FDA and Biovista to Collaborate on Medication Safety

12 January 2010 (Last Updated January 12th, 2010 18:30)

The US Food and Drug Administration (FDA) has licensed Biovista's technology platform to help analyse, identify, and better understand the way certain drugs can cause harmful side effects. The FDA's Office of Clinical Pharmacology, within the Center for Drug Evaluation and Research (CDER

The US Food and Drug Administration (FDA) has licensed Biovista's technology platform to help analyse, identify, and better understand the way certain drugs can cause harmful side effects.

The FDA's Office of Clinical Pharmacology, within the Center for Drug Evaluation and Research (CDER) will test the use of Biovista's Adverse Event Analysis (AEA) technology and work closely with Biovista scientists to carefully study the side effects of several drugs.

The goal of the collaboration will be to try to predict which patients may be most likely to experience adverse reactions to these medications so that healthcare providers can better protect their safety.

CDER director of the Office of Clinical Pharmacology Lawrence J Lesko said he hoped the technology would help improve how healthcare providers go about selecting the drugs they prescribe for their patients.

Biovista's AEA technology focuses on the mechanism of action-based correlations between drugs, disease efficacy and adverse events.

The AEA technology cross-correlates over 8,000 diseases and 12,000 adverse events known to medicine against any target, drug or combination, enabling researchers to link pre-clinical experimental data directly with potential clinical outcomes and risks.

The technology also helps researchers explain adverse events after these occur, in cases where these events were unexpected or not monitored for during trials and also to differentiate the causes of adverse events among a drug or the underlying disease.