Lilly, Centocor, Pfizer
2009 Clinical Trials Congress
In a sobering but illuminating first day, the 2009 Clinical Trials Congress surveyed the industry and considered a new idea: economics.
Are there truly singular contract research organizations (CRO)? Or are CROs interchangeable, like airlines? It's not an academic question in an era when drug, biotechnology and device firms are offloading large and sacred clinical programs to outside firms. The work done by every CRO—science—is driven by government regulations that permit little deviation from international norms. And the frequency with which sponsors hire and fire CROs would suggest that everything can be reduced to the lowest quoted price, or to deals hammered out by two colleagues who trust each other. Pfizer Win But there is an intriguing counter-example in Parexel. The Waltham, Mass. firm has 10,300 employees and $1.3 billion in annual revenue. It has walked a different road in ways that initially made Wall Street nervous. Some of the analyst head-scratching has stopped in the wake of last month's announcement that Pfizer had selected Parexel as one of two preferred providers.…more...
It was a routine IND meeting at the FDA. Just a few low-level agency staffers were expected to attend. Instead, some of the FDA's most prominent, senior scientific and enforcement leaders…more...
Way, way back in 2004, your correspondent covered a small Tennessee software company, SiteWorks Solutions. Oracle bought it and, uncharacteristically for Oracle, wanted to discuss the purchase. We interviewed executives at…more...
A commercial North Carolina institutional review board (IRB), Copernicus Group IRB, has received ISO 9001 certification. The company has a paperless system to manage clinical trial forms. “To our knowledge, CGIRB…more...
Large life science companies have fired untold tens of thousands of employees during every year of the ongoing downturn—a period of both financial chaos and pharmaceutical mega-mergers. Here's one estimate, and another. Yesterday, having digested Schering Plough, Merck announced it would terminate 15,000 people and close eight research locations. Which doesn't mean the research industry is devoid…more...
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...
Most of the ClinPage podcasts are done in a pretty typical Q&A format. Today, however, we're posting a different type of audio: some snippets from the 2009 Clinical Trials Congress, held earlier this year. We thank the Institute for International Research (IIR), which organizes a fabulous conference every year, for their permission to do this. The speaker…more...
The best minds on Wall Street like Pfizer’s $68 billion acquisition of Wyeth. Last week, to take just one example, a prominent firm (which advised Pfizer on the merger) said it believes its client is poised for a revival once it has Wyeth drugs in its pipeline.Yesterday, Merck took a page from the same play book, buying…more...
In a sobering but illuminating first day, the 2009 Clinical Trials Congress surveyed the industry and considered a new idea: economics.
Exco InTouch discusses Pfizer’s endorsement, and the use of its technology in a new type of project.
Thoughts on recent sponsor news: GSK cuts hundreds of R&D jobs and Pfizer abandons cardiovascular disease.
What to count (or not), and why.
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
With impressive numbers, Pfizer’s Mike Collins talked about how the company is streamlining its clinical trial process.
Sponsors are abuzz about site relationship management (SRM). In the first installment of our series, Wyeth describes its efforts to become the sponsor of choice.
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