Pharmaceutical Allies: QbD and Six Sigma

A rather lengthy but good PowerPoint presentation from an ISPE breakfast seminar on the link between QbD and Design for Six Sigma, courtesy of consultant Murray Adams.

--Paul Thomas

Quality Risk Management in Jersey

Roche and Dyadem have put together a program on Quality Risk Management for the end of this month in Princeton, N.J. Dyadem's offerings are well positioned for the QbD movement . . . should be an interesting program.

--Paul Thomas

Progressive Collaborations: GSK Gets First Contributor to Patent Pool

Another exciting collaboration speeding development: Alnylam has become the first company to jump into the patent pool that GSK has established to aid development of drugs to confront tropical diseases. Alnylam will contribute some 1,500 current and pending patents, tripling the number that GSK has already contributed itself.

GSK CEO Andrew Witty: “The key objective of the pool is to make it easier for researchers across the world to access intellectual property that may be useful in the search for new medicines to treat neglected tropical diseases. The more companies, academic institutions and foundations that join the pool, the more effective it will be. Alnylam’s announcement today is therefore a welcome and significant step forward.”

--Paul Thomas

Public and Private: Janssen Alliance for TB Drug Development May Serve as Model

An interesting note from a few weeks ago on an agreement between Janssen subsidiary Tibotec and the not-for-profit TB Alliance to share resources and expertise. Says the alliance's president and CEO Mel Spigelman, “Since the TB Alliance was founded, we have assembled the largest pipeline of new TB drugs in history . . . " It's a great model for collaboration, cost sharing, and bringing needed drugs to market that otherwise would not have gotten the full resources and backing they deserve.

--Paul Thomas

Real-Time Neurochemical Monitoring of Trial Patients?

A good article in the Irish Times detailing some of the work in the Emerald Isle to speed drug development. The lead is about the work of John Lowry at the National University of Ireland Maynooth. Some of Lowry's research is available online. Here is a journal article detailing his team's efforts to enhance the selectivity of its biosensors. And here is a thorough video on Lowry and his biosensor work.

--Paul Thomas

Microsoft's Les Jordan on DIA 2009

Microsoft's IT Life Sciences specialist Les Jordan offers up a nice summary of his experience at DIA last week, including photos and (for romantics) a shot of the San Diego sunset.

--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