The Life Sci VC blog takes a closer look at the improved rate of 2011 approvals of NDAs by the FDA. A couple weeks ago, many commentators -- and including FDA's Janet Woodcock -- ballyhooed the improvement in NDA approval rates and wondered aloud if this signalled big pharma R&D turning the corner toward more success in development of new drugs -- especially given some changes in R&D models over the past years.
Bruce Booth took a bit more somber (and realistic) approach to the data. He noted two facts that should be considered before one declares unconditional victory in revamping the big pharma R&D machine. Firstly, Booth notes that the majority of new NDAs were not sponsored by the originating organization and only 7 of 18 came from big pharma. Thus, most did not originate the sponsors R&D group but rather in its BD group. The jury must remain out on the value of any new R&D structures or models that have been implemented in the past five years as this data really doesn't speak to those changes.
Secondly, Booth noted that most of the newly improved drugs have been in development a long long long time -- since the 1990's -- and again appear to be from legacy R&D efforts rather than from any new fangled permutation that has arisen since then. So again, any new changes in R&D will have to await their day in court to assess whether they are more effective than "the old ways".
Finally, Booth concludes, it is great to celebrate the increased rate of NDA approvals but it is too early to attribute it to changes in R&D models. One can also conclude that business development activity is very important in the mix of bringing new drugs to market. And, one cannot forget that the time to market is a very long and complex journey making it damn difficult to assess the effectiveness of changes to the R&D model in the short-term.
Posted by Bruce Lehr July 29th 2011.
I agree with Bruce Booth's point that it takes 12-15 years from concept to approval for most novel (especially non-oncology non-HIV) drugs. Nothing new there - I remember working on CTLA4-Ig at BMS in the late 1990's.
However, his point is perhaps more that we cannot use the recent upturn cited by Janet Woodcock as a proof of improved Discovery (the R in R&D.) Much of the investments to improve R&D have focused on the "D" side in the past decade. Perhaps resulting in better attrition profiles, or shorter development times. This could then have result in more filings/approvals.
I would also think that it is better to measure the "birthday" of a drug candidate either by the date it was patented, or by Regulatory's approval for testing in man. Both are in public domain databases. I am sure that the timlines will still be as described. But the end result that new models are yet to be proven avoids the reality that the "BD" component is part of that new model - versus assuming all innovation comes from within. Selecting the right BD candidate is often guided by internal basic science, not whim. I think the jury is still out on the "upturn" of NDA's. Regretablly the data to prove one way or the other may be out there. It is just very expensive to license/buy.
Posted by: Terry McCormick | 07/29/2011 at 06:50 PM