Bioengineering, Children's Health Among Topics At Feb. Forum

2002 FDA Science Forum
FDA: Building a Multidisciplinary Foundation
February 20-21, 2002
Washington Convention Center
Washington DC

Agenda

The 2002 FDA Science Forum will focus on the importance of FDA's many scientific and regulatory disciplines to the Agency's decision-making process. On the first day speakers and participants will address the role of research and review in the formulation of FDA's public health policies. The second day will feature the principles of public health surveillance and the relation of surveillance to current scientific issues, from both domestic and global perspectives.

An integral part of this year's science forum will be interactive breakout sessions that discuss in depth the importance of research, review, policy and regulation in the development of FDA's public health policies. The break out sessions on the first day will focus on the importance of sound research and review in responding to public health issues. The break out sessions on the second day will focus on impact of policy and regulation on public health programs.

The FDA Science Forum is open to all those interested in learning more about FDA's multi-faceted scientific approach to many diverse public health issues. Information about the program can be found on FDA's website at http://vm.cfsan.fda.gov/~frf/sxfda.html or by contacting Dr. Suzanne Fitzpatrick at email sfitzpat@oc.fda.gov, or by phone (301) 827-4591. Online registration for the science forum is available at www.aoac.org.

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February 20, 2002
8:30 a.m	Opening Remarks
9:00 - 9: 30 a.m.	The Importance of Science in Public Policy Decision Making
	Dr. Rita Colwell Director, National Science Foundation
9:30 - 10:00 a.m.	The Role of Regulatory Research and Review Science in Anticipating Public Health Issues
	Dr. Bernard Schwetz Acting Principal Deputy Commissioner, FDA
10:00 - 10:30 a.m.	Break
10:30 - 12:30 p.m.	Breakout Session 1 - The Science and Regulation of Foods Derived from Bioengineered Plants and Animals
	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
	Dr. Pat Hansen, Center for Food Safety & Applied Nutrition, FDA
	10:35 - General discussion of the science of bioengineering plants for food - past, present, and future.
	Dr. Peter Day Rutgers University
	11:05 - General discussion of the science of bioengineering animals for food - past, present, and future.
	Dr. James Murray University of California, Davis
	11:30 - FDA oversight of bioengineered animals and foods from bioengineered plants.
	Dr. Eric Flamm Office of the Commissioner, FDA
	11:50 - Post-market issues for bioengineered plants: Starlink case study.
	Dr. Pat Hansen Center for Food Safety & Applied Nutrition, FDA
	12:10 - Panel discussion of issues and questions concerning bioengineered foods
	Dr. Laura Tarentino, Moderator Center for Food Safety & Applied Nutrition, FDA
	Breakout Session 2 - Tissue Engineered Combination Products
	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.
	10:30 - Introduction
	Kiki B. Hellman, PhD, Moderator Center for Devices and Radiological Health, FDA
	10:35 - Overview of Tissue Engineered Combination Products
	Peter C. Johnson M.D., CEO Tissue Informatics
	10:55 - Overview of Regulatory Issues of Tissue Engineered Combination Products -
	Dr. David Krause Center for Devices and Radiological Health, FDA and Dr. Joyce Frey-Vasconcells Center for Biologics Evaluation and Research, FDA
	11:15 - Case Study - Apligraf (approved product)
	Tamyra Toole RN, JD Organogenesis
	11:35 - Case Study - unapproved tissue engineered combination product
	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.	Lunch and Sigma Xi Poster Session
2:30 - 4:30 p.m.	Breakout Session 3 - Children?s Health Issues
	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
	Dr. Dianne Murphy, Moderator Center for Drug Evaluation and Research, FDA
	2:35 - Pre-clinical: Usefulness of animal juvenile models to assess long-term exposure
	Dr. Joseph DeGeorge Center for Drug Evaluation and Research, FDA
	2:55 - Pre-clinical: Juvenile rhesus monkey exposure to neurotropic drugs: behavioral and safety concerns
	Dr. Merle Paule National Center for Toxicological Research, 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
	Dr. William Slikker National Center for Toxicological Research, FDA
