CHARLOTTESVILLE, Virginia, February8, 2011 — Biovista announced today that it is co-presenting a webinar with FDA/OCP on Predicting Serious Adverse Events Using Mechanism of Action, on Thursday, 24 February 2011.
Biovista’s President, Dr. Aris Persidis, will co-present together with Dr. Darrell Abernathy, Associate Director for Drug Safety in the Office of Clinical Pharmacology at the FDA.
A major reason for drug failures in clinical trials is serious adverse events (SAEs). There is an increasing need to understand potential SAEs before these are observed in trials. This would lead to more rationally designed inclusion/exclusion criteria for trial design and monitoring. The webinar will introduce new approaches and technologies that use mechanism of action (MoA) to predict SAEs, to develop inclusion/exclusion criteria on a MoA basis, and also to explain SAEs after they happen. The integration of these approaches within current FDA thinking will be discussed, together with relevant elements of the collaboration between Biovista and FDA/OXP on the topic.
The development and adoption of these approaches may improve patient cohort stratification, which is a major element of successful drug development.
Further information on the webinar and registration details can be found at http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=T11664_00648