Biomarker Editorial: The Many Lives of the Biomarker
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David S. Lester, PhD SVP Strategy and Corporate Development, Gene Express, Inc.
Correspondence Address David S. Lester, 1 Deborah Drive, Morristown, NJ 07960 [email protected]
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Biomarker Editorial: The Many Lives of the Biomarker
Biomarkers became “legitimate” at the joint NIH/FDA/industry meeting held at the National Institutes of Health in April of 1999. Definitions were made distinguishing different types of biomarkers and numerous interesting applications were presented. This was considered to be a milestone in terms of creating the biomarker industry as a business. It is often forgotten that biomarkers have been around for as long as life science or biomedical research has been performed. A recent diagnostics conference presentation focused on the future of imaging as a biomarker/diagnostic in drug development and biomedical research. The audience was reminded that X-rays have been used as a medical diagnostic for over 120 years! The only difference was that the term biomarker was not used. They were called biological or clinical endpoints, diagnostics, outcomes, and so on. Since this 1999 NIH meeting, the pharmaceutical industry has spent hundreds of millions of dollars searching for, identifying, and developing new biomarkers. The regulatory agencies in virtually all countries have embraced the importance of biomarkers in drug development and, to a lesser extent, in drug approval. Many technology companies have sprung up focusing on developing specific biomarkers, biomarker technology platforms, and multiplex assays. In addition, many biomarker services have grown out of existing contract research organizations and
central labs and companies focused on delivering biomarker contract services. There have been many detailed reports, reviews, chapters, and even books published about biomarkers. In fact, a parallel industry to the pharmaceutical/biotech industry has been created. Biomarkers have even entered the consumer markets. Companies such as Nestlé, Procter & Gamble, and Unilever all recognize that biomarkers provide an opportunity to legitimize the science behind their products. Multiple technologies, highly integrated in other industries, have been translated into life sciences and biomedical research. Techniques such as spectroscopy (visible, fluorescence, IR, acoustic spectroscopy, mass spectroscopy) have all been published upon as potential platforms for methodologies. Likewise, it is valuable to consider all platforms when discussing biomarkers. Too often individuals discuss biomarkers and imaging as two separate entities—imaging is a technology that provides a biomarker endpoint. However, with all of this activity, internal resources, and finances spent on biomarkers, one often hears debates as to the value of biomarkers. Do we have too many? Do we need them for this or that application? If we consider that we have always used them in biomedical and life sciences research, then there is no argument as to their value. So, what is the problem? There
Drug Information Journal, Vol. 41,
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