	3:45 - Exposure to environmental toxicants in the postnatal period: long-term effects in children of lead, mercury, pesticides, and other toxins.
	Dr. Ana Maria Osorio Environmental Protection Agency
	4:00 - CDER's Experience; What we have learned from the Pediatric Initiative in children
	Dr. William Rodriguez Center for Drug Evaluation and Research, FDA
	4:15 - Panel Questions
	Breakout Session 4 - Genomics
	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
Dr. Martha Moore National Center for Toxicological Research, FDA
	2:35 - Overview: Promise of the genomic technology and requirements for its use in FDA decision-making
	Dr. James MacGregor National Center for Toxicological Research, FDA
	2:55 - Panel Discussion
	Moderator-Dr. Martha Moore National Center for Toxicological Research, 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: Dr. Tom Cebula -CFSAN/FDA Dr. Frank Sistare- CDER/FDA Dr. Raj Puri -CBER/FDA Dr. Konstatin Chumakov- CBER/FDA Dr. Fred Kadlubar -NCTR/FDA Dr. Joe Hackett -CDRH/FDA Dr. Larry Lesko -CDER/FDA Dr. David Feigal -CDRH/FDA Dr. Bob Delongchamp -NCTR/FDA Dr. Emily Winn-Deen -Celera Genomics Dr. Roger Ulrich -Rosetta Inpharmatics
February 21, 2002
8:00 - 8:30 a.m.	Integrating Science Into Public Health Surveillance Programs
	TBA
8:30 - 10:30 a.m.	Breakout Session 5 - Bioterrorism
	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, PhD Director, Center for Biologics Evaluation & Research, FDA
	8:40 - Overview of Bioterrorism Research Efforts.
	D.A. Henderson, MD, MPH Hopkins Center for Civilian Biodefense Studies
	8:55 - Detection testing methods
	Richard Meyer, PhD Centers for Disease Control
	9:10 - Discussion and questions
	9:20 - Models: Anthrax
	Stephen Leppla, PhD National Institute of Dental Research, NIH
	9:35 - Models: Smallpox
	Peter Jahrling, PhD USAMRIID
	9:50 - Quality control issues for vaccines
	Konstantin Chumakov, PhD Center for Biologics Evaluation & Research, FDA
	10:05 - Discussion and questions
	Breakout Session 6 - Antibiotic Resistance
	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, PhD, Moderator Center for Veterinary Medicine, FDA
	8:45 - The effects of drug use patterns on the prevalence of resistance in the hospital setting.
	Phillip Carling, MD Carney Hospital
	9:05 - Treatment strategies to limit the emergence of resistance: lessons from the pharmacology of antibacterial agents.
	George Drusano, MD Albany Medical College
	9:25 - Judicious Use of Antibiotics in Production Agriculture
	Barb Determan, DVM National Pork Producers
	9:45 - Use of antimicrobial agents in food animals
	Keith Sterner Michigan State University
	10:05 - Audience Participation/Question and Answer
10:30 -11:00a.m.	Break
11:00 - 12:00 p.m.	2002 Scientific Achievement Awards Ceremony
12:00 - 1:00 p.m.	Lunch
1:00 - 3:00 p.m	Breakout Session 7 - Botanicals: Challenges to Regulatory Science
	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
	Dr. Paul Coates, Moderator Office of Dietary Supplements, NIH
	1:05 - Overview of Botanicals
	Dr. Freddie Ann Hoffman Pfizer, Inc.
	1:20 - Analytical Challenges
	Dr. Voon Ong Memory Pharmaceuticals
	1:35 - Toxicological and Health Effects
	Dr. Norman Farnsworth University of Illinois at Chicago
	1:50 - Botanical-Drug Interactions
	Dr. Shiew-Mei Huang Center for Drug Evaluation & Research, FDA
	2:05 - Open Discussion with Audience
	Additional Panelists:
	Dr. Joseph Bentz, American Herbal Products Assn. Dr. Anita Mishra-Szymanski, AOAC Dr. Christine Lewis, CFSAN/FDA
	Breakout Session 8 - Bovine Spongiform Encephalopathy (BSE)
	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
	Dr. Elisa Elliot Center for Food Safety & Applied Nutrition, FDA
	1:05 - The Impact of Human Exposure to BSE Agents on FDA Blood Donor Referral Policies
	a. Reason for the Concern
	Dr.Jaroslav Vostal Center for Biologic Evaluation & Research, FDA
	b. Recent FDA Regulatory Action
	Dr.David Asher Center for Biologic Evaluation & Research, FDA
	1:35 - BSE-FDA/CVM Feed Rule Inspection, Current Data and Regulatory Perspective.
	Dr. Stephen F. Sundlof Center for Veterinary Medicine, FDA
	1:55 - BSE-International Perspective
	Dr. William Hueston University of Minnesota
	2:20 - Closing Remarks
	Dr. Murray Lumpkin Office of the Commissioner, FDA
	2:40 - Audience Participation/Question and Answer Phase
3:00 - 4:30 p.m.	Panel Discussion - New Issues, New Challenges--Reflections on the Agency by Former FDA Leaders
	Dr. Jane Henney Mr. Richard Cooper Mr. Paul Hile
4:30 p.m.	Closing Remarks