Compliance? Huh?
Are Academics Competent?
What’s wrong with non-industry clinical trials, and how to fix them.
Is the industry’s reliance on me-too drugs on the verge of reversing? Could pharma be on the cusp of a new cycle of innovation? That’s the possibility raised by Ian Lloyd. He has been studying industrial R&D for more than 20 years and currently serves as editorial director of Citeline, part of the Informa empire of trade shows and scientific publications. Citeline recently issued its annual report on clinical R&D. The British firm draws upon a mix of proprietary, unpublished research and public data from government trial registries such as ClinicalTrials.gov. Biologics & Small Molecules Citeline’s research process is intensive. The organization monitors the medical literature and corporate press releases. That’s easy enough. But Citeline also periodically labors to verify that a much-heralded compound in clinical testing is in fact progressing toward regulatory approval or market launch. The vetting process knocks some projects out of the database, ensuring it contains only…more...
SAS runs an annual one-day conference about healthcare and the life sciences. With merciful brevity written into its DNA, the meeting can pack its program densely with substance. There is no…more...
"Contagion" is one of the top films in America just now. It has been bested only by two movies at the box office—one about cartoon lions and another about a maid…more...
Individuals and companies tend to have one arch-villain, one adversary that looms larger than all others. In the pharmaceutical industry, at any given moment, industry veterans might identify the main villain…more...
Earlier this week, JNJ said it will buy the Swiss medical device firm Synthes for $21.3 billion. A debased U.S. dollar isn't worth much these days. Still, 21.3 billion of anything remains an impressively tall pile. Uniquely in big pharma, JNJ has a record of megadeals that have been years ahead of peer companies. With numerous semi-autonomous…more...
Have contract research organizations (CRO) turned the corner? Is the current downturn about to pass? Those were the questions we put to Michael Martorelli, director, Fairmount Partners. Martorelli is a savvy Philadelphia-based observer of the CRO industry. By constitution, he is a plain-speaking and numbers-oriented guy who helps to find buyers and sellers for CROs; his firm…more...
How bad are the job losses in pharma? How long will they last? As a starting point, every month brings new, grim numbers from Challenger, Gray & Christmas, a Chicago firm that specializes in executive recruiting. Recent Challenger data suggest that, at the moment, the job losses in pharma are intensifying relative to other industries. In 2010,…more...
Is the most time-honored business model in clinical trial outsourcing out of step with our era? Most contract research organizations (CRO) charge on the basis of time and materials. Such companies resemble construction firms that erect skyscrapers. If the design of the skyscraper changes, the builder adjusts its fee. If more steel is needed, that goes on…more...
What’s wrong with non-industry clinical trials, and how to fix them.
At the 2010 annual DIA meeting, the FDA offered two perspectives on multiregional trials
FDA commissioner Margaret Hamburg addresses the DIA meeting in Washington, D.C.
Norman Goldfarb discusses recent industry trends and his upcoming conference in Boston in May.
As the new year begins, some reflections on the biggest clinical trials of the new year.
A productive and independent Florida site works lean and doesn’t apologize for being in business.
The owners of Chiltern are buying MDS Pharma’s six central labs.
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