FDA’s drug center to consolidate AI efforts under single council

The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the Biden administration to ensure the safety and security of machine learning software.

In an email to agency staff, CDER Director Patrizia Cavazzoni, M.D., said the new council would replace the center’s separate AI-related steering committee and policy working groups and would continue its work within the federal government-wide AI Community of Practice.

Its remit will also include overseeing how AI is used within pharmaceutical R&D and applications from drugmakers as well as how AI programs may be tapped internally by the agency’s product reviewers and other administrative employees.

“While multiple CDER groups have previously been involved in AI initiatives spanning policy, regulatory, and technology efforts, the changing external and federal environments for AI have brought new governance needs,” Cavazzoni wrote in the email.

“The advent of novel AI applications, such as generative AI and large language models, is likely to expand opportunities for use of AI within CDER, including by non-technical staff. This will require increased AI education and coordination,” she said. “There has also been a rapid increase in CDER regulatory submissions incorporating AI, and the scope and impact of AI use in drug development are expanding.”

The email specifically cites the October 2023 executive order on ensuring the “secure and trustworthy development” of AI, which included directives for government agencies to establish their own AI safety programs and especially in the context of its use within healthcare.

At the same time, the government announced it would launch the AI Safety Institute, tasked with developing standards and technical guidance for biotech R&D and regulatory rulemaking, under the National Institute of Standards and Technology.

Cavazzoni said the new council “will soon conduct an inventory of all CDER AI projects, expand tracking of AI efforts in CDER, and establish a centralized process through which offices will be required to seek consultation and support for deployment of all future AI projects” while aiming to offer a consistent voice in the drug center’s communications to the public and the industry on AI issues.

It will also perform “a landscape assessment to better understand CDER staff’s knowledge of and application of AI in their daily work,” she said.

The council will include representatives from all CDER offices and be co-led by Tala Fakhouri, Ph.D., associate director for data science and AI policy; Qi Liu, Ph.D., associate director for innovation and partnership in the Office of Clinical Pharmacology; and Sri Mantha, director of the Office of Strategic Programs.

Source:  https://www.fiercebiotech.com/medtech/fdas-drug-center-consolidate-ai-efforts-under-single-council

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