Engineers Nail QbD in Philadelphia
Last week posed a scheduling quandary for anyone interested in Pharmaceutical Quality by Design and Process Analytical Technologies. Three important meetings were taking place....of course, the AAPS...
View ArticleA Biotech Bailout, in Some Form, Makes Sense
While the term bailout is being tossed around liberally to suggest any government assistance in these challenging economic times, U.S. biotech leaders appear to asking for just that, or at least an...
View ArticleFDA's Most Wanted (or, the Rogues Gallery of Biotech)
Am looking forward to BIO, and to hearing from the brilliant, quirky, altruistic and non-altruistic people who are driving that industry forward. But while developing an article on compliance...
View ArticleNotes from BIO 2009: Irish Pharma--Can Innovation and Quality Trump Cost and...
Some slighting asides were made during one session at BIO, on biopharma capacity...they weren't part of the official powerpoint presentations, but came unofficially during the Q&A, and they showed...
View ArticleNotes from BIO 2009: Up to $400,000/Day to Support an Inspection, Genentech Says
“We are seeing an increasing frequency of inspections from FDA and the rest of the world,” says John O'Connor, PhD, senior director of Corporate Inspection Management for Genentech. “The question is,...
View ArticleNotes from BIO 2009: On Genentech's Bio-QbD Pilot and Impending "A-MAb" Case...
Genentech has taken a lead role in advancing the state of Quality by Design for biopharmaceuticals. At this week's BIO conference, Lynne Krummen, Genentech’s senior director of regulatory affairs,...
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Notes from BIO 2009: Basketball Star Dominique Wilkins Roams Show Floor
I managed to grab a picture with NBA Hall-of-Famer, Dominique Wilkins, who was being led around the show floor by a group of BIO officials. Wilkins, who suffers from diabetes, is an ambassador for Novo...
View ArticleReport from BIO 2010: Does Every Region Really Win in the Biotech Game?
In a press conference today at Chicago’s McCormick Place, representatives of Battelle released their annual report, “Battelle/BIO State Biosciences Initiatives 2010.” The Battelle report seeks to track...
View ArticleBIO 2010: FDA’s Midthun, Throckmorton on Increasing, and Integrating, the...
During an FDA Town Hall meeting at BIO 2010 today, FDA’s Karen Midthun (Acting Director, CBER), and Douglas Throckmorton (Deputy Director, CDER) fielded questions from the audience about current...
View ArticlePartnership Across the Pond: EMA, FDA Foster a Culture of Convergence
Hilde Boone, Pharm, MSc, is the European Medicines Agency’s liaison official at the U.S. FDA. Boone’s post was established this past winter (FDA, reciprocating, also has a representative in London who...
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