He joins a team of experts in smart drug development and manufacturing, with Ajaz Hussain, who, as everyone in pharma who has not been under a rock for the past seven years knows, had led the PAT Team at FDA and championed modern manufacturing science at CDER for years. Also at the company are Doug Dean and Frances Bruttin, who had played a role in some of the original FDA Science Advisory Board meetings, in helping shape the PAT and 21st Century GMP’s agenda.
Complementing the chemists and analytical experts, Mahboubian-Jones has always brought the crucial perspective of the physicist and the process control engineer to discussions of PAT. Scholarly without being pompous (no allusions to “Popperian traps” or “Procrusteam standards” in his talks . . . but more on that later), he has taught FDA teams and, as a consultant for Optimal, has seen, first hand, the opportunities that drug companies routinely lose by failing to change their processes. His has always been the quiet voice of reason, distinguishing PAT-like pharma projects from the real thing and insistently pointing out the need for industry to change. Click on for brief video clips where he discusses PAT and the process trajectory and the Design Space.
When I heard the news, I reacted as I did when Ajaz Hussain left a “curing” industry to join PMI. I confess that I considered it selling out. Not that I’m a knee-jerk liberal, exactly, but I’ve had a strong bias against Big Tobacco from an early age.
Of course there are the “Hollywood” reasons why everyone hates the concept of Big Tobacco. On a personal level, I spent years as a child trying to convince my late "Marlboro man" father to stop smoking. In his last months in the hospital, we would find him, IV pole at his side, sneaking a smoke in the garden. No doubt it’s one of the strongest addictions there is.
But, in this world, ethical issues are rarely black and white, but different shades of grey, as Dr. M-J patiently reminded me. PMI is working on a paradigm that could change the way that drugs are manufactured in the future. (Click here for a nice, if not so recent look from Laura Bush at Biopharm International . . . surely much progress has been made in this early-phase work since that time.)
Of course, they are working on this out of economic self interest. But isn’t that force driving pharma as well (for good and for bad)? And, as Adam Smith reminds us, it’s just that kind of self-interest that can, and often does, transform lives for the better.
So, it will be interesting to see what PMI does five years from now, with the pharma talent it now has. Give it another 10 years, considering its resident manufacturing science expertise and the strong incentive to do something with all that tobacco, and it could give Big Biotech a rude awakening. Will pharma industry leadership realize the potential threat before that time comes, and adopt PAT and other modern practices?
Tellingly, we’ve seen the most articulate proponents of PAT leave the industry or FDA--Hussain, Ali Afnan and now Mahboubian-Jones. Perhaps this says something about the reluctance of this industry to change itself for the better.
This week, a two-day symposium hosted by FDA and University of Rhode Island’s College of Pharmacy examined PAT and QbD adoption, and the issues and best practices entailed, from the perspective of industry and FDA. We’ll have coverage of this important program on our websites (and informal coverage on this blog) over the next few days.