Tuesday, November 06, 2007

How Much Ya Got?

I often hear the commonly quoted metric of 10 years and $1B as the time and cost to bring a drug to market. After seeing, hearing, observing drugs reaching the market for less than $1B I decided to do some poking around in an effort to validate said metric. Well valid it is according to recently published data from the Tufts Center for the Study of Drug Development (Tufts CSDD); the average capitalized cost to bring one new biopharmaceutical product to market, including costs of failures, is $1.24B (in 2005 dollars). Current Tufts CSDD data indicate that the average time to bring a biopharmaceutical product to market from the start of clinical testing is 8.0 years, and the likelihood of success is 30%. For traditional pharmaceutical products the average time to bring a product to market from the start of clinical testing is 7.5 years, and the likelihood of success is 21.5%. Now these time frames do not include the discovery period or the time to execute IND enabling studies that allow a potential product to enter the clinic. Considering that point I would venture to guess that the 10 year metric is indeed a conservative one. Do your thoughts or data points differ? Please let me know…


Anonymous said...

I'm comfortable taking a lead and pushing it through IND-enabling studies in less than two years, with a budget of about $3.5M. Depending on what's involved in discovery (is the target validated; is a focused library being used to screen; how robust is the screening assay; how much tweaking of the hits are required to come up with a lead, and is everything required already in house), average numbers are another two years and another $3M (+/- 75%). So altogether, it's the standard deviation that kills, and, in spite of putting the best available thoughts into the project, still has a significant randomness associated with each event in the process. And ten years is certainly within one standard deviation; so is $1B.
Martin Cunningham

Adam said...

Hi Martin. Thank you very much for the thoughtful feedback. Please contact me arubenstein@rnaventures.com