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Author Archives: Peter ODonnell
Advertising Industry’s European Woes
October will see the relaunch of a longstanding European battle—over what sort of information patients should get about prescription medicines. Like many European battles, this one has a long history, pitting companies’ championing of their products against campaigners fears of unbridled direct-to-consumer advertising. The explosive cocktail of debate has been made all the more volatile [...]
Posted in Regulatory Tagged EPHA, EU, Europe, European Medicines Agency, European Public Health Alliance, JOhn Dalli, Peter O'Donnell, Regulatory Leave a comment
Spin-offs from Spin-offs
The Protean capacity of the pharmaceutical industrial and academic complex to adapt and reinvent itself is one of the defining characteristics of the last 20 years. From mergers to spin-offs, from acquisitions to new partnerships, the constantly shifting kaleidoscope of pharma intelligence is a monument to unfailing initiative and energy.
Alongside industry and academia, a whole [...]
Posted in Regulatory Tagged biotech, EU, HIV/AIDS, partnerships, patients, Peter O'Donnell, pharma, Protean capacity, R&D, Regulatory, spin-offs, subjects Leave a comment
How Much Transparency is too much Transparency?
Europe’s bid to become-whiter-than-white in terms of disclosure of pharmaceutical data to the world outside is running into snags. It’s a long story—driven over the years by strong demands from health activist lobbies, academics, patient associations, and even just ordinary relatives of ordinary patients in cases where medication appears to have done more harm than [...]
Have Your Say on Electronic Health Records!
How much can the use of electronic health records (EHR) help in developing new medicines? How should their use be regulated? And will everyone be happy with this growing trend, anyway?
If you have views on EHR (and if you haven’t, then you aren’t very close to the coalface of clinical trials!), then you also have [...]
Posted in IT Tagged EHR, EHR4CR, electronic health records, EU, Innovative Medicines Initiative, IT, Peter O'Donnell, survey Leave a comment
Small Steps to Tackle Big Problems
The announcement in Nature Medicine of a cheap and portable blood test1 that could provide a breakthrough for diagnosing infections in poorer countries has focused attention again on the huge chronic challenges of healthcare in the developing world. Meanwhile, commanding less high-profile media attention, but making a consistent contribution to treatment as opposed to diagnosis, [...]
Posted in Regulatory Tagged Africa, ARV, developing country, EDCTP, HIV, infections, Nature Medicine, Peter O'Donnell, Regulatory, WHO Leave a comment
Lönngren's Shadow on Rasi's Back
Anyone who hoped the appointment of a new boss at the European Medicines Agency was going to expunge the recent unpleasantness over conflicts of interest must be disappointed by the recent appearance in the European Parliament of the chosen candidate for the post.
Guido Rasi, the Executive Director-designate, spent the best part of two hours in [...]
Posted in Regulatory Tagged EMA, European Medicines Agency, European Parliament, Guido Rassi, Peter O'Donnell, Thomas Lönngren Leave a comment
Europe Still Searching for the Right Rules on Clinical Trials
The search for effective clinical trials legislation in Europe goes on—and on, and on. It was in the late 1980s that the European Union first conceived the idea of creating its own rules. It took more than a decade until it produced the 2001 directive. It took another three years to put the finishing touches [...]
Posted in Regulatory Tagged 2001 directive, EU, Europe, JOhn Dalli, Peter O'Donnell, regulation, Regulatory 1 Comment
Spending, But Wisely
The European Union puts more than $10 billion a year into funding research—on top of what the 27 EU member states spend themselves, and of course in addition to the billions that industry invests in its own R&D. But it isn’t sure that it is getting value for money, so it is on the brink [...]
Making Common Cause
How much do drug industry associations really have in common with each other? The question is provoked by a routine administrative announcement from London in mid-May, about two associations’ that plan to share office space. The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) are to relocate to a single office. [...]
A Manifesto from Rasi