Biomarker Development (biomarker + development)

Distribution by Scientific Domains


Selected Abstracts


Advancing Alcohol Biomarkers Research

ALCOHOLISM, Issue 6 2010
Cynthia F. Bearer
Biomarkers to detect past alcohol use and identify alcohol-related diseases have long been pursued as important tools for research into alcohol use disorders as well as for clinical and treatment applications and other settings. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) sponsored a workshop titled "Workshop on Biomarkers for Alcohol-Induced Disorders" in June 2008. The intent of this workshop was to review and discuss recent progress in the development and implementation of biomarkers for alcohol use and alcohol-related disorders with a goal to formulate a set of recommendations to use to stimulate and advance research progress in this critical area of alcoholism research. Presentations at this workshop reviewed the current status of alcohol biomarkers, providing a summary of the history of biomarkers and the major goals of alcohol biomarker research. Moreover, presentations provided a comprehensive overview of the current status of several well-recognized biomarkers of alcohol use, a summary of recent studies to characterize novel biomarkers and their validation, along with perspectives and experiences from other NIH institutes and from other federal agencies and industry, related to regulatory issues. Following these presentations, a panel discussion focused on a set of issues presented by the organizers of this workshop. These discussion points addressed: (i) issues related to strategies to be adopted to stimulate biomarker discovery and application, (ii) the relevance of animal studies in biomarker development and the status of biomarkers in basic science studies, and (iii) issues related to the opportunities for clinical and commercial applications. This article summarizes these perspectives and highlights topics that constituted the basis for recommendations to enhance alcohol biomarker research. [source]


Future Prospects for Biomarkers of Alcohol Consumption and Alcohol-Induced Disorders

ALCOHOLISM, Issue 6 2010
Willard M. Freeman
The lack of reliable measures of alcohol intake is a major obstacle to the diagnosis, treatment, and research of alcohol abuse and alcoholism. Successful development of a biomarker that allows for accurate assessment of alcohol intake and drinking patterns would not only be a major advance in clinical care but also a valuable research tool. A number of advances have been made in testing the validity of proposed biomarkers as well as in identifying potential new biomarkers through systems biology approaches. This commentary will examine the definition of a biomarker of heavy drinking, the types of potential biomarkers, the steps in biomarker development, the current state of biomarker development, and critical obstacles for the field. The challenges in developing biomarkers for alcohol treatment and research are similar to those found in other fields. However, the alcohol research field must reach a competitive level of rigor and organization. We recommend that NIAAA consider taking a leadership role in organizing investigators in the field and providing a common set of clinical specimens for biomarker validation studies. [source]


Current status of biomarkers in head and neck cancer

JOURNAL OF SURGICAL ONCOLOGY, Issue 8 2008
Steven S. Chang MD
Abstract As our understanding of HNSCC increases so has biomarker development. HPV16 integration is a significant marker of favorable prognosis and response to therapy for HNSCC. EGFR-amplification and overexpression is a poor-prognostic indicator. For premalignant lesions, LOH of 3p&9p21 loci confers an elevated risk of malignant transformation. As molecular targets are identified, these will be candidates for biomarkers for detection, diagnosis, prognosis, and therapy. Validation of these biomarkers requires demonstration of independence of significance beyond known biomarkers. J. Surg. Oncol. 2008;97:640,643. © 2008 Wiley-Liss, Inc. [source]


Youden Index and Optimal Cut-Point Estimated from Observations Affected by a Lower Limit of Detection

BIOMETRICAL JOURNAL, Issue 3 2008
Marcus D. Ruopp
Abstract The receiver operating characteristic (ROC) curve is used to evaluate a biomarker's ability for classifying disease status. The Youden Index (J), the maximum potential effectiveness of a biomarker, is a common summary measure of the ROC curve. In biomarker development, levels may be unquantifiable below a limit of detection (LOD) and missing from the overall dataset. Disregarding these observations may negatively bias the ROC curve and thus J. Several correction methods have been suggested for mean estimation and testing; however, little has been written about the ROC curve or its summary measures. We adapt non-parametric (empirical) and semi-parametric (ROC-GLM [generalized linear model]) methods and propose parametric methods (maximum likelihood (ML)) to estimate J and the optimal cut-point (c *) for a biomarker affected by a LOD. We develop unbiased estimators of J and c * via ML for normally and gamma distributed biomarkers. Alpha level confidence intervals are proposed using delta and bootstrap methods for the ML, semi-parametric, and non-parametric approaches respectively. Simulation studies are conducted over a range of distributional scenarios and sample sizes evaluating estimators' bias, root-mean square error, and coverage probability; the average bias was less than one percent for ML and GLM methods across scenarios and decreases with increased sample size. An example using polychlorinated biphenyl levels to classify women with and without endometriosis illustrates the potential benefits of these methods. We address the limitations and usefulness of each method in order to give researchers guidance in constructing appropriate estimates of biomarkers' true discriminating capabilities. (© 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source]


