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CBER’s Compliance Office Absorbing Impact of Cell/Gene Therapy Wave in its Pre-Market and Surveillance Operations

Nov 20th, 2018

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The high demands that the review staff is facing at FDA’s Center for Biologics Evaluation and Research from industry’s rapidly expanding engagement with cell and gene therapies (CGTs) is also being felt at CBER’s compliance office on both the pre-market and surveillance side of its operations.

Like CBER reviewers, compliance officials are stressing the importance of enhanced communication – both with sponsors and internally between investigators and reviewers ‒ to address the manufacturing challenges that CGTs present.

As the wave of CGT activity was building, CBER Office of Compliance and Biologics Quality (OCBQ) Director Mary Malarkey took the opportunity to explain its impact on her office at the fall 2017 PDA/FDA conference. [Editor’s Note: See IPQ March 2, 2018 for more on the workload pressure that CBER’s review staff is facing from CGTs.]

Representatives of OCBQ’s Division of Manufacturing and Product Quality (DMPQ) are actively involved in the pre-approval and pre-license inspections and “sit in on every license application,” she noted.

The Novartis CAR-T approval that had recently occurred, marking the first in this class, was “quite an accomplishment for all of us,” Malarkey commented. She pointed out that there has been a “huge increase in the number of biologic license applications” (BLAs) with which her office is engaged – an increase that has continued to expand through 2018, both at the IND and BLA levels.

 [The story continues for subscribers on p. 2.  Nonsubscribers can get information on individual IPQ subscriptions and organization-wide licenses by contacting Peter Blachly ([email protected]).]

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