Archive | Opinion Editorial

Should QbD Practices Be Patented?

Should QbD Practices Be Patented?

    by Agnes Shanley

    Recently we heard of a very smart PAT/QbD route being patented, but that news only seemed to beg the question of whether  giving exclusivity to a few companies would impede further adoption of QbD within the industry. Does it stimulate or prevent good scientific practices and could it, in the long term, hurt patients in the future?  Here’s an editorial on this topic that was published in Pharmaceutical Manufacturing.  What are your thoughts?

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    Cutting Through the QbD Foliage, Aiming for the Roots

    Cutting Through the QbD Foliage, Aiming for the Roots

      By Hedley Rees, Managing Director, Biotech PharmaFlow Ltd

      These days in Pharma development circles, hardly a day goes by without mention of Quality by Design (QbD). Who is doing it properly? Is it too expensive? What is the business case? Can small companies afford it? How do we get executive management interested?

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      Can Biopharma Avoid the Fate of Small-Molecule Manufacturing?

      Can Biopharma Avoid the Fate of Small-Molecule Manufacturing?

        By Ali Afnan, President, Step Change Pharma, Inc.

        Biopharmaceuticals are now center stage and a hotbed of activity in the pharmaceutical industry. For mature, small-molecule-dominated companies dealing with the patent cliff, biopharma is a new lifeline. Many generic companies are investing in and planning to make biosimilars.

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        Can QbD Get Its Definitions Straight?

        Can QbD Get Its Definitions Straight?

          By Emil W. Ciurczak, Contributing Editor

          I have been following a number of conversations on LinkedIn that are driving me to imbibe large amounts of adult beverages. The number of people who disagree on what various terms mean is astounding. For example, we all think we know what PAT means, no? Apparently, no.

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          von Eschenbach: Why FDA Lags Behind

          von Eschenbach: Why FDA Lags Behind

            Former FDA Commissioner Andrew von Eschenbach took to the Wall Street Journal this week to weigh in on the problems of his former employer, and to encourage Congress to better support the Agency. FDA doesn’t have the “scientific tools and resources” it needs, von Eschenbach writes. (Registration required for full article.)  “Congress has starved the agency of critical funding, limiting its scientists’ ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery.”

            Posted in Opinion Editorial, QbD News1 Comment

            Channeling Don McLean

            Channeling Don McLean

              By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

              February can be a difficult month, even when the winter is as mild as the one we just experienced in much of the U.S. But, for anyone working in or observing the pharmaceutical industry, this February brought to a climax the swell of bad drug manufacturing news that had been building since last year. Some of the lowlights:

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