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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)
List 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: Prac
About the author
RAMIN RAHBARI, MS, MBA, is an expert in biomarkers at Innovative Scientific Management and has previously held similar consulting and research positions at IBM, Cognizant and Pfizer.
JONATHAN VAN NIEWAAL, MBA, is Technology Principal at Innovative Scientific Management and has held software development and technology delivery roles in the healthcare, financial services, and technology industries.
MICHAEL R. BLEAVINS, PHD, DABT, is the founder of White Crow Innovation, LLC, a Michigan-based drug development consulting company, and cofounder of Michigan Technology and Research Institute.
Summary
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)
