Academic Press Biomarkers, Diagnostics and Precision Medicine in the Drug Industry: Critical Challenges, Limitations and Roadmaps for the Best Practices

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 Review Practical resource offering strategies to optimize the successful use of biomarkers and targeted therapies in drug development About the Author Dr. Abdel Halim is an internationally-recognized key opinion leader with 25+ years of experience in different aspects of biomarkers, personalized medicine and IVD; from strategic planning to actualization. He is the VP of Translational Medicine, Biomarker and Diagnostics at Celldex Therapeutics, USA. Before Celldex, Dr. Halim held multiple leadership positions in the pharmaceutical and diagnostic industries. He oversaw the development and validation of assays for 1,000+ biomarkers and molecular entities on different platforms, from point-of-care device to NGS, and their applications in 200+ PI-PIV clinical trials and patient managements. Also, Abdel has led several CDx programs as LDT or universal IVD systems, and he has multiple FDA-approved high complexity diagnostic tests. Dr. Halim has served on 20+ governmental and public expert panels and advisory groups in the US, Canada and EU, and on 20+ committees to establish guidelines to promote quality in clinical laboratory and diagnostic industries. Abdel is one of only four laboratory professionals in the US who are triple board certified in Molecular Diagnostics, Clinical Chemistry and Diagnostics, and has delivered approximately 100 scientific speeches, published 65+ peer-reviewed articles, authored two chapter books and featured by the top diagnostic news; College of American Pathologist magazine and Clinical Laboratory News.