Treasure Trove: Merck, Lilly, Amgen, Pfizer, and More from EMEA/EFPIA London Workshop

Milestones in the evolution and acceptance of Quality by Design were the recent meetings/workshops in London and Frankfurt bringing together regulators, industry professionals and other concerned parties (namely, EFPIA) to discuss the challenges confronting QbD and, more importantly, drilling down and assessing how QbD will play out for specific types of drugs, specific processes, and specific manufacturers--a growing recognition that there is no one-size-fits-all QbD--far, far from it.

What's also encouraging is that plenty of materials and presentations are being shared with the industry. The mock QbD examples that were the focus of the Frankfurt meeting (sponsored by PDA and EFPIA) will be made public in the coming months, following final revisions. (Click here for my discussion with PDA's Volker Eck on the key learnings from Frankfurt.)

Now, the key presentations from the EMEA/EFPIA meeting in London have been posted to the web. (Thanks for Alicia Tebar Perez of dTC Consulting for calling our attention to this.) Included are contributions from Gert Thurau of Merck, Pfizer's Liz Coulson, Wyeth's Graham Cook, Lilly's Martin Diller, and others. Enjoy!

Where Lies QbD's Competitive Advantage?

I've had the good fortune of speaking this week with Volker Eck, senior director of science and technology at PDA, and a day later with Graham Cook, Wyeth's senior director for process knowledge/Quality by Design. Both men were integral participants in late September's workshop in Frankfurt,  hosted by PDA, to unveil and discuss EFPIA's mock examples of Quality by Design implementation.

By all accounts, the mock examples were well received and the meeting was an important step toward helping manufacturers not just interpret ICH guidances but grasp how QbD might look for their products and processes. The mock examples are now being finalized, following input from the Frankfurt meeting and one earlier with EMEA in London, and are expected to be made public later this year.

You can read my summary of Eck's take on the meeting here, and I hope to have a podcast of my interview with Cook available within a week or two. Eck was insightful in that he said that many manufacturers at the Frankfurt meeting were still clearly struggling to "translate" the ICH documents, and the mock examples, to their own operations. With QbD, manufacturers can only truly learn by doing and thus will have to dive in

EFPIA Ready to Roll Out Its QbD "Concept Cars"

In anticipation of its QbD workshop in Frankfurt on Sept. 22-23, PDA has released a special report on the impending EFPIA "Mock QbD" examples that will be summarized and discussed at the meeting. In the report, Wyeth's Graham Cook, Merck's Robert Schnepf, and Abbott's Brian Withers discuss the thinking behind, and importance of, the EFPIA examples, which will focus on terminally sterilized injectables, lyophilized injectables, small molecule API's, and monoclonal antibody API's.

Cook explains: You could compare the Mock documents to a concept car that you might see at a motor show. It has the look and feel of the future model, but not necessarily all technological parts are fully developed or built in to enable it to operate at full performance. Creating scientifically credible stories for the development of the hypothetical drug substances described in the Mock documents is not easy and so, in many cases, the team members would base the sections they were writing on real examples from within their companies and change them to fit the story we were trying to tell. When the groups had to decide what process steps or unit operations should be discussed, the principal selection criteria was to show examples that could be used to illustrate ideas and the use of tools, and perhaps provide a model for others.

Thanks to Parexel's Siegfried Schmitt for calling our attention to this on the Quality-by-Design LinkedIn group.

--Paul Thomas