FDA’s Helen Winkle: E-55 must broaden its scope beyond PAT, to manufacturing

Ajaz Hussain, former deputy director of FDA's CDER's Office of Pharmaceutical Science (OPS) and former head of FDA's Process Analytical Technologies (PAT) team, was instrumental in spreading the word about advanced drug manufacturing science and the role that PAT can play in enabling a "quality by design" approach to developing new drugs. He had a great impact on the Agency, and on many in the industry. But on May 15, his former boss, Dr. Helen Winkle, who now heads up FDA's PAT team, put her own, public stamp on PAT within FDA, when she spoke at ASTM's E-55 committee meeting in Toronto. Among the key points she made:
  • The FDA remains as committed to PAT as ever
  • Standards setting will take time and a great deal of patience
  • E-55 needs to broaden its focus, to address drug manufacturing, rather than looking, narrowly, at PAT. (PAT is, after all, only one tool in a growing toolkit for companies that choose to take a more scientific approach to drug manufacturing.)
Dr. Winkle mentioned, and dismissed, rumors circulating in the industry that FDA is no longer serious about PAT. She has, admittedly, been quite a bit more "low key" than Ajaz Hussain, who seized every opportunity---and created quite a few of his own---to convince industry of the benefits of applying PAT. For many, PAT's "human face" at the FDA is now either that of Moheb Nasr, Chris Watts or Ali Afnan. But Dr. Winkle's appointment to head FDA's PAT team reflects the Agency's full endorsement of PAT. Bureaucracies aren't given to too many dramatic gestures. How do most government agencies support a project? By assigning it to a higher-level director. One wonders at the dynamics of any face-to-face meetings between Sandoz and FDA en route to the Omnitrope approval. Such meetings would have brought old team mates together under very different circumstances. Were there any rivalries, envies that surfaced? (This is a blog, after all....But I digress...) Hussain's efforts were undoubtedly crucial in securing FDA approval for the drug. But the fact that the drug was approved---if one is to believe Sandoz --- based on evidence from "analytical science" and demonstration of "modern manufacturing processes," may show FDA's new resolve re: PAT and the role that it may play in biopharma development, and in the Agency's assessment of new biologics. Right now, biopharma and biotech are described as the "future" of an industry where traditional drug firms are "dinosaurs," yet only a few bio companies are even on the E-55 committee. Will the Sandoz approval change this? Stay tuned to further coverage, here, in PAT Insider and within the pages of our magazine. -AMS