1998 FDA Science Forum

Biotechnology:
Advances, Applications & Regulatory Challenges

Program

Monday, December 7

5:00 pm Registration Opens
7:00 pm Registration Closes

Tuesday, December 8

7:00 am Registration and Poster Set-Up

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

Breakout Session A
Biofarming and Biopharming (Bioengineered Plants and Animals as Sources of Foods and Drugs)
Moderators: James Maryanski, Ph.D., Steven Bauer, Ph.D.

10:30 am Overview and Future Applications in Agricultural Biotechnology
Roger N. Beachy, Ph.D.
Scripps Research Institute

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

Breakout Session B
Microbial Pathogens, Antibiotics, and Resistance
Moderators: Linda Tollefson, D.V.M., M.P.H., Thomas A. Cebula, Ph.D.

10:30 am Public Health Impact of Antibiotic Resistance in the United States
J. Todd Weber, M.D.
Centers for Disease Control and Prevention, FDA

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

Breakout Session C
Therapeutic and Preventive Agents I
Moderator: Philip D. Noguchi, M.D.

2:00 pm Potential Hazards of Live Attenuated HIV Vaccines
Ruth M. Ruprecht, M.D., Ph.D.
Dana-Farber Cancer Institute

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

Breakout Session D
New Models/Methods for Safety and Efficacy Evaluation

2:00pm The Biotechnology Revolution and the Evolution of Safety Assessment
James T. MacGregor, Ph.D., D.A.B.T.
Center for Drug Evaluation and Research, FDA

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

  

Wednesday, December 9

7:30 am Registration

8:30 am - 11:00 Breakout Sessions

Breakout Session A
Therapeutic and Preventive Agents II
Moderator: Kiki B. Hellman, Ph.D.

8:30 am Tissue Engineering and the FDA Perspective
Kiki B. Hellman, Ph.D.
Center for Devices and Radiological Health, FDA

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

Breakout Session B
Diagnostics and Detection Methods
Moderators: Jerome Donlon, Ph.D., Steven Gutman, M.D.

8:30 am Comparison Between Conventional Cytochrome P450 Genotesting Using PCR and Mutation-Specific Endonuclease, with Oligonucleotide Arrays Using the Affymetrix™ GeneChip® CYP450 System
David A. Flockhart, M.D., Ph.D.
Georgetown University Medical Center

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

1:45 pm Plenary Session
Regulatory Challenges: Translating Scientific Advances into Regulatory Action

• Opening Remarks
  Elkan R. Blout, Ph.D., Senior Advisor for Science, FDA
  The Regulation of Biotechnology in the 21st Century
• Kathryn Zoon, Ph.D., Director, Center for Biologics Evaluation and Research, FDA
  Biotechnology in Drug Discovery and Development
• Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA
  Device-Specific Issues Related to Biotechnology
• Bruce Burlington, M.D., Director, Center for Devices and Radiological Health, FDA
  Emerging Issues in Food Biotechnology
• Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, FDA
  Biotechnology at the Center for Veterinary Medicine: A Source of New Microbial, Plant and Animal Products and a Tool for Exploring Food Safety Issues
• Stephen Sundlof, D.V.M., Ph.D., Director, Center for Veterinary Medicine, FDA

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.