IFPAC’s Cruel and Unusual Program

Most any trade show has its share of frustrating session overlaps and will proclaim itself to be “more than you can handle.” But for anyone with an analytics (or PAT or QbD) bent, this year’s IFPAC 2009 annual meeting—January 25-28 at the Baltimore Marriott Waterfront Hotel—is a bit, well, cruel. For what once was viewed as a small, niche meeting (a intimate forum for process chemists), there’s quite a lot to ingest. IFPAC, the International Forum for Process Analytical Chemistry, has come to be dominated by pharmaceutical talk, and now includes lengthy sessions on process analytical technology (PAT) and Quality by Design (QbD).

IFPAC is really the original PAT/QbD conference, says Emil Ciurczak, a PAT and spectroscopy expert and a Pharmaceutical Manufacturing contributing editor. Location is also key, he says. “With its proximity to FDA in Maryland (no accident), this assures a large presence of all levels from the Agency. PAT and QbD are still ‘new’ to many companies, so the ability to interact with so many Agency people is a combination of reassurance and learning experience,” he says.

In addition, Ciurczak says, “there are more and more companies willing to share successful projects; they seem most likely to choose to present before a mix of peers and FDA personnel. That makes IFPAC the ‘perfect storm’ for learning about PAT and QbD.”

All of which means it’s a tough show for one person to handle. Take Monday afternoon, which features six concurrent session tracks, each with industry and regulatory notables. The first, on Product Quality Lifecycle Implementation, has talks by AstraZeneca’s Bruce Davis, Wyeth’s John Levins, Abbott’s Stephen Tyler, and GSK’s Theodora Kourti. The others on Monday afternoon:

• PAT and Green Chemistry, a session which includes FDA’s Chris Watts providing the Agency’s perspective on the topic, as well as green advice from five leading consultants
• PAT for Bioprocessing, with  presentations of several detailed pharma applications
• Process Analysis/Spectroscopy, including regulatory, academic, and industry discussions on LIBS (laser-induced breakdown spectroscopy)
• Chemometrics and Process Analysis, featuring FDA’s Thomas Brueggemeyer on anticounterfeiting techniques
• Instrumental Concepts for Process Analysis, highlighted by GSK speakers on light-induced fluorescence

This comes after a Monday morning Plenary session that includes CDER’s Moheb Nasr on QbD, Amgen’s VP of Quality Martin VanTrieste on countering product adulteration, representatives from the MIT-Novartis Center for Continuous Processing, and several other speakers.

Tuesday and Wednesday offer little reprieve, each with six or seven concurrent tracks in the morning and afternoon. Some highlights:

• A short course on Chemometrics by Spectroscopic Solutions’ president Frederick H. Long, Ph.D. (Sunday a.m.)
• An FDA Workshop on Quality by Design in Pharmaceutical Development and Manufacturing (Sunday p.m.)
• Novartis’ Marc Goeller on the Novartis/FDA QbD CRADA project (Tuesday a.m.
• CPAC’s Mel Koch on the impact of new tools on PAT, and a discussion of “NeSSI” (Tuesday a.m.)
• Pfizer’s Steve Hammond, Roche’s Huang Tian, and FDA’s Robbe Lyon on Chemical Imaging (Tuesday a.m.)
• Merck’s John Higgins, Nathan Pixley, and Gert Thurau on a Standard PAT Toolbox for Drug Product Processing Platforms (Wednesday a.m.)

Seriously, folks. It’s a bit much.