Convergence: FDA official offers insights on clinical holds, use of AI at CBER

LONG BEACH, CA – The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) saw a decrease in the number of clinical holds placed on biological products in recent years, thanks to early engagement with sponsors and other efforts by the center.

Speaking at RAPS Convergence 2024 last week, Christopher Joneckis, associate director for review management at CBER, said that the newly agency’s INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) program, new procedures for instituting clinical holds, and staff training have helped to reduce the number of clinical holds. FDA launched the INTERACT program in 2018 to allow sponsors of early-stage investigational biologics to meet with FDA before conducting clinical studies.

Joneckis also noted an increase in the number of applications containing AI and machine learning (AI/ML) elements and said the center has observed a similar uptick in its use of AI tools internally. He added that he has noted an increased interest in face-to-face meetings in wake of the COVID-19 pandemic.

The number of clinical holds placed on investigational new drug applications (INDs) for biological products has steadily decreased over the past three years – from 26% in FY 2021, 22% in FY 2022, 13 % in FY 2023, and to 8.4% as of the third quarter of FY 2024.

He attributed the steady drop to revised internal practices at CBER in instituting clinical holds, early communication with sponsors though INTERACT to discuss salient issues related to clinical development, better outreach to sponsors, and better training for the center’s review staff. “Getting staff on board and training has helped,” Joneckis said.

Face-to-face meetings

Joneckis said another trend is an increase in face-to-face meetings with sponsors after FDA began allowing more face-to-face meetings after the COVID-19 pandemic. “FDA is slowly rolling out more face-to-face meetings, a lot of these refusals were that they were not eligible” at the time of request, he said, referring to applications submitted meeting requests earlier on.

As of Q3 FY 2024, FDA granted 89 requests for virtual face-to-face meetings out of 116 requested. There were 51 requests granted for hybrid in-person/virtual meetings out of 53 meetings requested. Joneckis noted that all meeting types became eligible for in-person face-to-face and virtual face-to-face in January 2024.

Growing use of AI in applications

Joneckis also discussed the agency’s greater reliance on AI/ML tools in reviewing biologics license applications (BLAs) as well as its increasing uptake in BLA submissions.

A review of submissions between 2016 and 2023 found that CBER received over 60 submissions incorporating AI/ML elements, with most of these submissions occurring over the last three years. AI tools are mostly being used in applications for oncology and infectious diseases.

CBER is also moving to adopt AI tools for its internal business practices. “We are looking at facilitating internal business practices and we are using AI” in sifting through applications, Joneckis said. He explained that “there is a lot of repetition and low-hanging fruit, which saves time.”

These tools are also being used in reviewing adverse events and their link to electronic health records to discern any trends. However, Joneckis pointed out that while AI/ML can be used to “facilitate and augment” data it “does not replace human reviews.”

Convergence: FDA official offers insights on clinical holds, use of AI at CBER

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