Forum Chair: Norris E. Alderson, Ph.D., CVM, FDA
The 2000 FDA Science Forum focuses on one of the agency's highest priorities, the strength of the science base, to assure that all of our review, regulatory and policy decisions are grounded in science. The Forum plays a critical role in strengthening our science base by assuring that our scientists are trained in new developments in science and new technologies that are becoming part of our regulatory responsibility.
The major theme of this Forum is the Science of Safety, addressing the diverse disciplines of risk management of FDA. Session topics include: the Food Safety Initiative, postmarket surveillance, gender differences, risk communication, and contemporary issues in risk assessment. The Forum will bring FDA scientists together with industry, academia, government agencies, consumer groups and the public to explore the scientific and practical issues related to the safety evaluation and risk management of FDA-regulated products. Speakers and panelists will address emerging issues in the safety assessment of foods, drugs, biologics and medical devices. A poster session, sponsored by the FDA Chapter of Sigma Xi- the Scientific Research Society, will feature all areas of FDA science.
The 2000 FDA Scientific Achievement Awards will be presented to FDA scientists who have made exceptional contributions to the agency. Awardees from each of the Centers and ORA will be recognized along with FDA-level award recipients in the categories of Excellence in Analytical Science, Excellence in Laboratory Science, Excellence in Review Science and Outstanding Intercenter Scientific Collaboration.
The Office of the Senior Advisor for Science is proud to sponsor the 2000 FDA Science Forum on FDA and the Science of Safety: New Perspectives, as well as the Scientific Achievement Awards program. Thanks also to the American Association of Pharmaceutical Scientists, the FDA Chapter of Sigma Xi and the FDA Office of Women's Health for their support in sponsoring the Forum. Special thanks are given to the Forum organizing committee for arranging an excellent program and to the participants for making this an exciting and informative meeting.
Bernard A. Schwetz, D.V.M., Ph.D.
Acting Deputy Commissioner and Senior Advisor for Science
Science Forum Organizing Committee
Monday, February 14 | |
7:30 am - 4:30 pm | Registration (Lobby#2 Alcove) |
8:30 am - 9:00 am | Welcome and Opening Remarks
Norris E. Alderson, Ph.D., Center for Veterinary Medicine, FDA John B. Cox , American Association of Pharmaceutical Scientists |
9:00 am - 9:30 am | Plenary Session (Room 40)
Whose Mistake Was It? Research on Errors in Medical Care John M. Eisenberg, M.D., Agency for Healthcare Research and Quality |
9:30 am - 10:00 am | Science and the FDA
Jane E. Henney, M.D., Commissioner of Food and Drugs, FDA |
10:00 am - 10:30 am | Break - (Lobby #2) |
10:30 am - 1:00 pm | Breakout Sessions A & B - Attendees should select one session. |
Breakout Session A: The Food Safety Initiative - The Risk Perspective (Room 30/31
) Moderator: Robert L. Buchanan, Ph.D. | |
10:30 am - 10:55 am | The Promise and the Progress of the Food Safety Initiative
Susan Alpert, M.D., Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
10:55 am - 11:20 am | Building Better Outbreak Investigations: From Detection to Source
Craig W. Hedberg, Ph.D., University of Minnesota Abstract |
11:20 am - 11:45 am | Outbreak Coordination and the Positive Impact on Public Health
Arthur P. Liang, M.D., M.P.H., Centers for Disease Control and Prevention |
11:45 am - 12:10 pm | Research Opportunities under the Food Safety Initiative
Arthur J. Miller, Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
12:10 pm - 12:35 pm | Methylmercury Risk Assessment under the Food Safety Initiative
P. Michael Bolger, Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
12:35 pm - 1:00 pm | The Power of Prevention Strategies
Robert E. Brackett, Ph.D., University of Georgia Abstract |
Breakout Session B: Postmarket Surveillance - Beyond Passive Surveillance (Room 32/33)
Moderator: Thomas P. Gross, M.D., M.P.H. | |
10:30 am - 11:00 am | Medical Device Surveillance Network: A New Approach to Reporting
Susan N. Gardner, Ph.D., Center for Devices and Radiological Health, FDA Abstract |
11:00 am - 11:30 am | Pharmacovigilance in France: Role of the Regional Centers
Nicholas D. Moore, M.D., Ph.D., University of Bordeaux Abstract |
11:30 am - 12:00 pm | Bayesian Data Mining in Large Frequency Tables with an Application to the FDA Spontaneous Reporting System
William DuMouchel, Ph.D. AT&T Laboratories Abstract |
12:00 pm - 12:30 pm | Postmarket Surveillance in a HACCP Environment
John E. Kvenberg, Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
12:30 pm - 1:00 pm | The Value and Limitations of Drug Pregnancy Registries
Janet D. Cragan, M.D., Centers for Disease Control and Prevention, FDA Abstract |
1:00 pm - 2:00 pm | Lunch (On your own) |
2:00 pm - 4:30 pm | Breakout Sessions C & D - Attendees should select one session. |
Breakout Session C: Contemporary Issues in Risk Assessment (Room 30/31)
Moderator: David W. Gaylor, Ph.D. | |
