Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 5 | 5 |
List of Tables | 8 | 1 |
List of Figures | 9 | 1 |
Biomarkers in Drug Discovery - Introduction | 10 | 1 |
Introduction | 10 | 1 |
Biomarkers in Drug Discovery - Overview | 11 | 8 |
History of Biomarkers | 11 | 2 |
Biomarkers Cater to the Unmet Needs in Drug Discovery | 13 | 1 |
High Attrition Rates | 14 | 1 |
High Drug Discovery Cost | 15 | 1 |
Time Consuming | 15 | 1 |
Safety and Efficacy | 15 | 1 |
Invasiveness, Selectivity and Sensitivity | 15 | 1 |
Biomarker Discovery and the Validation Process | 16 | 1 |
Discovery | 16 | 1 |
Development | 17 | 1 |
Reproduction and Assay | 17 | 1 |
Verification | 17 | 1 |
Assay Development | 17 | 1 |
Preclinical and Clinical Development | 17 | 1 |
Launch | 17 | 1 |
Regulatory Submission and Market Planning | 17 | 2 |
Biomarkers in Drug Discovery - Market Characterization | 19 | 6 |
Market Size and Forecasts | 19 | 1 |
Global Biomarkers Market Geographic Landscape | 20 | 1 |
Introduction | 20 | 1 |
North America | 20 | 1 |
Europe | 20 | 1 |
Asia | 21 | 1 |
Row | 21 | 1 |
Drivers and Barriers | 21 | 1 |
Drivers for the Global Biomarkers Market | 22 | 1 |
Time and Cost-Saving | 22 | 1 |
Better Regulatory Norms and Validation Procedures | 22 | 1 |
Extensive Range of Applications in Different Industrial Sectors | 22 | 1 |
Integration of Omics Increases the Scope of Application for Biomarkers in Other Technologies | 23 | 1 |
Advantageous Over Conventional Drug Discovery Methods | 24 | 1 |
Barriers for the Global Biomarkers Market | 24 | 1 |
Lack of Awareness about Intelligent and Novel Technological Advances | 24 | 1 |
Complex Biomarker-based Techniques May Lead to False Positive Results Misleading the Clinical Trials | 24 | 1 |
Funding Organizations Require Strong Clinical Data and Validation | 24 | 1 |
Cumbersome and Lengthy Development | 24 | 1 |
Biomarkers in Drug Discovery - Time Trends | 25 | 5 |
Historic Trend | 25 | 1 |
Predictions Based on Biomarkers | 25 | 1 |
Validation Versus Qualification | 25 | 1 |
Lack of Synergy between Mechanism and Pattern | 25 | 1 |
Regulatory Approval of Biomarkers | 26 | 1 |
Difference in Regulation of Single Biomarkers and Panel of Biomarkers | 26 | 1 |
Measures of Success | 26 | 1 |
Future Trend Growing Demand for Personalized Medicine | 27 | 1 |
Companion Diagnostics Market | 27 | 1 |
Drivers and Barriers for Companion Diagnostics Market | 28 | 1 |
Regulations of Companion Diagnostics EU | 28 | 1 |
Regulations of Companion Diagnostics US | 29 | 1 |
Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery | 30 | 6 |
Role of Imaging as a Predictive Biomarker | 30 | 2 |
Biomarker Discovery Using Proteomics via Mass Spectrometry | 32 | 2 |
High-Throughput Proteome Screening for Biomarker Detection | 34 | 2 |
Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery | 36 | 13 |
Application of Biomarkers in Drug Discovery | 36 | 2 |
Lead Identification and Optimization | 38 | 1 |
Potential Role of Biomarkers in Lead Identification and Optimization | 39 | 1 |
Target Validation | 39 | 1 |
Toxicological Assay (Preclinical and Clinical) | 39 | 1 |
Mechanism of Action | 40 | 1 |
Monitor Therapy and Dose Response | 40 | 1 |
Stratify Patient Population | 40 | 1 |
Filing and Post-Marketing Surveillance | 41 | 1 |
Benefits of Biomarker Utilization | 41 | 1 |
Disease Understanding | 41 | 1 |
Project Prioritization through Early Attrition | 41 | 1 |
Streamlining Clinical Trials | 41 | 1 |
Reducing Cost of Drug Development | 42 | 1 |
Expediting Drug Development | 42 | 1 |
Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen | 42 | 1 |
Drug Repositioning | 42 | 1 |
Challenges in Biomarker Utilization | 42 | 1 |
Variability | 42 | 1 |
Validity | 43 | 1 |
Measurement Errors | 43 | 1 |
Bias | 43 | 1 |
Confounding | 43 | 1 |
Cost | 43 | 1 |
Acceptability | 43 | 1 |
Biomarker Classification | 44 | 1 |
Biomarker Categories | 45 | 1 |
Types of Biomarkers | 45 | 1 |
Type 0 Markers | 45 | 1 |
Type I Marker | 46 | 1 |
Type II Biomarker | 46 | 1 |
