Description
With all the multitude of challenges facing the pharmaceutical research and development process, the industry is actively exploring the relationships between human genetics and drug responsiveness, susceptibility to disease and disease severity. In Pharmacogenomics and Personalized Medicine, leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while also presenting a realistic perspective on the challenges, practicalities and obstacles in its application. Focusing on DNA data and associated analytical methodologies, with a consideration for complementary RNA-based studies, this volume includes a wide array of vital, cutting-edge research. Comprehensive and timely, Pharmacogenomics and Personalized Medicine will assist novice and experienced investigators alike in the understanding of the current scientific challenges in applying pharmacogenomics to drug discovery and clinical development. Preface Contributors Challenges, Opportunities and Evolving Landscape in Pharmacogenomics and Personalized Medicine: An Industry PerspectiveNadine 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 ImplicationMyong-Jin Kim, Shiew-Mei Huang, Atiqur Rahman, Felix W. Frueh, Lawrence J. Lesko Applications of Pharmacogenomics in Drug DiscoveryDuncan McHale Applications of Pharmacogenomics in Clinical TrialsMonique Franc Pharmacogenomics applications in drug metabolism: from genotyping to druglabel-challenges?Ann K. Daly The Genetics of Adverse Drug Reactions – Promises and ProblemsMartin Armstrong Strategies and resources for marker selection and genotyping in genetic association studiesNicole Soranzo, Dong-Jing Fu and Qingqin S. Li Study Design and Statistical Methods in Pharmacogenomics Research: From Candidate Genes to Genome Wide ScreensNicholas J. Schork, Nathalie Malo, Eric J. Topol Holy SNP, Batman! Reyna Favis Use of Predictive Biomarker Classifiers in the Design of Pivotal Clinical TrialsRichard Simon Translation of biomarkers into clinical utility William Trepicchio and George Mulligan Pharmacogenomic Study Feasibility Assessment and Pharmaceutical Business Decision-MakingMonique 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 DiseaseRamon Cacabelos Pharmacogenomics applications in Psychiatric disorders Todd Lencz and Anil K. Malhotra Pharmacogenomics in HIV DiseaseAmalio Telenti Pharmacogenomics and Cardiovascular Drugs Grard 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
