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Officials with the Jackson County Sheriff's department say the body of Timothy Gordon, Sr. was found just after 12 p.m. Saturday on the Escatawpa River. Friday evening around 5:30, Gordon and anotherMore >>
The search in Moss Point is over. The body of 55-year-old boater Timothy Gordon has been pulled from the Escatapwa River. Now investigators are saying marijuana may have been involved in the accident.
Monday, May 13 2013 12:24 PM EDT2013-05-13 16:24:04 GMT
MARION COUNTY, MS (WDAM) - A weekend-long drug raid left 22 individuals behind bars, and more arrests to come. According to Marion County Sheriff Berkley Hall, the drug raid is the result of severalMore >>
A weekend-long drug raid left 22 individuals behind bars, and more arrests to come.More >>
Friday, May 17 2013 11:04 PM EDT2013-05-18 03:04:19 GMT
It is the end of an era for one Biloxi elementary school. A long-time PE teacher is retiring at the end of the month. And when he leaves, so will a popular tradition he started three decades ago.More >>
It is the end of an era for one Biloxi elementary school. A long-time PE teacher is retiring at the end of the month. And when he leaves, so will a popular tradition he started at the school three decades ago. Thousands of students consider him the "coolest" teacher around.More >>
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NEW YORK, March 26, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes
GBI Research's new report, "Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes" provides information and analysis on the major trends and issues affecting biomarkers in the drug discovery process. The report describes the history of biomarkers and their role in fulfilling the unmet needs of the conventional drug discovery process. The drivers and barriers for the biomarkers market, along with the key issues faced in the application of biomarkers in the drug discovery process, are highlighted. The report discusses some important technologies being used in the discovery and validation of biomarkers. The integration of different types of biomarkers in each phase of the drug discovery and development process is also studied. Additionally, the report talks about the strategic consolidations that have taken place within the global biomarkers market. These include mergers, acquisitions, and strategic partnerships among companies involved in the manufacturing of biomarkers for drug discovery and research. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.
According to Food and Drug Administration (FDA), a biological marker or biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or biological responses to a therapeutic intervention. It can define a physiologic, pathologic or anatomic characteristic or measurement that is thought to relate to some aspect of normal or abnormal biologic function. Changes in biomarkers following treatment may identify safety problems related to a drug candidate or reveal a pharmacological activity that predicts an eventual benefit from treatment. Biomarkers may reduce uncertainty in drug development and evaluation by providing quantitative predictions about drug performance.
Before the application of biomarkers in drug discovery, the process had various drawbacks such as high attrition rates, high costs and erroneous predictions about drug safety and efficacy. The integration of biomarkers has addressed these issues and made the drug discovery process smoother and less costly. The conventional symptom-based drug R&D process, also called the "one-size-fits-all" or "blockbuster" model, is being replaced by personalized medicine so that targeted treatment can be designed for individuals based on their genetic codes
GBI Research analysis indicates that the global biomarkers market has seen substantial growth since 2004, due to improvements in technology and the creation of favorable regulatory norms for the application of biomarkers in drug discovery.
This report focuses on the applications of biomarkers in drug development, the market characterization, and promising biomarkers in various therapy areas. Historic and future trends, strategic consolidations and regulatory norms are the other areas discussed in the report.
- An overview of biomarkers in the drug discovery process along with their use, efficiency and limitations. - Annualized market data from 2004 and forecast forward to 2018. - Key market drivers and restraints for the biomarkers market. - Important technologies being used in the discovery of biomarkers. - Promising biomarkers that are expected to be used in the drug discovery process in the future. - The integration of different types of biomarker in each phase of the drug discovery and development process - Analysis of partnership and M&A deals from 2011 until August 2012.
Reasons to buy
- Develop better strategies for biomarkers research by understanding the market dynamics for the biomarker drug discovery industry. - Develop market entry and market expansion strategies by identifying the key areas for high growth and opportunities. - Understand the factors shaping the biomarkers drug discovery market. - Reinforce the R&D pipeline by identifying the key biomarker tests that can provide more accurate and early diagnosis of diseases. - Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.
