This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe. His experience as an industrial chemist is not pharma-limited or pharma-centric, so he brings a much needed, broad view to pharmaceutical PAT. In a note to colleagues today, he wrote of "time for change." "I was recruited by the Agency to work on PAT and to realize the desired state, and I have done all that I could. My aspirations with regard to protecting the public health have not changed and will not change." 

One wonders whether Dr. Afnan might have been frustrated by the pace of acceptance of PAT and QbD within the industry. At times, it has seemed glacial. And there have been more than a few abrupt changes and reversals in FDA message and leadership over the years--most dramatically, the sudden replacement of QbD for PAT as the FDA mantra after Dr. Hussain left. Maybe that was a good thing. After all, QbD is a much broader and more ambitious concept with much more C-level appeal than PAT, which tended to appeal more to the engineering crowd. But, without some transition or bridge, it may also have confused some people, because PAT is the enabling foundation for QbD. (At Interphex Puerto Rico last week, consultant Manuel Hormaza mentioned that he has been seeing more groups trying to do QbD without PAT, and then running into problems.)

When Ali Afnan, Chris Watts and Ajaz Hussain went forth seven years ago to discuss the benefits of PAT for improving manufacturing efficiency and quality, it seemed that the message itself, and the fact that these methods had already been proven in other industries, would be enough to spur widespread change. 

No doubt that change is coming. Slowly but surely.

Perhaps too slowly for any change agent. And that is, clearly, what Dr. Afnan is. Change agents don't worry about being politically correct and they speak their minds, even when that means being controversial. This industry needs more of them.

In May, FDA will hold a workshop on QbD and PAT that will bring the original PAT band of Hussain, Afnan and Watts together, albeit in very different roles. The program reads like a "who's who" of PAT and QbD...and the grandson of Deming will reportedly be in attendance. We'll have more information on this conference on our website later this week.

In his new role, Dr. Afnan will no doubt continue to spur change within an industry that needs it. In this brief video clip, he spoke on real time release and QbD at an industry event last Fall.

AMS