1997 FDA FORUM ON REGULATORY SCIENCES

A Culture of Science at FDA: Partnerships in Research and Review

December 9, 1997, Natcher Conference Center, NIH

Monday, December 8
2-5:00pm	Sigma Xi Poster Session & Registration	Lower Level and Atrium
Tuesday, December 9
7:30am	Sigma Xi Poster Session & Registration	Lower Level and Atrium
8:30am	Welcome Michael A. Friedman, M.D Lead Deputy Commissioner	Auditorium
	Opening Remarks Elkan Blout, Ph.D Senior Advisor for Science Food and Drug Administration
	Chair's Remarks: Forum Goals Joy Cavagnaro, Ph.D Center for Biologics Research and Evaluation
8:45am	From Genes to Drugs: A Genomic Perspective William A. Haseltine, Ph.D. Chairman of the Board & Chief Executive Officer Human Genome Sciences, Inc.
9:25am	U.S. EPA's Research Planning Process: How Well Does it Work? Penny A. Fenner-Crisp, Ph.D. Special Assistant to the Assistant Administrator Office of Prevention, Pesticides and Toxic Substances U.S. Environmental Protection Agency
9:50am	A Culture of Science: The Researcher-Reviewer Interface at FDA Bernard A. Schwetz, D.V.M., Ph.D Interim Chief Scientist Office of Science Food and Drug Administration
10:15am	Break
10:45am	Scientific Achievement Awards Ceremony	Auditorium
	Welcome Elkan Blout, Ph.D Senior Advisor for Science
	FDA: A Scientist-Based Agency Bernard A. Schwetz, D.V.M., Ph.D Interim Chief Scientist
	Presentation of 1997 Center/Office of Regulatory Affairs Scientific Achievement Awards
	Presentation of 1997 FDA Scientific Achievement Awards
1:00pm	Lunch (on your own)
1:30 - 4:20	Discussion Group Sessions	Balcony
	Group 1: Enhancing the development of "emerging science" and its use in regulatory decisions.
	Group 2: Bridging the communication gap between research and review scientists.
	Group 3: Optimizing and leveraging FDA resources to enhance flexibility in problem-solving.
1:30 - 2:20pm	Group 1: Balcony A Group 2: Balcony B Group 3: Balcony C
2:20 - 2:30pm	Break
2:30 - 3:20pm	Group 1: Balcony A Group 2: Balcony B Group 3: Balcony C
3:20 - 3:30pm	Break
3:30 - 4:20pm	Group 1: Balcony A Group 2: Balcony B Group 3: Balcony C
4:20 - 4:30pm	Break
4:30pm	Summary of Discussion Group Discussions	Auditorium
5:00pm	Closing Remarks: Next Steps Joy Cavagnaro, Ph.D., Chair

* Discussion Group Topics

Enhancing the development and use of "emerging" science
- Define the role of science in regulatory decisions.
- How could developments in "emerging" science benefit the regulatory process? To what extent is "emerging" science used or incorporated in arriving at regulatory decisions at the present time?
- What are the obstacles to a more effective use of "emerging" scientific knowledge in regulatory decisions?
- What approaches could be taken to facilitate use of "emerging" science knowledge in regulatory decisions?
Bridging the communication gap between research and review scientists
- Electronic information exchange (Intranet, Internet, searchable lab research summaries, etc.)
- Mechanisms for stimulating informal interactions between reviewers and researchers to foster collaboration.
- Formal approaches to facilitating interaction (e.g., joint seminars, formal details, dual assignments, etc.)
Optimizing and leveraging FDA resources to enhance flexibility in problem-solving
- Breaking down barriers; using resources where needed.
- Definition of resource optimization and examples at FDA
- Definition of resource leveraging and examples at FDA
- Definition of the virtual team concept, its advantages and disadvantages, and emerging virtual teams at FDA.

Last updated on 11/28/97 by frf