1 Table of Contents 1 Table of Contents 5 1.1 List of Tables 8 1.2 List of Figures 9 2 Biomarkers in Drug Discovery - Introduction 10 2.1 Introduction 10 3 Biomarkers in Drug Discovery - Overview 11 3.1 History of Biomarkers 11 3.2 Biomarkers Cater to the Unmet Needs in Drug Discovery 13 3.2.1 High Attrition Rates 14 3.2.2 High Drug Discovery Cost 15 3.2.3 Time Consuming 15 3.2.4 Safety and Efficacy 15 3.2.5 Invasiveness, Selectivity and Sensitivity 15 3.3 Biomarker Discovery and the Validation Process 16 3.3.1 Discovery 16 3.3.2 Development 17 3.3.3 Launch 17 4 Biomarkers in Drug Discovery - Market Characterization 19 4.1 Market Size and Forecasts 19 4.2 Global Biomarkers Market – Geographic Landscape 20 4.2.1 Introduction 20 4.2.2 North America 20 4.2.3 Europe 20 4.2.4 Asia 21 4.2.5 Row 21 4.3 Drivers and Barriers 21 4.3.1 Drivers for the Global Biomarkers Market 22 4.3.2 Barriers for the Global Biomarkers Market 24 5 Biomarkers in Drug Discovery - Time Trends 25 5.1 Historic Trend 25 5.1.1 Predictions Based on Biomarkers 25 5.1.2 Validation Versus Qualification 25 5.1.3 Lack of Synergy between Mechanism and Pattern 25 5.1.4 Regulatory Approval of Biomarkers 26 5.1.5 Difference in Regulation of Single Biomarkers and Panel of Biomarkers 26 5.1.6 Measures of Success 26 5.2 Future Trend – Growing Demand for Personalized Medicine 27 5.2.1 Companion Diagnostics Market 27 5.2.2 Drivers and Barriers for Companion Diagnostics Market 28 5.2.3 Regulations of Companion Diagnostics – EU 28 5.2.4 Regulations of Companion Diagnostics – US 29 6 Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery 30 6.1 Role of Imaging as a Predictive Biomarker 30 6.2 Biomarker Discovery Using Proteomics via Mass Spectrometry 32 6.3 High-Throughput Proteome Screening for Biomarker Detection 34 7 Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery 36 7.1 Application of Biomarkers in Drug Discovery 36 7.1.1 Lead Identification and Optimization 38 7.1.2 Potential Role of Biomarkers in Lead Identification and Optimization 39 7.1.3 Target Validation 39 7.1.4 Toxicological Assay (Preclinical and Clinical) 39 7.1.5 Mechanism of Action 40 7.1.6 Monitor Therapy and Dose Response 40 7.1.7 Stratify Patient Population 40 7.1.8 Filing and Post-Marketing Surveillance 41 7.2 Benefits of Biomarker Utilization 41 7.2.1 Disease Understanding 41 7.2.2 Project Prioritization through Early Attrition 41 7.2.3 Streamlining Clinical Trials 41 7.2.4 Reducing Cost of Drug Development 42 7.2.5 Expediting Drug Development 42 7.2.6 Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen 42 7.2.7 Drug Repositioning 42 7.3 Challenges in Biomarker Utilization 42 7.3.1 Variability 42 7.3.2 Validity 43 7.3.3 Measurement Errors 43 7.4 Biomarker Classification 44 7.4.1 Biomarker Categories 45 7.4.2 Types of Biomarkers 45 7.4.3 Reasons for Surrogate Endpoint 'Failure' 47 8 Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development 49 8.1 Discovery 50 8.1.1 Predictive Safety Biomarkers 50 8.1.2 Mechanism of Action Markers 50 8.2 Preclinical Development 50 8.2.1 Prognostic and Epidemiological Biomarkers 50 8.2.2 Diagnostic Biomarkers 51 8.3 Clinical Development 52 8.3.1 Disease Progression Markers or Response to Therapy Markers 52 8.3.2 Surrogate Biomarkers 52 9 Biomarkers in Drug Discovery - Case Study 53 9.1 Role of HER2 Gene in Herceptin Development for Breast Cancer 53 9.1.1 Activation of Antibody-Dependent Cellular Cytotoxicity 53 9.1.2 Prevention of the Formation of p95HER2 53 9.1.3 Inhibition of HER2-activated Cell Proliferation 54 9.1.4 Inhibition of HER2-regulated Angiogenesis 54 9.1.5 