Biomarkers, Diagnostics and Precision Medicine in the Drug Industry: Critical Challenges, limitations and Road maps for the Best Practices

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, accelerating time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. Biomarkers, Diagnostics, and Precision Medicine in the Drug Industry 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. Biomarkers, Diagnostics, and Precision Medicine in the Drug Industry serves as a reference to drug developers, IVD providers, healthcare givers, academics, and researchers for best practices to help increase the probability of success. 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 sideAddresses 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 managementFeatures case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas INDICE: 1. Drug development crisis 2. Potential role and possible applications of biomarkers in different phases of drug development with examples from different classes of biomarkers 3. Possible role of diagnostics and precision medicine to enhance probability of success in drug development and enhance patient care 4. Attributes of a good biomarker and a diagnostic test 5. Lack of good strategic planning to include biomarkers in a clinical development program with emphasis on intra- and inter-organizational disorientation and conflict of interests 6. Complexity of biomarker discovery including potential lack of commutability of preclinical models to human trials 7. Inter and intra-subject biological variabilities and its impact on biomarker utility 8. Inconsistency in assay development and validation, and lack or improper operational quality control 9. Preanalytical variables and their possible impact on biomarker results 10. Analytical discrepancies and their imminent risk on drug development and patient care 11. Roadmap and plans for the best practices

• ISBN: 978-0-12-816121-0
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 400
• Fecha Publicación: 01/08/2019
• Nº Volúmenes: 1
• Idioma: Inglés