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...superstar Genentech. Together, the two strategies form the nucleus of how Roche plans to deliver best-in-class products--faster, more cheaply and more reliably--to market. "The days of an attrition-based pipeline are over," says Lee Babiss, head of global pharma research. "We've responded by making R&D much more efficient...
...growing need to produce bigger and bolder breakthroughs as portfolios mature and patents lapse. The market wants fewer "me too" products, instead demanding originality. And drugmakers are working overtime to distinguish themselves: in 2006 the top seven pharmaceutical companies spent twice as much on marketing (33%) as on R...
Meanwhile, not only are regulators scrutinizing steep pricing models, but in this post-Vioxx era, agencies like the U.S. Food and Drug Administration (FDA) are also requiring more and more testing. That has led many firms to consult regulators much earlier in the R&D process. "You must align expectations as early as you can with the FDA," Roche CEO Severin Schwan says. "It leads to a much more efficient, effective use of resources on both sides...
...demand for cancer drugs, for one, will grow exponentially with this treatment approach. But more important, Roche can now use biomarkers to determine much earlier in the R&D process whether a drug will pan out. Down the pipeline, diagnostics identify which patients most benefit from a therapy, giving clinical trials tailored to that subset a better chance of succeeding. Moreover, any patient for whom the drug wouldn't work or whom the drug could harm can be excluded...
British forecaster EvaluatePharma says Roche is on track to take over as Big Pharma's top dog by 2014, up from No. 5 today. But it won't get there without a fight. Crosstown rival Novartis is also revamping how it does R&D and holds a 13% stake in Alnylam. U.K. concern GlaxoSmithKline already underwent its own re-engineering, and the results are evident. In 2000 its pipeline had two major prospects; now, stocked with 34 late-phase drugs on the horizon, it appears to be one of the industry's healthiest...