The Center for Alternatives to Animal Testing is an academic center affiliated with the Division of Toxicological Sciences in the Department of Environmental Health Sciences of the Johns Hopkins University Bloomberg School of Public Health.

 

Johns Hopkins School of Public Health

Abstract for TestSmart--Pharmaceuticals: An Efficient and Humane Approach to Predictors of Potential Toxic Effects of Drugs

Transgenic Animals: Current and Future Applications in Pharmaceutical Safety Assessment

Frank Sistare
US Food and Drug Administration

Denise Robinson
ILSI

  1. Use of Currently Available Transgenic Models for Carcinogenicity Testing (75')

    This portion of the breakout will be conducted as a roundtable discussion initiated by panelists with the goal of stimulating input from the breakout group participants. Focusing on the more thoroughly evaluated transgenic models for carcinogenicity assessment, the following questions are posed:

    1. When is the use of these transgenic models appropriate? What do they add to the safety assessment process?
    2. If you are using these models, how are you using them (as replacements, adjuncts, prechronic screens, etc.)
    3. How do you justify choice of a specific model?
    4. If you don't use Tg models, why not? What are the barriers? What additional information is needed to increase their usefulness?
    5. If there are shortcomings, which transgenic models in existence may overcome those shortcomings, and need to be further evaluated?
  2. Development and Application of Other Transgenic Models - Case Examples

    There are a number of transgenic models that are being developed and evaluated for application to specific safety assessment questions. An important issue is how to facilitate an appropriate level of evaluation of these promising new models and how best to integrate such models into the safety assessment process. Using several specific examples of existing transgenic models that are being evaluated to better understand drug transport, distribution and metabolism, and mechanism of action, discussants will define the general model characteristics, what strategies are being taken to evaluate the potential of the model, and the currently available information on model performance against their proposed applications.

    Following each presentation, participants will be asked to consider the following questions:

    • How would you assess the value of this model?
    • What is needed to gain broader acceptance/confidence in this model?
    • What would be an appropriate evaluation procedure for this model (testing protocol, a battery of test chemicals, etc.)?
    • Where in the safety assessment process would this model best be integrated?
    • How would you extend these recommendations to other existing or future models?