1996 FDA FORUM ON REGULATORY SCIENCES
December 5, 1996

Final Program


7:30 am   Registration and poster set-up

8:30 am - 5:00 pm   SIGMA XI POSTER SESSION (all day)

8:30 am   Chair's Welcoming Remarks
     Albert Pohland, Ph.D.
     Center for Food Safety and Applied Nutrition

8:45 am   Opening Remarks
     Elkan R. Blout, Ph.D.
     Senior Advisor for Science
         and
     Michael A. Friedman, M.D.
     Deputy Commissioner for Operations


9:00 am - 11:00 am   SESSION I: MICROBIAL PATHOGENESIS

 Carl E. Cerniglia, Ph.D., Session Chair
 National Center for Toxicological Research

9:00 am   Plenary Lecture: Bovine Spongiform Encephalopathy (BSE) Update
     Clarence J. Gibbs, Jr., Ph.D.
     National Institutes of Health

9:30 am   Pathogenic Protozoa in Food and Drink, An Update: 1681-1996
     George J. Jackson, Ph.D.
     Center for Food Safety and Applied Nutrition

9:50 am   Xenotransplantation: Public Health Perspectives
     Amy Patterson, M.D.
     Center for Biologics Evaluation and Research

10:10 am   Antimicrobial Resistance Monitoring of Zoonotic Enteric Pathogens
       Linda Tollefson, D.V.M., M.P.H.
       Center for Veterinary Medicine

10:30 am   Helicobacter pylori - Status of Research and Vaccine Development
       Dennis Lang, Ph.D.
       National Institutes of Health

10:50 am   Questions and Answers


11:00 am - 12:00 pm   POSTER SESSION (with authors)

12:00 - 2:00 pm   1996 FDA Scientific Achievement Awards Luncheon

      Moderator: Elkan R. Blout, Ph.D., Senior Advisor for Science
      Awards presentation: David A. Kessler, M.D., Commissioner of Food and Drugs


2:00 pm - 3:50 pm  SESSION II: METHODOLOGY

 J. Christopher Cordaro, Ph.D., Session Chair
 Center for Drug Evaluation and Research

2:00 pm   Plenary Lecture: Rapid Methods for the Detection of Foodborne Pathogens
     Peter Feng, Ph.D.
     Center for Food Safety and Applied Nutrition

2:30 pm   Genetic Detection Methods to Identify Foodborne Pathogens
     Walter E. Hill, Ph.D.
     Office of Regulatory Affairs

2:45 pm   Development and Commercialization of Polymerase Chain Reaction (PCR)-based Methods
      for the Detection of Foodborne Pathogens
     Scott Fritschel, Ph.D.
     Qualicon

3:00 pm   Detection of Pathogens by Automated Fatty Acid Analysis
     Myron Sasser, Ph.D.
     Midi

3:15 pm   Automated ELISA for Detection of Foodborne Pathogens
     Carol Gravens, M.A.
     bioMérieux Vitek, Inc.

3:30 pm   Questions and Answers


3:50 pm - 5:15 pm   SESSION III: CONTROL UPDATES

 D.B. Shah, Ph.D., Session Chair
 Center for Food Safety and Applied Nutrition

3:50 pm   Plenary Lecture: The Incidence and Control of Microbial Biofilms in Device-Related Infections
     J. William Costerton, Ph.D.
     Montana State University

4:20 pm   Hazard Analysis Critical Control Points (HACCP)
     John E. Kvenberg, Ph.D.
     Center for Food Safety and Applied Nutrition

4:40 pm   Infections/Medical Devices/Risk Assessment
     Katharine Merritt, Ph.D.,
     Center for Devices and Radiological Health

5:00 pm   Questions and Answers


5:15 pm   Concluding Remarks
      B.A. Schwetz, D.V.M., Ph.D.
      Associate Commissioner for Science