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The pharmaceutical industry has faced many significant challenges since the early 1990s. The fundamental issue that needs to be addressed is how to improve the efficiency of drug discovery and development. The current research and development (R&D) cost for developing a new therapeutic drug is greater than $800 million. Additionally, it takes an average of 12 years to get a new drug to market with an attrition rate greater than 90%. Reviewing the overall pharmaceutical R&D process, it has become clear that many of the drug failures are due to our lack of knowledge in population diversity, which is responsible for differences in drug efficacy and toxicity. In fact, not a single approved drug is 100% safe and efficacious for all patients. For researchers, the key question is: How can we discover biomarkers that can be used to distinguish patients who will respond to the drug without adverse effects from those who will not respond and/or will have adverse effects? There is tremendous urgency to address this question. Biomarkers also fit perfectly with the vision of personalized medicine, the new expectation of medical practice. This is why biomarker research has been a central focus in many research labs across academia, government agencies, and the pharmaceutical industry. There are many different ways to define biomarkers based on molecular properties, applications, and methods.
List of contents
Biomarker Sample Collection and Handling in the Clinical Setting to Support Early-Phase Drug Development.- Gene Expression-Based Biomarkers of Drug Safety.- Profiling Gene Expression Signatures Using Fluorescent Microspheres.- Real-Time Polymerase Chain Reaction Gene Expression Assays in Biomarker Discovery and Validation.- SAGE Analysis in Identifying Phenotype Single Nucleotide Polymorphisms.- Single Nucleotide Polymorphisms and DNA Methylation Analysis Using Pyrosequencing Methods.- The Application of Laser Capture Microdissection for the Analysis of Cell-Type-Specific Gene Expression in a Complex Tissue:.- The Use of Two-Dimensional Gel Electrophoresis for Plasma Biomarker Discovery.- Difference In-Gel Electrophoresis: A High-Resolution Protein Biomarker Research Tool.- Label-Free Mass Spectrometry-Based Protein Quantification Technologies in Protein Biomarker Discovery.- Top-Down Quantitative Proteomic Analysis Using a Highly Multiplexed Isobaric Mass Tagging Strategy.- SELDI Technology for Identification of Protein Biomarkers.- Sandwich ELISA Microarrays: Generating Reliable and Reproducible Assays for High-Throughput Screens.- LC-MS Metabonomics Methodology in Biomarker Discovery.- GC-MS-Based Metabolomics.- NMR-Based Metabolomics for Biomarker Discovery.- Unraveling Glycerophospholipidomes by Lipidomics.
Summary
The pharmaceutical industry has faced many significant challenges since the early 1990s. The fundamental issue that needs to be addressed is how to improve the efficiency of drug discovery and development. The current research and development (R&D) cost for developing a new therapeutic drug is greater than $800 million. Additionally, it takes an average of 12 years to get a new drug to market with an attrition rate greater than 90%. Reviewing the overall pharmaceutical R&D process, it has become clear that many of the drug failures are due to our lack of knowledge in population diversity, which is responsible for differences in drug efficacy and toxicity. In fact, not a single approved drug is 100% safe and efficacious for all patients. For researchers, the key question is: How can we discover biomarkers that can be used to distinguish patients who will respond to the drug without adverse effects from those who will not respond and/or will have adverse effects? There is tremendous urgency to address this question. Biomarkers also fit perfectly with the vision of personalized medicine, the new expectation of medical practice. This is why biomarker research has been a central focus in many research labs across academia, government agencies, and the pharmaceutical industry. There are many different ways to define biomarkers based on molecular properties, applications, and methods.
Additional text
From the reviews:
"... extremely useful to pharmaceutical scientists who are involved in research all the way from early drug discovery through clinical trials." - Doody's Book Review
"The book is … for the bench scientist and is full of helpful advice on how to achieve high quality data using up-to-date technical approaches in genomics, proteomics and metabonomics. … I warmly recommend this … to all practicing toxicologists." (Roy Forster, British Toxicological Society Newsletter, June-August, 2009)
Report
From the reviews:
"... extremely useful to pharmaceutical scientists who are involved in research all the way from early drug discovery through clinical trials." - Doody's Book Review
"The book is ... for the bench scientist and is full of helpful advice on how to achieve high quality data using up-to-date technical approaches in genomics, proteomics and metabonomics. ... I warmly recommend this ... to all practicing toxicologists." (Roy Forster, British Toxicological Society Newsletter, June-August, 2009)
