Recently at AbbVie we shifted from an OnPremise solution to a cloud-based OnDemand version of I2E. Reduced maintenance efforts and larger, “ready-to-query” full-text corpora are straightforward advantages that come in mind. However, the new set-up also poses several challenges requiring novel TDM strategies to be developed. Herein we discuss some of the approaches, highlighting both advantages and limitations that have been encountered. In particular, the use of internal ontologies and macros and the creation of focused sub-corpora are addressed.

There are many steps in regulatory compliance processes where text mining can bring value. Mundipharma has implemented an I2E AMP workflow to automatically extract data elements for IDMP (IDentification of Medicinal Products) from Summary of Product Characteristics (SmPC) documents. This text analytics approach brings benefits for business intelligence beyond IDMP. We are looking at other document types (e.g. dossiers, CMC, response to questions), and to provide insight into internal regulatory data quality and data governance.