Emerging Technologies and Their Impact on Regulatory Science

    Basic Details
    Date
    Tuesday, November 16, 2021
    Type
    Publication
    Description

    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.

    Author(s)

    Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda-Kenzaoui, Denise Hinton, Akihiko Hirose, Arnd Hoeveler, Masamitsu Honma, Marta Hugas, Seichi Ishida, George E.N. Kass, Hajime Kojima, Ira Krefting, Serguei Liachenko, Yan Liu, Shane Masters, Uwe Marx, Timothy McCarthy, Tim Mercer, Anil Patri, Carmen Pelaez, Munir Pirmohamed, Stefan Platz, Alexandre J.S. Ribeiro, Joseph V. Rodricks, Ivan Rusyn, Reza M. Salek, Reinhilde Schoonjans, Primal Silva, Clive N. Svendsen, Susan Sumner, Kyung Sung, Danilo Tagle, Li Tong, Weida Tong, Janny van den Eijnden-van-Raaij, Neil Vary, Tao Wang, John Waterton, May Wang, Hairuo Wen, David Wishart, Yinyin Yuan, William Slikker Jr.

    Corresponding Author

    William Slikker Jr.; Office of the Center Director, National Center for Toxicological Research, Office of the Chief Scientist, Food and Drug Administration, Silver Spring, MD, USA

    Email: William.Slikker@fda.hhs.gov