11 Drug Development and Production
11.1 Introduction
Development is the conversion of a biologically active compound into a safe
marketableproduct.It is amulti-disciplinaryprocess, which requires thecollabor-
ation of teams of workers from many different disciplines. Its success is dependent
on their skills and judgement. This chapter will outline the work carried out by
these teams in the main areas of the development process. The activities in many of
these areas are interdependent, which means that they should take place consecu-
tively or at the same time. Consequently, as speed is of the essence in all
development work, these activities will require careful planning and coordination.
The development process normally takes between seven and ten years from
initiation to marketing the drug. Furthermore, only one in 400–1000 drug
candidates considered for development ever reach the market. Consequently,
development is very expensive, the average cost of successfully developing a
drug being estimated to be about 350 million pounds in 1999. As a result, the
high risk nature of development means that it is necessary to plan a comprehen-
sive strategy to reduce both the pharmaceutical and financial risks. The first step
in this strategy is to define product pharmaceutical and financial targets and
assess whether the drug will reach these goals. Consequently, it is essential
to assess whether the new drug will be able to compete with existing competitors
and what advantages it may have over those competitors. This assessment
should be repeated at appropriate points in the development to ensure that
the development is still viable. The management of this and other aspects of the
development is often performed by monitoring itscritical path(Figure 11.1).
This consists of the activities that determine the time taken for the drug to
Fundamentals of Medicinal Chemistry, Edited by Gareth Thomas
#2003 John Wiley & Sons, Ltd
ISBN 0 470 84306 3 (Hbk), ISBN 0 470 84307 1 (pbk)