2001 FDA Science Forum

Day 2: Begins with "Breakfast with the Authors" where individuals can network and talk with the authors of the posters presented. The plenary session addresses the future direction of leveraging at FDA followed by three breakout sessions on the topic. The afternoon includes the FDA Scientific Achievement Awards Ceremony and closes with an exciting Center Director Roundtable session moderated by the Office of Science Coordination and Communication.

 

Thursday, February 15
7:30 am - 4:30 pm	Registration
8:30 am - 9:00 am	Welcome and Opening Remarks Don Marlowe and Marilyn Lightfoote, M.D., Ph.D., 2001 Science Forum Chairs, FDA Center for Devices and Radiological Health Elizabeth D. Jacobson, Ph.D., Senior Advisor for Science (Actg), FDA E. James Bradford, Ph.D., Executive Director, AOAC International Jane E. Henney, M.D., Commissioner of Food and Drugs
9:00 am - 9:45 am	Plenary Session: Health Informational Privacy: Individual Right or Public Good Larry Gostin, J.D., LL.D (Hon.) Georgetown University Law Center Abstract
9:45 am - 10:30 am	Plenary Session: Modeling & Simulation for Trans-disciplinary Collaboration: From Aerospace to Pharmaceuticals William McQuay, USAF/DOD Abstract
10:30 am - 10:45 am	Break
10:45 am - 12:15 pm	Breakout Sessions A & B - Attendees should select one session.
	Breakout Session A: Three Perspectives on Confidentiality, Conflict of Interest, and Privacy Issues Surrounding the Advancing Science of Gene Therapy Lisa Troutman, Moderator The Conduct of Clinical Trials is Not Rocket Science, But... Philip Noguchi, M.D., FDA Center for Biologics Evaluation & Research Abstract Consumer Protection and Privacy in the era of advancing gene therapy Linda F. Golodner, President, National Consumers League Abstract On The Front Line: Investigator's Perspective W. French Anderson, M.D., Keck School of Medicine of the University of Southern California Abstract
	Breakout Session B: Modeling & Simulation Across Pharmaceutical Boundaries Larry Lesko, Ph.D., Moderator Modeling & Simulation of Clinical Trials in Drug Development Don Stanski, Pharsight Abstract Bioinformatics   Genomic Microarry Data Management in Drug Design Mark Boguski, M.D., Ph.D., Rosetta Impharmatics Abstract The Utility of Computational Fluid Dynamics in the Design of Artificial Heart Devices Greg Burgreen, University of Pittsburgh Abstract
12:15 pm - 1:30 pm	Poster Session and Box Lunch Enjoy lunch on-site as you discuss research with poster authors
1:30 pm - 2:30 pm	Breakout Sessions C & D - Attendees should select one session.
	Breakout Session C: Privacy & Confidentiality Issues in Registries and in Outcomes/Epidemiology Research Linda Silvers, Moderator Vaccine and Other Registry Privacy Issues Gail Horlick, M.D., Centers for Disease Control Abstract Effect of State Privacy Legislation on Epidemiological and Outcomes Research: A Case Study Deborah Shatin, Ph.D., Center for Health Care Policy and Evaluation, UnitedHealth Group Abstract
	Breakout Session D: Modeling and Simulation in Clinical Product Development for the New Millennium Richard Kenney, M.D., Moderator The Exposure Response Relationship and Clinical Trial Simulation Nicholas H.G. Holford, MB, ChB, MSc, MRCP (UK), FRACP Abstract Animal Scale Up Robert L. Dedrick, Ph.D., National Institutes of Health Abstract
2:30 pm - 3:30 pm	Breakout Sessions E & F - Attendees should select one session.
	Breakout Session E: Scientific, Privacy, & Ethical Issues Surrounding the Advancing Science Genetic Predisposition for Breast Cancer Peter Honig, M.D., Moderator Genetic Testing: Issues in Protecting the Privacy of Research Participants Judy Garber, M.D., Beth Israel, Harvard An Overview of the Science of Hereditary Breast Cancer Susan F. Honig, M.D., FDA Center for Drug Evaluation & Research Abstract
	Breakout Session F: Modeling & Simulation: The Path to the Future Ginette Michaud, Moderator Learning in Silico: 21st Century Product Development Jonathan C. Peck, M.A., Institute for Alternative Futures Abstract Predicting Weather and Climate Phillip A. Arkin, Ph.D., NOAA, U.S. Department of Commerce Abstract
3:30 pm - 5:00 pm	Ballroom Session & Afternoon Snack: Mock Accreditation Assessment AOAC International
5:00 pm	Adjourn for the Day
Friday, February 16
7:00 am - 4:30 pm	Registration
7:30 am - 9:15 am	Sigma Xi Poster Session: Breakfast with the Authors Enjoy a continental breakfast as you discuss research with poster authors
9:15 am - 9:30 am	Opening Remarks Bernard Schwetz, D.V.M., Ph.D., Acting Deputy Commissioner, FDA
9:30 am - 10:00 am	Plenary Session: Next Generation Leveraging Sharon Smith Holston, Deputy Commissioner for International & Constituent Relations, FDA
10:00 am - 10:30 am	Plenary Session: Public Health Preparedness for Bioterrorism: Why Leveraging is Essential Brigadier General Schaeffer, United States Army Abstract
10:30 am - 10:45 am	Break
10:45 am - 12:45 pm	Breakout Sessions G, H, & I - Attendees should select one session.
	Breakout Session G: Scientific Training Outside the Boundaries Suzy Fitzpatrick, Ph.D., DABT, Moderator FDA & Industry Partnerships for Emerging Technology Training Gary Dykstra, FDA Abstract Applications of ELISA Rapid Screening Methods to FDA Field Investigations Frederick A. Hegele, General Mills Abstract Lessons from Biotechnology Sue Markland Day, President, Bay Area Biosciences Center Abstract
	Breakout Session H: Partnering Across the Boundaries Jaroslav Vostal, M.D., Moderator FDA and Academia: JIFSAN, A Success Story Paul Mazzocchi, Ph.D., University of Maryland Abstract FDA and Industry: The Secrets of Creating a Successful CRADA Raj Puri, Ph.D., FDA Center for Biologics Evaluation & Research Abstract PQRI - Leveraging to Success Helen Winkle, FDA Center for Drug Evaluation and Research Abstract Partnering For Solutions: Creation of the New Wireless Medical Telemetry Service Donald Witters, M.S., FDA Center for Devices & Radiological Health Abstract
	Breakout Session I: Global Partnering: MRAs and How They Affect You Linda Horton, Moderator International Leveraging: FDA's Agreements with Counterparts in Other Countries: Agency Perspective Linda R. Horton, Director, International Agreements, Office of International Programs, Food and Drug Administration Abstract Pharmaceutical/Medical Device Industry View of EU MRA Phil Budashewitz, Ph.D., Elan Corporation Abstract Accountable Governance in the Era of Globalization: Consumer Concerns with International Harmonization, Equivalency and Mutual Recognition Mary Bottari, Public Citizen's Global Trade Watch Abstract Food Industry View of Equivalence Agreement Rhona S. Applebaum, Ph.D., National Food Processors Association Abstract
12:45 pm - 2:15 pm	FDA Scientific Achievement Awards Ceremony & Reception Moderator: Elizabeth D. Jacobson, Ph.D.
2:15 pm - 4:15 pm	FDA Center Director Roundtable: FDA Science At the Boundaries A discussion with FDA's Leadership regarding managing science across the boundaries. Moderator: Elizabeth D. Jacobson, Ph.D.
4:15 pm	Adjournment