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

FAQ's from ICH: What's Your Take?

Some discussion has started up around ICH's Q&A document on our LinkedIn group. If you're not a registered LinkedIn user, my apologies. I will summarize these responses some time soon. In the meantime, I would love to hear other thoughts about the value of ICH's document, and any answers that you take issue with.

--Paul Thomas

FAQ's from the ICH Quality Implementation Working Group

ICH regularly receives industry's questions regarding the implementation of Quality by Design. (Have a question? Submit it to ICH here.) Granted, not all the questions are worthy of response, but those that are are compiled in one Q&A document and made public, as part of the ongoing (and neverending) effort to educate the industry on QbD's finer points.

Some intriguing questions contained within, though perhaps few surprises if you've been following QbD for a while:
--Is there a regulatory expectation to develop a Design Space? (No.)
--Are GMP's different under QbD? (No.)
--Do traditional sampling approaches apply to real-time release testing? (No.)
--What happens when you wander outside of the DS? (It's a deviation under GMP.)

The Q&A's should tide you over until the Trivial Pursuit Quality by Design Edition hits store shelves.

--Paul Thomas

Webinar: Constructing a Design Space from a Mechanistic Model

A heads up: This Aug. 20 webinar promises to "review how to construct a design space from a mechanistic (e.g. kinetic) model, taking account of parameter uncertainty and lack of fit." Sponsored by DynoChem, but should be a good technical program for anyone (and it's free).

--Paul Thomas

Putting a Dollar Value on Pharmacogenomics

Few would argue that pharmacogenomics (using genomic markers to predict drug response in patients) will play a role in targeting drug leads and getting compounds to market faster. Researchers (consultants with NERA consulting and the University of North Carolina) have taken steps to quantify the impact that pharmacogenomics could have. The greatest economic benefits could result from the ability of pharmacogenomics to identify successful preventative medicines and thereby reduce overall healthcare costs, the researchers say in their new report on the economics of pharmacogenomics. They also suggest that their work justifies giving pharmaceuticals a larger slice of the overall healthcare financing pie. The full report can be downloaded free of charge.

--Paul Thomas

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

Does Bing Have More Bang for the (Life Sciences) Buck?

If you're a researcher or pharma professional, should you prefer Bing to Google? Microsoft's Life Sciences IT expert Les Jordan (not surprisingly) thinks so. His latest blog entry details what Microsoft is up to in life sciences, but also takes a closer look at how Bing might have advantages over the "G" search engine for the industry's professionals:

Sponsored Targeted search by Therapeutics. Try this side by side with the “other” large search engine. Type “Diabetes” into Bing (http://www.bing.com) and into the “G”. I won’t give you the link ;-). Notice the difference:

“G” – gives you News on Diabetes as the first link. News! Who wants news on their disease? I need treatments, symptoms, diet, prevention, etc.

Bing – The first link is a definition (from content provided by Bing Health from Mayo Clinic), but notice on the left: Articles, Symptoms, Diet, Complications, Prevention, and Test – that’s what people are looking for! Also notice the related searches right under that - “pre-diabetes”, “Diabetes care”. Helps you sub-set your search instead of pouring through the “blue links”. Powerful.

Sponsored Targeted search by drug name. Again try this side by side between Bing and “G”. Let’s stay on the theme of diabetes. Type in Insulin into the search. Notice the differences:

“G” – A “Wikipedia” entry. Better than news, I’ll give you that…but still, it isn’t an authoritative source, and I’ll need to dig more to get the info I need, like “what are the side effects”, etc.

Bing – The first link is an authoritative article on insulin on “Bing Health” from Mayo Clinic. But notice the left side: Articles, Side Effects, Ingredients, Drug Interactions – that’s the kind of information people are usually looking for.

My first few experiences with Bing have been good ones. Would be interested in hearing your thoughts.

--Paul Thomas