Drug Safety, Bridging the Gap - Washington DC 2010

Safety pharmacology emerged a decade ago because drug failures were poorly anticipated. The terfenadine case highlighted the danger (and prediction difficulty) of rare but lethal adverse events. In the last ten years there has been much progress. New regulations have evolved. Mechanisms of drug adverse effects have been elucidated. Industrial safety pharmacology has emerged as the life partner of drug discovery.
Nevertheless, there remain important unresolved questions. For example, from an industry perspective, how much safety pharmacology should a company provide for regulatory consideration when seeking new use approval for a novel therapeutic? From the regulator perspective, how much information is required from industry to permit a decision? From the academic perspective, how can basic science be used to inform the decision making process? From all perspectives, how do we know when models and methods have been validated?
With the emergence of biologics, and the application of new approaches and techniques for drug discovery, the need for clarity, transparency and accountability has grown. It is the expense of time, resources and effort that require attrition not drug discovery. Therefore it is essential that the three corners of the safety triangle can see one another, recognise one another s position, communicate and interact.
The purpose of this meeting therefore is to highlight the gaps between industry, academia and regulators and identify ways of bridging them. To do so, participants are encouraged to consider ways of overcoming the three main obstacles to progress: the restrictions of economics, the clarity of regulatory guidance and the limits of scientific knowledge.