Posts from May 2015

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?

I2E enables extraction and integration of historical preclinical safety information, crucial to optimizing investment in R&D, alleviating concerns where preclinical observations may not be human-relevant, and reducing late stage failures.

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).

The recent two day II-SDV meeting in the beautiful town of Nice on the Côte d’Azur, France, started with a day of talks considering the question of how to best maximise the value of data extracted from a wide range of sources: patents, full text articles and even big data.

The programme kicked off with a presentation from Aleksander Kapisoda from Boehringer Ingelheim (BI) describing how innovative use of custom search techniques beyond that currently offered by standard public search machines can bring tangible benefits to a global pharmaceutical company.