Biosecurity, Public Health and the Role of Industry
May 12, 2005
Senators Joe Lieberman (D-CT), Orrin Hatch (R-UT) and Sam Brownback (R-KS) have unveiled the BioShield II legislation designed to energize a biodefense sector that will provide the medicines the nation needs to combat the threat of bioterrorism. The Center for American Progress has assembled an expert panel to debate the issues surrounding this legislation and the biological threats facing America today.
Note: All video provided in QuickTime (MPEG-4) format.
|Kathleen Jaeger assumed the duties of the Generic Pharmaceutical Association’s (GPhA) President and Chief Executive Officer in April 2002. Prior to joining GPhA, Kathleen was a Partner in the Washington, D.C., office of Kirkpatrick & Lockhart LLP, where she served as the national practice leader of K&L’s Food and Drug Practice Group. Before joining K&L, Ms. Jaeger was a Partner with the law firm of McKenna & Cuneo L.L.P, and appointed chairperson of the Food and Drug Practice group as well as served on several recruitment and marketing committees. During private practice, Ms. Jaeger represented both U.S. and foreign corporations in a wide variety of pharmaceutical matters involving the U.S. Food and Drug Administration (FDA) and related governmental bodies. She routinely assisted clients in the development of competitive research and marketing product strategies, and advised clients in regulatory and legal matters affecting all stages of product development and life cycle management. In addition, Ms. Jaeger developed congressional testimony and position papers for both the National Pharmaceutical Alliance (NPA) and the GPhA, which was created through the merger of NPA and other generic industry associations in 2000. Ms. Jaeger also has interfaced extensively with federal and state legislative and regulatory bodies on the federal generic approval process; state formularies and generic substitution restrictions; the value of generic products and the need to maintain current generic rebate levels; and the opportunities for states to dramatically lower prescription drug spending through educational programs and incentives that enhance the usage of generic pharmaceuticals. Ms. Jaeger received her J.D. from Catholic University Law School in 1990 and her B.S. in Pharmacy with a Minor in Chemistry from the University of Rhode Island in 1987. Ms. Jaeger grew up in a family-owned community pharmacy and practiced pharmacy at the National Institute of Health for a year during law school.|
|Chuck Ludlam has served for nearly four years as Counsel to Senator Joseph Lieberman. In that capacity he developed the Lieberman-Hatch bills to provide incentives for R&D on bioterror countermeasures. They have led to the enactment of Project BioShield (July 2004) and are included in S. 3, the Republican Leadership bioterrorism bill (introduced in January 2005). Prior to joining Senator Lieberman, Chuck served for seven years as the principal lobbyist for the Biotechnology Industry Organization, representing 1000 biotech and pharmaceutical companies. He has also served for twenty years as counsel to House and Senate Committees, two years as counsel to the Carter White House, and three years as counsel to an independent regulatory agency. He graduated from University of Michigan Law School (J.D. 1972) and Stanford University (B.A., 1967). He has extensive personal experience with tropical medicine, having served as a Peace Corps Volunteer in Nepal (1968-1970) and visited 65 countries worldwide.|
|Jonathan D. Moreno, Ph.D. is a fellow at the Center for American Progress. He is the Emily Davie and Joseph S. Kornfeld professor of biomedical ethics and director of the Center for Biomedical Ethics at the University of Virginia. He is immediate past president of the American Society for Bioethics and Humanities. Moreno currently co-chairs the National Academy of Sciences Committee on Guidelines for Human Embryonic Stem Cell Research. He is also a bioethics advisor for the Howard Hughes Medical Institute, a faculty affiliate at the Kennedy Institute of Ethics at Georgetown University, and is a fellow of the Hastings Center and the New York Academy of Medicine. His forthcoming book, Is There an Ethicist in the House?, will be published by Indiana University Press in 2005. Among Moreno’s previous books are In the Wake of Terror: Medicine and Morality in a Time of Crisis (MIT Press, 2003), and Undue Risk: Secret State Experiments on Humans (Routledge, 2001). He is under contract to the Dana Press for a book tentatively entitled Mind Wars: National Security and the Brain . Moreno has published more than 200 papers, reviews and book chapters, and is a member of several editorial boards.|
