Download or read book Development and Application of Biomarkers written by Roger L. Lundblad and published by CRC Press. This book was released on 2016-04-19 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: First introduced to biomedical research in 1980, the term biomarker has taken on a life of its own in recent years and has come to mean a number of things. In biomedical science, biomarker has evolved to most commonly mean a characteristic that can be used either as a diagnostic or a prognostic, but most significantly as a screening indicator for p

Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Download or read book Neuroscience Biomarkers and Biosignatures written by Institute of Medicine and published by National Academies Press. This book was released on 2008-01-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.

Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Download or read book Glutamate Related Biomarkers in Drug Development for Disorders of the Nervous System written by Institute of Medicine and published by National Academies Press. This book was released on 2011-08-05 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glutamate is the most pervasive neurotransmitter in the central nervous system (CNS). Despite this fact, no validated biological markers, or biomarkers, currently exist for measuring glutamate pathology in CNS disorders or injuries. Glutamate dysfunction has been associated with an extensive range of nervous system diseases and disorders. Problems with how the neurotransmitter glutamate functions in the brain have been linked to a wide variety of disorders, including schizophrenia, Alzheimer's, substance abuse, and traumatic brain injury. These conditions are widespread, affecting a large portion of the United States population, and remain difficult to treat. Efforts to understand, treat, and prevent glutamate-related disorders can be aided by the identification of valid biomarkers. The Institute of Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop on June 21-22, 2010, to explore ways to accelerate the development, validation, and implementation of such biomarkers. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary investigates promising current and emerging technologies, and outlines strategies to procure resources and tools to advance drug development for associated nervous system disorders. Moreover, this report highlights presentations by expert panelists, and the open panel discussions that occurred during the workshop.

Download or read book The Detection of Biomarkers written by Sibel A. Ozkan and published by Academic Press. This book was released on 2021-12-05 with total page 615 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical researchers. Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection. Locates biomarker detection in its research context, setting out present and future prospects Allows clinical researchers to compare various biomarker assays systematically Presents new methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical Gives innovative biomarker assays that are viable alternatives to current complex methods Helps clinical researchers who need reliable, precise and accurate biomarker detection methods

Download or read book Biomarkers Diagnostics and Precision Medicine in the Drug Industry written by Abdel Halim and published by Academic Press. This book was released on 2019-06-08 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Download or read book Statistical Methods in Biomarker and Early Clinical Development written by Liang Fang and published by Springer Nature. This book was released on 2019-12-26 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

Download or read book Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development written by Steven J. Potts and published by Humana. This book was released on 2016-10-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the Methods in Pharmacology and Toxicology series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development. Comprehensive and practical, Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy.

Download or read book Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2021-01-15 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of the overall disability determination process, the Social Security Administration uses a step-by-step approach to understand how severe an individual's condition is and whether it meets program criteria for disability. The use of various types of biomarkers has been suggested as a way to strengthen the amount and quality of objective evidence available to the review process. At the request of the Social Security Administration, the National Academies of Sciences, Engineering, and Medicine's Board on Health Care Services organized a virtual workshop on July 21, 2020, titled The State of the Science of the Use of Biomarkers to Establish the Presence and Severity of Impairments. Workshop discussions focused on the current and potential uses for biomarkers; explored legal and ethical implications associated with biomarker use in clinical decision making; and considered the possible uses of nongenetic biomarkers as tools for the diagnosis or prognosis of the severity of specific physical and mental impairments. This publication summarizes the presentations and discussion of the workshop.

Download or read book Proteomic and Metabolomic Approaches to Biomarker Discovery written by Haleem J. Issaq and published by Academic Press. This book was released on 2013-05-20 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteomic and Metabolomic Approaches to Biomarker Discovery demonstrates how to leverage biomarkers to improve accuracy and reduce errors in research. Disease biomarker discovery is one of the most vibrant and important areas of research today, as the identification of reliable biomarkers has an enormous impact on disease diagnosis, selection of treatment regimens, and therapeutic monitoring. Various techniques are used in the biomarker discovery process, including techniques used in proteomics, the study of the proteins that make up an organism, and metabolomics, the study of chemical fingerprints created from cellular processes. Proteomic and Metabolomic Approaches to Biomarker Discovery is the only publication that covers techniques from both proteomics and metabolomics and includes all steps involved in biomarker discovery, from study design to study execution. The book describes methods, and presents a standard operating procedure for sample selection, preparation, and storage, as well as data analysis and modeling. This new standard effectively eliminates the differing methodologies used in studies and creates a unified approach. Readers will learn the advantages and disadvantages of the various techniques discussed, as well as potential difficulties inherent to all steps in the biomarker discovery process. A vital resource for biochemists, biologists, analytical chemists, bioanalytical chemists, clinical and medical technicians, researchers in pharmaceuticals, and graduate students, Proteomic and Metabolomic Approaches to Biomarker Discovery provides the information needed to reduce clinical error in the execution of research. Describes the use of biomarkers to reduce clinical errors in research Includes techniques from a range of biomarker discoveries Covers all steps involved in biomarker discovery, from study design to study execution

Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers proteomics biomarker discovery and validation procedures from the clinical perspective.

Download or read book Biomarkers for Alzheimer s Disease Drug Development written by Robert Perneczky and published by Humana Press. This book was released on 2018-03-07 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume aims to build a new generation of experts with a broader understanding of key topics in the Alzheimer’s disease field. Chapters guide readers through innovative approaches to the discovery of novel biomarkers in cerebrospinal fluid, innovation in blood-based biomarkers, a comprehensive overview of magnetic resonance imaging and molecular imaging approaches and their value for developing drugs for Alzheimer’s disease, cutting-edge developments in neuropathology and their relevance for Alzheimer’s disease trials, novel genomic strategies for biomarker development, and related topics including neuropsychological testing and advanced analytical methods.Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Biomarkers for Alzheimer's Disease Drug Development aims to ensure successful results in the further study of this vital field.

Download or read book The Handbook of Biomarkers written by Kewal K. Jain and published by Springer Science & Business Media. This book was released on 2010-02-06 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Download or read book The Neuroethics of Biomarkers written by Matthew L. Baum and published by Oxford University Press. This book was released on 2016-02-11 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neuroscientists are mining nucleic acids, blood, saliva, and brain images in hopes of uncovering biomarkers that could help estimate risk of brain disorders like psychosis and dementia; though the science of bioprediction is young, its prospects are unearthing controversy about how bioprediction should enter hospitals, courtrooms, or state houses. While medicine, law, and policy have established protocols for how presence of disorders should change what we owe each other or who we blame, they have no stock answers for the probabilities that bioprediction offers. The Neuroethics of Biomarkers observes, however, that for many disorders, what we really care about is not their presence per se, but certain risks that they carry. The current reliance of moral and legal structures on a categorical concept of disorder (sick verses well), therefore, obscures difficult questions about what types and magnitudes of probabilities matter. Baum argues that progress in the neuroethics of biomarkers requires the rejection of the binary concept of disorder in favor of a probabilistic one based on biological variation with risk of harm, which Baum names a "Probability Dysfunction." This risk-reorientation clarifies practical ethical issues surrounding the definition of mental disorder in the DSM-5 and the nosology of conditions defined by risk of psychosis and dementia. Baum also challenges the principle that the acceptability of bioprediction should depend primarily on whether it is medically useful by arguing that biomarkers can also be morally useful through enabling moral agency, better assessment of legal responsibility, and fairer distributive justice. The Neuroethics of Biomarkers should be of interest to those within neuroethics, medical ethics, and the philosophy of psychiatry.

Download or read book Imaging Biomarkers written by Luis Martí-Bonmatí and published by Springer. This book was released on 2016-11-03 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book to cover all aspects of the development of imaging biomarkers and their integration into clinical practice, from the conceptual basis through to the technical aspects that need to be considered in order to ensure that medical imaging can serve as a powerful quantification instrument capable of providing valuable information on organ and tissue properties. The process of imaging biomarker development is considered step by step, covering proof of concept, proof of mechanism, image acquisition, image preparation, imaging biomarker analysis and measurement, detection of measurement biases (proof of principle), proof of efficacy and effectiveness, and reporting of results. Sources of uncertainty in the accuracy and precision of measurements and pearls and pitfalls in gold standards and biological correlation are discussed. In addition, practical use cases are included on imaging biomarker implementation in brain, oncologic, cardiovascular, musculoskeletal, and abdominal diseases. The authors are a multidisciplinary team of expert radiologists and engineers, and the book will be of value to all with an interest in the quantitative imaging of biomarkers in personalized medicine.