NIH Summit Workshop on Predictive Drug Toxicology
June 15–17, 2004

About the Workshop

A major reason for the tremendous cost of drug development is the high rate of drug candidate failure during clinical testing. The withdrawal of drug candidates in late-stage testing has a significant impact on driving up the expense of bringing drugs to market and reducing the number of drug candidates moving through the pipeline. It is recognized that failure to detect drug toxicities in preclinical testing contributes to drug candidate failure during clinical phase testing. As part of the Molecular Libraries Initiative of the NIH Roadmap, this workshop will address our current understanding of drug-induced toxicities; discuss new procedures that may improve absorption, distribution, metabolism, excretion and toxicology (ADMET) analysis; and identify new techniques and research to prevent the selection of compounds that will fail in clinical testing. In this workshop, researchers from academia, the pharmaceutical industry, and the FDA will describe areas in which additional research is needed to improve predictive analyses and discuss what new science may be needed to improve preclinical testing to reduce the failure rate of drug candidates.

Target Audience

Attendees of this workshop will include researchers from the academic and research institute communities, pharmaceutical and biotechnology industries, regulatory agencies, and researchers from other relevant fields (e.g., computational biology and bioinformatics). The interactive structure of the workshop will foster an exchange of information and networking opportunities. This will enhance an interdisciplinary understanding of new research and technical areas that need to be developed and brought to the preclinical evaluation of compounds to identify potential toxicities or interactions with other compounds.

Conference Goals

Identify opportunities and barriers to improve the preclinical evaluation of drug candidates that will identify drug-induced toxicities or prevent toxicity due to abnormal ADMET parameters.

Identify new biomarkers, in vitro and in vivo models, and research ideas that may be brought to preclinical testing to improve predictive ADMET analysis.

Identify strategies to reduce the number of drug candidate failures due to drug-induced toxicities by 50% in 5 years.

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