Efficient Communication Reduces Regulatory Uncertainty

CDO Magazine Podcast Series

By Chris Houchin

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), speaks with Chris Houchin, Partner at Guidehouse, in a video interview about leveraging AI at the agency, developments in data-driven healthcare, and improving communication regarding frontier topics like explainability, data integrity, bias, and data security.

Speaking about the FDA’s approach to leveraging AI, Marks says that the agency is open to the use of AI but according to best practices. The application is being seen across multiple areas, from manufacturing to post-market surveillance. He mentions that the agency is using AI in manufacturing particularly in the complex biologics product area which involves multiple critical quality attributes that need to be checked during manufacturing.


Watch the full video below.

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