Biomarkers in Drug Development : A Handbook of Practice, Application, and Strategy

By focusing on how to identify, develop, and integrate biomarkers into drug development, this book will improve biomarker use and enhance pharmaceutical decision making. The coverage includes case studies showing how biomarkers can substantively impact drug development timelines and costs, enable better compound selection and reduce late stage attrition, and facilitate personalized medicine. It describes biomarker technologies, characterization and validation, and applications including in discovery, preclinical safety assessment, clinical trials, and translational medicine. The text, a useful resource for the pharmaceutical industry, also looks at practical issues and intellectual property concerns.

Michael R. Bleavins, PhD, is cofounder of Michigan Technology and Research Institute. He retired from Pfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-three years of experience in pharmaceutical research, development, and biomarkers with more than sixty-five peer-reviewed publications. Claudio Carini, MD, PhD, FRCPATH, is Chief Medical Officer and Vice President for Clinical Research at Fresenius. Previously, Claudio served as Global Head of Translational Medicine at MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudio has more than twenty years of experience in the field of immunology and biomarkers and has authored more than 200 publications in international and domestic peer-reviewed journals. Mall Jurima-Romet, PhD, is Senior Director for Development and Regulatory Services and MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. Mall has authored over forty peer-reviewed publications and is an adjunct professor at the University of Montreal. Ramin Rahbari, MS, is cofounder and Senior Consultant at Innovative Scientific Management. Previously, Ramin has held positions at Pfizer, Synaptic, and Parke-Davis pharmaceutical companies, leading cross-functional biomarker teams.