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07/29/2011

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Terry McCormick

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.

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