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Companion Biomarkers in Drug Development --- Aarkstore Enterprise

Posted Nov 19 2010 10:34am

The term “companion biomarker” means that a particular diagnostic test is specifically linked to a therapeutic drug either in drug development or in the clinic. Biomarkers of disease have long played an important role in diagnostic medicine as evidenced by the intense use of specific clinical laboratory tests in the diagnosis of disease. Biomarkers can be used in five very distinct ways in drug development: 1) companion biomarkers can be correlated with biological events during drug development in order to validate drug targets or to predict drug response; 2) biomarkers can be used as companion diagnostics in drug development to characterize patient populations in order to better understand the extent to which new drugs reach intended therapeutic targets can alter proposed therapeutic pathways and achieve successful clinical outcomes; 3) biomarkers can be used to stratify patient populations for drug response in primary prevention or disease-modification studies, particularly in specific clinical areas such as neuron degeneration and cancer; 4) clinically useful biomarkers are becoming increasingly useful to make proper therapeutic decisions regarding candidate drugs; and 5) clinically useful biomarkers are becoming increasingly required by the FDA and other outside authorities to make proper regulatory decisions regarding candidate drugs. This TriMark Publications report describes new biomarker technology platforms developed for the analyses of drug targets that are connected to the effectiveness of therapeutic agents in a clinical setting. The emphasis is on those companies that are actively developing and marketing new companion diagnostic tests for performing biomarker tests during drug development, as opposed to the more routine and clinically accepted companion markers that are manufactured and marketed by large diagnostic companies for routine clinical use.


Table of Contents :
1. Overview 13
1.1 Statement of Report 13
1.2 About This Report 13
1.3 Scope of the Report 13
1.4 Objectives 13
1.5 Methodology 15
1.6 Executive Summary 16

2. Introduction: Companion Diagnostics in Drug Development 19
2.1 Companion Diagnostics as Biomarkers 20
2.1.1 Potential Benefits of Biomarkers as Companion Diagnostics 22
2.2 Biomarkers in Different Phases of Drug Development 22
2.2.1 Drug Discovery and Development Process 22
2.2.2 Biomarkers in Drug Development 24
2.3 Drug Targets 24
2.3.1 Target Discovery Using Functional Genomics 26
2.3.2 Functional Genomics 26
2.3.3 Target Validation 28
2.3.3.1 Target Discovery 28
2.3.3.2 Lead Identification 28
2.3.4 Target and Biomarker Discovery 29
2.3.4.1 Biomarker Validation 29
2.4 Biomarkers in Drug Discovery, Development and Clinical Diagnostics 29
2.4.1 Role of Biomarkers in Drug Discovery, Preclinical, Clinical Development and Diagnostics 29
2.4.2 The Pipeline Problem 31
2.4.3 Biomarkers in the Drug Discovery Process 32
2.4.4 Segmentation of Biomarker Usage 32
2.4.5 Efficacy of Biomarkers as Surrogate Endpoints 33
2.4.6 Biomarkers Used to Reduce the Cost of Drug Development 34
2.4.7 Biomarkers: Challenges and Opportunities 34
2.4.8 Biomarkers in Early Safety and Toxicity Assessment 35
2.4.9 Biomarkers in Determining Validation Parameters 35
2.4.10 Challenges in Development of Biomarkers 36
2.4.11 Using Biomarkers in Early Clinical Development 36
2.4.12 Translational Biomarkers 36
2.4.13 Use of Biomarkers in “Go”/No-Go” Decisions 37
2.4.14 Diagnostic Tests 37
2.4.15 Biomarkers in Deal Making 37
2.4.16 Payors Use Biomarkers in Decision-Making 37
2.5 World Pharmaceutical Markets 38
2.5.1 World Market Summary 38
2.5.2 Company Performance in this Segment 40
2.5.3 Forces Affecting the Structure of the Pharmaceutical Industry 41
2.5.3.1 Threats 41
2.5.3.2 Competitive Forces 42
2.6.1 Industry Overview 42
2.6.1.1 Pharmaceutical Industry Drug Pipeline 44
2.6.1.2 Asia-Pacific to Replace United States and Europe as Pharmaceutical Industry Center 54
2.6.1.3 The Changing Pharmaceutical Business Model 54
2.6.2 Benefits for Companion Diagnostic Tests in Drug Development 55
2.6.3 Strategies for the Creation of Partnerships - Predicting and Overcoming Challenges in Creating Drug Response Profiling Diagnostics 57
2.6.4 Options and Applications 57
2.6.4.1 Clinical Applications of Genomics: The Use of Evidence Based Frameworks by Decision-Makers 57
2.6.5 Challenges, Drivers and Trends 58
2.6.5.1 Macro Trends in Biomarkers 58
2.6.5.2 Biomarkers: Industry SWOT Analysis 61
2.6.6 Breakaway Technologies 62
2.6.7 Collaboration for Companion Diagnostics 63
2.6.8 Key Stake Holders in Companion Diagnostics 63
2.9 Future Developments 65

