Biomarkers
This call is now closed for applications and is only available for reference purposes.
The Medical Research Council (MRC), as part of its initiatives to target bottlenecks in translation, launched a call for proposals for the development and evaluation of biomarkers. This MRC led initiative is a key part of the MRC-NIHR strategies for health research.
Background
For the purposes of this call a biomarker is an objective measurement that acts as an indicator of normal biological processes, or pathogenic processes or pharmacologic responses to therapeutic intervention (for example cholesterol, troponin T and I and FDG-PET). Evaluation means demonstrating the utility of the marker(s) for the use in preclinical, clinical, or public health studies; it does not refer to the process of gaining regulatory approval.
Biomarkers are valuable tools for accelerating the development of new medical treatments. They can serve to identify groups of people at greatest risk, or who will benefit most from treatment; can provide preclinical evidence of safety or efficacy; and can provide faster or more complete evidence of treatment effects and treatment safety in clinical studies.
There is a shortage of well-characterised biomarkers suitable for use in the development of new medical treatments. Rigorous development and evaluation of a potential biomarker is often seen as a major undertaking and is high-risk. However, the risk in exploring a putative biomarker for clinical studies is reduced if the biomarker is biologically plausible; that is, it can be linked closely to the pathology of the disease or is on a pathway that is closely linked to the effect of a treatment.
The processes of biomarker development and evaluation can be similar to those used for drug development in that the performance of a potential biomarker is tested in an appropriate human or animal population, using a robust study design with sufficient power to judge its value with confidence. This requires a cross-discipline approach involving laboratory scientists, clinicians, trial methodologists and epidemiologists and in many cases will benefit from collaboration between academia and industry.
Scope of the call
In this call the MRC invited applications to further develop potential biomarkers and/or to evaluate potential biomarkers for their predictive and prognostic capability for the diagnosis of disease, disease heterogeneity and underlying mechanisms, susceptibility, exposure or response to interventions. Studies that evaluate biomarkers as markers of either pharmacological activity or efficacy in pre-clinical development will also be considered, as will those proposing the further qualification of safety biomarkers to support early clinical trials.
The primary objective should be to select, evaluate and qualify a biomarker (or discrete panel of biomarkers) as an indicator of a normal biological process, pathogenic process, or pharmacologic response to therapeutic intervention. Any suitable technological approach will be considered.
Applications which are centred on discovery of potential biomarkers, for example though genome, proteome, metabolome screens, are excluded.
We particularly encourage:
- Exploratory preclinical development of biomarkers that could be used in proof of concept or proof of mechanism trials early in drug development as valuable efficacy and safety evaluation tools to increase confidence in the intervention tested before further development. The validation of such markers might include the testing of their response to a range of drugs of known effect in humans.
- Rigorous clinical evaluations or comparisons of potential biomarkers, with good statistical power.
- Studies on bridging biomarkers - ‘back translation’ studies on the use of clinical biomarkers in pre-clinical settings (for example, markers that are sensitive to the effects of drugs in animals as well as in humans) to enable better evaluation of new interventions
- Proposals to qualify biomarkers capitalising on existing well-characterised cohorts.
- Collaborative research, involving either academic-industry or academic-academic partnerships. Rapid progress will often need a multidisciplinary approach, or sharing of resources and knowledge.
Funding available
Funding in the amount of £10 million is available to spend under this call and it is anticipated that we will fund a range of proposals across a range of investigators and institutions.
Panel Membership
Chair – Professor Nancy Rothwell, MRC Research Professor and Deputy President and Deputy Vice-Chancellor, Faculty of Life Sciences, University of Manchester
Professor Asif Ahmed, Institute of Biomedical Science, Birmingham University
Professor Daniel Altmann, Department of Infectious Diseases, Imperial College
Dr Stephen Anderton, Institute of Immunology & Infection Research, University of Edinburgh
Dr Jane Armitage, Clinical Trial Service Unit, University of Oxford
Dr Raj Chopra, Senior Medical Director Discovery Medicine and Epidemiology, Astra Zeneca,
Professor John Danesh, Department of Public Health and Primary Care, University of Cambridge
Professor Paul Farrell, Department of Virology, Imperial College
Professor Rebecca Fitzgerald, Hutchison/MRC Research Centre, University of Cambridge
Professor Barry Furr, Astrazeneca
Professor Stephen Gillespie, Centre for Medical Microbiology, University College London
Dr Peter Grabowski, School of Medicine & Biological Sciences, University of Sheffield
Professor Stephen Hunt, Department of Anatomy & Developmental Biology, University College London
Dr Rajiv Jalan, Institute of Hepatology, University College London
Dr Paul Kellam, Department of Infection, Division of Infection & Immunity, University College London
Professor Alan Knox, Department of Respiratory Medicine, University of Nottingham
Professor Debbie Lawlor, Division of Epidemiology, MRC CAiTE Centre, University of Bristol
Professor Alistair Lax, Department of Oral Medicine and Pathology, Kings College London
Professor John Mathers, Institute for Ageing and Health, University of Newcastle
Dr Hugh Pearson, Institute of Membrane & Systems Biology, University of Leeds
Dr Ed Rainger, Department of Physiology, University of Birmingham
Professor Ian Sabroe, Unit of Respiratory Medicine, Royal Hallamshire Hospital
Professor Neil Scolding, Department of Neurology, University of Bristol
Professor Ian Stratford, School of Pharmacy and Pharmaceutical Sciences, University of Manchester
Professor Thomas von Zglinicki, Institute for Ageing and Health, University of Newcastle
Assessment process
Proposals will be assessed by a specially convened panel including experts from MRC Research Boards, translational research panels, and additional independent experts. The composition of this panel will be published on the MRC website in due course and will reflect the range of applications received.
- Funding decisions will be made in October 2008
- Applicants will be advised of the outcome in October 2008
The decision of the panel will not be open to appeal. Please note that MRC reserves the right to amend this process if demand is unexpectedly high.