PAT in Perspective: Preaching to the Wrong Choir

I recently was asked why PAT wasn’t taking off like Tickle-Me Elmo did a few Christmases ago. The answer was simple: “The same 50 people are presenting the same materials to the same 50 people over and over!” Simply put, a lot of technology was being presented to a room full of scientists. Of course, they loved the latest instruments. They had to; it’s in their blood. To them, PAT was the greatest thing since sliced bread. They would get great new toys, better answers and more knowledge. Unfortunately, they don’t write the checks for new equipment.At these meetings, all one heard about was near-infrared, Thermal Effusivity, acoustics, laser-induced fluorescence, chemical imaging and so forth. Despite the exhorting of Dr. Ajaz Hussain (late of FDA, now with Sandoz) that PAT was not technology, but a new mind-set, everyone still dwelled upon the hardware and software. The audiences at pre-Guidance PAT meetings consisted of virtually the same people at each and every meeting. And the variety of talks? Can you say lip-synch? After two or three PAT meetings, the majority of the listeners could, themselves, give most of the presentations.Armed with the pre-Guidance “warm acceptance,” Dr. Hussain and the FDA were not prepared for the comments received on the FDA webpage. It would seem as if no one from Quality Assurance in any company was aware of the PAT Guidance prior to its issuance. Thus, when the draft version appeared, they were “shocked and awed.” QA serves as the policeman of cGMP; they are tasked with following SOPs and MMFs and dotting “i’s” and crossing “t’s.” Suddenly (from their perspective), the FDA was saying, “Use whatever science you can support; don’t worry about cGMPs.” Previously, HPLC was king and QA was tasked with following forms and filling in the correct spaces. Now, what should they do?In addition, the managers who could sign the checks were never educated about PAT. It sounded like an expensive experiment, at best. It would require lots of new hardware, new software and more employees but gave no guarantees. At worst, there could be a view into the workings of the process, where the FDA could exercise even more control and issue even more warnings. In short, the money people never were presented with a viable monetary scenario.Recently, I was asked to participate in a PAT conference this coming December. My first response was, “Not if it is the same as all the others.” Now, since I rarely turn down a free meal and a chance for the spotlight, the nice lady was surprised. When she inquired as to why I was reticent, I told her basically what I have just finished saying to you. As she is a quick study, she asked what should be done. To her credit, she was willing to break with tradition and attempt to attract previously ignored decision-makers.This meeting [IQPC's PAT Business Strategies Summit, Philadelphia, Pa., December 5-7, 2005] will have actual case studies, not necessarily concentrating on the technologies, but personnel and validation issues. In addition, costs versus benefits will be addressed. Biopharmaceutics as well as solid dosage form strategies will be discussed. And, for a change, generic drug companies will be represented, in addition to the big pharma companies who normally support PAT.The panel discussions will include, in addition to technical services and engineering managers, people who will address the business aspects of PAT. Speakers will address the actual costs of PAT: before, during and after the process itself. In fact, for the first time (that I have seen) an entire (extended) session will address, “The Economics of PAT: How to Articulate the Benefits Case to Internal Decision Makers.”Of course, a PAT meeting needs to mention the technical end, but for the first time, that will not be the main thrust in a happening. Of course, I will “mention” near-infrared, but I plan on putting it in an economic context. Indeed, technical papers will take up less time than the economics of PAT. I am becoming quietly optimistic about PAT.Will that one meeting make PAT happen? Only in the movies! BUT, it is a crack in the technical façade that has been the impression all managers had of PAT. Now, maybe the thrust that Ajaz intended will be seen and PAT will be recognized as a new paradigm to understand and control pharmaceutical production — not just a technical program. It remains to be seen if other conference organizers will take the hint.About the AuthorEmil W. Ciurczak has more than 35 years experience in pharmaceutical manufacturing, analytical R&D, and regulatory compliance. He was a member of the validation subcommittee for the Pharmaceutical Advisory Committee for FDA and a consultant to the FDA.He is the co-author or co-editor for several texts, including Handbook of Near-Infrared Analysis (1st & 2nd ed) and Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy. He is also Contributing Editor to Spectroscopy and is on the Editorial Boards for American Pharmaceutical Review, JPAT and Journal of NIRS.Ciurczak holds a B.A. and M.S in Chemistry from Rutgers University and an M.S. in Chemistry from Seton Hall University. He holds patents for both instruments and software relating to spectroscopic analyses and has over 60 publications.