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The organizing committee of the Global Summit on Regulatory Science (GSRS20) recruited a world-class set of authors carefully selected to address the theme of Emerging Technologies and Their Impact on Regulatory Science. Emerging technologies will play a major role in regulatory science in the future. One could argue that there has been an evolution of use and incorporation of new approaches from the very beginning of the safety assessment process. As the pace of development of novel approaches escalates, it is evident that assessment of the readiness for these new approaches to be incorporated into the assessment process is necessary. By examining the areas of Artificial Intelligence (AI) and Machine Learning (ML); Omics, Biomarkers, and Precision Medicine; Microphysiological Systems and Stem Cells; Bioimaging and the Microbiome, clear examples as to how to assess the reproducibility, reliability and robustness of these new technologies have been revealed. In a group movement, there is a call for product developers, regulators, and academic researchers to work together to develop strategies to verify the utility of these novel approaches to predict impact on human health.
Robert Ball, MD, MPH, ScM, Deputy Director of the Office of Surveillance & Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, offers an assessment of the Sentinel Initiative in this review.