In this issue: Biotechnology Journal 11/2009

BIOTECHNOLOGY JOURNAL, Issue 11 2009
Article first published online: 13 NOV 200
Forensic identification on chips Choi and Seo et al., Biotechnol. J. 2009, 4, 1530,1541 Short tandem repeat (STR) analysis can be used for genetic fingerprinting of individuals as it is done for forensic human identification. However, the current state-of-the-art STR genotyping processes and instruments are labor intensive, expensive, time consuming, and lack portability. Micro-total-analysis systems or lab-on-a-chip platforms based on microfabrication technologies have the capability to miniaturize and integrate bioanalysis steps in a single format and have already been successfully applied for forensic STR typing. Researchers from Daejeon, Korea, highlight up-to-date work on advanced microdevices for high-throughput STR genotyping, and a portable integrated microsystem for on-site forensic DNA analysis. Surface plasmon resonance on chips Maynard et al., Biotechnol. J. 2009, 4, 1542,1558 Technologies based on surface plasmon resonance (SPR) have allowed rapid, label-free characterization of protein-protein and protein-small molecule interactions. SPR has become the gold standard in industrial and academic settings, in which the interaction between a pair of soluble binding partners is characterized in detail or a library of molecules is screened for binding against a single soluble protein. In spite of these successes, SPR is only beginning to be adapted to the needs of membrane-bound proteins which are promising targets for drug and biomarker development. This team of authors from Austin, Minneapolis and Rochester (all USA) describe current SPR instrumentation and the potential for SPR nanopore arrays to enable quantitative, high-throughput screening of G-protein coupled receptor ligands and applications in cellular biology. Nucleotide immobilization on chips Sethi et al., Biotechnol. J. 2009, 4, 1513,1529 The development of oligonucleotide-based microarrays (biochips) is of major interest in science and biotechnology industry and has applications in a wide range of research areas including genomics, proteomics, computational biology and pharmaceuticals. Especially microarrays have proven to be a unique method for time and cost efficient analysis of thousands of genes at one. Authors from Delhi and Lucknow, India discuss currently used chemical strategies for immobilization of oligonucleotides and put a special emphasis on post-synthetic immobilization on glass surfaces. Recent advances on these synthesis pathways are presented in detail. [source]


Surface plasmon resonance for high-throughput ligand screening of membrane-bound proteins

BIOTECHNOLOGY JOURNAL, Issue 11 2009
Jennifer A. Maynard Dr.
Abstract Technologies based on surface plasmon resonance (SPR) have allowed rapid, label-free characterization of protein-protein and protein-small molecule interactions. SPR has become the gold standard in industrial and academic settings, in which the interaction between a pair of soluble binding partners is characterized in detail or a library of molecules is screened for binding against a single soluble protein. In spite of these successes, SPR is only beginning to be adapted to the needs of membrane-bound proteins which are difficult to study in situ but represent promising targets for drug and biomarker development. Existing technologies, such as BIAcoreTM, have been adapted for membrane protein analysis by building supported lipid layers or capturing lipid vesicles on existing chips. Newer technologies, still in development, will allow membrane proteins to be presented in native or near-native formats. These include SPR nanopore arrays, in which lipid bilayers containing membrane proteins stably span small pores that are addressable from both sides of the bilayer. Here, we discuss current SPR instrumentation and the potential for SPR nanopore arrays to enable quantitative, high-throughput screening of G protein coupled receptor ligands and applications in basic cellular biology. [source]


Promises of Biomarkers in Drug Development , A Reality Check

CHEMICAL BIOLOGY & DRUG DESIGN, Issue 6 2007
Estelle Marrer
Biomarkers have been a buzz word in drug development for the last 5 years. But where do we stand now? This perspective article will demonstrate to which extent biomarkers have impacted drug development and the use of drugs. In particular, the different types of biomarkers, their identification, validation and use in different phases of drug development from drug discovery, to approval, to clinical application will be discussed as well as the state-of-the-art biomarker technologies and promising future methods. The high interest in biomarkers has generated the need for development of new technologies and refinement of existing ones. Besides discussing their perspectives of applications, the present article also illustrates the future of biomarker development in terms of qualification for regulatory use and co-development. [source]