New Report "Companion Biomarkers in Drug Development" available through Aarkstore Enterprise

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.

Online PR News – 08-September-2009 – – 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 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 Target Discovery 28 Lead Identification 28
2.3.4 Target and Biomarker Discovery 29 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 Threats 41 Competitive Forces 42
2.6.1 Industry Overview 42 Pharmaceutical Industry Drug Pipeline 44 Asia-Pacific to Replace United States and Europe as Pharmaceutical Industry Center 54 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 Clinical Applications of Genomics: The Use of Evidence Based Frameworks by Decision-Makers 57
2.6.5 Challenges, Drivers and Trends 58 Macro Trends in Biomarkers 58 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

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