Drug Development Handbook from C.H.I.P.S.

Biomarkers in Drug Development
A Handbook of Practice, Application, and Strategy
edited by Michael R. Bleavins

Discover how biomarkers can boost the success rate of drug development efforts!

Biomarkers in Drug Development 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
Part 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


Part 1 - What is a Biomarker and Role 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 2 - Identifying New Biomarkers: Technology Approaches

  1. Imaging as a Localized Biomarker: Opportunities and Challenges
  2. Protein Biomarker Discovery Using Mass Spectrometry Based Proteomics
  3. Quantitative Multiplexed Patterning of Immune-Related Biomarkers
  4. Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity
  5. The Use of High Through-Put Proteomic Arrays for the Discovery of Disease-Associated Molecules

Part 3 - Characterization and Validation

  1. Characterization and Validation Biomarkers in Drug Development: A Regulatory Perspective
  2. "Fit for Purpose" Method Validation and Assays for Biomarker Characterization to Support Drug Development
  3. Molecular Biomarkers from a Diagnostic Perspective
  4. Strategies for the Co-Development of Drugs and Diagnostics - An FDA Perspective on Diagnostics Regulation
  5. Importance of Statistics in the Qualification and Application of Biomarkers

Part 4 - Biomarkers in Discovery and Pre-Clinical Safety

  1. Qualification of Safety Biomarkers for Application to Early Drug Development
  2. Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor
  3. Biomarkers for the Immunogenicity of Therapeutic Proteins and its Clinical Consequences
  4. New Markers of Kidney Injury

Part 5 - Translating From Pre-Clinical Results to Clinical and Back

  1. Translational Medicine - A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers
  2. Clinical Validation and Biomarker Translation
  3. Predicting and Assessing an Inflammatory Disease and Its Complications - An Example from Rheumatoid Arthritis
  4. Pharmacokinetic and Pharmacodynamic Biomarker Correlations
  5. Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints

Part 6 - Biomarkers in Clinical Trials

  1. Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development
  2. Integrating Molecular Testing into Clinical Applications
  3. Biomarkers for Lysosomal Storage Disorders
  4. The Value Chain in the Development of Biomarkers for Disease Targets

Part 7 - Lessons Learned: Practical Aspects of Biomarker Implementation

  1. Biomarkers in Pharmaceutical Development - The Essential Role of Project Management and Teamwork
  2. Integrating Academic Laboratories Into Pharmaceutical Development
  3. Funding Biomarker Research and Development Through the Small Business Innovative Research (SBIR) Program
  4. Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices
  5. The Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to be Rare or Hard to Find
  6. Biomarker Patent Strategies - Opportunities and Risks

Part 8 - Where Are We Heading/What Do We Really Need

  1. IT Supporting Biomarker-Enabling Drug Development
  2. Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine
  3. Ethics of Biomarkers: Where are the Borders of Investigative Research, Informed Consent, and Patient Protection
  4. Pathodynamics: Improving Biomarker Selection By Getting More Information From Changes Over Time
  5. Optimizing the Use of Biomarkers for Drug Development: A Clinician Perspective
  6. Nanotechnology-Based Biomarker Detection


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Biomarkers in Drug Development
A Handbook of Practice, Application, and Strategy
edited by Michael R. Bleavins

2010 • 760 pages • $159.00 + shipping
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