Claudio Carini, MD, PhD, FRCPath, has been involved in the application of biomarkers in precision medicine for the past 18 years. He is currently appointed as H. Faculty in the Department of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences & Medicine at King's College, School of Medicine, London. He is a member of the F-NIH Biomarkers Consortium Steering Committees for Cancer, Inflammation & Immunity, and Neuroscience. He is also a senior member of the Scientific Advisory Boards for several biotechnology companies and a member of the New York Academy of Sciences. Claudio was formerly the Global Head of Clinical Immunology and Biomarkers at Pfizer Inc., where he led precision medicine activities across multiple therapeutic areas and facilitated international collaborations with prestigious academic institutions. He also held senior roles in pharmaceutical companies (Wyeth, Novartis, and Roche) and faculty positions at Harvard and Johns Hopkins Medical School. He is a strong believer of open innovation networks, and in his roles he has been collaborating extensively with different stakeholders to speed up the clinical application of scientific research through public-private partnerships. He has served in several national and international scientific boards: F-NIH Inflammation/Immunity; MRC, Inflammation/ Immunology Initiative-Rheumatoid Arthritis Consortium; MRC, Stratified Medicine, SLE Consortium; IMI, ABIRISK, EU/EFPIA ; The PML Consortium. Claudio has over 200 publications in national and international peer-reviewed journals. He has also co-edited three books in the field of Biomarkers and Precision Medicine: Biomarkers in Drug Development: A Handbook of Practice Application and Strategy, (2010), Clinical and Statistical Considerations in Personalized Medicine, (2014), and Handbook of Biomarkers & Precision Medicine (2019 in press). Mark D. Fidock, PhD, is Vice President of Precision Medicine Laboratories within the IMED Biotech Unit, AstraZeneca, Cambridge, UK. He received his PhD from the University of East Anglia, UK, in Molecular Pharmacology. Mark is a trained molecular biologist/pharmacologist and gained extensive experience in drug development early in his career while at Pfizer Ltd, Sandwich, UK. He supported the development and approval of four new therapies and provided leadership for the Biomarker and Translational Medicine activities across multiple therapeutic areas. Mark joined AstraZeneca in 2013, appointed to the role of Head of Precision Medicine Laboratories and a member of the Precision Medicine and Genomics Leadership Team. He has overall accountability for all clinical testing activities that enables diagnostic development and regulatory approval. Mark leads a global multidisciplinary team providing strategy and direction in the development of Companion Diagnostic tests linked to targeted therapeutics across Oncology; Respiratory; and Cardiovascular, Renal, & Metabolism. These laboratory tests are deployed across both early- and late-phase clinical trials with the intent for global regulatory approval. By 2019 Mark had achieved >25 regulatory approved companion diagnostic tests across 3 major markets (USA, EU and Japan) linked to 4 AstraZeneca targeted therapies. Mark has a passion for innovative diagnostic science, driving research such as the use of artificial intelligence across tissue and molecular diagnostics to enable approaches that improve clinical testing outcomes with the ambition to change clinical care pathways. Mark has published more than 30 peer-reviewed articles in scientific journals and an active editor of the Journal of Precision Medicine. As an internationally recognized expert in Precision Medicine he holds an honorary position at the University of Cambridge and a member of the Institute of Translational and Stratified Medicine, Plymouth, scientific advisory board. Alain J. van Gool, PhD, is a professor of Personalized Healthcare and heads the Translational Metabolic Laboratory at the Radboud university medical center, Nijmegen Netherlands, with a strong passion in the application of biomarkers in translational medicine and personalized healthcare. Being trained as biochemist and molecular biologist, Alain worked at pharmaceutical industry (Organon, Schering-Plough, MSD), academia, applied research institutes, and university medical centers in EU, USA, and Singapore. He has been leading technology-based laboratories, cross-functional expert teams, therapeutic project teams, and public-private consortia, many of which were focused on the discovery, development, and implementation of translational biomarkers in a variety of therapeutic areas. His technical expertise resides most strongly in molecular profiling through x-omics, analytical biomarker development, and applications in translational scientific research. Alain is a strong believer of public-private partnerships and thrives to work with specialists to translate research findings to applications. With that background, he currently also acts as Strategic Advisor to the Executive Board of Radboudumc, coordinates the Radboudumc Technology Centers, is Scientific Lead Technologies of DTL (the Dutch Techcenter for Life Sciences), is Chair Biomarker Platform of EATRIS (the European infrastructure for Translational Medicine), is co-initiator of Health-RI (the Netherlands Personalized Medicine and Health Research Infrastructure), and project leader and PI of the Netherlands X-omics Initiative, thus contributing to the organization and coordination of local, national, and European technology infrastructures. Alain has published 40 peer-reviewed articles in scientific journals and is a frequently invited keynote speaker at scientific conferences and public events. Complementing his daily work, he enjoys contributing as translational biomarker scientist to editorial boards of scientific journals, funding agencies, and scientific advisory boards of start-up enterpreneurs, multinational companies, diagnostic organizations, public-private consortia, and conference organizers.
This handbook is hardcover and was published at CRC Press / Taylor and Francis Group in 2019. From the first time I opened it, I could notice that the printing and quality of paper is exceptional. The handbook has 631 pages and very nicely coloured figures, schemes and drawings, that are very easily understandable and very helpful in processing the text of the handbook. The field of biomarkers is approached in this book in a scholastic manner, starting from the first discovery and use of biomarkers to the regulatory approaches in the field of precision medicine, passing from preclinical studies, translational medicine, clinical trials, and implementation in practice. Several case-studies are presented related to HIV diagnosis, infertility, coagulation, BRCA identification, but also case-studies related to biomarker-based clinical trials... This handbook is complete, exact, succinct and unique, and gathers information from different perspectives, useful to different players from the field of biomarkers in precision medicine, making it a an excellent tool for learning. First of all, I would recommend this handbook to researchers from the medical and connected fields. It could help the development of this engaging field of personalized care due to highly accurate and relevant data presented by the authors. Secondly, I would recommend it to medical doctors from all specialties since it offers a deep and comprehensive approach into a field that only a few decades ago was hardly recognized and since the practice of medicine in most specialties during the following years will, for sure, include a personalized approach to patients. Both these addressees, researchers and medical practitioners, can make a difference. Least but not last, I would say that even residents and medical students would benefit from the comprehensive approach that this book provides. - Costela Serban, ISCB December 2019