David Powell, Contract Manager, National Institute for Social Care and Health Research
What has been your route into the industry?
I trained as a biomedical scientist specialising in haematology and blood transfusion science after which I developed an interest in blood clotting disorders. This led me to a research post in London and then to become the haematology manager of a large private laboratory. It was there that I first came into contact with clinical trials through the central laboratory services offered to the pharmaceutical industry. I then spent 6 years working for a biotechnology company in South Carolina, USA, where I worked on human monoclonal antibody development and became involved in setting up clinical trials. Following my return to the UK I was employed as commercial research manager in Cardiff which involved making internal arrangements for clinical trials, contracting and costing.
Why have you become involved in your particular specialisation?
I have found that my broad experience in NHS and private laboratories, research experience, knowledge of drug development, experience of clinical trials and an interest contracts and costing fits my present role perfectly.
What do you consider to be the biggest challenge at the moment and why?
Despite the widespread use of model agreements in the UK there are many types of study for which models do not exist. In addition some Sponsors, especially those based outside the UK, and some NHS and UK based academic organisations require changes to these model agreements but there is considerable uncertainty among R&D managers about what is acceptable. There is considerable pressure to grant R&D Permission within a relatively short period of time but the continuing need for each participating site to negotiate contracts for studies for which an unmodified agreement is available makes meeting these deadlines difficult.
What do you consider to be the biggest threat at the moment and why?
The steady decline in the number of clinical trials and clinical investigations conducted in the UK will harm the economy and patients who might benefit from involvement in clinical research using new drugs and devices will lose out
Who will be most interested in the subject matter of the conference and in particular, your topic?
NHS and university R&D managers and anyone involved in setting up research studies in the NHS.
What do you expect your delegates to “take away” with them at the end of the conference?
An idea of the types of contracts that might be used for particular kinds of clinical research and how and why they might be modified.
David Powell will be leading the Structuring and Reviewing Clinical Research Contracts event on Tuesday 6th March 2012 at DoubleTree by Hilton Hotel, Manchester
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