Advances in Discovery, Formulation, and Delivery of New Modalities
Thomas O'Connor, PhD (he/him/his)
Deputy Office Director
US Food and Drug Administration
Silver Spring, Maryland
Advanced analytics leveraging AI/ML in the pharmaceutical manufacturing industry offers many possibilities, including, but not limited to, enhancing process control, increasing equipment reliability and throughput, and supporting product release. Areas of consideration for AI/ML technologies in drug manufacturing include managing the data associated with AI/ML models, standards for developing and validating AI/ML models, and the lifecycle management of continuously learning AI/ML systems. FDA has engaged stakeholders to collect feedback on the identified areas of consideration through discussion papers and workshops.