Senator Edward M. Kennedy, D-MA has represented Massachusetts in the United States Senate for forty-three years (seven full-terms) and is now the second most senior member of the Senate. Throughout his career, Kennedy has fought for issues that benefit the citizens of Massachusetts and the nation.

Kennedy is currently the senior Democrat on the Health, Education, Labor and Pensions Committee in the Senate. He also serves on the Judiciary Committee, where he is the senior Democrat on the Immigration Subcommittee, and on the Armed Services Committee, where he is the senior Democrat on the Seapower Subcommittee. He is also a member of the Congressional Joint Economic Committee and the Congressional Friends of Ireland, and a trustee of the John F. Kennedy Center for the Performing Arts in Washington, D.C.

Dr. Randall Lutter is US FDA Deputy Commissioner for Policy. In this capacity, he provides guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.

Lutter joined the FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.

Before joining FDA, Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers. He is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.

Jean-Hugues Trouvin has served as the Chair of the Biologics Working Party (BWP) of the European Medicines Agency (EMEA) for the past six years. With the BWP he contributed to the drafting and implementation of the many concept papers and guidelines on the quality and pharmaceutical/ biological development of biological products, including gene and cell therapy.

He was one of the rapporteurs of the guidelines and regulatory approach for comparability issues of biosimilar medicinal products. Trouvin graduated in Pharmacy and received a Doctorate in Pharmacology from the University of Paris, where he is Professor in the Faculty of Pharmacy. He worked as assessor and expert for the French Health Authorities from 1986, and was chairman of the French Biotechnology Working Party from 1989 to 1993, in charge of reviewing the biological and pharmaceutical quality aspects of biological and biotechnology-derived medicinal products.

He was Director of the Directorate for Evaluation of Medicinal Products and Biologics at the French Agency for Health Product Safety (AFSSAPS) from 2001 to July 2007. At the European level, he has participated in the Biotechnology/Pharmacy Working Party since 1986, and was the French CPMP member from 1995 to 2004. In addition, since 1992, he has been involved in the ICH (International Conference on Harmonisation) Process for Biotechnology Topics, including the CTD documentation.