Biomarkers & Imaging Discovery & Development Project Grants

This scheme funds research in all types of biomarkers (predisposition, screening, diagnostic, prognostic, predictive, pharmacological and surrogate response) using invasive (i.e., surgical specimens or biofluids) and imaging technologies (i.e., MRI, CT, PET, SPECT, other nuclear medicine methods, ultrasound or optical) .

What is covered?

This scheme, managed by the Biomarkers and Imaging Discovery and Development Committee (BIDD), reviews and funds biomarker and imaging research of the following types:

1. Biomarker discovery projects using human samples (preclinical assay development using cell lines and/or animal models will be considered for pharmacological biomarkers).
   In broad terms, these include:
   1. Discovery of biomarkers using hypothesis or non hypothesis (e.g. -omic) driven approaches. The work should be focussed on discovery/development of the biomarker(s) for application on clinical material and not on understanding the biology of the disease (genes/proteins/metabolites).
      A clear rationale should be provided for the need to discover additional biomarkers instead of concentrating on already existing, not fully qualified, biomarkers. In addition, appropriate clinical material and where appropriate trial data, should have been identified from the outset for retrospective correlation of the biomarker with clinical outcome.
   2. Definition of distribution of biomarker levels in a limited number of specimens.
   3. Retrospective study of the relationship between the biomarker and clinical outcome.
2. Biomarker assay development projects - these might be performed at different stages from the original assay set-up at the discovery stage to the validation of the assay for use on clinical material. Cell lines could be used at initial stages but it is expected that the assay will be transferred to human samples during the life of the project.
3. Biomarker qualification projects - these include the prospective study of the correlation between the biomarker and clinical outcome.
4. Imaging discovery and evaluation projects - these include all whole-body preclinical and clinical imaging studies, development of imaging agents, contrast agents and other imaging technologies. Research in this area might be expected to include screening, diagnostic, prognostic, predictive and pharmacological imaging research.

Please refer to the respective biomarker roadmap (i.e., diagnostic, pharmacological, prognostic/predictive or screening) for a schematic representation of the different projects supported by BIDD.

The following types of research fall outside the remit of this scheme:

• Biomarker discovery using cell lines or non-human tissue. Funding for these types of studies should be sought from the Biological Sciences Committee (BSC).
• Genome wide association studies (GWAS) for the identification/qualification of genetic predisposition biomarkers. If you require funding for GWAS please contact Carole Swan.
• Sample collection only applications without a translational hypothesis. Funding for sample collections associated with clinical trials should be sought from Clinical Trials Advisory and Awards Committee (CTAAC).
• Studies that include the development of an imaging technology that requires administration of unlicensed/experimental reagents (i.e., PET probes or contrast agents) to patients where an application should be made to the New Agents Committee (NAC).
• Projects that include the development of animal models (e.g. xenografts, etc.) for the study of pharmacological biomarkers should be submitted to the Discovery Committee (DC).
• Projects that include the development of either an imaging or an invasive biomarker as part of a drug discovery project should be submitted to the Discovery Committee (DC).
• Projects that use cellular imaging to address questions of tumour biology or (in the case of whole body imaging) to address questions of tumour biology in animal models should be submitted to the Biological Sciences Committee (BSC).

Eligibility

Applications will be accepted from scientists, clinicians or health care workers in UK universities, medical schools, hospitals and some research institutions.

Period of funding

Funding is provided for up to 60 months. However projects supported by BIDD are expected to have an average duration of 24 months.

Funding value

Applications should not exceed £100,000 per annum; £500,000 in total for a five-year study.

How to apply

BIDD operates a two-step application process - reviewing proposals as outline applications, before deciding whether a full proposal should be invited at a subsequent meeting. Detailed feedback is provided at this stage to assist in refining and improving the final (full) proposal and increase the chances of funding. Projects that are less than 9 months in length can be submitted straight as full applications.

In reviewing applications Cancer Research UK expects the following:

• that the processing and handling of biological samples conforms with prevailing regulatory standards;
• that definition of the sample types and preparation/handling/shipping SOPs are provided for development of invasive biomarkers;
• that a biostatistician is involved in all biomarker projects from the outset;
• that a pathologist is involved in biomarker projects that are collecting/handling human samples;
• that data are provided on assay specificity, sensitivity, accuracy and precision to ensure that the assay is fit for purpose. Although the level of data will vary significantly depending on the stage of the biomarker discovery/development, this information is required for all stages except for BIDD Assay Development Stage 1 projects, where a description of how these requirements will be addressed, is required.

Specifically, the following information should be provided for assays (imaging and non imaging):

• Performance characteristics, including sensitivity, specificity and accuracy.
• Information on whether the assay is quantitative, semi-quantitative, or qualitative.
• Information on the statistical design used or to be used to establish the correlation with the clinical parameter of interest during development of the assay.
• Description of the assay (platform, what is to be measured, controls, scoring procedures, interpretation, etc.).
• Data from preliminary testing of assay - analytic performance.

For biomarker qualification projects (including retrospective correlation of the biomarker to the clinical outcome) the following information should be provided:

• Available data on clinical performance and/or clinical utility including relevant data on false positivity or false negativity.
• Clear statistical design that ensures that the hypothesis aligns with the underlying trial and the sample size is adequate to address the hypothesis.
• Measurement of precision and reproducibility (within lab and between labs if more than one lab is going to be performing the assay/imaging test).
• Data to support proposed cut-off point(s) if assay/imaging results are not reported as a continuous variable.

Submission deadlines

Additional Information

Review Committee - Biomarkers & Imaging Discovery & Development Committee

Contact Details

For enquiries relating to this scheme, please contact:

Maria Lioumi
Email: maria.lioumi@cancer.org.uk