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