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 MichiganTechnology and Research Institute. He retired fromPfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-threeyears of experience in pharmaceutical research, development, andbiomarkers with more than sixty-five peer-reviewed publications. CLAUDIO CARINI, MD, PhD, FRCPath, is Chief MedicalOfficer and Vice President for Clinical Research at Fresenius.Previously, Claudio served as Global Head of Translational Medicineat MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudiohas more than twenty years of experience in the field of immunologyand biomarkers and has authored more than 200 publications ininternational and domestic peer-reviewed journals. MALLE JURIMA-ROMET, PhD, is Senior Director forDevelopment and Regulatory Services at MDS Pharma Services, whereshe provides strategic and scientific consulting to pharmaceuticaland biotech sponsors, and leads drug development program teams.Malle has authored over forty peer-reviewed publications andis an adjunct professor at the University of Montreal. RAMIN RAHBARI, MS, is cofounder and Senior Consultant atInnovative Scientific Management. Previously, Ramin has heldpositions at Pfizer, Synaptic, and Parke-Davis pharmaceuticalcompanies, leading cross-functional biomarker teams.