ostrich

The ostrich has become a staple of many pharmaceutical science presentations of late, symbolizing an industry that is reluctant to change. Perhaps it could symbolize some of the more shortsighted pharma CEO's at this point in the 21st century. With all due respect, as CEOs face a tough balancing act today, I have a few questions for this elite group:

Today, Chris Watts, last of the PAT Team leaders to have stayed at FDA, will be leaving the Agency. He has been with FDA for eight years, and plans to return to California, and the San Diego area. Of his stint at the Agency, he writes, "The experience far exceeded my expectations . . . and I can only hope that future opportunities offer as much." Of course, biopharm company recruiters will want to take note that such talent might be available, locally.

I spoke yesterday with Rutgers' Fernando Muzzio, just to catch up on what's happening with the C-SOPS (Center for Structured Organic Particulate Systems) project that his institution, as well as Purdue, NJIT, and PR Mayaguez, are heading up. C-SOPS continues to expand in partners, grants, and technologies that it hopes to license, Muzzio said, and we'll share more on this in the next month or two on PharmaManufacturing.com.

A few weeks ago, we hosted a webcast which addressed questions surrounding the relatively slow uptake of single-use technologies for biopharma measurement and control. Speakers Michael Kowolenko (formerly Sr. VP with Wyeth Biotech and Biogen Idec), Kit Erlebach (Merck) and Paul Priebe (Sartorius Stedim) offered a range of perspectives on what has been holding back single-use in biopharma. (A partial transcript is below.

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.

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.

Had been checking for updates on this for so long that I missed last week's closure. 

FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

Our intrepid contributor Emil Ciurczak is covering this week’s IFPAC 2010 show in Baltimore. What follows is his first installment, a brief summary of pre-conference activities: