Biomarkers in Drug Discovery and Development: A Handbook of Practice, Application, and Strategy

ISBN-13: 9781119187509 / Angielski / Twarda / 2020 / 608 str.

Michael R. Bleavins; Ramin Rahbari; Jonathan Van Niewaal

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List of Contributors viiPreface xiiiPart I Biomarkers and Their Role in Drug Development 11 Biomarkers are Not New 3Ian Dews2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 15Gregory J. Downing3 Enabling Go/No Go Decisions 31J. Fred Pritchard and M. Lynn Pritchard4 Developing a Clinical Biomarker Method with External Resources: A Case Study 43Ross A. FredenburgPart II Identifying New Biomarkers: Technology Approaches 515 Imaging as a Localized Biomarker: Opportunities and Challenges 53Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research 89Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges 113Miranda K. Culley and Stephen Y. ChanPart III Characterization, Validation, and Utilization 1398 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective 141Federico Goodsaid9 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 149Jean W. Lee, Yuling Wu, and Jin Wang10 Applying Statistics Appropriately for Your Biomarker Application 177Mary ZacourPart IV Biomarkers in Discovery and Preclinical Safety 21911 Qualification of Safety Biomarkers for Application to Early Drug Development 221William B. Mattes and Frank D. Sistare12 A Pathologist's View of Drug and Biomarker Development 233Robert W. Dunstan13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901 255Alan P. Brown14 New Markers of Kidney Injury 281Sven A. BeushausenPart V Translating from Preclinical to Clinical and Back 30715 Biomarkers from Bench to Bedside and Back - Back-Translation of Clinical Studies to Preclinical Models 309Damian O'Connell, David Adler, Frank Kramer, and Matthias Ocker16 Translational Medicine - A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 333Giora Z. Feuerstein, Salvatore Alesci, Frank L.Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo Jr.17 Clinical Validation and Biomarker Translation 347Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt18 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 365Christina Trollmo and Lars Klareskog19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints 379Calvert Louden and Ruth A. RobertsPart VI Biomarkers in Clinical Trials 38920 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development 391Kay A. Criswell21 Integrating Molecular Testing into Clinical Applications 409Anthony A. KilleenPart VII Big Data, Data Mining, and Biomarkers 42122 IT Supporting Biomarker-Enabled Drug Development 423Michael Hehenberger23 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 447Gregory P. Fusco24 Computational Biology Approaches to Support Biomarker Discovery and Development 469Bin Li, Hyunjin Shin, William L. Trepicchio, and Andrew DornerPart VIII Lessons Learned: Practical Aspects of Biomarker Implementation 48525 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 487Lena King, Mallé Jurima-Romet, and Nita Ichhpurani26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 505Bruce D. Car, Brian Gemzik, and William R. FosterPart IX Where are We Heading and What Do We Really Need? 51527 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection 517Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus28 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find 537Michael R. Bleavins and Ramin Rahbari29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow 553Patrick McConville and Deanne ListerIndex 585

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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.