Aarkstore enterprise---Companion Biomarkers in Drug Development

   

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


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From:Aarkstore Enterprise
Contact: Neel
Email: press@aarkstore.com
URL: www.aarkstore.com