The Lancet offers some more sobering statistics on the recent failures to get new drugs developed, tested and licensed. It cites EMA figure for 2010 (through October) that show 38 positive opinions and 41 applications were finalized as compared to 117 positive opinions and 125 finalized applications in 2009. some additonal positive opinions and approvals can be expected to occur in those last two months but not enough to make up the difference from prior year. Drug approvals are DOWN with several celebrated failures occuring in late stage trials.
The editors echo the need to change the existing drug R&D model - an echo that is by now resounding throughout the pharma industry as ROI on R&D continues to plummet. Some familiar suggested fixes are suggested (but let's repeat them anyway lest someone actually pay attention):
- Increased collaboration between academia and industry and among companies in industry itself
- Companies sharing information to avoid repeating expensive mistakes in development (i.e pursuing a failed drug target) or learning from flawed clinical trial designs and methodologies
- More funding in academia to support not only discovery but to provide expertise to bridge the translational and interdisplinary gaps
- Academic augmentation of discovery work aimed at the developing world
- Finally government funding of more basic research or so-called curiosity-driven science which history suggests will lead to bigger breakthroughs for the future
Again, not earth-shattering stuff, but the message is becoming more consistent across a number of commentators on the industry as well as from clinicians, regulators and the industry itself. Now we need to actually do something about it.
Posted by Bruce Lehr Jan 7th 2011.