Comprehensive Biomarker Discovery and Validation for Clinical Application

Comprehensive Biomarker Discovery and Validation for Clinical Application

Author: Péter Horvatovich

Publisher: Royal Society of Chemistry

Published: 2013-06-17

Total Pages: 385

ISBN-13: 1849734364

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This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and EMEA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well-described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers, and those managing biobanks.


The Handbook of Biomarkers

The Handbook of Biomarkers

Author: Kewal K. Jain

Publisher: Humana

Published: 2014-09-19

Total Pages: 0

ISBN-13: 9781627038362

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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.


Biomarker Validation

Biomarker Validation

Author: Harald Seitz

Publisher: John Wiley & Sons

Published: 2015-02-23

Total Pages: 264

ISBN-13: 3527680667

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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.


Companion and Complementary Diagnostics

Companion and Complementary Diagnostics

Author: Jan Trøst Jørgensen

Publisher: Academic Press

Published: 2019-05-09

Total Pages: 0

ISBN-13: 9780128135396

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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.


Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine

Author: Claudio Carini

Publisher: CRC Press

Published: 2019-04-16

Total Pages: 1025

ISBN-13: 0429574622

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"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.


Biomarkers in Cancer Screening and Early Detection

Biomarkers in Cancer Screening and Early Detection

Author: Sudhir Srivastava

Publisher: John Wiley & Sons

Published: 2017-06-07

Total Pages: 494

ISBN-13: 1118468821

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Prepared by world leaders on this topic, Biomarkers in Cancer Screening and Early Detection offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers, from their discovery and development to their validation, clinical utility, and use in developing personalized cancer treatment. Offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers Provides immediately actionable information and hopefully also inspiration to move discovery and clinical application forward Offers vital knowledge to help develop personalized cancer treatment for individual patients with specific cancers


Development and Application of Biomarkers

Development and Application of Biomarkers

Author: Roger L. Lundblad

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 294

ISBN-13: 1439819807

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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


Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges

Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges

Author: Sanjeeva Srivastava

Publisher: Springer

Published: 2016-09-30

Total Pages: 120

ISBN-13: 8132228375

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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.


The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification

Author: Federico Goodsaid

Publisher: Academic Press

Published: 2013-07-16

Total Pages: 207

ISBN-13: 0123944082

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The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities


Biomarkers in Inflammatory Bowel Diseases

Biomarkers in Inflammatory Bowel Diseases

Author: Nik Sheng Ding

Publisher: Springer

Published: 2019-05-13

Total Pages: 355

ISBN-13: 3030114465

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This book provides a comprehensive and complete overview of biomarkers in clinical practice for inflammatory bowel disease (IBD) bringing together the literature in a clear and concise manner. The book bridges the gap between growing knowledge at the bench and current and future applications of biomarkers in clinical practice. The central structure of the book focuses on prognostic and predictive biomarkers in IBD with an emphasis on the fields of research and scientific techniques (genomics, proteomics and metabonomics) that have led to biomarker discovery and places these biomarkers within a clinical context to help understand their utility in clinical practice. This book will be of use to clinicians who have an interest in using biomarkers in clinical practice as well as clinician researchers and scientists involved in the biomarker research pipeline. The author team comprises experts from around the world in order to bring together the literature in an effort to inform clinicians and researchers about the current state-of-the art in biomarker discovery. It is intended to assist future research efforts and indicate how biomarkers might be best applied to clinical practice both at present and in the future.