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Monthly Archives: March 2010
Timing of Euro Agency's Event on Orphan Regulation Looks Ill-Conceived
The European Medicines Agency issued a rather bizarre press release at the end of last week that no doubt succeeded in raising a few eyebrows.
The Agency was seeking to promote a conference designed to celebrate a decade of orphan regulation in Europe. The meeting will take place at its London headquarters, and it will bring [...]
The Cost of Snow on the Drug Development Process
I’m pretty sure that no one wants to talk about snow. Especially for those in the Baltimore-DC-Philadelphia triangle, who received record amounts of snowfall this year.
Posted in CRO/Sponsor, Regulatory Tagged Baltimore, capital, cost, DC, drug development process, employee, fired, headline, inches, lawyers, Lisa Henderson, mid-Atlantic, money, Philadelphia, snow, snowmageddon, union, Virginia, Washington D.C., washington hospital center, weather Leave a comment
PRO Q&A with FDA
In preparation for a recent conference on patient reported outcomes, I reached out to FDA’s Dr. Laurie Burke in the Center for Drug Evaluation and Research. Burke, Associate Director, Office of New Drugs, was actually brought up during the PRO meeting, when a presenter credited her early involvement/familiarity with ePRO as meaningful. Nowadays she’s on [...]
Posted in CRO/Sponsor, IT, Sites Tagged electronic patient reported outcomes, ePRO, FDA, FDA PRO Guidance, Laurie Burke, patient-reported outcomes, PRO Leave a comment
A Critical Path to New TB Treatments
FDA Commissioner Margaret Hamburg announced on March 18, a new joint initiative between industry, FDA, and non-profit organizations designed to fast-track modern combination treatments for tuberculosis. Where once it took more than two decades to create new therapies for TB, this collaboration is expected to produce working treatments in less than six years, providing much-needed [...]
FDA, Pharma, and Alliance Partner to Treat TB
The FDA Commissioner is expected to help launch the Critical Path to TB Drug Regimens (CPTR)—an initiative aimed at accelerating the development and approval of new treatments for tuberculosis (TB). Supporting the initiative are the TB Alliance, the Bill & Melinda Gates Foundation, the Critical Path Institute (C-Path), and 10 pharmaceutical companies: Johnson & Johnson, [...]
Terms like Theranostics Cause Confusion and Irritation
I suspect I wasn’t the only person to go straight to Google for help today when I read this message heading in my inbox: Theranostics paves the way for personalized medicine.
I thought initially that Theranostics must be a company name, and sure enough there are several businesses with that word in their name. But when [...]
Posted in CRO/Sponsor Tagged confusion, diagnostic therapy, Frost& Sullivan, Jane Ganter, John Funkhouser, PharmaNetics, Philip Ward, Theranostics 2 Comments
Polite Request: Remove Shaggy Dogs from Press Releases
Two highly entertaining items of mail have popped up in my inbox during the past couple of days. The first of them was this quite ridiculous photo that I just have to share with you:
Have you ever seen a physician or investigator working like this? The immaculately tidy desk and the family photos of perfect [...]
Posted in CRO/Sponsor, IT Tagged Carestream, dogs, journalist, Philip Ward, press release, Roche, sceptical, skeptical 2 Comments
Not a NICE Week in the U.K.
Spare a thought for the decision-makers at the National Institute for Health and Clinical Excellence (NICE) in the U.K. They are meeting today to hear Bayer’s appeal against the institute’s decision not to recommend public funding for Nexavar (sorafenib) in patients with advanced hepatocellular carcinoma (HCC).
There are an estimated 600 U.K. patients with advanced HCC, [...]
Posted in CRO/Sponsor Tagged Bayer, British Medical Journal, CRO/Sponsor, HCC, Karol Sikora, Nexavar, NICE, Philip Ward, UK 1 Comment
Chasing After Amyloid