New drugs are moving more quickly to market today compared with those launched during the height of the Great Recession, but the pipeline is no faster than it was two decades ago.
That’s a key finding of a new report, released jointly on Monday by QuintilesIMS Institute and STAT, that illustrates shifting forces that have high stakes for drug innovation and pricing. The report, which analyzed the lifespans of 667 new drugs launched in the United States over the past two decades, was prepared independently by the QuintilesIMS Institute, in consultation with STAT.
The IMS report raises questions about why the pace of drug development has, overall, been stagnant since the 1990s, with the average drug taking 12 years to be launched after its original patent was filed. That matters because the speed of getting medications to market dictates when patients can be helped — and when companies can get a return on their investment.
No surprise here. Several years ago my company undertook a massive effort to see if we could optimize drug development timelines. Each department involved with drug development, from preclinical testing to NDA submission was given the responsibility of detailing every single step involved with their part of the NDA project. Essentially a massive flow chart was constructed listing in minute detail the thousands of required steps. We then took a step back and tried to figure out how much, if any time could be shaved off each step, down to individual days. The exercise took about one year and was excruciatingly detailed. After all was said and done we calculated that under the best case scenario we could only shave one year off in total.
The reasons are complex, but irrespective of the class of drug there are simply too many required hurdles, some internal, most regulatory that stand in the way of meaningfully accelerating drug development timelines.
It’s fabulous. …..
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