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Animal Models for Safety and Efficacy Testing of Agents that Cannot be Tested in Humans

National Capital Area Chapter

Society of Toxicology

Fall Symposium

November 18, 2003

Towers Auditorium

Howard University Hospital Complex

2401 Georgia Ave. N.W.

Washington D.C. 20059

The goal of this symposium is to help educate toxicologists and generate discussion about the use of animals for safety and efficacy testing when the conduct of such studies in human populations would be considered unethical. This regulation, often called the “Animal Rule” was published in the Federal Register in May of 2002. This regulation specifies that animal studies alone can be used to demonstrate effectiveness when: 1. The pathophysiological mechanism for the toxicity of the substance (chemical, biological, radiological or nuclear) and its treatment or prevention is well understood; 2. The drug effect is demonstrated in two animal species, unless one species has been well characterized; 3. The endpoint in animal studies is clearly related to the human endpoint; 4. PK/PD data are available to allow selection of an effective human dose. Examples of drugs and biologicals approved under the animal rule will be presented. In addition, this symposium will explore ethical standards used in determining when and under what circumstances human trials are appropriate or inappropriate. Perspectives from both the FDA and the EPA will be presented.

7:45 AM Registration and Continental Breakfast

8:30 AM Welcome and Opening Comments

Sidney Green, Ph.D.,

President, NCAC-SOT

David Jacobson-Kram, Ph.D.

Program Chair

8:45 9:30 "Use of Animal Models When Ethics Prohibit Use of Human Subjects: Examples and Challenges."

Tracey MacGill, Ph.D., U.S. FDA

9:30–9:35 Questions and discussion

9:35 10:20 Certainty and Benefit in Medical Research on Human Beings”

Daniel P. Maher, Ph.D., Ph.L., Catholic University of America

10:20–10:25 Questions and discussion

10:25– 10:45 Break

10:45– 11:30 "Rising to the Challenge - the FDA's New Rule Using Animal Efficacy Data for Approval of New Drugs and Biologics"

David Green, Ph.D., U.S. FDA

11:30–11:35 Questions and discussion

11:35 12:20 “Product Development Challenges When Applying the Animal Rule”

Doris Snow, Ph.D. Dynport Corporation

12:20–12:30 Questions and discussion

12:30–1:30 Lunch

1:30–1:50 “Ciprofloxacin and Inhalation Anthrax: Primate Model for Effectiveness”

Stephen Hundley, Ph.D. U.S. FDA

1:50–2:35 “Grappling with the acceptability of already-completed third-party human research at EPA”

John Carley, Ph.D. U.S. EPA

2:35 2:40 Questions and discussion

2:40–3:00 Break

3:00–3:45 “Computational Toxicology: Application to Human Health

Jack Fowle, Ph.D. U.S. EPA

3:45 4:00 Questions, discussion and concluding remarks





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