The pharmaceutical industry is interested in developing, standardizing, and validating sensitive and specific new and novel tests or batteries of tests thatwill provide faster and less expensive alternatives to the use of standard laboratory animal tests,( i.e., assays for carcinogenicity, immunologic toxicity, reproductive or developmental toxicity, dermal toxicity, and neuro or other organ system toxicity including acute local and systemic toxicity).

The proposed tests should use cell cultures or animal models that are relevant to human experience and can be extrapolated to estimate risk to humans.

In addition, the industry is interested in developing both high throughput screens that can be used to prioritize chemicals for definitive testing and in developing specific tests that meet regulatory requirements for toxicity tests.

The endpoints for these assays should take advantage of the new technologies such as genomics, transcriptomics, proteomics, and bioinformatics and of novel endpoints (biomarkers) including those that are non-invasive. Examples include but are not limited to:

A. Biokinetic models that include the integration of toxicodynamic and biokinetic modeling to predict systemic toxicity.

B. In vitro test methods (e.g., undifferentiated/ differentiated human/mammalian cell model systems, organotypic model systems) that can be used to predict acute and chronic toxicity by taking into account, for example, metabolism, the ability of chemicals to pass through barriers (i.e., blood brain, kidney, lung, gastrointestinal), and organ specific effects, or which allow the development of endpoints that can be extrapolated to in vivo biomarkers of toxicity.

C. Alternative assays to determine dermal irritation, dermal absorption, dermal hypersensitivity phototoxicity, and ocular toxicity.

D. Non-mammalian or invertebrate models for specific toxicities that utilize endpoint that are conserved across species so the results can be extrapolated to human risk.

There are plenty of opportunities to build system design teams around these topics.