Drug Safety - NRDD
Nature Reviews Drug Discovery 6, 937 (November 2007)
There is a pressing need to improve the understanding of safety issues during drug development and post-approval. Our interviewees this month explain their roles in efforts to enhance drug safety.
Julie Barnes, Ph.D. Chief Scientific Officer, BioWisdom Ltd., Cambridge, UK
Recent high-profile issues with drug safety have highlighted the need not only to improve post-marketing pharmacovigilance but also to identify drug candidates with good safety profiles earlier. To address these challenges, healthcare technology companies such as BioWisdom are providing intelligence to support decision-making about safety issues that arise during the development of new drugs. “Our approach is founded on the principles of ontology. This is a traditional science that applies a relationship-based approach to, for example, understand mechanisms of drug action as they pertain to adverse events,” explains CSO Julie Barnes.
Barnes’ career in drug development began when, following her Ph.D. in behavioural neuroscience, she took a postdoctoral position at GlaxoSmithKline (GSK) to develop a series of in vivo models and screens for evaluating new chemical entities for Alzheimer’s disease. Although initially very specialized in her discipline, over the next 15 years, she began to recognize the value of multidisciplinary research to bring different perspectives and technologies to a business problem.
“While at GSK, I saw projects come and go, clinical trials succeed and fail, and markets change,” she says. “Managing change and decision-making in such an environment is an experience that I am pleased to have had the opportunity to acquire.”
During this time, Barnes also experienced the rapid expansion in electronic information, which changed the behaviour of scientists from browsing current journals in company libraries to searching e-publications and other electronic data from their desktops. “Getting access to relevant information without being deluged with too much became an increasing challenge,” she explains.
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