Leading by Example

By Agnes Shanley, Editor in ChiefIt has been only four weeks since FDA’s Center for Drug Evaluation and Research deputy director Ajaz Hussain announced his decision to leave the Agency to head up Sandoz’ biopharmaceutical development program.His name has been synonymous with pharmaceutical process analytical technology (PAT), and his move to private industry, no doubt, has some people wondering whether the initiative can maintain its momentum within FDA. All signs point to a dedicated team that will continue his legacy, but Chris Watts, Ali Afnan, Moheb Nasr and other team members have already placed their own stamp on PAT within FDA, and are driving the concepts more forcefully in drug development and R&D.Dr. Hussain’s departure from FDA has also generated the kind of buzz one hears any time a public servant leaves the government for the private realm — speculation as to financial perks and the benefits of working for industry.But when you look closely at his decision, it reveals both shrewdness and a deep commitment to the principles he’s been advancing all along. First, he moved, not to a name-brand drug maker, but to a generic drug manufacturer. By working for a producer of lower-cost pharmaceuticals, he avoids appearing to have gone over to the “dark side.” His new job will also put him in an environment where the bottom-line benefits of PAT are immediately visible.Second, he will be focusing on biopharmaceuticals development, an area where PAT is still underdeveloped, and where there is still disagreement on how to apply it, let alone more-advanced forms of process control.Currently, biopharmaceutical manufacturers make up only 7% of ASTM’s E-55 committee. And some of those committee members appear to be urging their peers to get involved only to “stave off” the development of standards that they feel will be onerous — for example, standards that could help drive continuous processing in the pharmaceutical industry. “We’re dealing with microbes, with living organisms, and you just can’t handle bioprocesses continuously,” said one prominent biopharma executive on the committee at a recent industry meeting.Process control specialists would disagree, as there are ways of applying advanced control to drying and filtration, and even to fermentation and bioreactors, that could make manufacturing run, if not 24/7, then at least more continuously. Clearly, the controversy promises to continue.But with Ajaz, there will be one more biopharma industry representative, and a powerful one, on E-55 . It won’t be surprising if he wields even more influence in shaping PAT’s next phase by working “on the other side” and leading biopharma by example.We wish Dr. Hussain well, but can imagine him being frustrated while at FDA by the pace of PAT’s progress in the industry, for it’s still a very long way from becoming a household word.Only last week, we received an irate email from a high-level quality person at a pharmaceutical company. She was angry because we used the PAT acronym on a magazine cover without defining it. “What does it stand for, and how can I be expected to remember every ‘flavor of the month?’” she asked. Her reaction is understandable given the flood of acronyms we must all contend with today, but still… “flavor of the month?’There are signs of progress, though, and a shift from the concept of "PAT as technology" to "PAT as strategic business tool." At least one December PAT conference will focus on ROI and business strategies, as distinguished spectroscopy expert Emil Ciurczak writes in his new column, “PAT in Perspective.” In our November PAT Insider newsletter and on PharmaManufacturing.com, we are pleased to present not only his column, which we know you’ll enjoy, but also an interview with Novartis’ PAT leader Jim Cheney. Cheney represents a new type of PAT practitioner, and his plans for Novartis’ global PAT program reflect a clear focus on manufacturing and business goals.In December’s PAT Insider, stay tuned for an article by Chris Watts and Ali Afnan on PAT’s new direction within FDA. If you have a moment, consider sharing some of your thoughts or “best practices” in PAT implementation with your peers by sending an email to [email protected] with your views or suggestions.