The industry/FDA dialogue at an August meeting in Washington, DC, sponsored by the Duke-Margolis Institute for Health Policy, resulted in some substantive ideas on how the communication pathways could be broadened to facilitate a more efficient CMC review process and improve outcomes for biological license applications (BLAs) submitted to the Center for Drug Evaluation and Research (CDER).
Explored were the communication pathways between sponsors and FDA and the increased communication challenges that result from CMO participation in the manufacturing process.
Setting up the dialogue at the Duke-Margolis meeting on where these additional communication opportunities may lie was a report at the opening session by CDER management on a center analysis of trends in complete response letters (CRLs) issued for BLAs. [An in-depth review of the CDER presentations on the analysis is provided in IPQ’s August 23, 2024 Weekly Supplement.]
The analysis found that while the number of CDER BLA approvals has been expanding rapidly over the past decade, so also has the number of CRs, and that the rate of CRs has been increasing. BLAs were CR’ed nearly half the time in 2023. CMC concerns have been prominent in the CRs, and facility problems in particular.
CR letters convey the issues that need to be addressed before the agency can approve an application that has been submitted and reviewed. Biologics regulated by CDER include new and biosimilar monoclonal antibodies for in vivo use as well as therapeutic peptides and proteins – for example, cytokines and enzymes.
The CDER team at the opening session included Center Director Patrizia Cavazzoni. She noted that the meeting provided an “important opportunity to collaboratively think about how we can improve the quality of BLAs and get to the point of prevention of CRs.”
Stressing the importance of communication, Cavazzoni pointed out that “the structure of today’s workshop really exemplifies the type of dialogue that we need to have…. This is a unique opportunity to really have an open and candid discussion about the issues.”
The one-day meeting included four panel discussions. These addressed: ● issues highlighted in the morning presentations ● mechanisms to improve multilateral communication for effective BLAs ● strategies for facility readiness in biologics manufacturing, and ● the next steps and strategies for improving BLAs.
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