Wednesday, February 20, 2002
8:30 a.m. Room 40	Opening Remarks
9:00 - 9:30 a.m. Room 40	Plenary Lecture: Changing Science for Changing Times Rita Colwell, Ph.D., D.Sc. (Hon) Director, National Science Foundation
9:30 - 10:00 a.m. Room 40	Plenary Lecture: The Role of Science in Anticipating Public Health Issues Bernard Schwetz, D.V.M., Ph.D. Acting Principal Deputy Commissioner, FDA
10:00 - 10:30 a.m.	Break
10:30 - 12:30 p.m. Room 30/31	Breakout Session 1 - The Science and Regulation of Foods Derived from Bioengineered Plants and Animals Chairs: Jeanette Glew, CFSAN, FDA and Mary Ditto, Ph.D., CFSAN, FDA
In this breakout session, a panel of speakers will examine the multi - disciplinary developments driving FDA's regulatory oversight of bioengineered foods. The technology in this field moves at a rapid pace and we will examine some of the emerging technological breakthroughs that will soon produce new commercial products, detection methods, and tools for safety analysis. We will have an interactive discussion with the panel and audience as to how FDA should handle breaking issues in the science of biotechnology from a regulatory standpoint and how research can underpin FDA's regulatory framework.
10:30	Introductory Remarks Patricia Hansen, Ph.D., CFSAN, FDA
10:35	Bioengineered plants for food - past, present, and future Peter Day, Ph.D., Rutgers University
11:05	The science bioengineered animals for food: past, present, and future James Murray, Ph.D., University of California, Davis
11:30	FDA Oversight of bioengineered animals and foods from bioengineered plants Eric Flamm, Ph.D., Office of the Commissioner, FDA
11:50	Post-market issues for bioengineered plants: Starlink case study Patricia Hansen, Ph.D., CFSAN, FDA
12:10	Panel discussion of issues and questions concerning bioengineered foods Laura Tarentino, Ph.D., Moderator, CFSAN, FDA Panelists: Peter Day, Ph.D. Eric Flamm, Ph.D. Pat Hansen, Ph.D. Ms. Geraldine June Gregory Jaffe, Ph.D.
10:30 - 12:30 p.m. Room 32/33	Breakout Session 2 - Tissue Engineering Chair: Kiki B. Hellman, Ph.D.
As the field of tissue engineering continues to expand and new product and attendant issues arise, the importance of sound scientific research and review is vital in the development of policies that will accelerate the availability of new products to the public. During this session, a series of associated issues will be posed to the panelists including Science Forum participants. The expert panel will discuss approaches in addressing difficult issues in order to demonstrate appropriate regulatory decisions. The expert panel will discuss approaches in addressing difficult issues in order to demonstrate appropriate regulatory decisions.
10:30	Introduction Kiki B. Hellman, Ph.D., CDRH, FDA
10:35	Developmental Status of the Field of Tissue Engineering Peter C. Johnson, M.D., CEO, Tissue Informatics
10:55	Regulatory Issues of Tissue Engineered Combination Products A Center for Device and Radiological Health Perspective David Krause, Ph.D., CDRH, FDA Joyce Frey-Vasconcells, Ph.D., CBER, FDA
11:15	Case Study - Apligraf (approved product) Janet Hardin Young, Ph.D., Organogenesis, Inc.
11:35	From Culture to Clinic: Addressing challenges of mesenchymal stem cell development Annemarie B. Moseley, Ph.D., M.D., Osiris Therapeutics Inc.
11:55	Panel Discussion
12:15	Question & Answer Session
12:30 - 2:30 p.m. Room 38/39	Lunch and Sigma Xi Poster Session All posters will be displayed for both days of the Symposium
2:30 - 4:30 p.m. Room 30/31	Breakout Session 3 - Children's Health Issues Chair: Diane Murphy, M.D.
The study of children's health issues presents unique challenges to scientists and regulators. These include issues related to children's growth and development, ethics, evaluation of short- and long-term toxicities, use of juvenile animal models, and extrapolation of data from adults to children. In this session, we will explore such issues through formal presentations and discussions with the panel.
