WASHINGTON, January 10, 2022 (Newswire.com) - A recently published article in Experimental Biology and Medicine (Volume 247, Issue 1, January, 2022) highlights the importance of emerging technologies in regulatory science. The article was coordinated by Dr. William Slikker, Jr., Director, National Center for Toxicological Research at the U.S. Food and Drug Administration in Arkansas (USA) and coauthored by a world-class set of authors selected by the organizing committee of the Global Summit on Regulatory Science (GSRS20).
There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools. When that occurs, those new technologies that reliably and routinely provide valid data for safety assessments as compared to existing procedures and reflecting human health effects will be incorporated into acceptable testing regimes.
Dr. Slikker said, "By examining the areas of Artificial Intelligence and Machine Learning; 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."
Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology and Medicine, said, "It is Science that will provide the answers to unprecedented challenges faced by people around the globe, from the pandemic to global warming. Fortunately, the creativity of the research community is in great abundance, allowing us to confront these challenges with new technologies which must be thoughtfully regulated. What this extremely important article espouses convincingly is that the academic research community, biopharma/biodevice/biotechnology industries, and regulatory agencies must work in synergy and harmony to harness the power that technological platforms created over the past twenty years provides to solve these worldwide human health challenges. This is an article that all researchers in academia, bioindustry and government should read."
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Source: Experimental Biology and Medicine