The trouble with Europe

It's always interesting to come to Europe and hear the latest about the Innovative Medicines Initiative, an attempt by the Europeans to develop a public-private approach to speed drug development. This is Europe's version of the Critical Path Initiative, and it has some real potential. As outlined by Jorgen Dirach, director of corporate research affairs at Novo Nordisk, at the 13th European Congress on Biotechnology, the IMI is hoping to fund new research efforts next year that will focus on new ways to speed more efficient clinical trials. One of the keys to making this new, collaborative approach work will be the development of a "virtual" research academy that is designed to accelerate academic research work by connecting researchers online. There's also €2 billion from the European Commission and private industry to prime the pump.

Europe has long been a hotbed of great science. Some of the leading institutes are at the top of their respective fields in drug research. The eager faces packing into one session on protein design are ample evidence of the keen interest in science here. And despite all the hype, Europe is still well ahead of Asia in terms of ongoing clinical trials. But there's always an air of concern here about the state of the industry, underscored by Dirach's comment that seven of 10 science students getting their PhDs in the U.S. have no plans to return to Europe. They'll stay in the U.S., going after well-paid jobs at some drug developers that are able to fund their work with money from some ambitious venture capital firms.

As long as the big money remains in the U.S., much of the science will as well. Nevertheless, great science will always earn the interest of developers--wherever it comes from. What ultimately ails Europe is the exact same set of problems that afflict American companies: The cost of research continues to multiply with no end in sight. I suspect that despite all the carefully worded support of public agencies on both sides of the Atlantic, that essential barrier will remain an ever-growing challenge. Regulatory groups are getting tougher about new approvals, not more lax. They have no great stake in lowering the barrier. As long as the bar remains high--as it should--reaching it will cost a fortune. The cost solution won't be found at the public level, but at private biotech companies that are leveraging investors' money into swifter development of biologics.

I will take issue with one off-hand comment of Dirach's. Referring to the cost of developing a drug, he said that "800 million dollars, or euros, it makes no difference." Anyone from the U.S. who had just purchased something in one of the Barcelona shops nearby would dispute that in a heartbeat. - John Carroll

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