Manufacturers' challenge is clear: how do take disparate, siloed R&D data from past and present and (cheaply and easily) use it to leverage ongoing development efforts.
Microsoft and Oracle are making major bids to provide holistic solutions for manufacturers implementing QbD. Smaller vendors (such as Blue Reference) are making a name for themselves by filling voids in the QbD IT space.
Editor’s Note: More information on Microsoft, Oracle, and Blue Reference can be found on PharmaQbD.com, via the following links:
Microsoft is leveraging its Amalga Life Sciences solution 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. “Many researchers now use Excel and other Office programs to store their lab data in spreadsheets they’ve cobbled together,” says Jim Karkania, Senior Director of Applied Research and Technology for Microsoft Health Solutions Group
“Amalga can search through these files, no matter what format they are in, and pull the relevant information as soon as it is needed.” 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. Amalga can integrate relational and graphical, Karkanias says.
Merck is one of the companies helping Microsoft to develop Amalga LS. Earlier this summer, Microsoft bought the assets of Rosetta Biosoftware (part of Rosetta Inpharmatics) from Merck. Merck has become an early adopter of Amalga Life Sciences and a development partner, Karkanias says, and will provide strategic input as the platform evolves. The two companies are currently developing a formal process for collaborating into the future, Karkanias says.
Oracle’s moves include the purchase this summer of the intellectual property of Conformia Software, a provider of process lifecycle management software for life sciences companies and a close collaborator with FDA on the role of IT in moving QbD forward. Oracle, which bought Sun Microsystems previously, says it plans to integrate the Conformia Product and Process Lifecycle Management (PPLM) software and technology into the Oracle Agile PLM suite. “This combination will enable pharmaceutical and bio-technology companies to accelerate innovation, meet regulatory objectives, and improve productivity,” Oracle said in its announcement.
The move follows Oracle’s acquisition this Spring of Relsys International, a provider of drug safety and risk management applications. It’s also heavily promoting its Crystal Ball software for Monte Carlo simulation and risk analysis (and which is, coincidentally, Microsoft Excel-based).
Oracle is “filling gaps” and adding to strengths that it already had in life sciences, says Life Sciences Strategy Director John Danese. “It gives us a good story in Quality by Design and PAT.” Like Microsoft, Oracle is relying heavily upon manufacturers’ input as it evolves its solutions, Danese says.
Those manufacturers are finally coming to grips with how to leverage QbD, Danese says. “The technology was evolving but few businesses understood how they were going to use it in the course of developing new products,” he says. “QbD is becoming more of a reality, and manufacturers are moving from hazy endpoints to moving ahead and incorporating QbD into their business operations and understanding its benefits.”
Since last year, Blue Reference has led a Quality by Design Product Development Consortium (PDC) that exists to flesh out these issues and improve the tools available for Quality by Design. While most of the consortium’s work is hush hush, one development that company founder Paul van Eikeren is now ready to share is a software prototype, Paradigm Discovery, whose primary purpose is to cull through manufacturers’ previous QbD-relevant data and extract that which can be applied to future efforts.
“It’s a QbD-aware, intelligent approach to finding relevant prior information,” or what he calls “information artifacts.” Paradigm Discovery resides on top of existing data sources and analyzes information artifacts, so that they can be structured, evaluated, compared , and put to use. “85 percent of data is in the form of free text,” van Eikeren estimates. “Anything in a database in a structured form can also be transformed to an information artifact. Being able to dredge up the past, and use it, is a big deal for manufacturers, he says.
“Think about how much money pharmaceutical companies have put into R&D over the past 30 years,” he says. “A certain fraction of that was spent in the non-clinical developmental world. But in almost all cases, that money didn’t produce a drug product, though it did produce a lot of information that they now can’t use. It’s a worthwhile investment to get access to that info.”