Biomarkers In Drug Discovery And Development

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Biomarkers in Drug Development

Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
Biomarkers in Drug Development Book PDF

Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
Publisher : John Wiley & Sons
Page : 559 pages
File Size : 55,8 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210420

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Biomarkers in Drug Development by Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari Pdf

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.

Biomarkers in Drug Discovery and Development

Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
Biomarkers in Drug Discovery and Development Book PDF

Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
Publisher : John Wiley & Sons
Page : 608 pages
File Size : 51,5 Mb
Release : 2020-02-28
Category : Medical
ISBN : 9781119187516

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Biomarkers in Drug Discovery and Development by Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins Pdf

This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. • Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine • Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory • Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring • Includes case studies of biomarkers that have helped and hindered decision making • Reviews of the first edition: “If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and “...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation.” (ChemMedChem)

Accelerating the Development of Biomarkers for Drug Safety

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Accelerating the Development of Biomarkers for Drug Safety Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 100 pages
File Size : 50,9 Mb
Release : 2009-08-20
Category : Medical
ISBN : 9780309131247

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Accelerating the Development of Biomarkers for Drug Safety by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Predictive Approaches in Drug Discovery and Development

J. Andrew Williams,Richard Lalonde,Jeffrey R. Koup,David D. Christ
Predictive Approaches in Drug Discovery and Development Book PDF

Author : J. Andrew Williams,Richard Lalonde,Jeffrey R. Koup,David D. Christ
Publisher : John Wiley & Sons
Page : 420 pages
File Size : 44,6 Mb
Release : 2012-02-14
Category : Medical
ISBN : 9781118230268

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Predictive Approaches in Drug Discovery and Development by J. Andrew Williams,Richard Lalonde,Jeffrey R. Koup,David D. Christ Pdf

Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

Biomarker Methods in Drug Discovery and Development

Feng Wang
Biomarker Methods in Drug Discovery and Development Book PDF

Author : Feng Wang
Publisher : Springer Science & Business Media
Page : 407 pages
File Size : 54,7 Mb
Release : 2008-03-11
Category : Medical
ISBN : 9781934115237

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Biomarker Methods in Drug Discovery and Development by Feng Wang Pdf

In this book, expert researchers provide a tool box for those who have a general interest in biomarker research and for those currently specializing in certain technologies but desiring an understanding of other available methodologies. Its chapters include validated, mature methods as well as new, incredibly promising protocols. This book is the perfect biomarker technical guideline and reference to stimulate more exciting biomarker research and technology development.

Handbook of Biomarkers and Precision Medicine

Claudio Carini,Mark Fidock,Alain van Gool
Handbook of Biomarkers and Precision Medicine Book PDF

Author : Claudio Carini,Mark Fidock,Alain van Gool
Publisher : CRC Press
Page : 1025 pages
File Size : 48,8 Mb
Release : 2019-04-16
Category : Mathematics
ISBN : 9780429574627

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Handbook of Biomarkers and Precision Medicine by Claudio Carini,Mark Fidock,Alain van Gool Pdf

"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.

Genomic Biomarkers for Pharmaceutical Development

Yihong Yao,Bahija Jallal,Koustubh Ranade
Genomic Biomarkers for Pharmaceutical Development Book PDF

Author : Yihong Yao,Bahija Jallal,Koustubh Ranade
Publisher : Academic Press
Page : 203 pages
File Size : 41,5 Mb
Release : 2013-07-16
Category : Medical
ISBN : 9780123977946

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Genomic Biomarkers for Pharmaceutical Development by Yihong Yao,Bahija Jallal,Koustubh Ranade Pdf

Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development. Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs Authored by leading international experts from industry and academia

Accelerating the Development of Biomarkers for Drug Safety

Forum on Drug Discovery Development and Translation
Accelerating the Development of Biomarkers for Drug Safety Book PDF

Author : Forum on Drug Discovery Development and Translation
Publisher : Unknown
Page : 128 pages
File Size : 55,6 Mb
Release : 2009-07-20
Category : Electronic
ISBN : 0309381703

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Accelerating the Development of Biomarkers for Drug Safety by Forum on Drug Discovery Development and Translation Pdf

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.

Genomics in Drug Discovery and Development

Dimitri Semizarov,Eric Blomme
Genomics in Drug Discovery and Development Book PDF

Author : Dimitri Semizarov,Eric Blomme
Publisher : John Wiley & Sons
Page : 496 pages
File Size : 49,7 Mb
Release : 2008-11-03
Category : Medical
ISBN : 9780470409763

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Genomics in Drug Discovery and Development by Dimitri Semizarov,Eric Blomme Pdf

Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

Biomarkers

Vishal S. Vaidya,Joseph V. Bonventre
Biomarkers Book PDF

Author : Vishal S. Vaidya,Joseph V. Bonventre
Publisher : John Wiley & Sons
Page : 632 pages
File Size : 53,8 Mb
Release : 2010-10-28
Category : Science
ISBN : 0470918551

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Biomarkers by Vishal S. Vaidya,Joseph V. Bonventre Pdf

This book provides an introduction to the field of biomarkers, how they have been and can be used, and how different approaches can be used to identify, characterize, and monitor biomarkers. The book has chapters on topics including HIV, Cancer, Parkinson’s, vascular injury, environmental exposure. A following section discusses the technologies (diagnostics and assays) to detect biomarkers and authors have emphasized the preclinical and clinical manifestation of the injury/disease process.

Biomarkers for Alzheimer’s Disease Drug Development

Robert Perneczky
Biomarkers for Alzheimer s Disease Drug Development Book PDF

Author : Robert Perneczky
Publisher : Humana Press
Page : 372 pages
File Size : 50,8 Mb
Release : 2018-03-07
Category : Medical
ISBN : 1493977032

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Biomarkers for Alzheimer’s Disease Drug Development by Robert Perneczky Pdf

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.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Improving and Accelerating Therapeutic Development for Nervous System Disorders Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 107 pages
File Size : 45,8 Mb
Release : 2014-02-06
Category : Medical
ISBN : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Drug Discovery and Evaluation Methods in Clinical Pharmacology Book PDF

Author : H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Publisher : Springer Science & Business Media
Page : 576 pages
File Size : 45,9 Mb
Release : 2010-12-15
Category : Medical
ISBN : 9783540898900

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology by H.Gerhard Vogel,Jochen Maas,Alexander Gebauer Pdf

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development

Steven J. Potts,David A. Eberhard,Keith A. Wharton, Jr.
Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development Book PDF

Author : Steven J. Potts,David A. Eberhard,Keith A. Wharton, Jr.
Publisher : Humana
Page : 0 pages
File Size : 40,5 Mb
Release : 2016-10-29
Category : Medical
ISBN : 1493954202

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Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development by Steven J. Potts,David A. Eberhard,Keith A. Wharton, Jr. Pdf

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.

Flow Cytometry in Drug Discovery and Development

Virginia Litwin,Philip Marder
Flow Cytometry in Drug Discovery and Development Book PDF

Author : Virginia Litwin,Philip Marder
Publisher : John Wiley & Sons
Page : 404 pages
File Size : 40,7 Mb
Release : 2011-04-20
Category : Medical
ISBN : 9780470922781

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Flow Cytometry in Drug Discovery and Development by Virginia Litwin,Philip Marder Pdf

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.