CDER and Biotech Quality Assessment

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The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.


In anticipation of continued growth in the range and nature of biopharmaceutical products, FDA’s Center for Drug Evaluation and Research (CDER) is reshaping its Office of Biotechnology Products (OBP) to be more responsive to changing regulatory needs. Now part of CDER’s new Office of Pharmaceutical Quality (OPQ), OBP has established four Divisions of Biotechnology Product Review & Research (DBPRRs), each with a cadre of reviewers and lab-based scientists capable of assessing the quality and safety of a range of biotech therapies in development or under review by the agency.

OBP previously had two divisions, one for monoclonal antibodies (mAbs) and another for “other” proteins, and reviewers specialized in certain product types. But OBP chief Steve Kozlowski sees a need for a new structure that will be more adaptable in handling a broader range of conjugates and enzyme-based products, as well as new forms of mAbs and proteins. The aim is for OBP to be able to manage its workload better as biotech product development continues to expand, Kozlowski explained at the January 2015 WCBP symposium in Washington, D.C.


Under the new arrangement, a central OBP group first evaluates incoming investigational new drug applications, new drug applications, and biologics license applications for biotech therapies and assigns oversight to an appropriate division review team. To facilitate this process, OPB is developing an “expertise tracker” system that can identify individuals with relevant experience related to product class and mechanism of action, along with clinical indication. The central group’s request for a “preferred reviewer” will be weighed by review division directors, who may suggest alternatives based on division workload and other considerations. Kozlowski noted that the system is new, that “nothing is absolute” at this time, and that experience will indicate which selection parameters are most useful. Reviewer cross training, he emphasized, will be important in expanding staff expertise to handle a broader range of assignments.

This organizational change fits broader OPQ goals of integrating quality review and compliance more seamlessly. It also will support the growing cadre of breakthrough drugs, which require accelerated reviews by FDA, as well as more applications for biosimilars that raise new analytical challenges. Biopharmaceutical companies may see different staffers handling their products, but the individuals should have the expertise needed to provide better reviews, oversight, and inspections important to a streamlined regulatory process.