ABSTRACT
Because the process is so complex and the different pieces interlock, it is often not possible to proceed in a sequential manner. The whole process would take far too long. In all except a few instances, where the risk of failure is exceptionally high, the watchword is ‘Planning for Success’. In practical terms this means that a great deal of work (writing protocols, ordering supplies, booking slots with internal providers or external contractors) is undertaken on the assumption that the compound will pass all the preceding stages successfully. There is also great pressure to carry out all these steps as quickly as possible, avoiding unnecessary delay in the writing-up of reports, etc. A saying in the pharmaceutical industry is that if a compound will enjoy peak year sales of US $400 million, every day of delay in getting to market before the patent expires costs over a million dollars. Of course this fails to take into account the high failure rate of projects and only applies to those that actually achieve such sales, but time pressure in drug development is intense and unrelenting.
