A series of three seminars on working with the FDA took place October 22 and 29 and November 4 at the Yale Anlyan Center in New Haven.

Presented by CURE and the Yale Biotechnology & Pharmaceutical Society, the series was sponsored by CURE, Bristol-Myers Squibb, and Rib-X Pharmaceuticals, with the participation of Achillion Pharmaceuticals, Pfizer, the U.S. Food and Drug Administration, and the law firm of Wilson Sonsini Goodrich & Rosati.

As the process of drug discovery involves a complex interplay among researchers, legal experts, business management teams, investors, and regulatory agencies, the seminars featured speakers from various backgrounds discussing topics such as generating pre-clinical data, filing a new drug application, managing clinical trials, marketing drugs nationally and globally, and creating value for investors. Also discussed were the changes the FDA is going through as the result of the Food and Drug Administration Amendments Act.

The October 22 panel featured two FDA officials, M. Yebba, Senior Public Affairs Specialist, and M. Haggerty, Drug Investigator.

The October 29 panel featured Dr. M. Garvey, Director of Worldwide Regulatory Strategy & Registration at Pfizer; Dr. C. Burgess, Associate Director - Regulatory Oncology ar Bristol-Meters-Squibb, and Dr. G. Shah, Senior Vice President and Chief Compliance Officer at Achillion Pharmaceuticals.

Devoted to intellectual property issues, the November 4 panel included presentations by Vern Norviel, Partner, and Jon Nygaard, FDA Specialist, at Wilson Sonsini Goodrich & Rosati.

Click here to download the Norviel presentation
Click here to download the Nygaard presentation