Biomarkers in drug development: a handbook of practice, application, and strategy

This book provides perspective; covers recent developments in technologies that have enabled the expanded use of biomarkers and discusses biomarker characterization and validation and applications throughout the discovery-developmentcontinuum. Importantly, several case studies of biomarkers that have helped and hindered decision making are presented, as well as an overview of the areaswhere proper use of biomarkers can substantively impact timelines and costs by streamlining development programs, enabling selection of better compounds and reducing late stage attrition, and facilitating personalized medicine. A book like this focusing on how to identify, develop, and truly integrate biomarkers can shape biomarker testing and use and enhance pharmaceutical decision making.Michael Bleavins is co-founder and President of Laboratory Centers, Michigan Technology and Research Institute. He retired from Pfizer in 2006 and has morethan 21 years of experience pharmaceutical research and development includingbiomarkers and translational medicine. Claudio Carini is Chief Medical Officer and Vice President for Clinical Research at Fresenius Pharmaceuticals Beforejoining Fresenius, Dr. Carini was Global Head of Translational Medicine and Head of The Biomarker Alliance at MDS Pharma. Mallé Jurima-Romet is Senior Director for Development and Regulatory Services at MDS Pharma Services. She has more than 20 years of biomedical and pharmaceutical research experience, with special emphasis upon biomarkers in drug development programs. Ramin Rahbari isChief Operating Officer at Innovative Scientific Management. Previously at Pfizer Global Research and Development, he has over twelve years of experience across multiple therapeutic area programs at various stages of development formthe basis for informed decision making and successful collaborations.

• ISBN: 978-0-470-16927-8
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 760
• Fecha Publicación: 05/03/2010
• Nº Volúmenes: 1
• Idioma: Inglés