William J. Kennedy, PhD., is a regulatory affairs professional with over 35 years of domestic and international experience. He has successfully managed the development, preparation, submission and approval of dozens of NDAs and major SNDAs. He has helped shape regulatory policy in the United States continuously since 1988, as a member and Chairman of PhRMA’s Regulatory Affairs Coordinating Committee, as PhRMA’s Chief Negotiator with Congress and FDA for FDAMA, and as the Co-Chairman of PhRMA’s PDUFA III Steering Committee. He is the author of several articles and is an often sought after speaker for his insight into the regulatory process. He was the recipient of RAP’s prestigious Special Recognition Award in 1998. Please see the Resume section at the end for a more complete description of Dr. Kennedy.