Because of the random sighting of Ira Spector at one conference or another, we’ve always had a soft spot for Wyeth. We don’t know Spector—no need to fret he has been consorting with the news media. But from remarks by Spector and his lieutenants over the years, we’ve gathered Wyeth…more...

When it comes to drug safety, some people believe the end is nigh. But maybe it’s somewhere in the middle. And maybe technology can help. That’s the message from Cynthia Verst, senior VP of the i3 Innovus late phase business. She says the contract research organization is seeing earlier requests…more...

Every other day, Adil Shamoo says he gets an inquiry about something untoward in a clinical trial. Shamoo, whose day job is professor of molecular biology, epidemiology and preventive medicine at the University of Maryland’s School of Medicine, is also the founder of Citizens for Responsible Care and Research (CIRCARE).…more...

The clinical trial technology landscape is consolidating, with firms buying each other or limping along. In that context, last month’s rebranding of the safety software of Phase Forward is interesting. To quote the press release: “Phase Forward is unifying its safety products under a new product family name—Empirica—for its suite…more...

Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical…more...

Talk about a rock and a hard place. Once drugs reach the market, or as a condition prior to approval, the industry’s handling of risk is caught between the needs of regulators, shareholders and public. At the 2008 Clinical Trials Congress, held in Orlando, there were signs that the burdens…more...

When will the drug safety wars end? How will they end? A new president? A Supreme Court decision? We thought Tom Lamb might know. He’s an attorney based in Wilmington, North Carolina. Like it or not, lawyers like Lamb are shaping the perceptions of the pharmaceutical industry and clinical trials.…more...

With the Oscars upon us, it’s time to reflect on something simple. Our brains store information and make sense of the world in stories. This is true in all cultures, all individuals. “She saved my career.” “They worked it out.” Homo sapiens specialize in stories. Stories are a more basic…more...

There has never been a time in the pharmaceutical industry when the coding of adverse events was more pivotal. The industry is not quite to the point of knowing that three identical events will trigger a product withdrawal. But it’s close. In that context, Phase Forward last week updated its…more...

Last week, the U.S. Supreme Court declined to hear an appeal of another court’s rejection of the suit brought by The Abigail Alliance for Better Access to Developmental Drugs. We hope that legal defeat allows Abigail to rest. With any luck, the Supreme Court has slowed a quixotic and ill-informed…more...