In recent years, the topic of biomarkers has been featured at many specialized scientific meetings and has received extensive media coverage. We, the coeditors, felt that a book that approached the topic with an emphasis on the practical aspects of biomarker identification and use, as well as their strategic implementation, was missing and essential to improve the application of these approaches. We each have experience working with biomarkers in drug development, but we recognized that the specialized knowledge of a diverse group of experts was necessary to create the type of comprehensive book that is needed. Therefore, contributions were invited from authors who are renowned experts in their respective fields. The contributors include scientists from academia, research hospitals, biotechnology and pharmaceutical companies, contract research organizations and consulting firms, and the FDA. The result is a book that we believe will appeal broadly to pharmaceutical research scientists, clinical and academic investigators, regulatory scientists, managers, students, and all other professionals engaged in drug development who are interested in furthering their knowledge of biomarkers.
As discussed in Part I, biomarkers are not new: They have been used for hundreds of years to help physicians diagnose and treat disease. What is new is a shift from outcome biomarkers to target and mechanistic biomarkers, the availability of “ omics, ” imaging, and other technologies that allow collection of large amounts of data at the molecular, tissue, and whole - organism levels, and the use of data - rich biomarker information for “ translational research, ” from the laboratory bench to the clinic and back. Part II chapter is dedicated to highlighting several important technologies that affect drug discovery and development, the conduct of clinical trials, and the treatment of patients.
In Part III we ’ ve invited leaders from industry and regulatory agencies to discuss the qualification of biomarker assays in the fit - for - purpose process, including perspectives on the development of diagnostics. The importance of statistics cannot be overlooked, and this topic is also profiled in this part with a practical overview of concepts, common mistakes, and helpful tips to ensure credible biomarkers that can address their intended uses. Parts IV to VI present information on concepts and examples of utilizing biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Examples are drawn from a wide range of target - organ toxicities, therapeutic areas, and product types. We hope that 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.
Part VII focuses on “ lessons learned ” and the practical aspects of implementing biomarkers in drug development programs. Many pharmaceutical companies have created translational research divisions, and increasingly, external partners, including academic and government institutions, contract research organizations, and specialty laboratories, are providing technologies and services to support biomarker programs. This is changing the traditional organizational models within industry and paving the way toward greater collaboration across sectors and even among companies within a competitive industry. Perspectives from contributing authors representing several of these different sectors are presented in this part, as well as a legal perspective on potential intellectual property issues in biomarker development. The book concludes with Part VIII on future trends and developments, including developments in data integration, the reality of personalized medicine, and the addressing of ethical concerns. The field of biomarkers in drug development is evolving rapidly and this book presents a snapshot of some exciting new approaches. By utilizing the book as a source of new knowledge, or to reinforce or integrate existing knowledge, we hope that readers will benefit from a greater understanding and appreciation of the strategy and application of biomarkers in drug development and become more effective decision makers and contributors in their own organizations.
Contents
PART I BIOMARKERS AND THEIR ROLES IN DRUG DEVELOPMENT
- 1 Biomarkers Are Not New
- 2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care
- 3 Enabling Go/No Go Decisions
PART II IDENTIFYING NEW BIOMARKERS: TECHNOLOGY APPROACHES
- 4 Imaging as a Localized Biomarker: Opportunities and Challenges
- 5 Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics
- 6 Quantitative Multiplexed Patterning of Immune-Related Biomarkers
- 7 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity
- 8 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules
PART III CHARACTERIZATION AND VALIDATION
- 9 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective
- 10 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development
- 11 Molecular Biomarkers from a Diagnostic Perspective
- 12 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation
- 13 Importance of Statistics in the Qualification and Application of Biomarkers
PART IV BIOMARKERS IN DISCOVERY AND PRECLINICAL SAFETY
- 14 Qualification of Safety Biomarkers for Application to Early Drug Development
- 15 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor
- 16 Biomarkers for the Immunogenicity of Therapeutic Proteins and its Clinical Consequences
- 17 New Markers of Kidney Injury
PART V TRANSLATING FROM PRECLINICAL RESULTS TO CLINICAL AND BACK.
- 18 Translational Medicine-A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers
- 19 Clinical Validation and Biomarker Translation
- 20 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis
- 21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations
- 22. Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints
PART VI BIOMARKERS IN CLINICAL TRIALS.
- 23 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development
- 24 Integrating Molecular Testing into Clinical Applications
- 25 Biomarkers for Lysosomal Storage Disorders
- 26 The Value Chain in the Development of Biomarkers for Disease Targets
PART VII LESSONS LEARNED: PRACTICAL ASPECTS OF BIOMARKER IMPLEMENTATION.
- 27 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork
- 28 Integrating Academic Laboratories Into Pharmaceutical Development
- 29 Funding Biomarker Research and Development Through the Small Business Innovative Research Program
- 30 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices
- 31 Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to be Rare or Hard to Find
- 32 Biomarker Patent Strategies: Opportunities and Risks
PART VIII WHERE ARE WE HEADING AND WHAT DO WE REALLY NEED?
- 33 IT Supporting Biomarker-Enabling Drug Development
- 34 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine
- 35 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection
- 36 Pathodynamics: Improving Biomarker Selection By Getting More Information From Changes Over Time
- 37 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective
- 38 Nanotechnology-Based Biomarker Detection
Index.
About the Authors
- MICHAEL R. BLEAVINS, PhD, is cofounder of Michigan Technology and Research Institute. He retired from Pfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-three years of experience in pharmaceutical research, development, and biomarkers with more than sixty-five peer-reviewed publications.
- CLAUDIO CARINI, MD, PhD, FRCPath, is Chief Medical Officer and Vice President for Clinical Research at Fresenius. Previously, Claudio served as Global Head of Translational Medicine at MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudio has more than twenty years of experience in the field of immunology and biomarkers and has authored more than 200 publications in international and domestic peer-reviewed journals.
- MALLÉ JURIMA-ROMET, PhD, is Senior Director for Development and Regulatory Services at MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. Mallé has authored over forty peer-reviewed publications and is an adjunct professor at the University of Montreal.
- RAMIN RAHBARI, MS, is cofounder and Senior Consultant at Innovative Scientific Management. Previously, Ramin has held positions at Pfizer, Synaptic, and Parke-Davis pharmaceutical companies, leading cross-functional biomarker teams.
Product Details
- Hardcover: 800 pages
- Publisher: Wiley; 1 edition (February 15, 2010)
- Language: English
- ISBN-10: 0470169273
- ISBN-13: 978-0470169278
- Product Dimensions: 6.5 x 1.6 x 9.2 inches
List Price: $169.00