Biomarker development

Xiang, F. Anderson, G. A. Veenstra, T. D. Lipton, M. S. Smith, R. D. Characterization of microorganisms and biomarker development from global ESI-MS/MS analyses of cell lysates. Anal. Chem. 2000, 72, 2475-2481. 

Advanced 2D-PAGE,2D-DIGE, and its Application for Biomarker Development... 

For these reasons, our research group includes basic researchers including a bioinformatics specialist, clinicians, pathologists, and industry partners, in a way that best-optimizes the use of 2D-DIGE related methods for biomarker development studies (Fig. 4). 

Gutman S, Kessler LG. The U.S. Food and Drug Administration perspective on cancer biomarker development. Nat Rev Cancer 2006 6 565-571. 

Recommendation Develop a coordinated strategy for biomarker development and population biomonitoring based on the potential for population exposure and public-health concerns. 

As the use of metabonomics advances, there are several challenges facing scientists using this tool that must be addressed in order to make it more mainstream and more relevant to predicting toxicity, and useful for hazard identification, human risk assessment and clinical medicine. First, advancing the use of metabonomics to identify mechanisms of toxicity is essential, and such efforts should help to increase the overall usefulness, validity, and relevance of toxicity prediction and biomarker development. Second, the use of metabonomic evaluations in the course of chronic toxicity rather than the heretofore emphasis on acute studies will help to establish its place in following the... 

Colombo R. 2008. Target validation to biomarker development focus on RNA interference. Mol. Diagn. Ther. 

HUPO) [117]. Cataloging of saliva [118], urine [119], cerebral spinal fluid [120,121] and the many other biofluids from various organs [122] (Figure 5.3) should lead to important advances in biomarker development. While there are no corresponding organizations dedicated to the proteomes of primates, mice, rats, and other experimental animals, such interests will evolve in time either as an outgrowth of HUPO or as separate entities. 

In the pharmaceutical industry, the techniques are being used to examine off-target effects particularly for the early identification of toxicity. MOA can be studied through metabolomics and can also be used as a quality control tool for complex mixtures such as foods or herbal medicines. Similarly, the tools and expertise of natural products chemists are essential in metabolomics, particularly in biomarker discovery (see also Volume 9). Biomarker discovery via untargeted metabolomics can lead to metabolite signatures (nuclear magnetic resonance (NMR) spectroscopy, mass spectrometry (MS), etc.) that are not present in current metabolomics databases. This is particularly true for plant secondary metabolism studies and nonmammalian metabolites. Structure elucidation then becomes critical to understanding the metabolomics results and for biomarker development. 

Marrer E, Dieterle F (2010) Impact of biomarker development on drug safety assessment. Toxicol Appl Pharmacol 243(2) 167-179. doi 10.1016/j.taap. 2009.12.015... 

FIGURE 6.1 Conceptual diagram of fit for purpose biomarkers method validation. The method validation processes include four activity circles prevalidation (preanalytical consid eration and method development), exploratory method validation, in study method validation and advanced method validation. The processes are continuous and iterative, dictated by the purpose of the biomarker application. The solid arrows depict the normal flow of biomarker development (prevalidation), method validation (exploratory or advanced), and application (in study method validation). The process could include moving the chosen biomarkers from exploratory mechanistic pilot studies to advanced validation and confirmatory studies, or from exploratory validation to advanced validation after changes in critical business decision. The broken arrows represent scenarios where validation data do not satisfy study requirements, necessitating assay refinement or modification. 

---