Opening Panel at CASSS 2018 WCBP Conference Assesses FDA’s 2017 CMC Regulatory Experience with Biotherapeutics and Key Challenges Going Forward

The opening plenary session of the 2018 CASSS Well-Characterized Biotechnology Products (WCBP) Conference, brought together a panel of FDA senior officials engaged in the CMC review process for biological products to assess the 2017 learnings and what the agency and industry needs to do to address the regulatory challenges and stresses going forward.

The dialogue that ensued shed considerable light on the daunting issues that all the health agencies are facing in trying to absorb an expanding wave of new, complex and diverse biotherapeutic products, processes and delivery systems, and to develop or adapt the appropriate standards and clearance pathways, potentially under expedited review timelines.

The panelists represented both the Center for Drug Evaluation and Research (CDER), which since the 1990s has been responsible for reviewing the WCBP BLAs, and the biologics center (CBER), which handles the rest of the BLA submissions, including those for cell and gene therapies, vaccines, and blood products.

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