In the current environment where minimising cost and delivering ROI are critical themes within the pharma and biotech industry, exploratory clinical trials play a crucial role in identifying the drugs that are likely to fail, therefore enabling a faster go/no-go decision that can save vital time and resources. Human microdosing studies offer the promise of improved candidate selection, reduced attrition rates, safer clinical studies and a potential reduction in the use of animals in early clinical development.

However, pharma manufacturers are still unclear about the reliability of Phase 0 studies, making it big area for debate. Questions have been raised over whether Phase 0 trials are useful, ethically acceptable, feasible, speed up the drug development process or save money, and whether there is room for improvement.

VIBpharma Exploratory Clinical Trials conference, being held Tuesday 1 and Wednesday 2 December 2009 in Brussels, Belgium, will bring experts from the pharmaceutical and biotech industry together to discuss these issues and the latest developments within the field of exploratory clinical trials. Through a series of presentation, case studies and interactive discussions, participants will gain practical insight into key issues such as gaining regulatory approval, implementing and running exploratory studies successfully and efficiently, the role of biomarkers, utilising effective modelling and simulations tools as well as the mitigation of safety risks.

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