Dimitri Semizarov, Eric Blomme

Genomics Drug Discovery

• Gebundenes Buch

Produktbeschreibung

New, effective strategies for early assessment of drug toxicity and efficacy

Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, pharmacogenetic, and toxicogenomic toolboxes, four promising and rapidly growing areas of genomics research that have begun opening the door to personalized medicine solutions. The authors thoroughly review and analyze all relevant technologies and analytical methods necessary for the competent design and execution of biomarker, pharmacogenomic, pharmacogenetic, and toxicogenomic studies. Moreover, by emphasizing the synergies among these areas, they arm pharmaceutical discovery scientists and drug development professionals with state-of-the-art strategies for reducing drug development time and costs, expediting a drug's approval, and improving its life cycle. Academic researchers will find in this book authoritative and integrated coverage of these rapidly developing and popular areas of genomic research.

Readers involved in laboratory, clinical, or modeling studies who are seeking to assess the toxicity and efficacy of drug candidates as early as possible can rely on this book to help guide their experiments. Topics include:
_ Weighing the relative advantages and disadvantages of available genomic technology platforms
_ Using pharmacogenomics and pharmacogenetics to position drug studies in the context of clinical trials
_ Identifying and validating biomarkers
_ Predicting and characterizing the toxicity of drugs
_ Applying study findings to improve the productivity of drug discovery

Today's pharmaceutical industry is characterized by exponentially rising R&D costs and a steadily decreasing percentage of approved drugs. Pharmaceutical discovery scientists therefore should take advantage of this book's unique integrated coverage of biomarkers, toxicogenomics, and pharmacogenomics in order to make their own discovery efforts as fruitful as possible.

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 480
• Erscheinungstermin: 1. November 2008
• Englisch
• Abmessung: 240mm x 161mm x 31mm
• Gewicht: 828g
• ISBN-13: 9780470096048
• ISBN-10: 0470096047
• Artikelnr.: 24927106

Autorenporträt

Dimitri Semizarov, PhD, is a Senior Group Leader in the Cancer Research Department of Abbott Laboratories' Global Pharmaceutical R&D. Dr. Semizarov leads cancer genomics research at Abbott, applying genomics technologies to enable personalization of cancer therapy. He is author or coauthor of more than twenty scientific articles and eight patent applications, as well as three book chapters (including two chapters in Wiley's Preclinical Development Handbook). Eric Blomme, DVM, PhD, Diplomate, American College of Veterinary Pathologists, is a Senior Project Leader for Cellular, Molecular, and Exploratory Toxicology in Global Pharmaceutical R&D at Abbott Laboratories. He has extensive drug discovery, toxicology, and screening experience working for Abbott, Pharmacia, Monsanto, Searle, Ohio State University, and Cornell University. Dr. Blomme has written over fifty journal articles and eight book chapters, and is a reviewer for multiple scientific journals in the fields of toxicology and pathology.

Inhaltsangabe

Preface. Chapter 1: Introduction: Genomics and Personalized Medicine
(Dimitri Semizarov). 1.1. Fundamentals of genomics. 1.2. The concept of
personalized medicine. 1.3. Genomics technologies in drug discovery. 1.4.
Scope of this book. References. Chapter 2: Genomics Technologies as Tools
in Drug Discovery (Dimitri Semizarov). 2.1. Introduction to genomics
technologies. 2.2. Gene expression microarrays: technology. 2.3. Gene
expression microarrays: data analysis. 2.4. Comparative genomic
hybridization: technology. 2.5. Comparative genomic hybridization: data
analysis. 2.6. Microarray-based DNA methylation profiling. 2.7.
Microarray-based microRNA profiling. 2.8. Technical issues in genomics
experiments and regulatory submissions of microarray data. 2.9. Conclusion.
References. Chapter 3: Genomic Biomarkers (Dimitri Semizarov). 3.1.
Introduction into genomic biomarkers. 3.2. DNA biomarkers. 3.3. RNA
biomarkers. 3.4. Clinical validation of genomic biomarkers. References.
Chapter 4: Fundamental Principles of Toxicogenomics (Eric Blomme). 4.1.
Introduction. 4.2. Fundamentals of toxicogenomics. 4.3. Analysis of
toxicogenomics data. 4.4. Practical and logistic aspects of toxicogenomics.
4.5. Toxicogenomics reference databases. 4.6. Conclusion. References.
Chapter 5: Toxicogenomics: Applications to In Vivo Toxicology (Eric
Blomme). 5.1. The value of toxicogenomics in drug discovery and
development. 5.2. Basic principles of toxicology in drug discovery and
development. 5.3. Toxicogenomics in predictive toxicology. 5.4.
Toxicogenomics in mechanistic toxicology. 5.5. Toxicogenomics and
target-related toxicity. 5.6. Predicting species-specific toxicity. 5.7.
Evaluation of idiosyncratic toxicity with toxicogenomics. 5.8. Conclusion.
References. Chapter 6: Toxicogenomics: Applications in In Vitro Systems
(Eric Blomme). 6.1. Introductory remarks on in vitro toxicology. 6.2.
Overview of the current approaches to in vitro toxicology. 6.3.
Toxicogenomics in in vitro systems: technical considerations. 6.4.
Proof-of-concept studies using primary rat hepatocytes. 6.5. Use of gene
expression profiling to assess genotoxicity. 6.6. Application of gene
expression profiling for the in vitro detection of phopholipidosis. 6.7.
Toxicogenomics in the assessment of idiosyncratic hepatotoxicity. 6.8. Do
peripheral blood mononuclear cells represent a useful alternative in vitro
model? 6.9. Current and future use of in vitro toxicogenomics. 6.10.
Conclusion. References. Chapter 7: Germ Line Polymorphisms and Drug
Response (Dimitri Semizarov). 7.1. Introduction into germline
polymorphisms. 7.2. Polymorphisms and drug response in oncology. 7.3.
Polymorphisms and response to anticoagulants. 7.4. Polymorphisms in
neuroscience. 7.5. Polymorphisms and drug response in immunology. 7.6.
Polymorphisms and response to antiviral agents. 7.7. Gene copy number
polymorphisms. 7.8. Conclusions: approaches to identification of
polymorphisms as predictors of drug response. References. Chapter 8:
Pharmacogenetics of Drug Disposition (Anahita Bhathena). 8.1. Introduction.
8.2. Genes and polymorphisms affecting drug disposition. 8.3. Genomic
biomarkers for PK studies. 8.4. Utility of PG--PK studies in early clinical
trials. 8.5. Limitations of PG--PK studies. 8.6. Genotyping technologies.
8.7. Conclusion. References. Chapter 9: Overview of Regulatory Developments
and Initiatives Related to the Use of Genomic Technologies in Drug
Discovery and Development (Eric Blomme). 9.1. Introduction into recent
regulatory developments in the genomic area. 9.2. FDA guidance on
pharmacogenomic data submission. 9.3. Pharmacogenomic data submission:
draft companion guidance. 9.4. Drug-diagnostic co-development concept
paper. 9.5. Regulations for in vitro diagnostic assays. 9.6. Biomarker
qualification. 9.7. Current initiatives relevant to pharmacogenomics. 9.8.
Future impact of genomic data on drug development. References. Index.

Rezensionen

?This book is highly recommended to active researchers in genomics and to the comparative and veterinary clinician or researchers looking for a focused review of the emerging discipline.? ( The Veterinary Journal , August 2009)
?Overall, it provides excellent, up-to-date coverage of the application of genomics in drug development.? ( Doody s Reviews , June 2009)