Biomarker Methods in Drug Discovery and Development

1. Front Matter

   Pages i-xviii

   PDF

2. Biomarker Sample Collection and Handling in the Clinical Setting to Support Early-Phase Drug Development

   • Chris B. Russell, Sid Suggs, Kristina M. Robson, Keith Kerkof, Lisa D. Kivman, Kimberly H. Notari et al.

   Pages 1-26

3. Gene Expression-Based Biomarkers of Drug Safety

   • Eric A.G. Blomme, Scott E. Warder

   Pages 27-49

4. Profiling Gene Expression Signatures Using Fluorescent Microspheres

   • Suzanne M Torontali, Jorge M Naciff, Kenton D Juhlin, Jay P Tiesman

   Pages 51-62

5. Real-Time Polymerase Chain Reaction Gene Expression Assays in Biomarker Discovery and Validation

   • Yulei Wang, Catalin Barbacioru, David Keys, Pius Brzoska, Caifu Chen, Kelly Li et al.

   Pages 63-85

6. SAGE Analysis in Identifying Phenotype Single Nucleotide Polymorphisms

   • Sandro J de Souza, I-Mei Siu, Janete M Cerutti, Gregory J Riggins

   Pages 87-118

7. Single Nucleotide Polymorphisms and DNA Methylation Analysis Using Pyrosequencing Methods

   • Jinsheng Yu, Sharon Marsh

   Pages 119-140

8. The Application of Laser Capture Microdissection for the Analysis of Cell-Type-Specific Gene Expression in a Complex Tissue:

   • William C. Okulicz

   Pages 141-169

9. The Use of Two-Dimensional Gel Electrophoresis for Plasma Biomarker Discovery

   • Brad Jarrold, Alex Varbanov, Feng Wang

   Pages 171-187

10. Difference In-Gel Electrophoresis: A High-Resolution Protein Biomarker Research Tool

    • David S. Gibson, David Bramwell, Caitriona Scaife

    Pages 189-209

11. Label-Free Mass Spectrometry-Based Protein Quantification Technologies in Protein Biomarker Discovery

    • Mu Wang, Jin-Sam You, Kerry G. Bemis, Dawn P.G. Fitzpatrick

    Pages 211-230

12. Top-Down Quantitative Proteomic Analysis Using a Highly Multiplexed Isobaric Mass Tagging Strategy

    • Bing Xie, Wayne F. Patton, Craig E. Parman

    Pages 231-249

13. SELDI Technology for Identification of Protein Biomarkers

    • Prasad Devarajan, Gary F. Ross

    Pages 251-271

14. Sandwich ELISA Microarrays: Generating Reliable and Reproducible Assays for High-Throughput Screens

    • Rachel M. Gonzalez, Susan M. Varnum, Richard C. Zangar

    Pages 273-290

15. LC-MS Metabonomics Methodology in Biomarker Discovery

    • Xin Lu, Guowang Xu

    Pages 291-315

16. GC-MS-Based Metabolomics

    • Sally-Ann Fancy, Klaus Rumpel

    Pages 317-340

17. NMR-Based Metabolomics for Biomarker Discovery

    • Narasimhamurthy Shanaiah, Shucha Zhang, M. Aruni Desilva, Daniel Raftery

    Pages 341-368

18. Unraveling Glycerophospholipidomes by Lipidomics

    • Kim Ekroos

    Pages 369-384

19. Back Matter

    Pages 385-396

    PDF

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.

• Clinical sample handling
• DNA
• Drug efficacy and toxicity
• Gene expression analysis
• PCR
• Pharmaceutical research & development
• SNP
• gene expression
• genes
• tissue

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)

• Procter & Gamble Pharmaceutical Inc, Mason, USA

  Feng Wang

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