Summary 2010

The McKim Conferences on Predictive Toxicology are convened to discuss the scientific barriers associated the paradigm shift to a more efficient hypothesis-driven testing paradigm as well as critical paths to overcome those barriers. A conceptual framework centered on adverse outcome pathways serves to integrate QSAR models and a wide variety of in vitro and in vivo test endpoints, and provides a logical structure for assembling and interpreting safety assessments of in vivo risks. Improved predictions for many short-term assessment endpoints are already being demonstrated by many regulatory agencies.

While the prediction of low-incident toxic effects such as cancer in populations still has many uncertainties, the assessment of chemical carcinogenicity, potency and susceptibility factors are routinely conducted by panels of experts even without the rodent carcinogenicity assay. This workshop will reinterpret the supporting evidence for carcinogenicity using more rigorous QSAR–based chemical categories which collate chemical on a basis of molecular initiations with DNA and other macromolecules. Once categorized, the in vitro and in vivo evidence coming soon can be arrayed along adverse outcome pathways to the assessment endpoints used by regulatory authorities.