Meeting Will Address CV Risk Testing in Drugs

The 7th Annual Summit on Cardiovascular Risk and Safety will be held January 24 and 25 in Washington, DC. Applied Clinical Trials is a co-organizer of the event and Editorial Director Lisa Henderson will give the welcome and review industry trends for the attendees. She will also be tweeting live during the event at #CVSafety.

This year’s conference chairperson is Karen Smirnakis, MD, PhD, Medical Directory, Global Safety for Amgen. She will also present the topic “Explore Industry Consideration for Global Regulatory Harmonization and Partnerships.” Smirnakis told Applied Clinical Trials that “an understanding of the key differences and similarities in global cardiovascular safety guidelines is essential for global development programs evaluating cardiovascular drug safety. During the 7th annual CBI conference, we will review some of these similarities and differences, and discuss the potential impact to cardiovascular risk assessment in clinical trials.

Other topics include CV Risk Assessment in Oncology Drug Development, Regulatory Requirements for CV Safety in Diabetes Drug Development, Virtual Population Simulation for Estimation of Baseline Event Rates and Anticipation of Possible CV Safety Concerns. A roundtable discussion, Early Phase Detection of CV Risk to Minimize Adverse Events aims to share strategies for use of high-quality data in early assessments of cardiac-safety related risk and risk minimization. The roundtable will offer the attendees discussion of the value of integrated assessments of effects on markers of potential benefit versus adverse effect in early phase clinical development.

Attendees who register by November 16, will save $300 on conference registration. Go to www.cbinet.com/cvsafety.

Editor’s Note: Conference producer CBI and Applied Clinical Trials are a part of Advanstar Communications Pharma/Science Group.