Biotechnology:
Advances, Applications & Regulatory Challenges
8:30 am Plenary Session
Welcome and Opening Remarks - Science Forum Chair
James T. MacGregor, Ph.D., D.A.B.T., Center for Drug Evaluation and Research, FDA
8:35 am Welcome
Jane E. Henney, M.D., Commissioner of Food and Drugs
8:40 am Keynote Address
Albert Gore, Jr. (Invited), Vice President, United States of America
8:50 am Remarks
Kathryn Zoon, Ph.D., Director, Center for Biologics Evaluation and Research, FDA
9:00 am Opportunities for Biomedicine and Biotechnology in the Next Century
Michael M. Gottesman, M.D., Deputy Director for Intramural Research, NIH
9:30 am Facilitating Innovation in a New Era of Drug Discovery: An Industry Perspective
Gordon M. Binder, Chair and Chief Executive Officer, Amgen, Inc.
10:00 am Coffee Break
10:30 am - 12:30 pm Breakout Sessions
10:55 am Enhanced Output Traits from Agricultural Crops
John Pierce, Ph.D.
DuPont Agricultural Products
11:20 am Improving Human Health Via Better Plants
Ganesh M. Kishore, Ph.D.
Monsanto Company
11:45 am Transgenic Livestock: Biotechnology for the Production of
Innovative Animals and Products
Robert J. Wall, Ph.D.
United States Department of Agriculture
12:10 pm Vaccines from Edible Plants
Carol O. Tacket, Ph.D.
Center for Vaccine Development
11:00 am Enterococcus Resistance
Barbara E. Murray, M.D.
University of Texas Medical School at Houston
11:30 am Biochemical and Genomic Approaches to the Identification of Compounds with Activity Against Mycobacterium tuberculosis
Clifton E. Barry, III, Ph.D.
National Institute of Allergy and Infectious Diseases, NIH
12:00 pm Mutators Among Escherichia coli and Salmonella enterica: Adaptation and Emergence of Bacterial Pathogens
Thomas A. Cebula, Ph.D.
Center for Food Safety and Applied Nutrition, FDA
12:30 pm Lunch (on your own)
2:00 pm - 4:00 pm Breakout Sessions
2:30 pm Production of Secretory IgA Plantibodies
Elliott Fineman, M.S., J.D.
Planet Biotechnology, Inc.
3:00 pm FDA Efforts on Safety Assessment of Vectors Used for Gene Therapy
Carolyn A. Wilson, Ph.D.
Center for Biologics Evaluation and Research, FDA
3:15 pm Gene Therapies: A Newer Model of Federal Regulation
Philip D. Noguchi, M.D.
Center for Biologics Evaluation and Research, FDA
3:25 pm Public Oversight of Gene Therapy
Andra E. Miller, Ph.D.
Center for Biologics Evaluation and Research, FDA
3:35 pm Prospects for Muscular Dystrophy Gene Therapy
Kenneth H. Fischbeck, M.D.
National Institutes of Health
2:30 pm Use of Transgenics, P53 and Tg.AC, and the Carcinogenicity of Genotoxic and Nongenotoxic NCE's
Raymond E. Stoll, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.
3:00 pm Genotyping of Metabolic Polymorphisms for Prediction of Adverse Drug Reactions and Human Cancer Susceptibility
Fred F. Kadlubar, Ph.D.
National Center for Toxicological Research, FDA
3:30 pm Surrogate Markers for Efficacy and Safety Testing
J. Carl Barrett, Ph.D.
National Institute for Environmental Health Sciences, NIH
4:00 pm Sigma Xi Poster Session & Social Hour (Refreshments and cash bar)
6:00 pm Adjournment
8:30 am - 11:00 Breakout Sessions
8:35 am Tissue Engineering Solutions to Clinical Problems
Joseph P. Vacanti, M.D.
Massachusetts General Hospital
9:00 am Polymeric Based Systems for Tissue Engineering
Robert S. Langer, Sc.D.
Massachusetts Institute of Technology
9:25 am Cell Design Principles in Cell and Gene Therapy and for Bioartificial Organs
Lola M. Reid, Ph.D.
University of North Carolina School of Medicine
9:45 am Break
10:00 am The Biomaterials Component for Tissue Engineered Medical Products
Jeffrey A. Hubbell, Ph.D.
Swiss Federal Institute of Technology and the University of Zurich, Switzerland
10:20 am Codifying Tissue Engineering Technology and Products
Peter C. Johnson, M.D.
Pittsburgh Tissue Engineering Initiative, Inc.
10:40 am Panel Discussion
10:45 am Questions and Answers
9:00 am Detection and Disinfection of Transmissable Spongiform Encephalopathy Agents
David M. Asher, M.D.
Center for Biologics Evaluation and Research, FDA
9:45 am Coffee Break
10:00 am Rapid Electrochemiluminescent Detection of E. coli O157:H7 Contamination and Electrochemiluminescent PCR Confirmation
C. Gerald Crawford, M.S., Ph.D.
United States Department of Agriculture
10:20 am A Sensitive PCR-Based Reverse ranscriptase Method for the Detection of Retroviruses
Keith Peden, Ph.D.
Center for Biologics Evaluation and Research, FDA
10:30 am The Role of Genetic Testing in the Practice of Medicine
Neil A. Holtzman, M.D., M.P.H.
Johns Hopkins Medical Institutions
11:00 am Lunch (on your own)
1:00 pm 1998 FDA Scientific Achievement Awards Ceremony
3:00 pm Break
3:15 pm Introductory Remarks
Jane E. Henney, M.D., Commissioner of Food and Drugs
3:30 pm Future Biotechnology Products and their Impact on FDA's Research Plan
Bernard A. Schwetz, D.V.M., Ph.D., Interim Chief Scientist & Director, National Center for Toxicological Research, FDA
3:45 pm Science Based Regulation
David Korn, M.D., Association of American Medical Colleges
4:00 pm Consumer Issues
Sidney Wolfe, M.D., Public Citizen
4:15 pm Consumer Issues in Food Biotechnology Regulation
Marion Nestle, Ph.D., M.P.H., New York University
4:30 pm Panel Discussion
Center Directors and Guest Speakers
Moderator: Jane E. Henney, M.D.
5:00 pm Adjournment
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Last updated on 1998-NOV-29 by frf.