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

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

Blue Reference's Van Eikeren Outlines QbD and Other Strategies

A good interview with Blue Reference's Paul Van Eikeren regarding the company's strategy, including a brief mention of its consortium with big pharma companies to develop a QbD enterprise solution based upon its Inference for R platform. (Here is the press release on that consortium from a while back.)

--Paul Thomas