Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

This book covers the discovery of molecular biomarkers, the development of laboratory testing techniques and their clinical applications, focusing on basic research to clinical practice. It introduces new and crucial knowledge and ethics of clinical molecular diagnosis. This book emphasizes the applications of clinical molecular diagnostic test on health management, especially from different diseased organs. It lets readers to understand and realize precision healthcare.

Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity covers background on artificial intelligence (AI), its link to precision medicine (PM), and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as AI has gained significant attention during the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems have enabled the generation of large datasets, making autoimmunity an ideal target for AI and precision medicine. More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large datasets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. - Allows the readers to gain an overview on precision medicine for autoimmune diseases leveraging AI solutions - Provides background, milestone and examples of precision medicine - Outlines the paradigm shift towards precision medicine driven by value-based systems - Discusses future applications of precision medicine research using AI - Other aspects covered in the book include regulatory insights, data analytics and visualization, types of biomarkers as well as the role of the patient in precision medicine

Medical care is the most critical issue of our time and will be so for the foreseeable future. In this regard, the pace and sophistication of advances in medicine in the past two decades have been truly breathtaking. This has necessitated a growing need for comprehensive reference resources that highlight current issues in specific sectors of medicine. Keeping this in mind, each volume in the Current Issues in Medicine series is a stand‐alone text that provides a broad survey of various important topics in a focused area of medicine—all accomplished in a user-friendly yet interconnected format. This volume addresses advances in medical imaging, detection, and diagnostic technologies. Technological innovations in these sectors of medicine continue to provide for safer, more accurate, and faster diagnosis for patients. This translates into superior prognosis and better patient compliance, while reducing morbidity and mortality. Hence, it is imperative that practitioners stay current with these latest advances to provide the best care for nursing and clinical practices. While recognizing how expansive and multifaceted these areas of medicine are, Advances in Medical Imaging, Detection, and Diagnosis addresses crucial recent progress, integrating the knowledge and experience of experts from academia and the clinic. The multidisciplinary approach reflected makes this volume a valuable reference resource for medical practitioners, medical students, nurses, fellows, residents, undergraduate and graduate students, educators, venture capitalists, policymakers, and biomedical researchers. A wide audience will benefit from having this volume on their bookshelf: health care systems, the pharmaceutical industry, academia, and government.

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

Antibody-drug conjugates (ADCs) stand at the verge of a transformation. Scores of clinical programs have yielded only a few regulatory approvals, but a wave of technological innovation now empowers us to overcome past technical challenges. This volume focuses on the next generation of ADCs and the innovations that will enable them. The book inspires the future by integrating the field’s history with novel strategies and cutting-edge technologies. While the book primarily addresses ADCs for solid tumors, the last chapter explores the emerging interest in using ADCs to treat other diseases. The therapeutic rationale of ADCs is strong: to direct small molecules to the desired site of action (and away from normal tissues) by conjugation to antibodies or other targeting moieties. However, the combination of small and large molecules imposes deep complexity to lead optimization, pharmacokinetics, toxicology, analytics and manufacturing. The field has made significant advances in all of these areas by improving target selection, ADC design, manufacturing methods and clinical strategies. These innovations will inspire and educate scientists who are designing next-generation ADCs with the potential to transform the lives of patients.

There are 28 different collagens, with 46 unique chains, which allows for a collagen for each time and place. Some collagens are specialized for basement membrane, whereas others are the central structural component of the interstitial matrix. There are eight collagens among the 20 most abundant proteins in the body, which makes these molecules essential building blocks of tissues. In addition, lessons learned from monogenomic mutations in these proteins result in grave pathologies, exemplifying their importance in development. These molecules, and their post-translationally modified products serve as biomarkers of diseases in a range of pathologies associated with the extracellular matrix. Biochemistry of Collagens, Laminins, and Elastin: Structure, Function, and Biomarkers, Second Edition provides researchers and students current data on key structural proteins (collagens, laminins, and elastin), reviews on how these molecules affect pathologies, and information on how selected modifications of proteins can result in altered signaling properties of the original extracellular matrix component. Further, it discusses the novel concept that an increasing number of components of the extracellular matrix harbor cryptic signaling functions that may be viewed as endocrine function, and it highlights how this knowledge can be exploited to modulate fibrotic disease. - Provides an updated comprehensive introduction to collagen and structural proteins - Gives insight into emerging analytical technologies that can detect biomarkers of extracellular matrix degradation - Includes seven new chapters, including one on how collagen biomarkers are used in clinical research to support drug development and in precision medicine - Contains insights into the biochemical interactions and changes to structural composition of proteins in disease states - Proves the importance of proteins for collagen assembly, function, and durability

This book includes a series of reviews on general aspects of biomarker use in the study of psychiatric and neurodegenerative diseases and the development of medications involved in their treatment. It describes the pros and cons of the various approaches and covers the successes and failures in this research field. It is only by a thorough understanding of the shortcomings that progress can be made. The overall goal is to facilitate the understanding and treatment of these disorders, by providing a viable mechanism of catching up with other areas of modern medicine, such as diabetes and heart disease. Finally, it is anticipated that the development and application of valid biomarker tests and the leveraging of novel drug targets will help the fields of psychiatry on neurodegenerative disorders move into the area of personalized medicine where the right patients can receive the right medication at the right time for the best possible outcome.

This book provides a comprehensive overview of the fast-evolving subject of clinical application of cancer therapeutic biomarkers. The second edition captures significant progress of cancer immunotherapy and emphasizes the genetic basis for selective cancer treatment. It covers an in-depth insight on biomarkers across a broad area of cancer research and oncology with a wealth of integrated genetic and molecular information about specific therapies by a multidisciplinary team of internationally recognized experts. Each chapter focuses on a class of targeted, immunologic, or chemotherapy agents and their companion biomarkers that predict response, benefit or resistance, and severe adverse event. The book will serve as a handbook for health professionals and scientists on the current applicable biomarkers in the management of cancer. The vision into the systemic classification and statistical consideration of therapeutic biomarkers summarized by the book editors and chapter authors will help advance precision medicine—a precisely tailored cancer treatment strategy for cancer patient care.

User-friendly and concise, the new edition of this popular reference is your #1 guide for the appropriate use of immunohistochemical stains. Dr. David J. Dabbs and leading experts in the field use a consistent, organ system approach to cover all aspects of the field, with an emphasis on the role of genomics in diagnosis and theranostic applications that will better inform treatment options. Each well-written and well-researched chapter is enhanced with diagnostic algorithms, charts, tables, and superb, full-color histologic images, making this text a practical daily resource for all surgical pathologists. Features a systematic approach to the diagnostic entities of each organ system, including detailed differential diagnoses, diagnostic algorithms, and immunohistograms that depict immunostaining patterns of tumors. Covers many more antigens than other texts, and discusses antibody specifications with tables that convey information on uses, clones, vendors, sources, antibody titers, and types of antigen retrieval. Discusses diagnostic pitfalls through immunohistologic differential diagnosis wherever appropriate so you can provide the most accurate diagnoses. Contains new material on non-lymphoid malignancies, Hodgkin/non-Hodgkin lymphoma, and an expanded chapter on digital imaging and quantitative immunohistochemistry. Provides new grading schemes for several organs, along with new antibodies to cover more genomic immunohistochemistry applications. Offers more emphasis in the breast section of "eyes on" tissue for molecular/IHC prognostics compared to the current trend of gene-expression profiling of breast cancer. Expert ConsultTM eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, and references from the book on a variety of devices.