Download or read book Towards translating research to clinical practice Novel Strategies for Discovery and Validation of Biomarkers for Brain Injury written by Stefania Mondello and published by Frontiers Media SA. This book was released on 2015-02-25 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traumatic brain injury (TBI) is a major cause of death and disability and one of the greatest unmet needs in medicine and public health. TBI not only has devastating effects on patients and their relatives but results in huge direct and indirect costs to society. Although guidelines for the management of patients have been developed and more than 200 clinical trials have been conducted, they have resulted in few improvements in clinical outcomes and no effective therapies approved for TBI. It is now apparent that the heterogeneity of clinical TBI is underlain by molecular phenotypes more complex and interactive than initially conceived and current approaches to the characterization, management and outcome prediction of TBI are antiquated, unidimensional and inadequate to capture the interindividual pathophysiological heterogeneity. Recent advances in proteomics and biomarker development provide unparalleled opportunities for unraveling substantial injury-specific and patient-specific variability and refining disease characterization. The identification of novel, sensitive, objective tools, referred to as biomarkers, can revolutionize pathophysiological insights, enable targeted therapies and personalized approaches to clinical management. In this Research Topic, we present novel approaches that provide an infrastructure for discovery and validation of new biomarkers of acute brain injury. These techniques include refined mass spectrometry technology and high throughput immunoblot techniques. Output from these approaches can identify potential candidate biomarkers employing systems biology and data mining methods. In this Research Topic, we present novel approaches that provide an infrastructure for discovery and validation of new biomarkers of acute brain injury. These techniques include refined mass spectrometry technology and high throughput immunoblot techniques. Output from these approaches can identify potential candidate biomarkers employing systems biology and data mining methods. Finally, suggestions are provided for the way forward, with an emphasis on need for a multidimensional approach that integrate a panel of pathobiologically diverse biomarkers with clinical variables and imaging-based assessments to improve diagnosis and classification of TBI and to develop best clinical practice guidelines.
Download or read book Novel Strategies for Discovery Validation and FDA Approval of Biomarkers for Acute and Chronic Brain Injury written by S. Mondello and published by . This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Novel Strategies for Discovery Validation and FDA Approval of Biomarkers for Acute and Chronic Brain Injury written by S. Mondello and published by . This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Strategies for Discovery, Validation and FDA Approval of Biomarkers for Acute and Chronic Brain Injury.
Download or read book Biomarkers for Traumatic Brain Injury written by Alan H.B. Wu and published by Academic Press. This book was released on 2020-07-10 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers for Traumatic Brain Injury provides a comprehensive overview on the selection and implementation of serum-based and saliva-based biomarkers for traumatic brain injury. The book presents an economic analysis for implementing TBI biomarkers into clinical practice. In addition, it discusses the analytical tools needed to implement TBI biomarkers, including specifications for testing instruments and interpretative software. Neurologists, emergency department physicians, intensivists, and clinical laboratorians will find this book a great resource from which to familiarize themselves with the issues and processes regarding TBI biomarkers. Approximately 2 million people in the U.S. sustain a traumatic brain injury (TBI) each year with over 250,000 hospitalizations and 50,000 deaths. There has been a significant rise in interest in diagnosing mild concussions, particularly in the sports world. While imaging has been the gold standard, these procedures are costly and not always available. There is great potential in using serum-based biomarkers, hence the book seeks to enlighten readers on new possibilities. - Offers strategies for the selection and implementation of traumatic brain injury biomarkers - Discusses the importance of autoantibodies and post translational modifications for TBI - Covers the analytical tools needed to implement TBI biomarkers, including the specifications for testing instruments and interpretative software
Download or read book Translating Molecular Biomarkers into Clinical Assays written by Russell Weiner and published by Springer. This book was released on 2016-08-22 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.
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 Biomarker Discovery in the Developing World Dissecting the Pipeline for Meeting the Challenges written by Sanjeeva Srivastava and published by Springer. This book was released on 2016-09-30 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is oriented towards post-graduates and researchers with interest in proteomics and its applications in clinical biomarker discovery pipeline. Biomarker discovery has long been the research focus of many life scientists globally. However, the pipeline starting from discovery to validation to regulation as a diagnostic or therapeutic molecule follows a complex trajectory. This book aims to provide an in-depth synopsis on each of these developmental phases attendant to biomarker “life cycle” with emphasis on the emerging and significant role of proteomics. The book begins with a perspective on the role of biorepositories and need for biobanking practices in the developing world. The next chapter focuses on disease heterogeneity in context to geographical bias towards susceptibility to the disease and the role of multi-omics techniques to devise disruptive innovations towards biomarker discovery. Chapter 3 focuses on various omics-based platforms that are currently being used for biomarker discovery, their principles and workflow. Mass spectrometry is emerging as a powerful technology for discovery based studies and targeted validation. Chapter 4 aims at providing a glimpse of the basic workflow and considerations in mass spectrometry based studies. Rapid and aptly targeted research funding has often been deemed as one of the decisive factors enabling excellent science and path breaking innovations. With the need for sophistication required in multi-omics research, Chapter 5 focuses on innovative funding strategies such as crowdfunding and Angel philanthropy. Chapter 6 provides the latest advances in education innovation, the premise and reality of bioeconomy especially in a specific context of the developing world, not to mention the new concept of “social innovation” to link biomarkers with socially responsible and sustainable applications. Chapter 7, in ways similar to biomarkers, discusses the biosimilars as a field that has received much focus and prominence recently due to their immense potential in clinical and pharmaceutical innovation literatures. The broader goal post-biomarker discovery is to translate their use in clinics. However, the road from bench-to-bed side is arduous and complex that is subject to oversight from various national and international regulatory bodies. Chapter 8 underscores these regulatory science considerations and provides a concise overview on intellectual property rights in biomarker discovery. Thus, this book contributed by eminent biomarker scientists, clinicians, translational researchers and social scientists holistically covers the various facets of the biomarker discovery journey from “cell to society” in developing world. The lessons learned and highlighted here are of interest to the life sciences community in a global and interdependent world.