2:30	Introduction: Pediatric activities in the agency Dianne Murphy, M.D., CDER, FDA
2:55	Pre-clinical: Juvenile rhesus monkey exposure to neurotropic drugs: behavioral and safety concerns Merle Paule, Ph.D., NCTR, FDA
3:10	Panel questions
3:30	Clinical: Pharmacokinetic/Pharmacodynamic enzymes and receptors: What's known in pediatrics (infancy, childhood and adolescents), and adults: An Overview William Slikker, Ph.D., NCTR, FDA
3:45	Exposure to environmental toxicants in the postnatal period: long-term effects in children of lead, mercury, pesticides, and other toxins Ana Maria Osorio, M.D., Environmental Protection Agency
4:00	CDER's Experience: What we have learned from the Pediatric Initiative in children William Rodriguez, M.D., Ph.D., CDER, FDA
4:15	Panel Questions
2:30 - 4:30 p.m. Room 32/33	Breakout Session 4 - Genomics Chair: Martha Moore, Ph.D., NCTR, FDA
Rapid advances in genomic technology provide great promise for our ability to diagnosis illness, follow disease progression, detect infectious agents and understand pharmacological and toxicological responses. In this session, experts in genomics, information technology, toxicology and regulatory science will provide their perspectives as to what is required for this technology to be used in regulatory decision-making. Following a general overview of the relevant issues, the panel will address questions.
2:30	Introduction Martha Moore, Ph.D., NCTR, FDA
2:35	Overview: Promise of the genomic technology and requirements for its use in FDA decision-making James MacGregor, Ph.D., NCTR, FDA
2:55	Panel Discussion Moderator-Martha Moore, Ph.D., NCTR, FDA
The panel will be asked to address a series of questions some of which will be prearranged and some of which will come from the audience. The focus of this discussion will be to solicit opinions as to what will be required to utilize the new genomic technology in regulatory decision-making.
	Panel Members: Tom Cebula, Ph.D., CFSAN/FDA Frank Sistare, Ph.D., CDER/FDA Raj Puri, Ph.D., CBER/FDA Konstatin Chumakov, Ph.D., D.Sc., CBER/FDA Fred Kadlubar, Ph.D., NCTR/FDA Joe Hackett, Ph.D., CDRH/FDA Larry Lesko, Ph.D., CDER/FDA David Feigal, Ph.D., CDRH/FDA Bob Delongchamp, Ph.D., NCTR/FDA Emily Winn-Deen, Ph.D., Celera Genomics Roger Ulrich, Ph.D., D.A.B.T., Rosetta Inpharmatics
Thursday, February 21, 2002
8:00 - 8:30 a.m. Room 40	Plenary Lecture: The Interface between Science and Policy: An International Perspective Herman B.W.M. Koeter Office of Economic Cooperation and Development
8:30 - 10:30 a.m Room 30/31	Breakout Session 5 - Bioterrorism Chair: Kathryn Zoon, Ph.D., Director, CBER, FDA
Developing approaches to the threat of pathogens associated with bioterrorism poses unique regulatory challenges, among them that there are no ethical human studies that can test the efficacy of these protective measures. Discussion will focus on the role of FDA science in developing rational approaches to deal with these unusual challenges.
8:30	Introduction Kathryn Zoon, Ph.D., Director, CBER, FDA
8:45	Public Health Laboratory Preparedness: Bioterrorism The New Challenge Richard Meyer, Ph.D., Centers for Disease Control
9:05	Anthrax Toxin as a Target of Vaccines and Therapeutics Stephen Leppla, Ph.D., National Institute of Dental Research, NIH
9:25	Discussion and Questions
9:35	Medical Countermeasures against the Reemergence of Smallpox Virus Peter Jahrling, Ph.D., USAMRIID
9:55	Use of Oligonucleotide Microarray Hybridization for Rapid Identifications Konstantin Chumakov, Ph.D., CBER, FDA
10:15	Discussion and questions
8:30 - 10:30 a.m. Room 32/33	Breakout Session 6 - Antibiotic Resistance Chair: Patrick McDermott, Ph.D., CVM, FDA
Antimicrobial resistance is an increasing problem worldwide. Antimicrobial resistance is an increasing problem worldwide. Over the past four decades, many attempts have been made to define the scope of the problem and to ascribe the relative risks due to different usage practices in humans and animals. Despite numerous conferences and recommendations, there is still disagreement on what should be done to alleviate resistance, while protecting human and animal health. Four experts, representing both human and animal health perspectives, will make brief presentations and participate in a panel discussion with questions from the audience. This session will discuss antimicrobial resistance in human and animal bacteria, with emphasis on specific mitigation strategies that have been successful in reducing or reversing the prevalence of resistance. It is hoped that this forum will shed new light on practical and testable measures that can be taken to manage antimicrobial resistance in both humans and animals, and thereby preserve these important drugs for the future.
