Better access to the high value information in legacy safety reports has been, for many folk in pharma safety assessment, a “holy grail”. Locked away in these historical data are answers to questions such as: Has this particular organ toxicity been seen before? In what species, and with what chemistry? Could new biomarker or imaging studies predict the toxicity earlier? What compounds could be leveraged to help build capabilities?
Coming as I do from a decade of working in data informatics for safety/tox prediction, I was excited by one of the talks at the recent Linguamatics Spring User conference. Wendy Cornell (ex-Merck) presented on an ambitious project to use Linguamatics text mining platform, I2E, in a workflow to extract high value information from safety assessment reports stored in Documentum.
Access to historic safety data is a potential advantage that will be helped with the use of standards in electronic data submission for regulatory studies (e.g. CDISC’s SEND, the standard for exchange of non-clinical data).