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
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 a.m. Registration
and Continental Breakfast
8:30 a.m. 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,
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.,
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,
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.
1:50 – 2:35 “Grappling with the acceptability of already-completed third-party human research at EPA”
John Carley,
Ph.D.
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.
3:45 – 4:00 Questions,
discussion and concluding remarks