Biomarkers In Drug 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 : 40,9 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 : 624 pages
File Size : 47,6 Mb
Release : 2020-02-28
Category : Medical
ISBN : 9781119187523

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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)

Biomarkers in Clinical Drug Development

John Bloom,Richard A. Dean
Biomarkers in Clinical Drug Development Book PDF

Author : John Bloom,Richard A. Dean
Publisher : CRC Press
Page : 312 pages
File Size : 53,9 Mb
Release : 2003-05-20
Category : Medical
ISBN : 9780824755195

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Biomarkers in Clinical Drug Development by John Bloom,Richard A. Dean Pdf

Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.

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 : 55,8 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.

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

Abdel Halim
Biomarkers Diagnostics and Precision Medicine in the Drug Industry Book PDF

Author : Abdel Halim
Publisher : Academic Press
Page : 294 pages
File Size : 54,9 Mb
Release : 2019-06-08
Category : Medical
ISBN : 9780128161227

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Biomarkers, Diagnostics and Precision Medicine in the Drug Industry by Abdel Halim Pdf

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

Atkinson's Principles of Clinical Pharmacology

Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr.
Atkinson s Principles of Clinical Pharmacology Book PDF

Author : Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr.
Publisher : Academic Press
Page : 764 pages
File Size : 42,5 Mb
Release : 2021-10-16
Category : Medical
ISBN : 9780128198841

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Atkinson's Principles of Clinical Pharmacology by Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr. Pdf

Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK

Predictive Biomarkers in Oncology

Sunil Badve,George Louis Kumar
Predictive Biomarkers in Oncology Book PDF

Author : Sunil Badve,George Louis Kumar
Publisher : Springer
Page : 642 pages
File Size : 52,5 Mb
Release : 2018-12-06
Category : Medical
ISBN : 9783319952284

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Predictive Biomarkers in Oncology by Sunil Badve,George Louis Kumar Pdf

“Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.

Statistical Methods in Biomarker and Early Clinical Development

Liang Fang,Cheng Su
Statistical Methods in Biomarker and Early Clinical Development Book PDF

Author : Liang Fang,Cheng Su
Publisher : Springer Nature
Page : 354 pages
File Size : 46,6 Mb
Release : 2019-12-26
Category : Medical
ISBN : 9783030315030

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Statistical Methods in Biomarker and Early Clinical Development by Liang Fang,Cheng Su Pdf

This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

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 : 50,7 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.

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 : 40,8 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.

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 : 55,7 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 : 41,8 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.

Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System

Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Glutamate Related Biomarkers in Drug Development for Disorders of the Nervous System Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 74 pages
File Size : 45,5 Mb
Release : 2011-07-05
Category : Medical
ISBN : 9780309212243

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Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Glutamate is the most pervasive neurotransmitter in the central nervous system (CNS). Despite this fact, no validated biological markers, or biomarkers, currently exist for measuring glutamate pathology in CNS disorders or injuries. Glutamate dysfunction has been associated with an extensive range of nervous system diseases and disorders. Problems with how the neurotransmitter glutamate functions in the brain have been linked to a wide variety of disorders, including schizophrenia, Alzheimer's, substance abuse, and traumatic brain injury. These conditions are widespread, affecting a large portion of the United States population, and remain difficult to treat. Efforts to understand, treat, and prevent glutamate-related disorders can be aided by the identification of valid biomarkers. The Institute of Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop on June 21-22, 2010, to explore ways to accelerate the development, validation, and implementation of such biomarkers. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary investigates promising current and emerging technologies, and outlines strategies to procure resources and tools to advance drug development for associated nervous system disorders. Moreover, this report highlights presentations by expert panelists, and the open panel discussions that occurred during the workshop.

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 : 631 pages
File Size : 44,8 Mb
Release : 2019-04-16
Category : Mathematics
ISBN : 9780429576737

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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.

Comprehensive Biomarker Discovery and Validation for Clinical Application

Péter Horvatovich,Rainer Bischoff
Comprehensive Biomarker Discovery and Validation for Clinical Application Book PDF

Author : Péter Horvatovich,Rainer Bischoff
Publisher : Royal Society of Chemistry
Page : 385 pages
File Size : 42,8 Mb
Release : 2013
Category : Medical
ISBN : 9781849734226

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Comprehensive Biomarker Discovery and Validation for Clinical Application by Péter Horvatovich,Rainer Bischoff Pdf

This book covers proteomics biomarker discovery and validation procedures from the clinical perspective.