Biomedical Engineering Reference
In-Depth Information
1.1
INTRODUCTION
From its accidental beginnings in Alexander Fleming's laboratory, pharmaceu-
tical drug discovery and development has emerged as a multi-billion-dollar
industry that has revolutionized practically all aspects of human (and animal)
life as we know it. Over the past 100 years, serendipitous discovery has been
replaced by a structured process that in its current state is highly structured,
automated, and regulated. It is also expensive and lengthy and suffers from a
99% failure rate. Industry averages suggest that the cost to bring a new drug
to the market under this so-called blockbuster paradigm is in the neighbor-
hood of $1.5-2.0 billion and takes nearly 16 years (Fig. 1.1) [1].
1.1.1
Brief History of Pharmaceutical Industry
The origins of the pharmaceutical industry can be traced back to the 1800s
and the dye industry in Switzerland. From the dye industry, specialty chemistry
companies emerged with Ciba, Geigy, and Sandoz in Switzerland along with
Bayer and Hoechst in Germany evolving into the fi rst pharmaceutical compa-
nies. In the early 1900s, the center of pharmaceutical research and develop-
ment (R&D) migrated to the United States, specifi cally New Jersey, with
companies such as American Home Products, Johnson & Johnson, Warner
Lambert, Merck & Co., Pharmacia-Upjohn, Schering-Plough, BASF, Hoechst,
Schering AG, Hoffman LaRoche, and Novartis making it the location of choice
for their U.S. operations. The late 1900s saw the emergence of North Carolina
as a pharmaceutical industry hot spot with Glaxo-Wellcome making its U.S.
headquarters there. Also in the late 1900s, the biotechnology industry emerged
Target
Selection
Chemical
Selection
Clinical
Trials
Launch
Discovery
(2-10 years)
Preclinical Testing
Laboratory and animal testing
Phase 1
20-80 healthy volunteers - safety and dosage
Phase 3
3,000-5,000 patient volunteers used to monitor
adverse reactions to long-term use
FDA Review/
Approval
Years
0
2
4
6
8
10
12
14
16
Cost = $1.3B/new drug
Figure 1.1
Pharmaceutical research and development process.
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