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July 5, 2008
Shark Repellent
Empirica From Phase Forward
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
A-List Of Speakers At Harvard
Post-Approval? Or Pre-Apocalypse?
With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year.
Strategies from Wyeth, Actelion & Pfizer
CTC 2008: Proactive Risk Abatement
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
Litigation Into Perpetuity?
Drug Safety: A Lawyer’s View
A lawyer says litigation illuminates how the pharmaceutical industry thinks and conducts itself. A few forward-looking statements.
Trasylol, Bayer & Three Mile Island
Drug Safety Story Time
Reflections on the power of narrative and the industry’s wobbly reputation.
With Congress poised to legislate new mandates for post-approval studies, it seemed like a good time to talk to Richard Gliklich, the president of Outcome and a professor of surgery at Harvard Medical School. We covered his company’s substantive conference on what happens after drugs are approved here. Gliklich’s take-away… more...
Former deputy FDA commissioner Scott Gottlieb left the agency not long ago, returning to the American Enterprise Institute (AEI). Since leaving FDA, the prolific Gottlieb has written a large number of essays and articles for a variety of publications. We’ve got one of them in PDF format below. ClinPage heard… more...
The 2007 BIO conference finished up last week in Boston. It was not our favorite conference, if only because of the unfocused nature of the agenda and the badly signed architectural failure (also called a convention center) in which the event took place. Perhaps next year, in San Diego, will… more...
The recent Post-Approval Summit at Harvard, sponsored by technology firm Outcome, had several senior FDA speakers. Paul Seligman, associate director of safety policy and communication at the Center for Drug Evaluation and Research at FDA, addressed the thorny topic of drug safety and post-approval trials. He spent some time reviewing… more...
The Post-Approval Summit at Harvard, now in its third year, is the most cerebral conference on our calendar. It is also the meeting most larded with VIP speakers, including a preponderance of physicians who run a) large swaths of international companies or b) big slices of a regulatory bureaucracy in… more...
It’s impossible to predict how the PDUFA issue will play out this year. But the House bill 1561 has a number of interesting provisions. It was introduced last week by Henry Waxman and Edward Markey, two California Democrats and longtime critics of the pharmaceutical industry. The bill is, of course,… more...
The rules for FDA officials are strict: Thou shalt not plead for money from Congress. But the rules don’t necessarily apply to Susan Ellenberg, now a professor at the University of Pennsylvania’s medical school. Last week, she told the DIA‘s 22nd Annual Clinical Data Management Conference that the FDA needs… more...
The British trade publication Pharma Times describes the strategy of London lawyers representing the six patients in an ill-fated Phase I trial sponsored by TeGenero. That German sponsor had only $3.9 million in insurance on the trial, and the patients’ lawyers want more. Because TeGenero declared itself bankrupt as the… more...
This week Mark McClellan, the former head of the FDA, said insurance data and electronic health records (EHRs) should be mined for insights into drug safety. His statement is unusual by itself. In the past, ex-FDA bosses tended to be circumspect. One can only surmise that the Bush administration and… more...
Now that half of the U.S. Congress consists of experts on drug safety, we thought it might be a good time to have a chat with Chan Russell. He’s the founder of Phase Forward’s safety division, Lincoln Technologies. Russell sold the company in August 2005 but stayed aboard as president… more...
