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

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Knowledge Partner

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

INTERESTED IN LEARNING MORE ABOUT THIS TOPIC?
		Translating Toxicological Observation into Prediction Technology IQPC’s 1st North American Predictive Toxicology Summit will discuss and develop techniques that will provide guidance on the right balance between mitigation and management of safety risk. To find out more, download the brochure now!

Presenter:

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

Ernie has spent over 23 years working in the field of biomedical R&D most of which working in preclinical safety departments for major pharmaceutical companies. From 1992 to 2005 he worked at Hoffmann-La Roche, Inc. and for the last 5 years of that time he led their Non-Clinical Drug Safety Department of 120 members including the functional groups: Drug Metabolism, Non-Clinical Pharmacokinetics, Bioanalytical, Toxicology (including Safety Pharmacology and Teratology), and Pathology. The scope of their responsibilities spanned from early Discovery support through to NDA with particular emphasis on providing an integrated safety assessment to projects across all phases of Discovery and Development.

Ernie has been asked to lead several global initiatives on safety information management practices, including a global safety LIMS system at Roche and a global information repository for toxicogenomics data for the International Life Sciences Institute (ILSI). His in-depth knowledge and broad experience in both the informatics and safety assessment fields has made him a unique leader in today’s complex drug development landscape.

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