|Tara O’Toole is the CEO and Director of the Center for Biosecurity at the University of Pittsburgh Medical Center, and Professor of Medicine at the University of Pittsburgh. Dr. O’Toole has served on numerous government advisory committees and expert bodies dealing with biodefense, including panels of the Defense Science Board; the National Academy of Engineering Committee on Combating Terrorism; and the National Academy of Sciences Working Group on Biological Weapons. Her publications in the biodefense field include articles on medical management of Class A bioweapons agents; policy issues related to contagious disease containment; biodefense research and development strategies; and hospital preparedness issues. She is co-editor in chief of the journal Biosecurity and Bioterrorism – Biodefense Strategy, Practice and Science, and was one of the principal authors and producers of Dark Winter, an influential exercise conducted in June 2001 to alert national leaders to the dangers of bioterrorist attacks and Atlantic Storm, an international ministerial-level exercise held in January 2005. Dr. O’Toole was one of the original members of the Johns Hopkins Center for Civilian Biodefense Strategies and served as Director of the Hopkins Center from 2001-2003. In 2004, she was elected chair of the Board of the Federation of American Scientists. From 1993 to 1997, Dr. O’Toole served as Assistant Secretary of Energy for Environment Safety and Health. As Assistant Secretary, Dr. O’Toole was the principal advisor to the Secretary of Energy on matters pertaining to protecting the environment and worker and public health from the US nuclear weapons complex and DOE laboratories. From 1989-1993, Dr. O’Toole was a Senior Analyst at the Congressional Office of Technology Assessment (OTA) where she directed and participated in studies of health impacts on workers and the public due to environmental pollution resulting from nuclear weapons production, among other projects. Dr. O’Toole is a Board-certified internist and occupational medicine physician with clinical experience in academic settings and community health centers. She received her Bachelors degree from Vassar College, her MD from the George Washington University and a Master of Public Health degree from Johns Hopkins University. She completed a residency in internal medicine at Yale, and a fellowship in occupational and environmental medicine at Johns Hopkins University.|
|David Ozonoff received his bachelor’s degree in mathematics from the University of Wisconsin in 1962 and his MD degree from Cornell University Medical College in 1967. In 1968 he received an MPH degree from Johns Hopkins School of Hygiene and Public Health. He then pursued research work at MIT from 1968 to 1977, studying, among other things, the psychophysical difficulties of radiologists when reading chest x-rays. He and his colleagues also published one of the first two-dimensional x-ray reconstructions (CAT scans) in the literature in 1969. He also served as a consultant to the World Health Organization, assisting WHO in the preparation and writing of its contribution to the first International Conference on the Environment which took place in Stockholm in 1972. In 1975 he was a Macy Fellow in the History of Medicine and the Biological Sciences at Harvard, and in 1976 a Mellon Fellow in the History of Public Health at MIT. In 1977 he moved to the Boston University School of Public Health and in 1983 he became the Chair of the Department of Environmental Health, a position he held until last year. He is currently Professor of Public Health at Boston University School of Public Health, and Professor of Sociomedical Sciences and Community Medicine at Boston University School of Medicine and directs the Superfund Basic Research Center at Boston University. Dr. Ozonoff’s research has centered on epidemiological studies of populations exposed to toxic agents, especially the development of new methods to investigate small exposed populations. He has studied populations around Superfund sites in a number of places, most recently a very large cancer case control study in the Upper Cape region of Massachusetts involving exposure to PCE. Dr. Ozonoff frequently serves as advisor or consultant to local, state and federal agencies on matters of health effects from hazardous wastes and contaminated drinking water. He is the author of numerous scientific articles and is on the editorial boards of the Archives of Environmental Health, American Journal of Industrial Medicine and is the North American Editor-in-Chief of the online journal, Environmental Health. He is a Fellow of the Johns Hopkins Society of Scholars and a Fellow of The Collegium Ramazzini. In May 2002 he received the Scientist for the Public Good award from the Clean Water Alliance of Massachusetts.|