March 22, 2017Safety

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CDER Chief On OMOP

Woodcock At Harvard

May 11, 2011

Like those who work in quarries and mines, journalists covering the pharmaceutical industry wear special ear protection while on the job. It's all required by OSHA and has greatly advanced over the years. Certain terms that (for those in the life sciences) are oxymoronic or their own antonyms never reach the battered ears of journalists. Other words, which tend to have highly convoluted meanings (think "governance," "real-time," "proactive"), are automatically back translated into English. We had to yank out our earplugs yesterday while listening to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). It turns out that she speaks English fluently. Woodcock was speaking at the 2011 Post Approval Summit, a conference dedicated to Phase IV research. It's held at Harvard's medical school campus and sponsored by Outcome, a technology firm that specializes in registries. Woodcock has spoken at the Post Approval conference before, and seems…more...

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Quantum Leap

Spotless ECGs from ERT

March 14, 2011

It would be hard to find a firm handling more electrocardiogram (ECG) data than ERT. The company handles 9 million ECG data points annually. Not long ago, the firm decided to…more...

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Outcome's Outcomes Effort

A Registry of Registries

March 02, 2011

There is a new federal effort to organize disease registries. It's a meta-repository of all disease registries—a big list. The FDA will be advising on its design but play no formal…more...

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Quintiles At DIA

Toward Quality Trials

July 30, 2010

It’s easy to give a sharp salute to "quality." What modern research organization would oppose it? Quality refrigerators, quality cars, quality overnight packages can be defined easily. Quality in a clinical…more...

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Annals of Drug Safety

Future White House Transcript

June 02, 2010

Editor's Note: Through association with certain spiritual mentalists and accredited acupuncturists, the editor of ClinPage has received what he has been assured is a bonafide transcript from nine years in the future. From the year 2019, to be precise. The transcript below purports to be the byproduct of a U.S. Freedom of Information Act (FOIA) request. It…more...

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Pfizer's Michael Ibara

Toward A Neutral AE Facilitator

April 23, 2010

Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency. As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of…more...

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Pfizer's Warning

Starting Over On Safety

April 22, 2010

If pharmacovigilance were a movie, it would be Groundhog Day, except as a tragedy. Here's the plot. Reports of adverse events (AE) pop up and take years to be evaluated. The associated recriminations bounce between various interested parties. Good drugs exit the market. Bad ones linger. The industry's reputation gets bludgeoned either way. Luck is at work,…more...

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Pharmacogenetic Age

Quintiles Safety Assessment Tool

April 27, 2009

These days, can a clinical development program have too much safety? While risk evaluation and mitigation strategies (REMS) are hardly new, as this list of them on the FDA website attests, they remain only partially understood. In its own conversations with the sponsor community, Quintiles realized that many in the industry are unaware of the full spectrum…more...

Hearts Seen Whole

A Case For Centralized ECGs

Jeffrey Litwin of ERT discusses the benefits of centralizing ECG interpretation.

Huge QT Savings

NewCardio: Not Your Father’s ECG

A nascent but ambitious cardiology diagnostics outfit plans to jump into early-phase trials market this summer.

Consistent Adjudication

Icon Sees Cardiac Opportunity

Shortly after the release of new FDA guidance on diabetes trials, Icon Medical Imaging unveiled software to help.

Can Pharmacovigilance Scale?

Data-Mining 12 Million Lives

Chan Russell of Phase Forward discusses the company’s support for a large-scale project with FDA and the U.S. Army.

Frustrated Justices

Supreme Court Mulls Drug Labels

A recent Supreme Court discussion suggests the high court can’t get its head around current label regulations.

Public Citizen Gadfly

Wolfe on FDA, Tequin

Public Citizen’s health research advocate Sydney Wolfe talks turkey on the antibiotic Tequin and the possibility of change at the FDA.

Proactive Safety

SAS, GSK At SCDM Meeting

New thinking on how drug safety should be handled and assimilated in a litigious, electronic era.


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