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The Derek Crowther Early Clinical Trials Unit (DCU) and the Clinical and Experimental Pharmacology Group (CEP)

Introduction

The Derek Crowther Unit, directed by Professor Malcolm Ranson is a dedicated clinical trials unit at the Christie Hospital. Its facilities provide an environment and equipment to enable patient access to the newest treatment approaches and drug development. CEP was conceived in 2004 to fulfil the obvious and pressing need for biomarker-focused translational research in an era of mechanism-based therapies (MBTs), recognising the considerable opportunity for this activity that the juxtaposition to DCU brings. Reflecting CEP philosophy of team work between clinical and non clinical colleagues, CEP is co-directed by Prof Caroline Dive and Prof Ranson and biomarker research in CEP is influenced by current and future DCU activity.

The corridor containing CEP laboratories was named the PACCAR Centre for Therapeutics in September 2007 to reflect the significant funding received by CR-UK from the PACCAR foundation for the ongoing translational research.

DCU and Plans for Expansion

Named in honour of Professor Derek Crowther the first Director of Medical Oncology at the Christie, DCU opened in 2003 and was an important and significant landmark in the ongoing development of cancer clinical research at the Christie. In 2006/07 the unit supported over 100 trials, and 10,000 patient visits. DCU contains a dedicated clinical sample processing and storage laboratory and close onsite access to the CEP biomarker research laboratories. Plans are currently being pursued to expand DCU to make it one of the largest Units of its kind in the world. The DCU currently operates as an outpatient facility, although inpatient accommodation will be included in the new development. DCU activity from 2006-2007 is summarised below.

The Remit and Organisation of the Clinical and Experimental Pharmacology Group

The goals of CEP are therefore (i) To spearhead early clinical evaluation of novel Mechanism Based Therapies by providing pharmacokinetic and innovative pharmacodynamic biomarker analyses to GCLP standards using state of the art technologies, and (ii) To respond to a national deficit in clinical and non-clinical translational pharmacology specialists by providing world class training for biomarker research in oncology.
CEP was expanded significantly between 2004-2007 reflecting the breadth of its activities (in vitro, preclinical in vivo and clinical). A QA system was developed and implemented to meet the requirements of Good Clinical Laboratory Practice (GCLP) applied to clinical sample analyses where data have the potential to influence patient management. 2006 saw CEP move into purpose built, state of the art, translational laboratories at PICR.

Twin research themes within CEP are the evaluation of MBTs that promote tumour apoptosis (exploiting expertise of Professors Dive & Ranson) and those that prevent tumour angiogenesis (combining expertise in CEP with that of the adjacent collaborator Prof Gordon Jayson). The three Disease Focus Subgroups within CEP are lung cancer (led by Dr Fiona Blackhall), Colorectal Cancer (led by Mr Renehan) and Paediatric Cancers (led by Dr Guy Makin). CEP also extended its collaborations on biomarkers this year with clinical colleagues within MCRC (Prof Noel Clarke, GU cancers and Professors T Illidge and Radford, Haematological Malignancies).

CEP staff are organised into several teams, PD biomarkers, QA, PK, Clinical Proteomics and Biomarker Discovery, In vivo Pharmacology, and Molecular Pharmacology. Translational research studies include investigations of efficacy of novel drugs in hypoxic tumour cells (collaborating with Prof Ian Stratford and Dr Kaye Williams, School of Pharmacy, MCRC), and on optimal combinations and scheduling of novel with conventional therapeutics. Pre-clinically, CEP also develops and tests in vivo models with ‘switchable’ expression of drug targets or pathways. These models will facilitate the discovery of serological biomarkers, the development of tumour imaging tools with colleagues at the Wolfson Molecular Imaging Centre and evaluate on and off target effects of novel MBTs.

Training the Next Generation of Early Clinical Trialists

Training of translational scientists and academic pharmacologists (a national deficit): is achieved through a Clinical Pharmacology Fellowship Scheme for promising young doctors initiated in 2006. The Scheme is equally funded by CRUK and AstraZeneca leads to award of a PhD in Clinical and Experimental Pharmacology and has 2 Fellows in post and 2 recruited to start in 2007. The Fellows’ Projects are all biomarkers based and involve collaborations with many clinical colleagues within the MCRC. Fellows undertake their laboratory based research in CEP and elsewhere within MCRC and at AZ and attend one clinic per week in DCU.