Tag Archive | "Ali Afnan"

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?


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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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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Control, Innovation and the Consumer: Keys to a Different Drug Industry


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

Over the years, pharma’s key objective has changed very little: getting active pharmaceutical ingredient to the patient. Although we no longer dose extracts of willow tree bark, the practice of blending API with excipients to add bulk or facilitate flow dates back to the Romans. The Remington tablet press or gelatin capsules of 1875 remain virtually unchanged today. Regulations haven’t changed that much either, in the fifty years since most of them were drafted.

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Memoirs from IFPAC 2012


By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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IFPAC 2012: The Club Opens Up


by Agnes Shanley

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