Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes" comment,...
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.
I spent yesterday afternoon at the Forum for Medical Innovation in downtown Chicago, hosted by the Council for American Medical Innovation and moderated by former U.S. House of Representatives majority leader Dick Gephardt. The event also featured AstraZeneca CEO David Brennan as a guest speaker. [img_assist|nid=1172|title=David Brennan|desc=|link=none|align=right|width=128|height=86]
From Chemical Engineering Progress, Girish Malhotra presents his prescription for the pharmaceutical industry----QbD, PAT and control all play a key role, and chemical engineers will make it happen. The ultimate goal will be entirely new business models for pharma.
John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.
It all depends on how you look at things. According to new data, the number of new drugs approved by FDA in 2008 rose and was the highest it's been in three years. Not so fast, says blogger Merrill Goozner, who argues that numbers don't reflect what is really an...
The Competing Globally track also featured a presentation on Quality by Design, made by Russ Somma, President, SommaTech LLC, who worked for several years at Novartis and is also an editorial advisor on PharmaQbD.com. Mr. Somma joked that the industry never had quality by accident, "We don't just lumber...
Yesterday's announcement that Eli Lilly had sold off its Greenfield, Indiana, R&D facility to Covance is perhaps not just a big deal, but really a bellwether move that may signal a trend of Big Pharma companies not just outsourcing aspects of their R&D operations but selling them off altogether.
A paper by James Evans recently published in Science, explores the impact of the Internet on research publications. The problem: Fewer and more recent sources are being cited. For a video interview with Evans, click here.
Researchers at the Salk Institute in La Jolla have discovered a drug (for more, read on) that appears to provide the same benefits as exercise: improved endurance and metabolic function-----in mice. What's next?