Principles and Practice of Pharmaceutical Medicine

the process has inevitably become subdivided into
several functional sections, the following being the
most obvious:

Basic chemical or structural research: Explor-
ing the genetic basic of a disease or the micro-
structure of a receptor or enzyme active site, and
from that, developing tailored molecules to pro-
vide specific interactions and potential therapeu-
tic outcomes.

Pre-clinical research and development: Using
biological systems, up to and including animal
models, to explore the causes of diseases and the
potential safety and efficacy of new therapeutic
agents.

Clinical development: Using humans, both the
healthy and those with a disease, to evaluate the

safety and efficacy of a new drug. This section is

itself, by convention, subdivided into three

phases.

Regulatory and societal development: Ensuring

that the entire development of each new thera-

peutic is seen in the context of its need to meet

governmental requirements and that the appro-

priate value-added components (e.g. quality of

life, cost–benefit, evidence-based medicine,

relative competitive positioning) over and above

the basic demonstration of safety and efficacy

are integrated into the product’s database.

Post-market approval medical affairs: This

involves the promotion of each product by mar-

keting and sales functions and the oversight of

this process by pharmaceutical physicians. Two

other critical post-marketing components are as

CH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY 11

'82

0

400

800

1200

1600

2000

2400

2800

3200

3600

'83 '84 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 '96

Year

R&D expenditure

Figure 2.3 Total UK pharmaceutical R&D expenditure (including capital), 1982–1996 (*estimated for 1996) (from
the Centre for Medicines Research Report, 1996)

Market

evergreening

Medicinal chemistry Clinical pharmacology Regulatory

Pharmacology and biology Process chemistry Marketing

Molecular biology manufacturing

Genomics Toxicology Clinical research Medical affairs

Concept testing Drug design Clinical validation Product positioning

Figure 2.4 Integrated drug discovery and development (adapted from Taylor, 1993)