We love the progressive thinking that's going on in pharma. That's why I enjoy my job and what makes covering this side of the industry so much more interesting and positive than looking at the financial side and all the marketing scandals. As we do every year, we've covered this year's IFPAC process analytics conference, a hotbed for some of that thinking, and promoted it on our web site. Only this year, thanks to our talented multimedia director Scott Babcock, we did some of this via video, and professionally edited video, not the "You Tube"-ish things that editors like me have thrown together in the past. Thanks to Robert Zutkis and IFPAC for allowing access, and to everyone, especially FDA's Janet Woodcock, for being so gracious about doing impromptu interviews, and for not running away at the sight of a video camera, and to Emil Ciurczak and colleague Jack Carroll for being open to experimenting with new media. They are both developing an online video course on Quality by Design, PAT and Analytics that will soon be up on our web site. You'll find the official report on IFPAC our web site. But here is a brief, unsanctioned one. Let's call it the PAT Gossip report. Please don't be offended, anyone, and remember. This is only a blog.
- Insiders say working conditions at FDA are much better, but budgets for travel to training conferences aren't expanding. "Travel is just for the big wigs, " said one.
- Ajaz Hussain is now working on transgenics at Philip Morris International, which is developing tobacco plant strains for cell culture for vaccine production.
- Martin Warman reports that there is life after Pfizer. He's now consulting and, given data management challenges facing most companies embarking on PAT, his work now takes him into the IT realm more often than instrumentation. Who knows? Perhaps he will return to Big Pharma
- Ron Miller reports that life after BMS is good. He is consulting and working on another book.
- Merck is looking for some PAT leaders, at the PhD, MS and BS levels. We hear that Wyeth is, too.
- Move over Tata Consultancy Services. Puerto Rico is considering a new export: PAT team leaders available on a contract basis. The island's universities are strong, and so are their training programs, one of which is taking an accredited PAT training course online to a Web format this year. Now for some extremely random thoughts, comments and questions, in no particular order. Why were some pharma PAT presentations this year almost completely identical to last year's? IFPAC offers access to some of the greatest minds in the industry. And some of the smaller ones, too. Like the person, who will remain nameless, who turned Scott and me away, literally at the door, at the opening night dinner. Thus, Scott had to lug very heavy, awkward video and lighting equipment all over the hotel and store it while grabbing a bite to eat. We didn’t have the electric power or Internet access we needed to cover the program at our booth either More revelations from this year’s conference? Don’t roll your eyes when your aunt complains that the generic version “just doesn’t feel the same” as old and expensive Brand Name X. She’s onto something. Don’t call her a hypochondriac. The fact is that the excipients used in formulation can show tremendous between-batch variability, even when they meet USP and other specs. At IFPAC, we heard no less an authority than Deputy FDA Commissioner Janet Woodcock suggest that there may be a connection between these complaints and measurable manufacturing issues" We just don’t know yet,” she said. One batch of excipient can meet basic USP specifications and yet perform completely differently, within the formulation, than another batch of the same material that meets specs.This is all part of the challenge of relating clinical outcomes to manufacturing issues, and a fundamental reason why pharma needs to use PAT. Want to Take Revenge on FDA Inspectors? Teach Them Instructors must have had fun designing the hands-on solid dosage training course for FDA’s Inspectorate last year.Using a lab featuring Emerson process control equipment and Optimal’s SynTQ, FDA students performed simple blending operations using lactose, but material from three different batches of lactose. If the blend was made with lactose from one batch, the reaction would be completed much faster than materials using the other batches. Huh? Isn’t lactose lactose? Not exactly. That’s just what prompted GSK’s Ray Scherzer to suggest that... Pharma needs more physicists and materials scientists (or, at least, industrial pharmacists with training in those areas----people who understand the mechanical and other physical properties of materials used in drug formulations Bored and want to see some intrigue unfold among PAT types? Start a conversation about dissolution test calibration or microbiological testing of pharma-grade water and watch otherwise reasonable people become unreasonable.Anti-USP sentiment appears to be on the rise in some quarters, with insiders of one camp accusing the organization of rank commercialism, conflicts of interest and impeding the interest of science.(But wait a minute: Does ASTM give its standards away for free Peter Rost is a favorite read among some folks we met.Said one insider, “He understands what pharma management is all about, because he worked alongside the guys who are so glued to Bloomberg and the stock results that they forget about what’s going on inside their plants. Too bad he doesn’t get into this side of the business. Consider that an open invitation, Peter… somehow, though, I think the subject matter might be a bit dry. One anonymous contrarian then posed a few interesting philosophical questions: Is standards development by consensus, as with E-55, really a good thing for FDA to be promoting? Ditto for the idea of real time/parametric release of product. "Doesn’t this approach allow industry to write its own rules," this person asked. "I mean, it would be one thing if all of pharma’s senior management were universally on board and always put the public health first and foremost in their minds, but many of them are too busy watching Bloomberg.” Is mechanical dissolution test calibration truly science based, since it eliminates the only baseline measurement now available? Would the FAA send planes out without mandating crash tests, using uniform testing methods, rather than tests developed by each vendor? One camp has argued convincingly that USP calibrating tablet quality can vary, leading to flawed results. The insider begs to differ. Using mechanical calibration does not provide any way to judge how the given drug will behave in the human bodyFurthermore, insider says, it forces each company or facility to develop its own internal standards, and FDA inspectors to master different internal standards at each facility. Isn’t that a waste of resources and money for an already cash-strapped Agency, and even for the companies themselves I don’t think anyone should worry too much about this. I hope that all drug companies the world over move to real-time product release, but I suspect they’ll still the USP tester tablets as a final check for a very long time to come. Will generics companies, in particular, suddenly throw out all their SOPs and go modern for the sake of trend setting Please note: We are firm believers and supporters of PAT, Quality by Design, parametric release and continuous quality improvement.We have drunk deeply of the Kool-Aid and support E-55, USP and science-based standards, and we know that FDA has never mandated mechanical calibration. But it’s important to remember that PAT and all this is still fairly new to pharma and that certain scientific basics remain unknown. As this insider says, PAT is a great thing and critical to the future of pharma, but some of the underlying science isn’t there yet, and until it is, any radical changes in industry regulation may be premature, with the industry risking “slapping lipstick on a pig Long story short, IFPAC is well worth a visit.