I was having a philosophical (read: political argument) with a lad I have known for two decades the other day. He was telling me some things about a former employer (large pharmaceutical manufacturer) that he has allowed me to share. Being a good little journalist, I will protect my source (unless you email me: he gave me permission to identify him, if necessary), but give you as much detail as possible.
To quote my friend, Process Analytical Technology and Analytical Services DO NOT MIX. In his first job, he was assigned to the FTIR, GC, Ion Chromatography labs and to perform Process Control and Analyzer Development (PCAD) research. Unfortunately, it seemed every time he was set to do a process-related experiment, an emergency (problem with an existing process) sample came in. He was required to drop everything to solve the problem. By the years end, he had solved a lot of little analytical problems, saving the company big bucks (allowing product out the door). However, he had done little in the way of PCAD work. At his former ("expletive deleted") company, the PAT group was a (little) sister to the Analytical group, subservient to analytical problems. As a result, they were always a treated as a second cousin, twice removed.
The problem, in his case (and, I suspect, many others) was that the savings of PAT (resulting from either direct cost savings due to problems solved or from new innovations) were difficult to credit to the PAT group directly. As a consequence, the parent groups budget was credited with the savings, making them look good. Or, more commonly, the PAT section would help initiate a project that would save money for another group. Naturally, this second group that his PAT section worked with claimed the savings at years end. This was justified to the PAT people as it was their budget, so they would claim the savings." Therefore, on paper, the PAT group would not be able to point to any savings. In the end, it was considered a cost saving measure to get the group out of Analytical Services.
This brings up the question of who should be given credit for PAT work. I already mentioned that it often takes years before a full-blown PAT project is up and running in any company. The PAT group, unfortunately, is a money pit during this time frame and, on paper, is seen as a loss. The question becomes, quite simply, who gets credit for cost savings as a result of PAT? In my friends words, In the end we would end up with the proverbial egg on our face because we could not justify our existence.
Another problem, possibly endemic to the PAT process, was that my friend was subjected to a new director/manager every 12-18 months. He essentially had to start over every year; he had to justify his existence, lay out his objectives (justifying each one), fighting for a budget, holding onto his group personnel, etc., etc., etc. That is no way for a long-term process analytical effort to be a success. Ladies and gentlemen, this is no way to run a railroad!
It has become a truism that a successful PAT effort needs a champion above the team. That is, a high level management-type needs to tell the directors of production, IT, QA, R&D, QC, etc. that they will make PAT succeed. When that happens, PAT happens. By the same token, the group making PAT succeed needs a safe harbor (to borrow a PAT term). There needs to be a clear mandate that the group will have certain leeway (time to succeed) and a secure budget, will share the credit and/or blame with all the other groups, and will be recognized as a real group.
The deliverables of the PAT group have to be measured in years, not months. Any troubleshooting function, assigned ad hoc, must be recognized as part of their deliverables. Considering that one in 10,000 potential small molecule APIs actually comes to market, I think that Big Pharma should be a little more patient with people involved with the analysis and production of the final products! Management doesnt tell the synthesis groups that they are failures 9,999 times out of 10,000 attempts; they should show the same restraint with groups attempting such a new concept as control of the product production!
