The Optimist Club: What Big Pharma R&D Execs are Doing to Save the Industry
This article was originally published in RPM Report
The output of pharmaceutical industry R&D is at an all-time low. But Big Pharma R&D execs say better times are coming soon. What do they know that everyone else doesn't? Optimism plays well with lots of key constituencies-including FDA, which is being spared public criticism on the state of R&D portfolios.
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The years 1996 and 1997 were terrific for the biopharmaceutical industry, with record numbers of new product approvals. It is now clear, though, that they were outliers from the historic rates of new product flow. That fact has important implications: the products approved in those years are the blockbusters industry is still living on, and they supported massive infrastructure that Big Pharma now needs to shed.
You have to go back to 1983 to find a year as bad as 2007 for R&D output. It was a terrible year by any measure. The key question for industry: does it need to learn to subsist on a trickle of new drugs coming to market each year, or is the current drought in fact a sign of a transition to a new, more innovative R&D model? The sparse class of 2007 does offer some glimmers of hope.
Wyeth has had some tough times with FDA on its current crop of NDAs.Those experiences sent a team of senior execs down to FDA to find out what is up at the agency. What the execs heard was a call to action. The meeting "caused us at Wyeth to realize that we have to find a different way to operate." The current series of delays and rejections for important new drug applications is not a temporary situation for companies to ride out, but rather a sign of new regulatory