Main description:

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.

Contents:

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 andPharmacogenomics 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