One of our magazine’s regular and most popular contributors is John Avellanet, managing director and principal of Cerulean Associates. (His most recent article, from our June issue, focuses on data integrity and understanding FDA’s current thinking on 21 CFR Part 11.)

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By Ali Afnan, Ph.D., Principal, Step Change Pharma, Inc.

The drug industry today is suffering from a lack of innovation. If it continues along this path, only stagnation can result.

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By Paul Thomas, Senior Editor

If you’re a LinkedIn member, you know that most discussion threads on the social media site tend to fizzle after a few posts. Rare is the LinkedIn discussion that goes beyond 5 or 10 comments. Recently, I posted a link to Gawayne Mahboubian-Jones’ article, Can You See the Real QbD?, and find that the discussion has gone viral, with 70 follow-up comments (and counting) of all shapes and sizes, from some of the industry’s most creative thinkers.

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Back in February, we reported on an important Pharmaceutical Quality by Design conference that was to take place in June, sponsored by NIPTE. The event was designed to stimulate discussions of case histories applying QbD to solid dosage form scaleup, and to facilitate interaction among industry practitioners, regulatory professionals, and thought leaders from academia.

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By Agnes Shanley

The last gasp of winter, 2011, brought  with it record snowfalls and tragic natural disasters, as well as some quiet and unheralded news that, some observers believe, may signal new competitive pressures in store for the drug industry.

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