concerns within the pharmaceutical industry about generating data that might be difficult to interpret in a regulated environment. There is also a growing apprec- tion for the challenges in translating this new information into clinical utility, including scientific, commercial, ethical, and policy challenges. Pharmacogenomics and Personalized Medicine, which is part of the Methods in Pharmacology and Toxicology series, comprises chapters on selected aspects of pharmacogenomics and personalized medicine. Our overall intent is to assist both novice and experienced investigators in understanding the current scientific ch- lenges in applying PGx to discovery and clinical development and in making app- priate decisions to engage in and interpret PGx research. Designed to share the experiences of leading experts in the field, the book is a useful guide for conducting PGx research--from discovery to the market, but we also aim to present a realistic perspective on the challenges, practicalities, and obstacles in applying pharmac- enomics. Generally, the book avoids statements such as "Pharmacogenomics is going to revolutionize the practice of medicine," which are neither realistic nor particularly useful to anyone. The book presents an industry perspective on the implementation of PGx in research and development, in drug discovery, and in clinical trials, including rec- mendations for a systematic approach for assessing the feasibility and added value of PGx studies in clinical trials.

Leseprobe

Preface Contributors Challenges, Opportunities and Evolving Landscape in Pharmacogenomics and Personalized Medicine: An Industry Perspective Nadine Cohen and Theresa Frangiosa Considerations for Sample Collections Intended for Pharmacogenomic analyses: The Pharmacogenomics protocol and informed consent form Deborah Ricci and Monique Franc Pharmacogenomics: The Regulatory Environment and Labeling Implication Myong-Jin Kim, Shiew-Mei Huang, Atiqur Rahman, Felix W. Frueh, Lawrence J. Lesko Applications of Pharmacogenomics in Drug Discovery Duncan McHale Applications of Pharmacogenomics in Clinical Trials Monique Franc Pharmacogenomics applications in drug metabolism: from genotyping to drug label-challenges? Ann K. Daly The Genetics of Adverse Drug Reactions - Promises and Problems Martin Armstrong Strategies and resources for marker selection and genotyping in genetic association studies Nicole Soranzo, Dong-Jing Fu and Qingqin S. Li Study Design and Statistical Methods in Pharmacogenomics Research: From Candidate Genes to Genome Wide Screens Nicholas J. Schork, Nathalie Malo, Eric J. Topol Holy SNP, Batman! Reyna Favis Use of Predictive Biomarker Classifiers in the Design of Pivotal Clinical Trials Richard Simon Translation of biomarkers into clinical utility William Trepicchio and George Mulligan Pharmacogenomic Study Feasibility Assessment and Pharmaceutical Business Decision-Making Monique Franc and Theresa Frangiosa Co-development of drugs and Pharmacogenomics based Diagnostics in Oncology Jeffrey Ross Pharmacogenomics applications in Epilepsy Chantal Depondt Pharmacogenomics in Alzheimer¿s Disease Ramon Cacabelos Pharmacogenomics applications in Psychiatric disorders Todd Lencz and Anil K. Malhotra Pharmacogenomics in HIV Disease Amalio Telenti Pharmacogenomics and Cardiovascular Drugs Gerard Siest, Hind Berrahmoune, Jean-Brice Marteau, and Sophie Visvikis-Siest Pharmacogenomic applications in Children Struan F.A. Grant and Hakon Hakonarson Pharmacogenomics of rare and monogenic disorders Paul Maher