-clinical)– commitment from HEI partners to these posts would be particularly welcome as will consideration of aligned clinical training opportunities.
We do not anticipate the nodes will provide doctoral training positions, in this first period of support, given their limited duration. However, strategic alignment of doctoral training funding by universities towards the nodes would be welcomed.
The focus of this call is on in vitro diagnostics with in vivo imaging applications not being within scope.
The call will have four phases
- Call workshop
- Expression of interest
The MRC and EPSRC held a workshop on 1 October 2014 in London to provide potential applicants with an overview of:
- The MRC Molecular Pathology Review’s findings and recommendations
- Actions being taken to address the recommendations
- Complementary partner investments
- The call’s objectives and process
Expression of interest
Applicants wishing to make a submission to the call will be required to provide an Expression of Interest (EoI) to a deadline of 10 November 2014.
EoIs will be reviewed by an expert panel, whose membership will be drawn from the UK and international research, clinical, service and industry sectors, including representation from both the MRC and EPSRC communities.
Given the broad nature of this call and the new approach that it represents, the aim of the EoI stage is to provide constructive specific and generic feedback, to aid applicants build a compelling case, and to refine the proposal stage assessment criteria. Although obligatory, the EoI phase is not a gating decision stage.
The EoI should be completed using the EoI form (DOCX, 270KB) and with reference to the guidance provided below. Submissions not made using the EoI form may be excluded.
Please provide a non-confidential title and summary. The MRC will be publishing these on our website, to assist potential partners identify developing nodes that they might bring value to.
Node Vision, Positioning and Objectives:
Vision: Please provide a summary of the node’s vision, to include how the vision meets the call’s remit.
Positioning: What is your node’s strategic focus and why has this been selected? The review identified a need to bring the research, clinical/service and industry sectors into closer proximity. In this call, we are keen to explore different models that might include a focus on, for instance, a technology, a disease, a mechanism common to many diseases, a Pathology sub-speciality (e.g. histopathology, chemical pathology, etc) or a combination of these. What is your node’s focus and how will this add value to existing capabilities?
Objectives: What are your node’s objectives both within the period of support and beyond?
Value Add: How do the node’s vision, strategy and objectives build on and add value to existing activity?
People: Please provide a brief description of the principal investigator and co investigator’s track record of research and/or funding and how they will help the node meet its objective? We expect that node leadership may be drawn from both within and beyond the speciality of Pathology.
Governance: What governance structure will the node have? How will the leadership provide clarity of direction and purpose and be open and responsive to the needs of the node’s multiple partners?
Inclusion and linkage:
Research: What are your key existing partnerships with discovery researchers, what new partnerships are planned, how will these be secured and together how will these help the node meet its objectives? While the node’s delivery facing activities are likely to be local in nature, the upstream partnerships for discovery may need to be more regional/national, to capture the breadth and quality of required inputs. These partnerships should include strong engagement with MRC and EPSRC communities.
Clinical Practice and Service: What are your key existing partnerships with clinical practice and local/regional NHS laboratory/Pathology/genetics services, what new partnerships are planned, how will these be secured and together how will these help the node meet its objectives? While local NHS clinical partnerships will be important in providing access to patients and helping to generate clinical pull, wider partnership may also be necessary to access the breath and quality of contributions required. We expect that the nodes will make use of a shared or linked infrastructure to support both the development and service delivery of new tests. As molecular pathology complements rather than replaces existing services, we would expect this common infrastructure to be linked to the capabilities of relevant local/regional service provision.
Industry: What are your key existing partnerships with industry, what new partnerships are planned, how will these be secured and together how will these help the node meet its objectives? Engagement with industry could help the nodes access synergistic assets and skills and potentially provide commercialisation routes for newly developed tests.
Use of funds:
Workplan: What will the node’s key programmes of work be and how will these help it meet its objectives? Please provide limited examples to support your case.
Infrastructure: What existing infrastructure (e.g. lab space, equipment, data management systems etc) will the node have access to, what new infrastructure will it require, how will this be secured and together how will this help it meet its objectives? Access to a common infrastructure able to support test discovery, development and service delivery can be cost effective. In addition, through providing a shared research environment, this shared infrastructure can play an important cultural role by helping to engender a common research language and shared values between currently disparate groups. How might this infrastructure help ensure the flow back of patient samples and results for research use?
Skills and Training: How will the node help address the skills shortages identified by the MRC Molecular Pathology review and meet its own needs?
What contributions are to be made by partner organisations? How will these help you meet your objectives? The nodes provide an opportunity to pool infrastructure and activities, for mutual benefit, across inter and intra-organisational boundaries. To succeed, the nodes will require the commitment of their partner organisations. This might include:
- Commitments from host/partner HEIs, in particular support for relevant academic posts.
- NIHR BRC/BRU, NHS R+D or equivalent funding.
- local NHS trust(s) support to align service provision.
- Backing, where appropriate, from host AHSCs, AHSNs, or equivalents in devolved administrations.
Drawing on the feedback provided to them and an application form and guidance, which will include assessment criteria, EoI applicants will have the option of making an application for support by 4pm on 10 February 2015.
Applications will be assessed by the expert panel, supplemented with additional expertise, if required, at its meeting in late March 2015. The expert panel will reach funding recommendations that will require ratification by the MRC’s Translational Research Group at its meeting before the end of March 2015.
To ensure continuing value for money and to assist in the identification of common challenges and networking needs and solutions, supported nodes will be required to report on progress to the expert panel. During the first 18 months of award, this reporting will be on a six monthly basis with the option, at the panel’s discretion, to change this to annual reporting thereafter. In cases of inadequate progress, the panel will have the option to recommend award termination.
|Workshop registration deadline||15 September 2014|
|Call workshop||1 October 2014|
|EoI deadline||4pm on 10 November 2014|
|Proposal call open||23 December 2014|
|Proposal deadline||4pm on 10 February 2015|
|Funding decisions||late March 2015|
For more information contact: Dr Jonathan Pearce email@example.com