(US & Canada) VIDEO | Efficient Communication Reduces Regulatory Uncertainty — CBER Director, US FDA

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

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-riven 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.

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Marks however stresses the need to maintain best practices and avoid having suboptimal outputs from suboptimally used artificial intelligence.

When asked about internal and industry-wide communication around frontier AI topics like explainability, avoiding bias, data integrity, and data security, he mentions that the agency has various AI committees that look at best practices for internal use and submissions.

Further, Marks says that AI is evolving remarkably rapidly and reveals that the agency explored its use several years ago with adverse event reporting, and its application and best practices will evolve.

Between various pilot programs, CEBR will be running workshops around the topics. For 2024, Marks says that the agency aims to be more patient-centric and is focused on working with sponsors to get products out to the benefit of patients.

He further highlights the communications aspect of drug development, especially for smaller companies involved in gene and cell therapy development. Marks adds that efficient communication reduces regulatory uncertainty which can be a combination of both informal and formal meetings.

Next, he goes on to speak about data-driven healthcare and says that it will increasingly be the application of platform-based gene therapies. Marks adds that the approval of the first CRISPR-Cas9 cell-based gene therapy is just the beginning of the application of platforms of gene therapy. This will involve collecting data from individual patients to understand whether a platform can be approved for a given indication.

Concluding, he adds that the job is to ensure products are high quality, safe, and effective, with processes being as streamlined as possible to reduce costs and improve access.

CDO Magazine appreciates Dr. Peter Marks for sharing his insights and data success stories with our global community.

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