WILLIAM B. SCHULTZ is a Partner in the law firm of Zuckerman Spaeder in Washington, D.C. He represents clients in court, before Congress and at the Food and Drug Administration (FDA). Prior to joining Zuckerman Spaeder, he held the position of Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice. He supervised the Civil Division’s Appellate Litigation and the Department’s lawsuit against the tobacco industry. He also served as Deputy Commissioner for Policy at the Food and Drug Administration (1994-1998) and as Counsel for the Subcommittee on Health and the Environment, U.S. House of Representatives, Committee on Energy and Commerce (1990-1994). Prior to entering the government, Mr. Schultz was an attorney at Public Citizen Litigation Group. He served as a Commissioner on the Scheuer-Gore Commission on the Drug Approval Process in 1982. He also served as a law clerk to U.S. District Judge William B. Bryant and was an Adjunct Professor at Georgetown University Law Center. Mr. Schultz received his B.A. from Yale University and his J.D. from the University of Virginia Law School.

PETER LURIE, M.D., M.P.H. is Deputy Director of Public Citizen’s Health Research Group, a Ralph Nader-founded advocacy group in Washington, D.C. He has been involved in efforts to ban or relabel multiple drugs and has petitioned to ban certain unsafe medical needles, to ban candles with lead wicks, to reduce worker exposure to beryllium and to lower medical resident work hours. During his academic career he wrote about needle exchange programs, ethical aspects of mother-to-infant HIV transmission studies and HIV vaccine trials in developing countries and the impact of economic development policies upon the spread of HIV.

BRUCE PATSNER, M.D., J.D., M.B.A. is a Research Professor with the Health Law & Policy Institute at the University of Huston Law Center in Houston, Texas. Previously, he was Director of Clinical Research at the Women’s Cancer Center of Nevada, University of Nevada School of Medicine in Las Vegas, Nevada. Prior to that position, he was Senior Medical Officer, the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). At FDA, Dr. Patsner was primary medical reviewer for a number of investigational new drug (IND) applications and primary or secondary medical reviewer on several new drug applications (NDAs). He was the CDER liason to a joint National Institutes of Health (NIH)/FDA Inter-agency Oncology Development Committee. He was one of FDA’s experts on pharmacy compounding of prescription drugs, herbal therapies for cancer and women’s health related conditions; he was the only board-certified GYN Oncologist within FDA/HHS and primary FDA expert on management of pre-invasive lower genital tract disease. He was primary medical officer for evaluation of all hormone therapy prescription drugs and for CDER’s evaluation of HPV vaccine applications to the Center for Biologics Evaluation and Research (CBER) – Gardisil® and consultant to the Center for Devices and Radiological Health (CDRH) for evaluation of gynecologic surgical technologies. Dr. Patsner was senior author or contributing author for various CDER Guidance Documents. He has authored or co-author numerous manuscripts for medical peer review, book reviews, law review publications, written medial journal articles and many electronic publications. Dr. Patsner received his B.A., cum laude, in Philosophy and Biology from Amherst College, his M.D., with honors, from Baylor College of Medicine, his M.B.A., Distinction in Finance from Rutgers University School of Business and his J.D. from Harvard Law School.

RICHARD A. SAMP is Chief Counsel for the Washington Legal Foundation (WLF) where he coordinates WLF’s litigation activity. Prior to joining WLF in 1989, he was a civil litigator with the Washington, D.C. law firm of Shaw Pittman LLP. He is a graduate of Harvard University and the University of Michigan Law School and clerked for federal Judge Robert E. DeMascio of Detroit.