BIO 2009 Coverage

 
BIO 2009 Coverage

This year's BIO show, May 19-22 in Atlanta, drew 14,352 attendees.

This page will provide news, blogs, articles, video and audio coverage from BIO 2009. Check back for updates.

Videos

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Articles & News

From the Editor: Who Needed PAT and QbD, Anyway?

Has the industry been on the road to Oz? Didn’t we already have what we needed…in the GMP code and good engineering principles?

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Bio QbD at Pfizer, Genentech: Shifting from Concept to Implementation

Think QbD is daunting? Double that for the biotech arena.

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Can You See the Real QbD?

Rather than helping, could the current brand of pharmaceutical Quality by Design be acting as a distraction and deterrent to quality?

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Product Roundup: Mission Possible

The deadly business of drug counterfeiting is growing, but so are the options available to prevent and fight it.

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Outsourcing: Cost versus Benefit

Does outsourcing manufacturing to nations with evolving GMP’s make economic sense? As FDA, USP and other organizations continue to study the heparin case, we promise to keep you informed.

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Ten Tips to Fight Pharmaceutical Counterfeiting

The pharmaceutical industry is under extraordinary strain. Facing the wrath of consumers because of the cost of products, constantly answering the questions of state and federal legislators looking to control health care costs, and losing value in the marketplace, the industry’s hands are more than full.

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FDA's Biopharma Approvals Doubled Last Decade, According to Tufts Report

U.S. regulatory approvals for new biopharmaceuticals nearly doubled in the last decade, compared to the 1990s, according to the Tufts Center for the Study of Drug Development, but drug developers "face substantial challenges" if they are to maintain that pace, the study's author says.

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Podcasts

Are QbD, Lean, and Time to Market Competing Concepts?

In today’s pharma world, speed to market often trumps QbD, while QbD can crowd out Lean and other operational excellence initiatives. It doesn’t have to be so, says Tunnell Consulting’s Bryan Winship, who also explains how to avoid the middle-management “black hole” in QbD efforts.

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Locating the Magic Spot in Mammalian Cell Lines

Catalent Pharmaceuticals’ new GPEx technology is a gene expression method which inserts genes into target cells, eliminating the need for markers. Mike Jenkins, GM of Catalent’s Middleton, Wis., facility explains how GPEx helps manufacturers turn the corner, quickly, from research to development.

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Pulmonary Aerodynamics: Creating Nanostructures Out of Drugs (not Polymers)

Savara, Inc. out of Austin, Texas, specializes in reformulating successful drugs for use in standard inhalable devices, by engineering the nano “whiffle ball” out of the drug itself, or a combination of drugs. Executive chairman Rob Neville explains in this audio.

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