Abstract
Unexpected toxicity is the single greatest cause of pipeline attrition.
Despite the fact that a typical preclinical safety program will consume about
1,300 rats and 90 dogs, there is no guarantee that the compound will not
present safety problems serious enough to warrant termination. Outlook for
Predictive Safety Technologies, a new CHA Advances report, surveys the
latest developments in discovery-stage and preclinical predictive safety
assessment tools-from in silico methods for lead selection and optimization to
high-content cell-based screens, toxicogenomics, tissue proteomics, and
advanced animal models. It provides the information and analysis you need to
get the best return-in terms of confidence, cost-benefit, and ease of
maintenance and use-on your preclinical safety technology investments.
Specifically, the report delivers:
- A comparative assessment of the leading predictive safety technologies,
with an emphasis on performance, specific applications in non-clinical
testing, and total cost of ownership
- Estimates of potential savings in research costs and animal use-including
a case study scenario of cost savings for a mid-sized biopharma company
- Adoption rates by industry-which technologies are attracting resources,
and why?
- A "virtual roundtable" where 10 leading safety experts in industry and FDA
provide their extended views on key scientific and business issues around
predictive safety technologies
- A quantitative survey (n=46) of the views, practices, and plans of
ADME/Tox researchers in industry and academia presented in easy-to-scan charts
- Expert insight into critical issues such as safety challenges presented by
large molecule drugs, the implications of FDA' s Exploratory IND Guideline, and
timelines to reduced FDA emphasis on animal safety studies
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