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.
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.
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.
Knowledge in the field of urologic pathology is growing at an explosive pace. Today’s pathologists, specialists, and residents require a comprehensive and authoritative text that examines the full range of urological diseases and their diagnosis. Written by recognized leaders and educators in the field, the text provides readers with a detailed understanding of all diagnostic aspects of urological disease. Inside this unique resource, readers will explore a broad spectrum of practical information—including etiology, diagnostic criteria, molecular markers, differential diagnosis, ancillary tests, and clinical management. This is sure to be the new definitive text for urological pathology!
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.
The use of biomarkers in basic and clinical research has become routine in many areas of medicine. They are accepted as molecular signatures that have been well characterized and repeatedly shown to be capable of predicting relevant disease states or clinical outcomes. In Role of Biomarkers in Medicine, expert researchers in their individual field have reviewed many biomarkers or potential biomarkers in various types of diseases. The topics address numerous aspects of medicine, demonstrating the current conceptual status of biomarkers as clinical tools and as surrogate endpoints in clinical research. This book highlights the current state of biomarkers and will aid scientists and clinicians to develop better and more specific biomarkers for disease management.
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
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.
This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
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
