the Center for the Study of Drug Development. Formerly a member of the National Advisory Council on Health Care Technology Assessment (1985–1988), Dr. Hansen has also been a consultant to the congressional Office of Technology Assessment for a panel on the Patent Term Restoration Act.

Donald E. Hill, B.S., retired from his position as Director of Product Certification, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA), in 1990, and is now a Regulatory Consultant to the biologics industry. Mr. Hill received his B.S. degree from Ohio State University College of Pharmacy in 1960. In the same year, he received a commission into the U.S. Public Health Service, where he served his entire government career of 30 years. As Director of Product Certification, he was directly involved in the licensing and quality control of biological products in the United States. He provided guidance to industry on facility requirements, licensing standards, joint manufacturing arrangements, and product promotion and advertisement. Mr. Hill has published several articles on FDA facility and licensing requirements for manufacturers of biologics and is a frequent guest lecturer at industry and professional society meetings and at educational seminars. In 1987, he was honored with the R. E. Greco Award as Regulatory Professional of the Year.

John Lloyd Huck, B.S., retired from his position as Chairman of the Board of Merck and Co., Inc., in 1986. After receiving his B.S. degree in chemistry from Pennsylvania State University, he served in the U.S. Army Air Corps during World War II. Mr. Huck began his career in the pharmaceutical industry as a research chemist with Hoffmann LaRoche in 1946. In 1958, Mr. Huck joined the Merck Sharp & Dohme Division of Merck & Co., Inc., as Director of Marketing. After progressing through a number of marketing and managerial positions, he was elected President and Chief Operating Officer of Merck & Co., Inc., in 1978 and Chairman of the Board in 1985. After retiring from Merck in 1986, he joined the Board of Directors of Nova Pharmaceutical Corporation and served as Chairman of the Board and Chief Executive Officer for several years. He is past Chairman of the Board of Pennsylvania State University and of the Morristown Memorial Hospital. In addition, he has served on the boards of a number of corporate, professional, and not-for-profit organizations.

David T. Karzon, M.D., is Professor in the Departments of Pediatrics and Microbiology and Immunology, Vanderbilt University School of Medicine. He received a B.S. and M.S. from Ohio State University and his M.D. from the Johns Hopkins University School of Medicine. Dr. Karzon has taught

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