Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is considered a subset of AI that allows models to be developed by training algorithms through analysis of data, without models being explicitly programmed.
FDA recognizes the increased use of AI/ML throughout the drug development life cycle and across a range of therapeutic areas. In fact, FDA has seen a significant increase in the number of drug and biologic application submissions using AI/ML components over the past few years, with more than 100 submissions reported in 2021. These submissions traverse the landscape of drug development — from drug discovery and clinical research to postmarket safety surveillance and advanced pharmaceutical manufacturing.
Poolbeg Pharma plc (LON:POLB) is a clinical stage infectious disease pharmaceutical company, with a novel capital light clinical model which enables us to develop multiple products faster and more cost effectively than the traditional biotech model.