Q 1. Where do you see changes in the industry's strategy to identify and mitigate risks for first-in-human clinical trials? Is there a trend towards more complex integrated FIH protocols?
There has been an increased focus on trying to identify and evaluate biomarkers for hepatic, renal and cardiovascular safety as well as markers of target engagement/efficacy. Incorporation of these additional end points can make FIH protocols more complex but potentially more informative.
Q 2.What difficulties do you face in the timing of the deployment of different safety tests and choosing different non-core battery tests?
Determining the applicability and utility of newer non-core tests and how to interpret and apply the data/information.
Q 3. What are the challenges in follow-up studies that may be triggered in order to characterize a specific adverse effect found in initial safety pharmacology studies?
Translation of findings from nonclinical studies to humans.
Dr Gary Eichenbaum will be speaking at Exploratory Clinical Development World Europe 2012 taking place in London on the 22-24 May 2012. His presentation is called "Approaches and considerations in cardiovascular safety assessment of compounds with QT effects and mixed ion channel activities".