Steve Nissen headlines Windhover's FDA/CMS Summit

The Food and Drug Administration’s (FDA) approach to drug safety is headed for significant changes in the wake of several high-profile drug withdrawals, critiques of the advisory committee process, and pending legislation to revamp its review procedures. These changes will have a lasting impact on the companies that develop and market regulated drugs.

Steven E. Nissen, M.D., FACC, Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, will headline an in-depth discussion of the changes underway and in consideration for the FDA’s drug evaluation and safety assessment procedures at Windhover’s FDA/CMS Summit.

The Summit will take place Dec. 4-5 in Washington, DC. Online registration is available at www.windhover.com/fda-cms.

Nissen, a former member of FDA’s Cardiovascular and Renal Drugs Advisory Committee and a key figure in the Cleveland Clinic’s emergence as a major clinical trials site, is a leading academic advocate for changes in FDA’s approach to assessing drug safety.

He coauthored an analysis of FDA’s review of Bristol-Myers Squibb’s Pargluva new drug application that coincided with the agency’s decision not to approve the drug.

Additionally, following the release of the recent Institute of Medicine review of the U.S. drug safety system, Nissen called for randomized trials when safety signals arise and for FDA to “raise the bar” on approval standards for first-in-class drugs.

Dr. Nissen’s outside perspective will complement those of top FDA policymakers, including acting Commissioner Andrew von Eschenbach, MD, Deputy Commissioners Janet Woodcock, MD, and Scott Gottlieb, MD, and Center for Drug Evaluation & Research Director Steven Galson, MD.

The summit comes at a watershed point for FDA -- one month after the Congressional elections will usher in a new Congress with an intensified focus on the agency. The FDA/CMS Summit will help pharmaceutical executives identify the issues at stake for the agency and its regulated industry constituents.

A complete agenda and registrations for the summit are available at www.windhover.com/fda-cms.

The FDA/CMS Summit is designed as a unique opportunity for face-to-face dialogues with top policymakers and executives. It is designed for industry executives in all areas of responsibility who want to create successful strategies for dealing with FDA and CMS. Attendees will get practical, real-life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles, and will also be able to benchmark their regulatory strategy against all the major pharmaceutical and biotechnology companies.

To register for the summit, contact Alexandria Riley at (203) 838-4401 ext. 113 or ariley@windhover.com; or register on the FDA-CMS Conference website at www.windhover.com/fda-cms.