Biovista announces that its President, Dr. Aris Persidis, will give a seminar at the NIH/DAIDS Medical Officer’s Safety Forum on Thursday, March 28th. The seminar, is entitled “Using Mechanism of Action to Predict Safety Signals and Understanding Sub-Populations.”

With the web being increasingly used to determine side effects of drugs, and with self-reporting patient social networking databases increasing in prominence, what is the future of safety science and pharmacovigilance? At present, drug safety is mostly reactive, waiting for a safety signal to be formally registered before it is evaluated and any necessary action is taken. This has led to the development of significant patient monitoring approaches and systems that are excellent at capturing and alerting on the occurrence of an event, but are not able to predict or explain a side effect ahead of time. Appropriately, pursuing adverse event hypotheses in the absence of a clinical observation would seem to be a waste of resources, and in certain cases, where the hypothesis is poorly developed, that would be the case. However, a purely reactive approach fails to take advantage of valuable and significant data that can predict potential adverse events and justify them mechanistically ahead of time. Mechanism of action (MoA) data and correlations with clinical outcomes is a powerful emerging way to infer potential clinical outcomes, whether safety or efficacy-driven. Such approaches are being validated with pre-clinical and clinical observations, increasing the confidence in their use in real-world scenarios. They represent proactive and complimentary tools to current reactive drug safety approaches. The seminar will evaluate some of these approaches and place them in context relative to purely reactive pharmacovogilance, or web-based self reporting tools. The use of MoA data to help define subpopulations that may have a different Benefit/Risk ratio will be described, including a number of case studies where use of MoA-based approaches can help direct clinical trial design.

The seminar will also be available remotely, and connection details are provided here:

In person:

Thursday, March 28, 2013

2:00PM – 3:00PM

6700A, RM 245

Bethesda, MD 20892

Remote Access:

Dial +1 (805) 309-0012

Access Code: 481-610-455