GoingToMeet

Webinar Schedules:
1:14 th October 2009
2:21st October 2009
1
The issue of drug safety has never been higher on the agenda of the Food and Drug Administration (FDA), EMEA and other global regulatory agencies. As a result of the Vioxx case and several high-profile product recalls in recent years, fears about serious adverse events are increasing. One of the major reasons for the decline in new regulatory approvals is clearly due to hesitancy surrounding the lack of sufficient clinical evidence of safety. Biomarkers are increasingly being seen by regulators as helping to provide the clarity, predictability, and certainty that they require and increase their confidence in decision making. New discoveries in traditional areas of biomarker research based on physiology and pathology are being made almost daily. Furthermore, genomics and proteomics-based biomarkers are making great progress in being able to predict possible adverse-events before they occur, rather than purely diagnosing negative reactions only after they have happened.

Drug development companies are investing heavily and spending more time on biomarker research and development than ever before. The ability to accurately predict adverse events related to areas like cardiology, nephrology, neurology, haematology and hepatology is extremely exciting. Validated safety biomarkers provide the opportunity for smarter and earlier decision making in R&D, meaning project „kill“ decisions are made quicker, later-stage projects become less risky and hundreds of millions of dollars can be saved.