Biomedical Engineering Reference
In-Depth Information
Through the mid-1970s, signifi cant advances in physiology, pharmacology,
enzymology, and molecular biology, stemming mostly from publicly funded
research, had propelled the understanding of the biochemical and molecular mecha-
nisms of many diseases and the action pathways of existing drugs (Cockburn and
Henderson
2001a
). Yet, as most of the drugs at that time were derived from nature
or through organic synthesis and fermentation, they were not suitable for the pro-
duction of complex macromolecules such as proteins, which consist of genetically
encoded long chains of amino acids. In the late 1970s to early 1980s, the advent of
biotechnology and the technological breakthroughs made possible by the more
versatile tools of
genetic engineering
marked a second watershed moment for the
industry.
4
2.2.3
The Genesis of a Drug: From Inception to Market
2.2.3.1
Creating a Drug by Discovery or Design
Human physiology is vastly complex, and there is a lot that is not known about the
onset, the triggers, or the pathways of many diseases and disorders. For these rea-
sons, interdisciplinary research spanning various scientifi c domains has become
essential for modern drug discovery. Input from scientists competent in a broad
range of disciplines is required in the process, e.g., skills and expertise in molecular
biology, physiology, biochemistry, analytic and medicinal chemistry, crystallogra-
phy, pharmacology, and even more distant areas such as information science and
robotics. Advanced interpretative and integrative capabilities are critical for suc-
cess. Collaboration transcending organizational, departmental, or therapeutic cate-
gory boundaries has grown increasingly important for drug discovery (Henderson
and Cockburn
1994
). Thus, the combination of interdisciplinary competencies and
openness to knowledge generated outside the fi rm can become the source of endur-
ing competitive advantage for pharmaceutical fi rms.
Importantly, creating new drugs in the twenty-fi rst century is no longer a series
of accidental, serendipitous breakthroughs. Instead, a long and systematic process
requiring steadfast commitment, diligence, and meticulous work has taken the place
of the previous haphazard experimentation. The majority of modern new drugs have
completed an involved and strictly regulated process to reach the market. We dis-
cuss the phases of this process next.
4
Two key events have come to be recognized as critical for the revolutionary union of genetics with
biotechnology. One was the 1953 discovery of the structure of
DNA
by James D. Watson and
Francis Crick, and the other was the 1973 discovery by Stanley N. Cohen and Herbert Boyer of a
recombinant DNA
(rDNA) technique by which a section of DNA from one organism (e.g., bacte-
rium) could be transferred into the DNA of another, so that the latter could be induced to produce
a specifi c protein. Popularly referred to as genetic engineering, this technique has come to defi ne
the foundations of modern biotechnology.
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