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 liaises with EMA). Boone embodies a new era of collaboration between American and European regulators, and among global authorities.
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 regulatory issues. What follows is a brief synopsis of this session:
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 how the biotech industry is evolving, and assess its economic impact by sector and by geography. This year’s marks the fifth annual report.
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, shared information on her company’s participation in FDA’s pilot program for biologics QbD.
“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, what’s the value of a duplicate inspection? We don’t believe it adds value to the product.
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 that some people in the industry may continue to see Ireland as an expensive place to do business.
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 trends, found a gem of an article in The Scientist that looks at the "flip side" of the industry: criminals...
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 indirect bailout. Members of major biotech companies and industry organization BIO will meet with Congress today to...
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 annual meeting in Atlanta, but also the Eastern Analytical Symposium and....the American Institute of Chemical Engineers meeting in Philadelphia.