8:30	Overview of FDA Activities Patrick McDermott, Ph.D., CVM, FDA
8:45	The effects of drug use patterns on the prevalence of resistance in the hospital setting Phillip Carling, M.D., Carney Hospital
9:05	Treatment strategies to limit the emergence of resistance: lessons from the pharmacology of antibacterial agents George Drusano, M.D., Albany Medical College
9:25	Judicious Use of Antibiotics in Production Agriculture Barbara Determan, D.V.M., National Pork Producers
9:45	Use of antimicrobial agents in food animals Keith Sterner, D.V.M., Michigan State University
10:05	Audience Participation/Question and Answer
10:30 -11:00 a.m.	Break
11:00 - 12:00 p.m. Room 40	2002 Scientific Achievement Awards Ceremony
12:00 - 1:00 p.m.	Lunch
1:00 - 3:00 p.m. Room 30/31	Breakout Session 7 - Botanicals: Challenges to Regulatory Science Chair: Paul Coates, Ph.D., Office of Dietary Supplements, NIH
Since the passage of the Dietary Supplements Health and Education Act (DSHEA) of 1994, there has been a proliferation of herbal and botanical products in the marketplace. In the conduct of its mission to ensure foods and drugs are safe for public consumption, DSHEA has created a number of major challenges to FDA. There is also a paucity of scientific information on botanicals regarding actions, interactions (for example with medications) and safety. Development of official analytical methods for analysis of active components in botanicals is a major challenge. Source identification, characterization of components, appropriate standards and analytical methodology are all major challenges for scientists dealing with whole plant as opposed to isolated compounds. These issues will be discussed during the Breakout Session on Botanicals.
1:00	Introductory Remarks Paul Coates, Ph.D., Office of Dietary Supplements, NIH
1:05	Overview of Botanicals Overview: US Regulation of Botanicals - A Historical Perspective Freddie Ann Hoffman, M.D., Pfizer, Inc.
1:20	Analytical Challenges Voon Ong, Ph.D., Memory Pharmaceuticals
1:35	Toxicological Challenges Norman Farnsworth, Ph.D., University of Illinois at Chicago
1:50	Botanical-Drug Interactions Shiew-Mei Huang, Ph.D., CDER, FDA
2:05	Open Discussion with Audience Additional Panelists: Joseph Betz, Ph.D., Office of Dietary Supplements, NIH Anita Mishra-Szymanski, AOAC Christine Taylor, Ph.D., CFSAN/FDA
1:00 - 3:00 p.m. Room 32/33	Breakout Session 8 - Bovine Spongiform Encephalopathy (BSE) Chair: Elisa Elliot, Ph.D., CFSAN, FDA
This break out session will present scientifically accurate information from various FDA scientists to counter any misconceptions regarding BSE for humans and demonstrate how information from scientific research is closely linked with implementing regulations and policy decisions, with the ultimate action of protecting public health. The impact on human exposure and international concerns are also discussed.
1:00	Introductory Remarks Elisa Elliot, Ph.D., CFSAN, FDA
1:05	The Impact of Human Exposure to BSE Agents on FDA Blood Donor Referral Policies Reason for the Concern Jaroslav Vostal, M.D., Ph.D., CBER, FDA
	Recent FDA Regulatory Action David Asher, M.D., CBER, FDA
1:35	BSE-Update on Changes to the Regulation, Compliance Rates, and Method Development Daniel McChesney, Ph.D., CVM, FDA
1:55	BSE - International Perspective William Hueston, D.V.M., Ph.D., University of Minnesota
2:20	Closing Remarks Murray Lumpkin, M.D., Office of the Commissioner, FDA
2:40	Audience Participation/Question and Answer Phase
3:00 - 4:30 p.m. Room 40	Plenary Session - Panel Discussion:  New Issues, New Challenges - Reflections on the Agency by Former FDA Leaders Moderator: Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner Jane Henney, M.D., FDA Commissioner (1998-2001) Mr. Richard Cooper FDA Chief Counsel (1977-1979) Mr. Paul Hile FDA Associate Commissioner for Regulatory Affairs (1976-1986)
4:30 p.m.	Closing Remarks