Explore the Implications of the Cardiorenal Panel meeting on Statin Drugs

This webinar will review the implications of the recent ruling by the FDA Cardiorenal Advisory Panel on December 15, 2009 that voted in favor of approval for Rosuvastatin.  The trial results, from the study, called Jupiter, showed that Rosuvastain improves CV outcomes when given for primary prevention in 18,000 asymptomatic patients. Most of these patients had normal cholesterol. The combined risk of heart attack, stroke and heart-related death fell by 47%.

These study results have wide ranging implications for cardiovascular drug development, but particularly for primary prevention of events. Two leading experts in cardiovascular drug development will provide insight into the implications of the recent ruling and discuss:

• Whether inflammatory markers can be used to define the population of interest?
• How sponsors can design studies for these kinds of indications?
• The importance of accurate adjudication of cardiovascular endpoints in primary prevention studies?

Who Should Attend?

Professionals in Medical Affairs, Clinical Operations, Regulatory Affairs, Marketing, and Medical Writing 

Expert Panalists.

Dr. C. Michael Gibson, MD FACC 

Dr. P. Ridker, MD FACC 

Dr. JH Goldman, MD FACC