'Translational Science, Myths and Realities'

'Translational science' is a branch of medical research that attempts to more directly connect preclinical research to the clinic. This area of research is growing in importance in the healthcare industry, and is a term whose precise definition is in flux. In the case of drug discovery and development, translational medicine typically refers to the "translation" of basic research into real therapies for real patients; The emphasis being on the linkage between the laboratory and the patient's bedside, without a real disconnect. This is often called the "bench to bedside" definition i.e. The applied research (pre-clinical and clinical) which is conducted to support drug development and which will aid in patient, dose and disease (segment) selection.
Many pharmaceutical companies are building Translational Science groups to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials. Traditionally, basic research has been separated from the clinical practice of medicine by a series of hurdles or fences, where new compounds were developed independently of the clinic, and often ‘thrown over the fence’ for safety testing and clinical trials. This has in the worst cases resulted in the identification of compounds for targets which were near impossible to develop clinically, or in clinical indications for which there was no commercial or clinical need. The move toward translational medicine is focused on removing the disconnect, and stimulating "bench to bedside" research.
Some examples of important questions that Translational Medicine can/may help answer are as follows:
 
•    What disease sub-type would the drug be best studied in?
•    What decision-making biomarker should be used in studies?
•    What drug schedule should be used?
•    What ‘Personalised medicine’ strategy, if any, should be pursued?
•    What Combination strategy, if any, should be pursued?
•     How is this drug differentiated from competitors?
•    How does acquired resistance develop, and how best can it be combated?

Dr Glen Clack MB BS MFPM

Clinical Development Director
Early Oncology
AstraZeneca Pharmaceuticals, Alderley Park, Mereside, Macclesfield Cheshire, SK10 4TG
Tel: 01625 518280    Fax: 01625 585626    e-mail: glen.clack@astrazeneca.com

Dr Glen Clack is the Associate Director of Discovery Medicine for Cancer and Infection based at AstraZeneca Alderley Park. This role involves overseeing the translational research programmes supporting over 30 products in late phase discovery and all phases of clinical development. He graduated from the Royal Free Hospital School of Medicine, London, spending 5 years in basic surgical training in the National Health Service.
He joined Zeneca in 1997, and has experience in all phases of clinical development within Oncology. Since 2002 he has been involved in Translational Science and Phase I studies with small molecule tyrosine kinase inhibitors, and has developed biomarkers that provided proof of mechanism and proof of principle of action. Within the industry, he also has had responsibilities on the Oncology Target Selection Team, and is the AstraZeneca nominated representative for several Academic and Regulatory Alliances/’Think Tanks’.
He also holds an honorary academic position within the Section of Human Metabolism of the Faculty of Medicine at the University of Sheffield, where he is writing his MD thesis; entitled ‘The use of bone turnover markers in drug development’.