Drugs development time

Fig. 2 Total drug development time from new drug synthesis to product approval. (From Tufts Center for the Study of Drug Development, 1998.)...

While the efficiency of the NDA and BLA review process has greatly improved, dramatically decreasing the time for regulatory review, the same cannot be said for overall drug development time, from identification of a new drug candidate to NDA or BLA submission, which has resisted the anticipated streamlining effects of new technologies and efficiencies. 

Kristina M. Lybecker focuses on the tensions inherent in the socioeconomic construct that is today s pharmaceutical industry. On the one hand, it has a social contract to develop medicines that enhance the health of the public, but on the other it seeks to maximize profit. Lybecker explains the major challenges facing the industry today, such as longer drug development times, rising R D costs, generic competition, and parallel importation. 

Longer drug development times and rising R D costs... 

In drug development, time is of the essence. Clinical protocols should be concise, straightforward, and logical. The demands upon the investigators, their staffs, and the patients must be reasonable. The FDA s guidelines for drug development by disease must be considered in order to expedite the final NDA review and approval. The objective to remember throughout protocol development, and execution and presentation of the acquired data, is to demonstrate efficacy and safety to fulfill FDA s requirements for NDA approval. 

Drug Development Time and Cost — A Changing Picture... 

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