Mind to Market

Monday, January 15, 2007

Biomedical Research

After discussing basic and applied research, I thought I'd stick with this theme and discuss a domain specific type of research, in this case biomedical research. The biomedical domain refers to the knowledge associated with the application of biological and physiological sciences to clinical medicine. Biomedical research can be either basic or applied according to the definitions already given. Since the goal of biomedical research is to advance the treatment of disease in humans, humans are a necessary component of the research. But don't get the idea that any experimental drug can be fed to some unsuspecting subject in the interests of science; the FDA regulates this type of research quite closely. Biomedical research can be divided into preclinical research and clinical trials; preclinical research includes the initial discoveries and studies leading up to the specific treatment and clinical trials involve the administration of the treatment in humans.

Any basic research in this process will be conducted in the early stages of preclinical research where novel technologies and drug targets are revealed. When a promising technology has been discovered, the more directed process of applied research is employed in order to bring the technology through the remainder of the preclinical research and clinical trials. As this process proceeds each stage requires and ever greater investment of resources and expertise culminating in Phase III clinical trials; large scale trials with human subjects.

An analogy has been made between biomedical research and a funnel in which 10,000 drug candidates have been introduced at the top and a single drug emerges at the bottom approved for use in humans. The funnel is about 15 years long and costs about $1 billion to get through, not an enterprise for the faint of heart or under funded. One key to reducing costs is to curtail the process when failure appears certain. The further along in the process failure occurs, the more expensive it becomes.

Although the end goal of biomedical research is to find treatments for human disease, humans are the last in line to be experimented with, reassuring to potential recipients of experimental treatments. Biomedical research can be conducted in a range of environments from in vitro; in a laboratory or controlled environment outside a living organism to in vivo; in a whole organism such as an animal or human. A relatively new environment of in silico represents computer modeling and simulation. If in vivo represents the most accurate, and expensive, environment to experiment in and in vitro represents a lower cost environment, in silico offers the potential for an even further reduction in cost. This has long been recognized in engineering where computer models are an essential component of the design process. However, due to the complexity and lack of mechanistic understanding of biological systems, computer modeling has been difficult and of limited validity. With drug development costs increasing rapidly and pressure to control prices putting pressure on the drug companies a new paradigm in drug development is sorely needed.

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