2:00 pm - 2:30 pm | Confidence Associated with Multiple Safety Factors: Probabilistic Values for Acceptable Daily Intakes
Ralph L. Kodell, Ph.D. ,National Center for Toxicological Research, FDA Abstract |
2:30 pm - 3:00 pm | Microbial Food Safety Risk Assessment at the FDA Center for Food Safety and Applied Nutrition: From Concept to Reality
Robert L. Buchanan, Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
3:00 pm - 3:30 pm | Risk Assessment Methodology for Medical Devices and Radiation-Emitting Products
Ronald P. Brown, Ph.D.,Center for Devices and Radiological Health, FDA W. Howard Cyr, Ph.D.,Center for Devices and Radiological Health, FDA Abstract |
3:30 pm - 4:00 pm | Recent Advances in Computational Toxicology and Regulatory Applications
Joseph F. Contrera, Ph.D., Center for Drug Evaluation and Research, FDA Edwin J. Matthews, Ph.D., Center for Drug Evaluation and Research, FDA Abstract |
4:00 pm - 4:30 pm | Imaging Technology: The Emerging Revolution in Toxicology and Risk Assessment
David S. Lester, Ph.D., Center for Drug Evaluation and Research, FDA Abstract |
Breakout Session D: New Scientific Perspectives: Women's Health and the Science of Gender Differences
(Room 32/33) Moderator: Jonca C. Bull, M.D. | |
2:00 pm - 2:30 pm | Investigation of Sexual Dimorphism in the Inflammatory Response to Biomaterials
K. Barry Delclos, Ph.D., National Center for Toxicological Research, FDA Abstract |
2:30 pm - 3:00 pm | Reproductive Toxicity: New Perspectives on Preclinical Studies for Vaccines
Marion F. Gruber, Ph.D., Center for Biologics Evaluation and Research, FDA Abstract |
3:00 pm - 3:30 pm | Gender Differences: New Perspectives in Pharmacokinetics and Pharmacodynamics
Raymond L. Woosley, M.D., Ph.D., Georgetown University Medical Center Abstract |
3:30 pm - 4:00 pm | Heart Smart: New Findings in Gender Differences in the Therapy of Cardiovascular Disease
Alexandra Lansky, M.D., Washington Cardiovascular Foundation |
4:00 pm - 4:30 pm | Risk Communication - Measuring Confidence in Hazard Claims: Gender Differences in the Perception of Risk
John D. Graham, Ph.D., Harvard Center for Risk Analysis Abstract |
Tuesday, February 15 | |
7:30 am - 4:00 pm | Registration (Lobby #2 Alcove) |
8:30 am - 9:00 am | Plenary Session (Room 40)
Science Based Decisions and Risk Assessment: A European Perspective Arpad Somogyi, D.V.M., Ph.D., European Commission Abstract |
9:15 am - 12:30 pm | Breakout Sessions A & B - Attendees should select one session. |
Breakout Session A: Walking and Talking: The Art and Science of Risk Communication (Room 30/31)
Moderator: Sandra L. Kweder, M.D. | |
9:15 am - 9:40 am | Ethics and Risk Communication
John H. Fielder, Ph.D., Villanova University Abstract |
9:40 am - 10:05 am | Perspectives on Risk Perception
Paul Slovic, Ph.D., University of Oregon Abstract |
10:05 am - 10:30 am | FDA's Role in Risk Management and Communication
Janet Woodcock, M.D., Center for Drug Evaluation and Research, FDA Abstract |
10:30 am - 10:45 am | Break |
10:45 am - 11:05 am | Risk Perception and Communication Needs from the Consumer Perspective
Stephen Fried, Philadelphia Magazine |
11:05 am - 11:30 am | The Journalist's Challenge in Deciphering and Communicating Scientific Risk
Lauran Neergaard, The Associated Press Abstract |
11:30 am - 12:30 pm | Panel Discussion
Moderator: Mark Barnett, M.P.H. |
Breakout Session B: Risk Assessment in Action (Room 32/33)
Moderator: Marcia L. Headrick, D.V.M., M.P.H. | |
9:15 am - 9:45 am | Relative vs. Additive Risk for Predicting Human Cancer Risk from Animal Data
David W. Gaylor, Ph.D., National Center for Toxicological Research, FDA Abstract |
9:45 am - 10:15 am | Listeria Risk Assessment
Richard C. Whiting, Ph.D., Center for Food Safety and Applied Nutrition, FDA Abstract |
10:15 am - 10:45 am | Managing Postmarket Risk of Human Drugs
Murray M. Lumpkin, M.D., Center for Drug Evaluation and Research, FDA |
10:45 am - 11:00 am | Break/Posters (Room 38/39) |
11:00 am - 11:30 am | CJD and Blood Safety: Addressing the Risk - Perspectives from FDA, Industry and the Consumer
Dorothy Scott, M.D., Center for Biologics Evaluation and Research, FDA Robert W. Kozak, Ph.D., Bayer Corporation Corey S. Dubin, Committee of Ten Thousand Abstract |
11:30 am - 12:00 pm | Spontaneous Combustion of Latex Examination Gloves
Scott G. McNamee, Ph.D., Center for Devices and Radiological Health, FDA Abstract |
12:00 pm - 12:30 pm | Risk Analysis Model of the Human Health Impact of Fluoroquinolone Use in Rearing David J. Vose, B.Sc., David Vose Risk Consultancy, Ltd. "La Coutancie" Abstract |
12:30 pm - 1:15 pm | Lunch (On your own) |
1:15 pm - 2:00 pm |
FDA Scientific Achievement Awards Ceremony (Room 40)
Welcome and Introductions Bernard A. Schwetz, D.V.M., Ph.D., Acting Deputy Commissioner and Senior Advisor for Science Remarks Jane E. Henney, M.D., Commissioner of Food and Drugs, FDA Presentation of Center and ORA Scientific Achievement Awards Presentation of FDA Scientific Achievement Awards Best Poster Awards |
2:00 pm - 4:00 pm | Sigma Xi Poster Session (Refreshments provided) (Room 38/39) |
4:00 pm | Adjournment |