Scope of Things

Michael Ibara on Changing the Clinical Trial Process for AI Application

November 7, 2023


There are concerns surrounding the uses of AI in clinical trials, particularly on the regulations side. In this episode of the Scope of Things, host Deborah Borfitz discusses with Michael Ibara, Pharm.D., Chief Data Officer at Elligo, about the roadblocks and challenges obstructing AI’s potential in clinical trials. Ibara also talks about his perspective on the necessary changes to the clinical trial process to further apply AI, why innovation is a key factor, and what can be done in terms of regulations both domestically and internationally. He also shares his experiences with building a better system of organizing and processing EHR data with the Astra Project.

Michael Ibara, Pharm.D., Chief Data Officer, Elligo
Michael Ibara has more than 20 years of experience in clinical research and development. Throughout his career, he has sought to improve healthcare by bringing together healthcare data and digital technologies. His interests include regulatory and policy implications for digital healthcare, exploring the factors needed to allow interoperability of healthcare data for all stakeholders involved, and implications for the use of big data, machine learning, and natural language processing to improve our ability to perform regulated clinical research.

Before joining Elligo, Michael was the Head of Digital Healthcare for the Clinical Data Interchange Standards Consortium (CDISC). There, he led the FDA eSource project and Healthcare Link efforts with registries, clinical trials, and mobile health to enable use of real-world data from healthcare for regulated research and decision making. Prior to CDISC, Ibara was Head of Business Development Coordination and Innovation and also Head of Pharmacovigilance Innovation at Pfizer, where he worked for 15 years in various positions, leading implementations of global systems and large-scale technologies.