At the very least, let's rename QbD "Intelligent Design." That way, columnist Emil Ciurczak quips, we can get faith-based government funding to teach it in U.S. public schools. For more on Quality by Design and the disconnect with some Pharma H.R.
There are no whole truths; all truths are half-truths. It is trying to treat them as whole truths that plays the devil."b "Truth is rarely pure, and never simple."c The news is again a-twitter with stories of another fallen hero: Avandia.
PharmaManufacturing will soon launch its first Wiki. It will cover the field of process analytical technologies (PAT) as it applies to pharmaceutical quality systems and Quality by Design . We're looking for contributions from the pharmaceutical, biopharmaceutical and other communities using PAT (for example, API and fine chemicals, but even...
It's our blog and we can crow if we want to....We just learned that Emil Ciurczak's monthly column, Therapeutic Dose, is a finalist for "best contributed column" in the 2007 American Society of Business Press Editors (ASBPE) awards.
Like most pharma magazines, we've been covering e-pedigrees and RFID; although we'd like to say that we've been immune to the hype surrounding this subject, we've spent an awful lot of time covering the ins and outs of the frequency debate because very few companies will discuss what they are doing.
News that industry and FDA relations are improving may elicit knowing looks from some quarters, particularly those politicians who say that the Agency's in industry's pocket. But sour relations between FDA and the drug companies it oversees have contributed to the risk aversion and innovation gridlock that still prevents some...
Chemical Engineering Progress just ran an interesting summary of the Society of Biological Engineering's first international conference on accelerating biopharmaceutical development, held in late March in California. Amgen's EVP of R&D, Roger Perlmutter, had a lot to say about the dearth of new drugs.
In our next issue, Bikash Chatterjee, president of Pharmatech consultants, USP advisor and president elect of ASQ's Northern California chapter responds to an article we'd published in April on FDA's move to become more scientifically-driven. It's a must-read; watch for it in June's issue.
Is Big Pharma heading down the road travelled by Detroit's Big Three automakers? API manufacturing expert Girish Malhotra asks that question as he examines the future of big pharma in an op ed that we'll publish next month. The parallels might seem striking: for years, U.S.
Many within the industry are more than curious about Michael Moore's new film, Sicko, which is expected to premiere in Cannes this summer. Do any of you remember Mr. Moore's debut feature, Roger and Me, which immortalized his fruitless quest to interview Roger Smith, then president of GM, to discuss...