3. Biomarker Development Tools 66
3.1 New Technologies in Functional Genomics 66
3.1.1 Genomics-Derived Drug Pipeline 66
3.1.2 Future of Genomics Technologies for Drug Target Identification 66
3.2 Overview of Microarrays 67
3.2.1 General Theory of Microarrays 68
3.2.2 GeneChip Probe Array Technology 69
3.2.3 DNA Microarrays 69
3.2.3.1 DNA Microarray Market Size 71
3.2.3.2 DNA Microarrays in SNP Analysis 72
3.2.3.3 DNA Microarrays in Cancer 72
3.2.4 Protein Microarrays 73
3.2.4.1 Reasons Why Researchers Use Protein Microarrays 74
3.2.4.2 Factors for Adoption of Protein Microarrays Technology 74
3.2.4.3 Future Innovations in Protein Microarray Technology 74
3.2.5 New Technologies 75
3.2.5.1 Antibody Microarrays 75
3.2.5.2 Peptide Microarrays 75
3.2.5.3 Peptide MHC Microarrays 75
3.2.5.4 Tissue Microarrays 75
3.2.5.5 Key Points for Developing Microarray Based Applications 76
3.2.5.6 Reasons Why Researchers use DNA Microarrays 77
3.2.5.7 Factors for Difficulties Applying DNA Microarrays Technology 77
3.2.5.8 Emerging Microarray Trends 78
3.2.5.9 Emerging Microarray Applications 78
3.2.5.10 Key Findings on Use of Microarrays 79
3.2.5.11 Advantages and Drivers of Microarrays 79
3.2.5.12 Limitations and Barriers to Use of Microarrays 81
3.2.5.13 qRT-PCR Use in Biomarker Identification and Drug Development 83
3.2.5.14 Microarray Quality Control (MAQC) Project 84
3.3 Theranostics 84
3.3.1 Theranostics in Drug Development 84
3.3.2 Trends in Theranostics 85
3.3.3 Timeline for Impact on Various Segments in Theranostics 85
3.3.4 Challenges for Biomarker Based Therapeutics Development 87
3.4 Pharmaceutical Development and Bioanalytical Services 88
3.4.1 Wyeth Singulex’s Erenna 88
3.5 Metabolomics in Drug Discovery 88
3.6 Bioinformatics 90
3.6.1 Definition and Role of Bioinformatics 90
3.6.2 Bioinformatics Sector Overview 93
3.6.3 Future Status of Bioinformatics 93
3.6.3.1 Future in Drug Discovery 93
3.6.3.2 Mergers and Acquisitions Could Deter Bioinformatics Growth 94
3.6.3.3 Barriers to Bioinformatics Growth 94
3.6.3.4 Types of Data and Bioinformatics Applications 94
3.6.3.5 Validated Core Modeling Technology 95
3.6.3.6 Applicability of Bioinformatics for Biomarker Discovery 95
3.6.3.7 Biomarker Data Management Compliant with Industry Standards 96
3.6.3.8 Data Management for Biomarkers 96
3.6.3.8.1 Data Transformation for Biomarker Development 96
3.6.3.8.2 Biomarker Data Collaboration 96
3.6.3.8.3 Interface for Online Data Sources for Genomic Structures 96
3.6.3.8.4 Target Markets for Informatics Software 96
3.6.3.8.5 Bioinformatics Drivers and Challenges in the Pharmaceutical Industry 97
3.6.3.8.6 Products of Bioinformatics 100
3.6.3.8.7 Informatics Tools and Functionalities 101
3.6.3.8.8 Bioinformatics in Lead Identification and Optimization 101
3.6.3.8.9 Bioinformatics in Drug Development and Formulation 102
3.6.3.8.10 Role of Bioinformatics in the Drug Discovery Value Chain 102
3.6.3.8.11 Bioinformatics Software for Drug Discovery and Biomarker Development 102
3.6.3.8.12 Bioinformatics Services 104
3.7 Biomarkers and Proteomics 105
3.7.1 Scientific Background 105
3.7.2 Applying Proteomics to Biomarker Discovery 106
3.7.2.1 Challenges Facing Biomarker Developers 106
3.7.3 Limitations of Proteomic Approaches to Biomarker Discovery 108
3.7.4 Validation of Biomarkers Using LC-MS/MS Systems 109
3.7.5 Use of Mass Spectrometry in Biomarker Discovery 109
3.7.5.1 Multiple Reaction Monitoring Assays (MRMs) 110
3.7.5.2 Gel-based Approaches 110
3.7.5.3 Non-Gel-based Approaches 111
3.7.5.4 SELDI-TOF MS 111
3.7.5.5 SELDI and Prognosis 112
3.7.5.6 SELDI and Treatment Monitoring 112
3.7.5.7 Limitations of Mass Spectroscopy 112
3.7.6 Partnerships for Developing Proteomic Biomarkers 114
3.7.7 Proteomics in Developing a New Cancer Marker 114
3.7.7.1 Translating Proteomic Oncology Discoveries to the Clinic: Development of Analytical Reference Materials, Reagents, Data, and Technology Assessment and Validation 115
3.7.7.2 Challenges of Discovering and Validating Clinical Protein Biomarkers 115
3.7.7.3 Importance of Proteomics in Biomarker Discovery 115
3.8 Toxicogenomics 115
3.8.1 Toxicogenomics Concerns in Drug Safety Data 116
3.8.2 Toxicogenomics and Prioritization of Drug Candidates 116
3.8.3 Genomic Biomarkers for Drug-Induced Nephrotoxicity 117
3.8.4 Use of Biomarkers of Drug-Induced Cardiotoxicity 117
3.8.5 Use of Biomarkers of Drug-induced Hepatotoxicity 117
3.8.6 Transgenic Biomarkers for Adverse Drug-Drug Interactions 117
3.8.7 Challenges to Toxicogenomics 118
3.8.8 The Future Use of Toxicogenomics in Drug Discovery 118

4. Market for Biomarkers in Drug Development 119
4.1 C-KIT (CD117) Expression 122
4.2 CCR5 -Chemokine C-C Motif Receptor 122
4.3 CYP2C19 Variants 123
4.4 CYP2C9 Variants 123
4.5 CYP2D6 Variants 124

For more information, please visit : http://www.aarkstore.com/reports/Companion-Biomarkers-in-Drug-Development-13521.

Contact :Sanaa

Aarkstore Enterprise

Tel : +912227453309

Mobile No: +919272852585

Email : contact@aarkstore.com

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