Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples.

This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.

• Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side
• Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management
• Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Drug developers (from startup biotech to well-established global companies) from early discovery to registrational phases, clinicians managing patients or clinical trials, clinical researchers, clinical laboratories, diagnostic companies, regulatory agencies and medical school graduate students

1. Pharmaceutical crisis
2. Applications of biomarkers for different purposes in drug development
3. Pharmacogenetics of therapeutics
4. Precision medicine and companion diagnostics in drug development
5. Essential attributes of an acceptable in-vitro diagnostic test
6. Fundamentals of Assay Development and Validation
7. Essentials of Laboratory Quality Management
8. Biological variables and their potential impact on biomarkers and precision medicine initiative
9. Pre-analytical Variables and their potential impact on biomarkers and precision medicine initiative
10. Analytical Discrepancies and their potential impact on biomarkers and precision medicine initiative
11. Road Map to Best Practices