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

FDA, EMEA Harmonize Around Clinical Practices

FDA and EMEA announced today a broad collaborative effort in the area of Good Clinical Practices. The joint effort bodes well for continued cooperation between the agencies on many fronts, and in the sharing of resources that is imperative if global regulatory authorities are to get the most out of their limited resources. The agreement also represents a significant step toward the agencies' recognizing each other's inspections as valid and binding, and toward reducing the regulatory burden upon drug companies who operate trials worldwide and must satisfy the requirements of multiple regulatory authorities.

--Paul Thomas