Description

Book Synopsis

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

    Table of Contents

    List of Contributors vii

    Preface xiii

    Part I Biomarkers and Their Role in Drug Development 1

    1 Biomarkers are Not New 3
    Ian Dews

    2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 15
    Gregory J. Downing

    3 Enabling Go/No Go Decisions 31
    J. Fred Pritchard and M. Lynn Pritchard

    4 Developing a Clinical Biomarker Method with External Resources: A Case Study 43
    Ross A. Fredenburg

    Part II Identifying New Biomarkers: Technology Approaches 51

    5 Imaging as a Localized Biomarker: Opportunities and Challenges 53
    Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro

    6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research 89
    Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro

    7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges 113
    Miranda K. Culley and Stephen Y. Chan

    Part III Characterization, Validation, and Utilization 139

    8 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective 141
    Federico Goodsaid

    9 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 149
    Jean W. Lee, Yuling Wu, and Jin Wang

    10 Applying Statistics Appropriately for Your Biomarker Application 177
    Mary Zacour

    Part IV Biomarkers in Discovery and Preclinical Safety 219

    11 Qualification of Safety Biomarkers for Application to Early Drug Development 221
    William B. Mattes and Frank D. Sistare

    12 A Pathologist’s View of Drug and Biomarker Development 233
    Robert W. Dunstan

    13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901 255
    Alan P. Brown

    14 New Markers of Kidney Injury 281
    Sven A. Beushausen

    Part V Translating from Preclinical to Clinical and Back 307

    15 Biomarkers from Bench to Bedside and Back – Back-Translation of Clinical Studies to Preclinical Models 309
    Damian O'Connell, David Adler, Frank Kramer, and Matthias Ocker

    16 Translational Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 333
    Giora Z. Feuerstein, Salvatore Alesci, Frank L.Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo Jr.

    17 Clinical Validation and Biomarker Translation 347
    Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt

    18 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 365
    Christina Trollmo and Lars Klareskog

    19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints 379
    Calvert Louden and Ruth A. Roberts

    Part VI Biomarkers in Clinical Trials 389

    20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development 391
    Kay A. Criswell

    21 Integrating Molecular Testing into Clinical Applications 409
    Anthony A. Killeen

    Part VII Big Data, Data Mining, and Biomarkers 421

    22 IT Supporting Biomarker-Enabled Drug Development 423
    Michael Hehenberger

    23 Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Health Care Data – Implications for Clinical Management and Clinical Trial Design: A Case Study in Anemia of Chronic Kidney Disease 447
    Gregory P. Fusco

    24 Computational Biology Approaches to Support Biomarker Discovery and Development 469
    Bin Li, Hyunjin Shin, William L. Trepicchio, and Andrew Dorner

    Part VIII Lessons Learned: Practical Aspects of Biomarker Implementation 485

    25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 487
    Lena King, Mallé Jurima-Romet, and Nita Ichhpurani

    26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 505
    Bruce D. Car, Brian Gemzik, and William R. Foster

    Part IX Where are We Heading and What Do We Really Need? 515

    27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection 517
    Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus

    28 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find 537
    Michael R. Bleavins and Ramin Rahbari

    29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow 553
    Patrick McConville and Deanne Lister

    Index 585

Biomarkers in Drug Discovery and Development

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    £170.00

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    Order before 4pm today for delivery by Sat 20 Jun 2026.

    A Hardback by R Rahbari, Jonathan Van Niewaal, Michael R. Bleavins

    15 in stock

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      Publisher: John Wiley & Sons Inc
      Publication Date: 1/30/2020 12:04:00 AM
      ISBN13: 9781119187509, 978-1119187509
      ISBN10: 1119187508
      Also in:
      Chemistry

      Description

      Book Synopsis

      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

        Table of Contents

        List of Contributors vii

        Preface xiii

        Part I Biomarkers and Their Role in Drug Development 1

        1 Biomarkers are Not New 3
        Ian Dews

        2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 15
        Gregory J. Downing

        3 Enabling Go/No Go Decisions 31
        J. Fred Pritchard and M. Lynn Pritchard

        4 Developing a Clinical Biomarker Method with External Resources: A Case Study 43
        Ross A. Fredenburg

        Part II Identifying New Biomarkers: Technology Approaches 51

        5 Imaging as a Localized Biomarker: Opportunities and Challenges 53
        Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro

        6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research 89
        Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro

        7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges 113
        Miranda K. Culley and Stephen Y. Chan

        Part III Characterization, Validation, and Utilization 139

        8 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective 141
        Federico Goodsaid

        9 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 149
        Jean W. Lee, Yuling Wu, and Jin Wang

        10 Applying Statistics Appropriately for Your Biomarker Application 177
        Mary Zacour

        Part IV Biomarkers in Discovery and Preclinical Safety 219

        11 Qualification of Safety Biomarkers for Application to Early Drug Development 221
        William B. Mattes and Frank D. Sistare

        12 A Pathologist’s View of Drug and Biomarker Development 233
        Robert W. Dunstan

        13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901 255
        Alan P. Brown

        14 New Markers of Kidney Injury 281
        Sven A. Beushausen

        Part V Translating from Preclinical to Clinical and Back 307

        15 Biomarkers from Bench to Bedside and Back – Back-Translation of Clinical Studies to Preclinical Models 309
        Damian O'Connell, David Adler, Frank Kramer, and Matthias Ocker

        16 Translational Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 333
        Giora Z. Feuerstein, Salvatore Alesci, Frank L.Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo Jr.

        17 Clinical Validation and Biomarker Translation 347
        Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt

        18 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 365
        Christina Trollmo and Lars Klareskog

        19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints 379
        Calvert Louden and Ruth A. Roberts

        Part VI Biomarkers in Clinical Trials 389

        20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development 391
        Kay A. Criswell

        21 Integrating Molecular Testing into Clinical Applications 409
        Anthony A. Killeen

        Part VII Big Data, Data Mining, and Biomarkers 421

        22 IT Supporting Biomarker-Enabled Drug Development 423
        Michael Hehenberger

        23 Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Health Care Data – Implications for Clinical Management and Clinical Trial Design: A Case Study in Anemia of Chronic Kidney Disease 447
        Gregory P. Fusco

        24 Computational Biology Approaches to Support Biomarker Discovery and Development 469
        Bin Li, Hyunjin Shin, William L. Trepicchio, and Andrew Dorner

        Part VIII Lessons Learned: Practical Aspects of Biomarker Implementation 485

        25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 487
        Lena King, Mallé Jurima-Romet, and Nita Ichhpurani

        26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 505
        Bruce D. Car, Brian Gemzik, and William R. Foster

        Part IX Where are We Heading and What Do We Really Need? 515

        27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection 517
        Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus

        28 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find 537
        Michael R. Bleavins and Ramin Rahbari

        29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow 553
        Patrick McConville and Deanne Lister

        Index 585

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