Download or read book Biomarkers of Brain Damage A Complex Challenge with Great Potential written by Olli Tenovuo and published by Frontiers Media SA. This book was released on 2021-05-10 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Olli Tenovuo is consultant and member of SAB for NeuroTrauma Sciences LLC (Georgia, USA) and ABCDx SA (Geneva, Switzerland). Jean-Charles Sanchez has a research grant to disclose from ABCDx SA, (Geneva, Switzerland). Damir Janigro is the CEO of FloTBI Inc. (Cleveland, USA), a company interested in biomarkers of neurological diseases.
Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.
Download or read book Biomarkers for Traumatic Brain Injury written by National Academies of Sciences, Engineering, and Medicine and published by . This book was released on 2024-01-04 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Academies Forum on Traumatic Brain Injury (TBI) convened a workshop in September 2022 to explore biomarkers used to more precisely and objectively diagnose and categorize suspected TBIs. Session discussions addressed developments in TBI biomarker classes including neuroimaging, blood-based, electrophysiological, and other physiological markers; how biomarkers may be used to better guide and monitor treatment after injury; and how they can be used to refine future research studies. Speakers also discussed potential impacts of biomarkers across the trajectory of TBI care and research, efforts to translate and incorporate biomarkers from research settings into clinical practice, and opportunities to advance the field. This Proceedings of a Workshop summarizes the presentations and discussions from the event.
Download or read book Translational Research in Traumatic Brain Injury written by Daniel Laskowitz and published by CRC Press. This book was released on 2016-04-21 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traumatic brain injury (TBI) remains a significant source of death and permanent disability, contributing to nearly one-third of all injury related deaths in the United States and exacting a profound personal and economic toll. Despite the increased resources that have recently been brought to bear to improve our understanding of TBI, the developme
Download or read book Biomarker Validation written by Harald Seitz and published by John Wiley & Sons. This book was released on 2015-06-02 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.
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 Pre Clinical and Clinical Methods in Brain Trauma Research written by Amit K. Srivastava and published by Humana. This book was released on 2019-07-13 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores current viewpoints and knowledge gaps in the field of traumatic brain injury (TBI). The chapters in this book cover topics ranging from development of in vitro and animal TBI models, to diagnostic imaging and disease monitoring in patients. Designing pre-clinical and clinical trials is also discussed. In Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory. Practical and thorough, Pre-Clinical and Clinical Methods in Brain Trauma Research is a valuable resource for both scientists and clinical researchers interested in learning about important techniques and their applications in the field of TBI.
Download or read book Biomarkers for Traumatic Brain Injury written by Svetlana Dambinova and published by Royal Society of Chemistry. This book was released on 2012 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to injuries sustained in sports and in combat, interest in traumatic brain injury (TBI) has never been greater. This book will fulfill a gap in understanding of what is occurring in the brain following injury that can subsequently be detected in biological fluids and imaging.
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 Neuroproteomics written by Andrew K. Ottens and published by . This book was released on 2009 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: "With the development of polypeptide ionization processes for mass spectrometry and the rapid processing of large-scale datasets with bioinformatics, researchers now have the tools necessary to propel neuroproteomics research to new levels. In Neuroproteomics: Methods and Protocols, experts in the neurological and analytical sciences present experimental details for applying proteomics to the study of the central nervous system (CNS) and its dysfunction through trauma and disease. Divided into four convenient sections, this collection covers CNS animal models used for neuroproteomics research, methods for separating and analyzing discrete subcomponents of the neuroproteome, large-scale approaches for CNS proteome characterization and quantification, as well as methods that evaluate biofluids and translate neuroproteomic results into clinical platforms. As a volume in the highly successful Methods in Molecular Biology series, chapters include brief introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and notes on troubleshooting and avoiding known pitfalls." "Authoritative and cutting-edge, Neuroproteomics: Methods and Protocols includes the clear "how-to" information needed to critically assess what can be accomplished in the field and how to best perform and evaluate neuroproteomic experiments in one's own research." --Book Jacket.
