How Artificial Intelligence Impacts the Global Regulatory Environment

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BioPharm International, BioPharm International, Regulatory Sourcebook October 2021, Volume 2021 eBook, Issue 4

Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.

In 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 organizations completed the exploratory research phase in under 12 months—a considerably shorter time frame than what is considered typical for this type of project (1). This is one example of AI-based products converging on the regulatory pathways toward mainstream health care.

Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.


About the author

Rajesh Talpade is is senior vice president of Product at MasterControl.

Article Details

BioPharm International
eBook: Regulatory Sourcebook eBook
October 2021
Pages: 22-25


When referring to this article, please cite it as R. Talpade, “How Artificial Intelligence Impacts the Global Regulatory Environment," BioPharm International Regulatory Sourcebook eBook (October 2021).