Exploring Challenges and Opportunities in Predictive Safety Tools: Trends from Industry-Wide Surveys

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Results of a recent industry wide survey show that biopharmaceutical companies are planning to make a gradual increase in investment in new, predictive safety technologies. While 53% of respondents say their organization’s spending levels will remain “about the same,” 26% claim they will increase their spending. The types of technologies that are generating the most interest (and investment) from biopharmaceutical companies are:

-  High content toxicity assessment assays or high throughput cell health profiles
-  Mechanistic or predictive toxicogenomics
-  Toxicity biomarkers

The four technology types that will be attracting the vast majority of “assessment resources” (resources dedicated to due diligence and evaluation of novel technologies) are:

-  Three-dimensional matrix of human hepatocytes/stem cells for toxicity assessment
-  Assays to detect risk of idiosyncratic liver toxicity
-  Mechanistic or predictive toxicogenomics
-  Systems toxicology or modeling of toxic pathways


Ernie Bush Director of Collaborative Projects Drug Safety Executive Council (DSEC)