Clinical and experimental pharmacology
Led by Professor Caroline Dive and Professor Malcolm Ranson
Derek Crowther Unit
Our aims of creating a seamless passage between the laboratory and the clinic in collaboration with the Christie Trust is perhaps best encapsulated in the development of the Derek Crowther Unit (DCU) and its links to the Paterson Institute’s Clinical and Experimental Pharmacology Group. The former is directed by Professor Malcolm Ranson and the latter led by Professor Caroline Dive.
The DCU is a designated early clinical trials unit. Its state-of-the-art facilities and staff provide the expertise, environment, and equipment that enables access of patients in the Northwest to the newest treatment approaches and drug developments via clinical trials. The clinical trials are sponsored by charities such as Cancer Research UK, and by Biotech and Pharmaceutical companies.
The unit, named in honour of Derek Crowther the first Professor of Medical Oncology at the Christie, is an important and significant example of the ongoing development of clinical cancer research at the Christie. The DCU opened to patients in April 2003 and currently hosts over 80 trials of small molecule and immune modulatory therapeutics. The Christie Hospital NHS trust is a Cancer Research UK Key Centre for Phase I trials and was a Key Centre for the National Translational Cancer Research network (NTRAC) prior to the award in 2006 of Experimental Cancer Medicine Centre (ECMC) status with colleagues from the Christie site.
Clinical and Experimental Pharmacology Group
The Clinical and Experimental Pharmacology Group (CEP) was formed in September 2003 with generous Cancer Research UK core funding and CEP:
- Receives funding from the NTRAC/ECMC schemes and from the Pharmaceutical Industry to expand this activity to its current critical mass of 35 researchers
- Is involved in pre-clinical and early clinical development of new anti-cancer therapies working in tandem with the DCU
- Validates and implements pharmacokinetic (PK) and pharmacodynamic (PD) assays and performs translation research to discover novel biomarkers of treatment response
Clinical trials
The European directive (2001/20/EC) on clinical trials as implemented in the UK requires laboratory investigations on samples obtained from trial patients be performed to a rigorous quality standard. Since its inception, CEP has actively developed its quality assurance systems based on the principles of good laboratory practice (GLP) and good clinical laboratory practice (GCLP).
Considerable progress has been made and all PK/PD studies are now conducted according to a study protocol with sample and document logging and tracking systems in place and with raw data outputs retained in a secured study file and where laboratory investigations carried out as per CEP standard operating procedures (SOPs). The CEP group moved to occupy a floor of the purpose built new Translational Research Facility (TRF) in 2006. This move allows implementation of the next stages of GCLP, involving qualification of test systems and apparatus and separation of key laboratory activities into custom designed test facilities. These are all directed at enabling the performance of the highest quality complex clinical trials at the DCU informed by ‘cutting edge’ translational science.
In addition to ECMC status, the demonstrated integration of DCU and CEP recently contributed to the decision by a major UK Pharmaceutical Company with an Oncology focus choosing this site as a key centre for its clinical trial activities. Furthermore, we have also gained a clinical infrastructure grant of £3.4 million from a consortium of research funders including Cancer Research UK, The Wolfson Foundation and the Wellcome Trust. These new funds will be used to double the capacity of the DCU, making it we believe, one of the largest phase 1 clinical trials unit worldwide.
The DCU and CEP have also obtained funding through this initiative to expand and develop an important facet in clinical trials of mechanism based therapies: the search for biomarkers of drug response. In particular CEP places emphasis on surrogate biomarkers of drug efficacy that will inform of the biological effective dose of a new therapy in addition to the traditional focus of a Phase I trial on determination of the maximum tolerated dose. In collaboration with colleagues in Manchester new ventures in clinical proteomics, transcriptomics and metabolomics will combine in the search for surrogate biomarkers measured in the patients’ blood. Overall, the DCU/CEP axis exemplifies that our declared intention, to have a Janus role between the clinic and the laboratory, has come to fruition.
Principal investigators
| Name | Job title | Email address |
|---|---|---|
| Caroline Dive | Professor of Pharmacology and Pharmacy | caroline.dive@manchester.ac.uk |
| Malcolm Ranson | Senior Lecturer and Honorary Consultant in Oncology | malcolm.ranson@manchester.ac.uk |
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