Herceptin Side Effects 55 9.2 Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia 57 10 Biomarkers in Drug Discovery - Regulatory Trends 59 10.1 Regulatory Landscape 59 10.1.1 Investigative/Exploratory Biomarker 59 10.1.2 Probable Valid Biomarker 59 10.1.3 Known Valid Biomarker 59 10.1.4 Letter Of Intent to Propose Biomarker Qualification 59 10.1.5 Structure of Biomarker Qualification Briefing Document 60 10.2 Validated Biomarker 62 10.3 Regulatory Acceptance of Valid Biomarkers 65 10.4 Regulatory Guidance from the FDA, EMA and MHLW 65 11 Biomarkers in Drug Discovery - Promising Biomarkers 66 11.1 Biomarkers for Alzheimer's Disease 66 11.1.1 Imaging Biomarkers 66 11.1.2 Fluid Biomarkers 67 11.2 Biomarkers for Cancer 67 11.2.1 Insulin-like Growth Factor 1 and 2 69 11.2.2 OVA1 69 11.2.3 Risk of Ovarian Malignancy Algorithm 69 11.2.4 Serum Markers 69 11.3 Biomarkers for Multiple Sclerosis 70 11.3.1 Serum Marker: Brain-Derived Neurotrophic Factor 70 11.3.2 Cerebrospinal Fluid Markers 70 11.3.3 Imaging Marker 71 11.4 Biomarkers for Rheumatoid Arthritis 71 11.4.1 Micro RNAs 71 11.4.2 Autoantibodies 72 11.4.3 Inflammatory Markers 72 11.5 Biomarkers for Hepatitis C 73 11.5.1 Serum Markers 73 11.5.2 Imaging Markers 73 11.5.3 Non-Structural 5A Protein 74 11.5.4 Micro RNA-22 74 12 Biomarkers in Drug Discovery - Strategic Consolidations 75 12.1 M&A Deals 75 12.1.1 Micromedic Buys 33% Stake in BioMarCare for $1m 75 12.1.2 ValiRx Plc Acquires Pharmatest's Biomarkers Business Unit 75 12.1.3 David H. Murdock Research Institute Acquires the Immune Tolerance Institute 76 12.1.4 Health Diagnostic Laboratory Acquires Harris Scientific 76 12.1.5 Myriad Genetics Acquires Rules-based Medicine 76 12.2 Licensing Agreements 77 12.2.1 SomaLogic Enters into Licensing Agreement with AmberGen 77 12.2.2 Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services 77 12.2.3 AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech 78 12.2.4 KineMed Extends Licensing Agreement with Bristol-Myers Squibb 78 12.3 Partnership Deals 79 12.3.1 KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers 80 12.3.2 Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics 80 12.3.3 Genedata and Roche Extend Collaboration of Biomarker Discovery 80 12.3.4 Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms 80 13 Biomarkers in Drug Discovery - Appendix 81 13.1 Market Definitions 81 13.2 Abbreviations 81 13.3 Bibliography 83 13.4 Research Methodology 86 13.4.1 Coverage 86 13.4.2 Secondary Research 86 13.4.3 Primary Research 86 13.4.4 Expert Panel Validation 87 13.5 Contact Us 87 13.6 Disclaimer 87
1.1 List of Tables
Table 1: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by EMA for Use in Drug Development, 2012 17 Table 2: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by FDA for Use in Drug Development, 2012 18 Table 3: Biomarkers in Drug Discovery, Global Biomarker's Market, Revenue ($bn), 2004–2011 19 Table 4: Biomarkers in Drug Discovery, Global Biomarker's Market, Revenue Forecast ($bn), 2011–2018 19 Table 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery by Mass Spectrometry, Problems and Solutions, 2012 33 Table 6: Biomarkers in Drug Discovery, Global, Examples of Biomarkers, 2012 47 Table 7: Biomarkers in Drug Discovery, Global, Herceptin Development Timeline, 2012 55 Table 8: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA-approved Drugs, 2012 62 Table 9: Biomarkers in Drug Discovery, Global, Imaging and Cerebrospinal Fluid Biomarker Categories in Alzheimer's Disease, 2012 66 Table 10: Biomarkers in Drug Discovery, Global, Prognostic and Diagnostic Biomarkers