Interview: Helen Winkle, the director of the FDA’S Office of Pharmaceutical Science, in the Center for Drug Evaluation and Research.

Listen to BioPharm International's Editor-in-Chief Laura Bush interview Helen Winkle on the challenges of regulating the quality of biopharmaceutical manufacturing and FDA efforts to improve the process, including an upcoming Quality by Design pilot for biotech products, changes to filing requirements for post approval changes, and the regulation of biosimilars.