Merck's Clark: Merger with S-P Will Increase Not Just Size But Innovation

Upon completion of Merck's merger with Schering-Plough, CEO Richard Clark shares thoughts on "Merging into the Fast Lane of Drug Development" in today's Huffington Post.

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!

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

Can Microsoft Fix What Ails QbD Efforts?

As QbD matures, so do IT offerings that bill themselves as the answer to drug manufacturers' drug development prayers. Manufacturers' challenge is clear: how do we take all our disparate, siloed R&D data from past and present and (cheaply and easily) use it to leverage our ongoing development efforts? As the ability of software to integrate and manipulate data from multiple formats improves, this massive challenge becomes more of a reality.

Of course, there is money to be made in bringing order to chaotic drug development data, as is evidenced by the companies getting into the market. Last week, I talked with Arvindh Balakrishnan about Oracle's efforts, and before that spoke with Blue Reference's Paul van Eikeren about his company's QbD IT consortium.

Microsoft looms large as well, and today we posted my interview with Jim Karkanias, Senior Director of Applied Research and Technology for Microsoft Health Solutions Group, about its Amalga Life Sciences solution.

Amalga is Microsoft’s attempt to make drug R&D data readily available, integrated, and robust, with the advantage that it leverages the Office format that is familiar to virtually everyone within a given organization. In the interview, Karkanias uses the example of a multidisciplinary team that is tasked with performing a gene expression study of a certain disease to illustrate how R&D will realize Amalga's potential. The fact that Amalga integrates relational and graphical data is what sets it apart, Karkanias says.

Merck is one of the companies helping Microsoft to develop Amalga LS. We'd love to hear more from anyone who's had experience with those solutions from the companies mentioned above, or other companies in the QbD IT space as well.

--Paul Thomas

QbD Presentations on Parade: DynoChem's User Meeting

DynoChem has made available presentations from its user group this past May. Registration is required to access the content, but among the materials available are:

Roles of Mechanistic and Empirical Modeling/DOE in Achieving Quality by Design, by Paul Stonestreet of GSK

Practical Insight on New Model Development: Filtration and Centrifugation, by Rich Ballenger of Abbott

Process Modeling Based Approach Towards Quality by Design for an API Synthetic Step, by Shawn Brueggemeier, Emily Reiff, Olav Lyngberg, Lindsay Hobson, and Jose Tabora, BMS

Practical Aspects of Distillation Modeling in DynoChem, by Carolyn Cummings of Amgen

An Example from GSK's Design for Manufacture Initiative: Use of Dynochem in Conjunction with Lab and Pilot Scale Data to Advance Process Understanding, by Dharmesh Bhanushali of GSK

How Process Safety and Environmental Lab Can Guide Process Development, by Viviane Massonneau of Merck

Lean and Green: The Value of API Process Design, by David am Ende, Pfizer

--Paul Thomas