Biomarkers, Diagnostics, and Precision Medicine in the Drug Industry: Critical Challenges, limitations and Road Maps for the Best Practices examines the challenges and limitations in biomarkers and laboratory tests, offering advice on best practices to ensure the proper application of biomarkers and bridging the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, including standard-of-care approved assays and for-investigational-use and for-research-use-only assays. The book also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples.
Users will find this to be an ideal resource that is perfect for drug developers, IVD providers, healthcare givers, academics and researchers who need best practices to help them increase their probability of success.
- Provides the unique insights of an expert with extensive experience in diagnostics, clinical laboratories, and drug discovery and development
- Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers
- Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas
1. Pharmaceutical crisis2. Applications of biomarkers for different purposes in drug development
3. Pharmacogenetics of therapeutics4. Precision medicine and companion diagnostics in drug development5. Essential attributes of an acceptable in-vitro diagnostic test6. Fundamentals of Assay Development and Validation7. Essentials of Laboratory Quality Management8. Biological variables and their potential impact on biomarkers and precision medicine initiative9. Pre-analytical Variables and their potential impact on biomarkers and precision medicine initiative10. Analytical Discrepancies and their potential impact on biomarkers and precision medicine initiative11. Road Map to Best Practices
Dr Abdel B. Halim is an internationally-recognized key opinion leader with 25+ years of experience in different aspects of biomarkers, precision medicine and IVD; from strategic planning to actualization. He is the Vice president of Biomarkers and Companion Diagnostics at Taiho Oncology (Otsuka holding). Before Taiho, Dr. Halim held multiple leadership positions in the pharmaceutical and diagnostic industries. He oversaw the development and validation of assays for several hundreds of biomarkers on different platforms and their applications in 150+ PI-PIII clinical trials and patient managements. Abdel has led 8 CDx programs and has track records for 5 FDA high complexity IVD approvals and 2 drug approvals. Abdel has served on 20+ governmental and public expert panels and advisory boards in the US, Canada and EU. Dr. Halim has served on 25+ committees to establish guidelines to promote quality in clinical laboratory and diagnostic industries and authored about 15 guidelines. Abdel has 70+ peer-reviewed publications, two book chapters and 100+ presentations including 40+ invited and keynote speeches in national and international meetings.
