A World First: Automated Local Literature Monitoring for Pharmacovigilance – Download our White Paper Today!
biologit News
Validation and Transparency in AI systems for Pharmacovigilance: a case study applied to the medical literature monitoring of adverse events
Recent advances in artificial intelligence applied to biomedical text are opening exciting opportunities for improving pharmacovigilance activities currently burdened by the ever growing volumes of real world data. To fully realize these opportunities, existing regulatory guidance and industry best practices should be taken into consideration in order to increase the overall trustworthiness of the system and enable broader adoption. In this paper we present a case study on how to operationalize existing guidance for validated AI systems in pharmacovigilance focusing on the specific task of medical literature monitoring (MLM) of adverse events from the scientific literature. We describe an AI system designed with the goal of reducing effort in MLM activities built in close collaboration with subject matter experts and considering guidance for validated systems in pharmacovigilance and AI transparency. In particular we make use of public disclosures as a useful risk control measure to mitigate system misuse and earn user trust. In addition we present experimental results showing the system can significantly remove screening effort while maintaining high levels of recall (filtering 55% of irrelevant articles on average, for a target recall of 0.99 on suspected adverse articles) and provide a robust method for tuning the desired recall to suit a particular risk profile.
Biologit featured in Enterprise Ireland's Big Ideas 2020 innovation showcase (Nov-2020)
Big Ideas 2020 is Enterprise Ireland's annual showcase of investor-ready startups, taking place online on 25 November. biologit is one of the featured startups presenting pitches to Ireland's investment community.
Pragmatic machine learning to reduce medical literature screening workloads - DIA Regulatory Science Forum (Oct-2020)
The biologit team in collaboration with Trinity College Dublin presented experimental results on the use of AI for reducing medical literature screening workloads while maintaining high quality of results.