for Cancer, 2012 68 Table 11: Biomarkers in Drug Discovery, Global, Micro RNAs as Biomarkers of Cancer, 2012 69 Table 12: Biomarkers in Drug Discovery, Global, Cerebrospinal Fluid Biomarkers in Multiple Sclerosis, 2012 70 Table 13: Biomarkers in Drug Discovery, Global, Micro RNA as Biomarker for Rheumatoid Arthritis, 2012 71 Table 14: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions, 2011–2012 75 Table 15: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Licensing Agreement Deals, 2011–2012 77 Table 16: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Partnerships Deals, 2011–2012 79`
1.2 List of Figures
Figure 1: Biomarkers in Drug Discovery, Global, Commonly Identified Biomarkers, 2012 10 Figure 2: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2012 11 Figure 3: Biomarkers in Drug Discovery, Global, Biomarkers Cater to the Unmet Needs of Conventional Drug Discovery Methods, 2012 13 Figure 4: Biomarkers in Drug Discovery, Global, Reasons for Attrition, 2012 14 Figure 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2012 16 Figure 6: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue Forecast ($bn), 2004–2018 19 Figure 7: Biomarkers in Drug Discovery, Global, Geographic Landscape – Global Biomarkers Market, 2012 20 Figure 8: Biomarkers in Drug Discovery, Global, Market Drivers and Restraints, 2012 21 Figure 9: Biomarkers in Drug Discovery, Global, Integration of 'Omics' Drives Global Biomarker Market, 2012 23 Figure 10: Biomarkers in Drug Discovery, Global, Roche, Companion Diagnostics Development Process, 2012 27 Figure 11: Biomarkers in Drug Discovery, Global, Diagnostic Criteria for Multiple Sclerosis, 2012 30 Figure 12: Biomarkers in Drug Discovery, Global, Case Study, 2012 31 Figure 13: Biomarkers in Drug Discovery, Global, Protein Identification by Mass Spectrometry, 2012 32 Figure 14: Biomarkers in Drug Discovery, Global, Peptide Identification by Tandem Mass Spectrometry, 2012 33 Figure 15: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Equalizer Bead Fractionation and ProteinChip SELDI System, 2012 34 Figure 16: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Fractionation Schemes, 2012 35 Figure 17: Biomarkers in Drug Discovery, Global, Biomarkers' Development and Drug Development Comparison, 2012 36 Figure 18: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Drug Discovery and Development, 2012 37 Figure 19: Biomarkers in Drug Discovery, Global, Drug Discovery Process, 2012 37 Figure 20: Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2012 38 Figure 21: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2012 40 Figure 22: Biomarkers in Drug Discovery, Global, Biomarker Classification, Disease and Drug-related Biomarkers, 2012 44 Figure 23: Biomarkers in Drug Discovery, Global, Biomarker Categories, 2012 45 Figure 24: Biomarkers in Drug Discovery, Global, Types of Biomarkers, 2012 45 Figure 25: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 47 Figure 26: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 47 Figure 27: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48 Figure 28: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48 Figure 29: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48 Figure 30: Biomarkers in Drug Discovery, Global, Biomarker Application in Each Stage of the Drug Discovery Process, 2012 49 Figure 31: Biomarkers in Drug Discovery, Relationship Between Different Types of Biomarkers and New Molecular Entities, 2012 51 Figure 32: Biomarkers in Drug Discovery, Global, Gleevec Approval Fact Sheet, 2012 57
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