BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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22 BioPharm International eBook October 2021 How Artificial Intelligence Impacts the Global Regulatory Environment Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices. I n January 2020, Sumitomo Dainippon Pharma, a pharmaceutical company based in Osaka, Japan, and Exscientia, an artificial intelligence (AI) drug discovery company based in Oxford, United Kingdom, initiated a Phase I clinical study of DSP-1181. The drug, designed to treat obsessive-compulsive disorder, was created using AI technology. Through their combined efforts, the two organi- zations completed the exploratory research phase in under 12 months—a considerably shorter time frame than what is con- sidered typical for this type of project (1). This is one example of AI-based products converging on the regulatory pathways toward mainstream health care. EMERGENCE OF AI The landscape of innovation in the life sciences industry is a global endeavor that's moving at a fast pace. While the incorporation of AI in health care is relatively new, the concept of the technology has been around for decades. In the early 1950s, computer scientists developed AI programs that could best their human counterparts at games of chess and checkers—still, the vision for this technology was far beyond complex board games (2). AI is designed to emulate human intelligence processes. It acquires information, determines how to analyze and use the information, and self corrects upon receiving new data. It can then provide useful guidance for making decisions or solving problems. An AI algorithm has a programmed ability to continue learning and adapting based on the data it receives, making it useful for processes that involve analyzing enormous amounts of data. Machine learning RAJESH TALPADE is senior vice president of Product at MasterControl. RAJESH TALPADE Regulatory Sourcebook Data Integrity ISSARONOW - STOCK.ADOBE.COM

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