Reasons for Surrogate Endpoint Failure | 47 | 2 |
Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development | 49 | 4 |
Discovery | 50 | 1 |
Predictive Safety Biomarkers | 50 | 1 |
Mechanism of Action Markers | 50 | 1 |
Preclinical Development | 50 | 1 |
Prognostic and Epidemiological Biomarkers | 50 | 1 |
Diagnostic Biomarkers | 51 | 1 |
Clinical Development | 52 | 1 |
Disease Progression Markers or Response to Therapy Markers | 52 | 1 |
Surrogate Biomarkers | 52 | 1 |
Biomarkers in Drug Discovery - Case Study | 53 | 6 |
Role of HER2 Gene in Herceptin Development for Breast Cancer | 53 | 1 |
Activation of Antibody-Dependent Cellular Cytotoxicity | 53 | 1 |
Prevention of the Formation of p95HER2 | 53 | 1 |
Inhibition of HER2-activated Cell Proliferation | 54 | 1 |
Inhibition of HER2-regulated Angiogenesis | 54 | 1 |
Herceptin Side Effects | 55 | 2 |
Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia | 57 | 2 |
Biomarkers in Drug Discovery - Regulatory Trends | 59 | 7 |
Regulatory Landscape | 59 | 1 |
Investigative/Exploratory Biomarker | 59 | 1 |
Probable Valid Biomarker | 59 | 1 |
Known Valid Biomarker | 59 | 1 |
Letter Of Intent to Propose Biomarker Qualification | 59 | 1 |
Administrative Structure | 59 | 1 |
Biomarker Qualification Overview | 59 | 1 |
Overall Summaries of the Following (as appropriate) | 59 | 1 |
Questions for the FDA | 59 | 1 |
Structure of Biomarker Qualification Briefing Document | 60 | 2 |
Validated Biomarker | 62 | 3 |
Regulatory Acceptance of Valid Biomarkers | 65 | 1 |
Regulatory Guidance from the FDA, EMA and MHLW | 65 | 1 |
Biomarkers in Drug Discovery - Promising Biomarkers | 66 | 9 |
Biomarkers for Alzheimer s Disease | 66 | 1 |
Imaging Biomarkers | 66 | 1 |
Magnetic Resonance Imaging | 66 | 1 |
Positron Emission Tomography Scans | 66 | 1 |
Fluid Biomarkers | 67 | 1 |
Cerebrospinal Fluid Biomarkers | 67 | 1 |
Plasma Biomarkers | 67 | 1 |
Biomarkers for Cancer | 67 | 2 |
Insulin-like Growth Factor 1 and 2 | 69 | 1 |
OVA1 | 69 | 1 |
Risk of Ovarian Malignancy Algorithm | 69 | 1 |
Serum Markers | 69 | 1 |
Micro RNAs | 69 | 1 |
Biomarkers for Multiple Sclerosis | 70 | 1 |
Serum Marker: Brain-Derived Neurotrophic Factor | 70 | 1 |
Cerebrospinal Fluid Markers | 70 | 1 |
Imaging Marker | 71 | 1 |
Biomarkers for Rheumatoid Arthritis | 71 | 1 |
Micro RNAs | 71 | 1 |
Autoantibodies | 72 | 1 |
Rheumatoid Factor | 72 | 1 |
Antibodies against Cyclic Citrullinated Peptide | 72 | 1 |
Inflammatory Markers | 72 | 1 |
Erythrocyte Sedimentation Rate | 72 | 1 |
C-Reactive Protein | 72 | 1 |
Biomarkers for Hepatitis C | 73 | 1 |
Serum Markers | 73 | 1 |
Imaging Markers | 73 | 1 |
Non-Structural 5A Protein | 74 | 1 |
Micro RNA-22 | 74 | 1 |
Biomarkers in Drug Discovery - Strategic Consolidations | 75 | 6 |
M&A Deals | 75 | 1 |
Micromedic Buys 33% Stake in BioMarCare for $1m | 75 | 1 |
ValiRx Plc Acquires Pharmatest s Biomarkers Business Unit | 75 | 1 |
David H. Murdock Research Institute Acquires the Immune Tolerance Institute | 76 | 1 |
Health Diagnostic Laboratory Acquires Harris Scientific | 76 | 1 |
Myriad Genetics Acquires Rules-based Medicine | 76 | 1 |
Licensing Agreements | 77 | 1 |
SomaLogic Enters into Licensing Agreement with AmberGen | 77 | 1 |
Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services | 77 | 1 |
AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech | 78 | 1 |
KineMed Extends Licensing Agreement with Bristol-Myers Squibb | 78 | 1 |
Partnership Deals | 79 | 1 |
KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers | 80 | 1 |
Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics | 80 | 1 |
Genedata and Roche Extend Collaboration of Biomarker Discovery | 80 | 1 |
Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms | 80 | 1 |
Biomarkers in Drug Discovery - Appendix | 81 | 7 |
Market Definitions | 81 | 1 |
Abbreviations | 81 | 2 |
Bibliography | 83 | 3 |
Research Methodology | 86 | 2 |
Coverage | 86 | 1 |
Secondary Research | 86 | 1 |
Primary Research | 86 | 1 |
Expert Panel Validation | 87 | 1 |
Contact Us | 87 | 1 |
Disclaimer | 87 | 1 |