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Author Archives: Kerri Nelen
Strategic Site Partnerships
During IIR’s Partnerships in Clinical Trials conference, I got the chance to speak with Christine Pierre, President and Chief Executive Officer of RxTrials, after she co-presented the session “Are There Really Strategic Site Partnerships?” with Applied Clinical Trials columnist Kenneth Getz.
Survivor Winner Trial Success
Can you tell what’s missing from the picture to the right? The one of Ethan Zohn, who won CBS’s Survivor: Africa back in early 2002. Here’s an obvious hint: It’s not a dashing smile. Instead, and in addition to good background lighting, it’s me. I’m missing from the pic.
In all my years attending industry meetings [...]
ePRO Expert Talks Shop
No more pregnant males. Sounds like the punch line of a joke but it’s actually one of the benefits of ePRO over paper. Others include no more missing data and data that’s time and date stamped. Together, these capabilities create a technology that can improve the way drugs are developed. That’s how Phil Lee sees [...]
Posted in CRO/Sponsor, IT, Sites Tagged drug development, electronic patient reported outcomes, EMA, ePRO, FDA, PHT, PRO 1 Comment
Seventy Yards to Health Reform Touchdown
Health care reform took center stage Tuesday morning at IIR’s 19th Annual Partnerships in Clinical Trials conference, where a three-member panel took turns answering questions from moderator Susan Dentzer, Editor-in-Chief of Health Affairs and Health Analyst for the News Hour with Jim Lehrer. Taking part in the discussion were former Senator Tom Daschle, Endo Pharmaceuticals [...]
Posted in Regulatory Tagged ACRO, Association of Clinical Research Organizations, conference, David Holveck, Devils, Douglas Peddicord, Endo Pharmaceuticals, football, game, Health Affairs, health care reform, HIPAA II, IIR 19th annual paertnerships in clinical trials conference, IT, Jim Lehrer, Kerri Nelen, legislation, News hour with Jim Lehrer, panel, PhD, Regulatory, Senator Tom Daschle, stimulas package, Susan Dentzer Leave a comment
A Legal PSA for Sponsors
Pharmaceutical companies: beware. Or at least take heed. A relatively recent decision made by a federal appeals court in San Francisco leaves drug makers more vulnerable to investor lawsuits. Granted the decision affects only companies headquartered in nine states (CA, OR, WA, AK, HI, AZ, NV, MT, ID) Guam, and the Mariana Islands, but it [...]
Chasing After Amyloid
“Insanity is doing the same thing over and over again and expecting different results.” It’s a phrase attributed to Albert Einstein, among others, and how one industry veteran views the approach drug makers take in developing treatments for Alzheimer’s—with a twist. For Cameron Durrant, MD, MBA, there’s a hammer involved.
“You whack your thumb with a [...]
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
Quintiles Steps Up Patient Outreach
I recently attended a conference on patient recruitment, and a few times during presentations I found myself thinking back to a conversation I had two weeks ago with Dr. Hugo Stephenson of Quintiles. The flashbacks were triggered by talk surrounding patient preselection at investigator sites and enrollment friendly protocol design. Which is essentially what Stephenson and [...]
Posted in CRO/Sponsor, IT, Sites Tagged Hugo Stephenson, iGuard, patient database, protocol design 1 Comment
Clinilabs Teams with Microsoft
As small-to-midsize pharma and biotechs become less active thanks to the economy, their usual partners, smaller CROs, face dwindling demand for their services. Outsourcing among big pharma continues, but data show that the bigger CROs are their preferred choice. So, what’s David to do when not only surrounded by Goliaths but also other Davids? Try to [...]
Pharma at Your Fingertips