Molecular Biomarkers
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Molecular Biomarkers Omar F. Laterza Clinical Development Laboratory, Merck Research Laboratories, Rahway, New Jersey Ronald C. Hendrickson Merck Research Laboratories Proteomics, Rahway, New Jersey John A. Wagner Department of Clinical Pharmacology, Merck Research Laboratories, Rahway, New Jersey
Key Words Molecular biomarkers; Genomics; Proteomics; Adiponectin Correspondence Address John A. Wagner, 126 E. Lincoln Avenue, RY34A-500, Rahway, NJ 07065.
In this review, we would like to introduce the term molecular biomarkers as a broad term to refer to all biomarkers that are measurable by methods based on the biomarker’s molecular properties. This definition would comprise a wide range of biomarkers from small to large molecules, from nucleic acids to proteins. We present an overview of the different classifications and uses of biomarkers, especially in the context of drug development. We also offer a summary of the different platforms being employed in the search for novel molecular bio-
INTRODUCTION The use of biomarkers in general is not a novel concept. In fact, biomarkers have been used to aid in the diagnosis and, in some cases, prognosis of diseases for centuries. For example, before routine laboratory testing, physicians used to taste urine for the presence of glucose to determine whether a person had diabetes. However, the use of biomarkers that portend to make drug development a more efficient and cost-effective process is a relatively new concept and has become a major area of research in the scientific community in the past few years. The purpose of this review is to provide a general perspective on the use of biomarkers in the pharmaceutical industry, to provide an overview of the technology used in the discovery and measurement of molecular biomarkers, and to present specific case studies of wisely used biomarkers in the drug development process. The US Food and Drug Administration (FDA) has recently highlighted in a document the Critical Path Initiative (1) that would make the development process of new medicines more efficient and effective and more likely to result in products that will ultimately benefit patients. According to this document, the drug development process has become increasingly more
markers such as genomics, proteomics, and other “-omics” technologies. A case study on the application of biomarkers in the development of new drugs for the treatment of diabetes is also presented. This includes an overview of the development of a specific biomarker, adiponectin, from its discovery using genomics methods and its subsequent re-identification using differential mass spectroscopy. An evolution of methods for the detection of adiponectin from a Western blot, to an ELISA, to an antibody-free mass spectrometry method is also illustrated.
challenging over the past couple of decades. For instance, a new medical compound that entered phase I in 2000 only had an 8% chance of entering the market, compared with a 14% chance in 1985. In turn, a compound entering phase I usually represents t
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