GC Biopharma Corp. Automates Drug Safety Literature Reviews with Generative AI

[Financial News] GC Biopharma Corp. has developed in-house software for monitoring pharmacovigilance literature, using generative artificial intelligence (AI) to identify drug safety information. The aim is to improve the efficiency of drug safety management by applying AI to the review of vast amounts of domestic and international academic literature.
GC Biopharma Corp. said on the 12th that it had developed PVLitrieve, generative AI-based software that supports pharmacovigilance (PV) literature monitoring, becoming the first pharmaceutical company in Korea to do so.
Pharmacovigilance literature monitoring involves finding and evaluating safety information related to a company’s own medicines in sources such as research papers and conference presentations. It is a demanding area for staff because the volume of literature to review is vast and requires ongoing monitoring.
When a list of literature to be reviewed is entered, PVLitrieve collects and analyzes its contents using AI, assessing the relevance of the safety information to the medicine in question and whether the requirements for a safety case report are met. It provides the analysis results and the rationale for its assessments in an Excel file.
However, the software uses a human-in-the-loop approach in which pharmacovigilance experts make the final decisions. AI supports the literature review, and experts check the results. In an initial validation conducted on about 600 papers, it recorded a negative predictive value of 100%.
GC Biopharma Corp. has filed an application for the relevant trademark and plans to add literature search and report-drafting functions next year. The company aims to develop the software into an integrated platform supporting the full range of pharmacovigilance work, from literature searches and analysis to assessments and report writing.
Choi Bong-gyu, head of GC Biopharma Corp.’s AI and Data Science Center, said, “It is significant that we have embedded generative AI technology in the field of drug safety management.” He added, “We will enhance the software’s capabilities to meet global regulatory requirements and improve the productivity and quality of pharmacovigilance work.”
[email protected] Jung Sang-hee Reporter