Drug Development Unit
The Drug Development Unit is a joint team between the Institute of Cancer Research and The Royal Marsden Hospital, it is led by Professor Stan Kaye. The Unit provides a seamless conduit between preclinical drug discovery, proof-of-principle Phase I trials, and tumour-specific evaluation of novel agents, and facilitates essential two-way collaboration between laboratory-based and clinical teams.
Clinical trials are conducted by Professor Stan Kaye, Dr Udai Banerji and Dr Johann de Bono. These involve studies of novel agents with new molecular targets, and a major theme for the Unit is the identification of predictive and pharmacodynamic biomarkers (including extensive studies with circulating tumour cells). Examples of trials include studies with the oral PARP inhibitor, olaparib, and the CYP-17 inhibitor, abiraterone. These drugs are expected to make a major impact on HR (homologous recombination)-deficient cancers and hormone-refractory prostate cancer, respectively.
The Unit is supported by Cancer Research UK, the Department of Health, and the Royal Marsden Hospital, through a core programme grant, and through funding as an Experimental Medicine Cancer Centre (ECMC) and NIHR Biomedical Research Centre. Novel agents developed under the aegis of Cancer Research UK are prioritized for trial in the Unit.
The Oak Foundation Drug Development Centre within the Royal Marsden is specifically designed for Phase I clinical trials. Opened in February 2005, it comprises 10 inpatient beds, 5 treatment chairs and 2 outpatient suites. There are also has laboratory facilities for sample preparation and storage, and a seminar room. A ward-based team of research nurses are able to provide 24-hour cover 5 days/week (for pharmacokinetic blood sampling, observations etc), and more than 30 concurrent studies are now under way.
In addition, the Drug Development Unit has a team of data managers, research nurses and clinical staff from both Cancer Therapeutics and Medicine. Pharmacokinetic and pharmacodynamic studies are conducted by Dr Florence Raynaud and Dr Michelle Garrett, respectively, in the GCLP-compliant laboratories within Cancer Therapeutics.
Close to 300 patients per year enter Phase I trials on the Unit, making it one of the largest in the world. In 2006, it achieved ”Outstanding” grading for previous and future work at a CR-UK Quinquennial Site Visit.