Tag Archive | "Bikash Chatterjee"

Tech Transfer’s New Framework

Technology transfer has become a more critical, yet more complex, concern for many drug manufacturers—especially larger companies that have sought to bolster their pipelines through acquisition. In such cases, say Bikash Chatterjee and Mark Mitchell of Pharmatech Associates, “the control and consistency of development data can vary dramatically.”

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Drug Manufacturing: Still Waiting for the Sea Change?

In Pharmaceutical Manufacturing’s April issue cover story, Agnes Shanley takes “The Pulse of Pharmaceutical Manufacturing.” The past decade has seen dramatic shifts in the way we talk and think about drug manufacturing, but, she asks, have practices really changed in the time since FDA’s PAT team was formed and then-Commissioner McClellan wondered why pharma manufacturing was “behind that of potato chip and soap making”?

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Profitability, Integrity and the Cost of Poor Pharma Quality

By Bikash Chatterjee, President and CTO, Pharmatech Associates

As major blockbuster drugs come off patent, the scramble among generics to capture these new markets is just beginning. We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma. We can also expect emerging market drug powerhouses to try and gain market share as these blockbusters come off patent. Pressure to be competitive in these new market opportunities is creating a sort of perfect storm.

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Making Cents: QbD Must Shift Its Focus

By Bikash Chatterjee, President and CTO, Pharmatech Associates

It has been nearly eight years since ICH first rolled out its concept paper on Pharmaceutical Development defining the framework for Quality by Design (QbD) and nearly seven since the FDA first embraced the concept in its 2004 guidance on Risk based cGMPs. During that time the industry has been warming up to the benefits of QbD. While adoption has been slow, it is gaining momentum.

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A Practical Roadmap to Pharmaceutical Process Validation

By Wai Wong and Bikash Chatterjee, Pharmatech Associates

In January 2011, the FDA issued its new guidance regarding Process Validation. Based upon experience gathered by the agency since 1987, the new guidance reflects the principles of the 2004 FDA initiative, Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach.

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Does Lean Six Sigma Enhance or Stifle Innovation in Drug R&D?

In the January issue of Drug Discovery Today, three authors from AstraZeneca R&D–Craig Johnstone, Garry Pairaudeau, and Jonas A. Pettersson–tackle the question of whether or not Lean and Six Sigma methodologies, when applied within drug R&D, enhance or stifle innovation. In “Creativity, innovation, and lean sigma: a controversial combination?”, the authors state that they, like other R&D scientists in the industry, “have attempted to adopt the principles of continuous process improvement, such as lean and six sigma, which have successfully revolutionized the cost and quality of manufacturing and service provision in recent decades. This trend for increasing process improvement is not without controversy, however, particularly when one considers the demand for increased innovation as well as cost effectiveness of delivery. There is a genuine and understandable concern that methodologies such as lean (six) sigma, which include standardization and the reduction of variation in their guiding principles, will restrict the freedoms required for innovative ideas to survive and flourish.”

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