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.
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Table of Contents
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
Authors
Abdel Halim Vice President, Biomarkers and Companion Diagnostics, Taiho Oncology, NJ, USA. 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.
