Biomarkers are essential to our vision of personalised medicine, allowing us to diagnose cancer sub-types, to select appropriate treatments and to predict and monitor response and resistance.
In Manchester, we have a large biomarker laboratory run to Good Clinical Practice (GCP) standards, with the necessary quality assurance processes required by EU regulations for clinical trials. Our strength is therefore in biomarker validation and standardisation according to GCP, leading to routine use in the clinic. Building on success that is unsurpassed nationally and at the forefront internationally, we are creating a new Centre for Cancer Biomarker Sciences, which will become a major hub for biomarker research and development within the Cancer Research UK network.
Particularly, our work focuses on the potential of tissue and circulating biomarker assays, and we have so far developed an extensive portfolio, including:
- Enumeration and characterisation of circulating tumour cells (CTCs)
- Multiplex ELISA panels for angiogenesis and cell death biomarkers
- CTC-derived mouse models – termed CDX – to study small cell lung cancer (SCLC) and other diseases
- A toolkit of approaches to assess tumour genetics via circulating nucleic acids (cfDNA and miRNA)
We are bringing together multidisciplinary teams within a series of integrated, specialised laboratories:
- Preclinical pharmacology laboratory, using CDX, PDX and cell line models, for therapy testing and biomarker development
- Genome biomarker laboratory for the analysis of tissue and circulating nucleic acids
- Cell and protein laboratory for the analysis of circulating tumour cells and circulating protein biomarkers
- Molecular pathology laboratory aligned to tissue biomarkers
- Bioinformatics and biomarker statistics hubs
- Pharmacometrics modelling hub
- Integration centre for clinical and biomarker data
Clinical qualification of biomarkers is hugely challenging, requiring a range of dedicated facilities and specialised skill sets, integration of different disciplines, access to large patient cohorts and extensive early phase clinical trial activities and access to highly sensitive and innovative technology platforms. Much of this is already in place in Manchester, but the Centre is now investing in further recruitment and expansion.
We have established partnerships with pharmaceutical companies, we are working with several comprehensive cancer centres in the USA and in Europe on biomarker studies and we also collaborate with manufacturers to drive forward development of advanced technological approaches. Indeed, we have joined the international CANCER-ID consortium, which focuses on the optimisation and standardisation of circulating biomarker assays for multi-centre trial use. Looking ahead, exciting projects with various partners are underway or in the pipeline, including studies in collaboration with AstraZeneca, Novartis, Roche, Abbvie, Boehringer and GSK, and Dana-Farber and Memorial Sloan Kettering.