2000 FDA Science Forum
FDA and the Science of Safety: New Perspectives

Sponsored by FDA, AAPS and Sigma Xi

February 14-15, 2000
Washington Convention Center
Washington, DC

Forum Chair: Norris E. Alderson, Ph.D., CVM, FDA

Program


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


The following individuals are gratefully acknowledged for their contribution to the planning, organization and implementation of the 2000 FDA Science Forum.

FDA Senior Science Council

Bernard A. Schwetz, D.V.M., Ph.D., Acting Deputy Commissioner and Senior Advisor for Science
Norris E. Alderson, Ph.D., Center for Veterinary Medicine
Robert L. Buchanan, Ph.D. , Center for Food Safety and Applied Nutrition
Neil D. Goldman, Ph.D., Center for Biologics Evaluation and Research
Steven I. Gutman, M.D., Center for Devices and Radiological Health
Elizabeth D. Jacobson, Ph.D., Center for Devices and Radiological Health
Robert C. Livingston, Ph.D., Center for Veterinary Medicine
James T. MacGregor, Ph.D., Center for Drug Evaluation and Research
Donald E. Marlowe, Center for Devices and Radiological Health
Robert T. O'Neill, Ph.D., Center for Drug Evaluation and Research
Michael C. Olson, Ph.D., Office of Regulatory Affairs
Samuel W. Page, Ph.D., Center for Food Safety and Applied Nutrition
William Slikker, Jr., Ph.D., National Center for Toxicological Research
Terry C. Troxell, Ph.D., Center for Food Safety and Applied Nutrition
James F. Yager, Office of Regulatory Affairs

Science Forum Organizing Committee

Chair
Norris E. Alderson, Ph.D., Center for Veterinary Medicine, FDA

Session Chairs, Center for Biologics Evaluation and Research, FDA
Steven R. Bauer, Ph.D.
Elizabeth Sutkowski, Ph.D.

Center for Drug Evaluation and Research, FDA
Joseph F. Contrera, Ph.D.
Sandra L. Kweder, M.D.

Center for Devices and Radiological Health, FDA
Robert Gatling, Jr., M.S.
Thomas P. Gross, M.D., M.P.H.
David S. Shindell, Ph.D.

Center for Food Safety and Applied Nutrition, FDA
Robert H. Hall, Ph.D.
Dennis M. Keefe, Ph.D.

Center for Veterinary Medicine, FDA
Eric S. Dubbin, D.V.M.
Marcia L. Headrick, D.V.M., M.P.H.

National Center for Toxicological Research, FDA
David W. Gaylor, Ph.D.
Paul C. Howard, Ph.D.

Office of Regulatory Affairs, FDA
Thomas J. Arista
Elise A. Murphy

Office of the Senior Advisor for Science, FDA
Susan A. Homire, D.V.M.
Bernard A. Schwetz, D.V.M., Ph.D.

Sigma Xi
W. Howard Cyr, Ph.D., Center for Devices and Radiological Health, FDA

Office of Women's Health, FDA
Jonca C. Bull, M.D.

American Association of Pharmaceutical Scientists
David Pang, Ph.D.

American Association of Pharmaceutical Scientists

FDA Chapter, Sigma Xi

FDA Office of Women's Health


PROGRAM
Monday, February 14
  
7:30 am - 4:30 pmRegistration (Lobby#2 Alcove)
  
8:30 am - 9:00 amWelcome 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 amPlenary 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 amBreak - (Lobby #2)
  
10:30 am - 1:00 pmBreakout 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 amThe 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 amBuilding 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 pmResearch 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 pmMethylmercury 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 pmThe 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 amMedical 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 amPharmacovigilance in France: Role of the Regional Centers
Nicholas D. Moore, M.D., Ph.D., University of Bordeaux
Abstract
  
11:30 am - 12:00 pmBayesian 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 pmPostmarket Surveillance in a HACCP Environment
John E. Kvenberg, Ph.D., Center for Food Safety and Applied Nutrition, FDA
Abstract
  
12:30 pm - 1:00 pmThe 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 pmLunch (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 pmConfidence 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 pmMicrobial 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 pmRisk 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 pmRecent 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 pmImaging 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 pmInvestigation 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 pmGender Differences: New Perspectives in Pharmacokinetics and Pharmacodynamics
Raymond L. Woosley, M.D., Ph.D., Georgetown University Medical Center
Abstract
  
3:30 pm - 4:00 pmHeart Smart: New Findings in Gender Differences in the Therapy of Cardiovascular Disease
Alexandra Lansky, M.D., Washington Cardiovascular Foundation
  
4:00 pm - 4:30 pmRisk 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 amPerspectives on Risk Perception
Paul Slovic, Ph.D., University of Oregon
Abstract
  
10:05 am - 10:30 amFDA's Role in Risk Management and Communication
Janet Woodcock, M.D., Center for Drug Evaluation and Research, FDA
Abstract
  
10:30 am - 10:45 amBreak
  
10:45 am - 11:05 amRisk 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 pmPanel 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 amRelative 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 amManaging 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 amCJD 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 pmSpontaneous Combustion of Latex Examination Gloves
Scott G. McNamee, Ph.D., Center for Devices and Radiological Health, FDA
Abstract
  
12:00 pm - 12:30 pmRisk 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 pmAdjournment


FDA Chapter, Sigma Xi | CFSAN | FDA


Last Updated on 2000-FEB-20 by frf