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

It's (Un)Official: QbD Moving at a Snail's Pace

Okay, 17 responses to a poll does not a scientific study make. But our highly unofficial survey of blog visitors on the progress of QbD does at least suggest that the QbD movement is taking its own sweet time, in your opinion. Here are the numbers:

What's your assessment of QbD in the pharma industry now?

Moving at a snail's pace (12): 70%
Has a healthy momentum (3): 17%
Really starting to snowball (0): 0%
Moving, but in the wrong direction (2): 11%

We'll do some more unofficial polling over the course of the next few months to explore the reasons that QbD as snail is triumphing over QbD as snowball.

--Paul Thomas

Tech Transfer: Good Science and a Common Sense Approach

The role of tech transfer in pharma has traditionally been to generate information. Under a QbD umbrella, however, tech transfer must generate a "knowledge store"--a database within in which you can manage and leverage your company's intellectual assets and resources. So says Russ Somma in the new series of video snippets on tech transfer that we've recently posted on PharmaQbD.com. Another of Somma's mantras: Good science and a common sense approach. To view the video series "Tech Transfer in a New Light," click the "Somma on Tech Transfer" tab above the video player on our home page.

--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

For QbD and PAT, Are You Part of the In-Crowd (or Outside Looking In)?

Consultant Jack Carroll (one of our editorial advisors) sent in this commentary on a few things that are holding back PAT and QbD, based upon what he's gleaned from the people attending his training courses. From the attendance at these courses, Carroll says, it's clear that there are currently two factions operating in the QbD/PAT sphere--the mavens and learners. In other words, the in-crowd and the outsiders who are looking in (but may have little financial or corporate support for their initiatives).

Carroll writes: "We find a big disconnect between the PAT and QbD in-crowd and those trying to learn the “art.” The principles are sound, obviously, but the buzz-words are understood differently between the mavens and learners."

--Paul Thomas

Oracle's Balakrishnan: Towards an Integrated QbD

Another person who has his finger on the pulse of QbD, and whom I've spoken to a few times in the past six months, is Oracle's Arvindh Balakrishnan. We spoke again last week to touch base, and the focus of our discussion was Balakrishnan's belief that QbD is at a turning point in that many manufacturers have gone beyond the "hodge podge" approach that defined earlier QbD efforts and now have coordinated, corporatewide QbD programs.

Here is the audio of the interview.

--Paul Thomas

What is Your QbD Pain Point?

I had a chance to catch up again with Blue Reference's Paul van Eikeren last week, to talk about the progress of QbD in pharma, and about IT solutions to meet manufacturers' QbD needs. I've been following Blue Reference closely for the past year since van Eikeren is a proven innovator and business success--as founder of electronic lab notebook pioneer Intellichem (now part of Symyx)--and it's clear that he now aims to make a big splash with Blue Reference by leveraging the synergies between its software and the Quality by Design movement.

Through its QbD product development consortium, Blue Reference is working closely with manufacturers to codevelop novel QbD-focused solutions, and van Eikeren now feels that he has hit upon something that will make a difference: what he calls Paradigm Discovery, software that aims to mine manufacturers' R&D data from the past, find useful information, and put it in a format that can assist current QbD efforts. Manufacturers' major QbD pain point, van Eikeren says, is not being able to draw upon years of data from the past, and get return on investment for drug development studies that may never have led to a marketed product. Since the product is still in early development and hasn't been demo'ed for clients yet, van Eikeren isn't saying too much about how it works. Here is the summary of what he was willing to share with me.

Stay tuned . . . I aim to follow up with van Eikeren every so often, since Blue Reference is one of those bellwether companies by which to gauge the progress of QbD itself.

--Paul Thomas