Change is very, very difficult to do in government,” says Steven Kozlowski, M.D. In 2012, the director of the FDA’s Office of Biotechnology Products (OBP) learned that the Center for Drug Evaluation and Research (CDER) would soon undertake a major restructuring. CDER had decided to reorganize around drug quality manufacturing, potentially including biologics. The plan would really change the Office of Pharmaceutical Science into the Office of Pharmaceutical Quality, and it would focus on greater integration between review and inspection to achieve better manufacturing consistency. “The reorg would fulfill a lot of ideas that had been talked about for a long time, like GMP [good manufacturing practice] for the 21st century, quality by design [QbD], and a whole variety of advanced manufacturing topics,” explains Kozlowski. “But there were questions about where OBP, the office responsible for reviewing the manufacture of all biologics in CDER, would fit into the plan [i.e., would OBP be integrated into this new system or be treated differently?].” For example, biosimilars were on the rise, so it would be beneficial to keep a group capable of dealing with the anticipated surge of biosimilars submissions intact.