Drugs that fail in clinical trials do so because either they don’t meet their clinical end point, and/or they cause “surprise”, unforeseen or serious adverse events (SAEs).

Once a drug has been licensed for use, public health, clinical organizations, and sponsors still need to continually monitor adverse effects that are associated with its usage to assess the public health, clinical and economic effects. Biovista allows organizations to rapidly build and deploy predictive safety decision-support tools that facilitate such proactive safety surveillance monitoring, for example to proactively determine the relative risk of adverse events before they occur, providing at the same time the differential biological plausibility reasoning that supports each finding. The required metrics are generated using Biovista literature analytics discovery technology and presented to the analyst in a concise, actionable report.

Current signal detection is typically based entirely on observed AEs, meaning ones that have actually occurred. However, there is an emergent trend to attempt to predict AEs before they happen (for example, the FDAs Critical Path and the FDAAA 2007 legislation both address the need for a rational way to consider rare or unforeseen AEs prior to the events themselves).

We use our profiling and screening technology to organize and review not only the explicitly known and observed AEs, but also to actively “derisk” a drug. This involves using our technology to understand possible and plausible AEs, even though these AEs may not have occurred yet. The “derisking” data are then used to develop inclusion/exclusion criteria for trials, REMS, RMPs and clinical development plans.

 
Biovista provides this data in 30-45 days, which is a major advantage when you are in clinical development mode.

For more information on our AE Analysis and Derisking service please contact us.