Biomarker validation : technological, clinical and commercial aspects / edited by Harald Seitz and Sarah Schumacher.

Format:

Book

Contributor:

Seitz, Harald, editor.

Schumacher, Sarah, editor.

Language:

English

Subjects (All):

Biochemical markers.

Physical Description:

1 online resource (267 p.)

Edition:

1st ed.

Place of Publication:

Weinheim, Germany : Wiley-VCH, 2015.

Language Note:

English

Summary:

Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.

Contents:

Cover

Table of Contents

Related Titles

Title Page

Copyright

List of Contributors

Chapter 1: Biomarkers - Past and Future

1.1 Introduction

1.2 Definitions of Biomarkers

1.3 Biomarkers in the Past

1.4 Novel Molecules and Structural Classes of Biomarkers by New Technologies

1.5 Biomarkers in Drug Research

1.7 Summary and Outlook

References

Chapter 2: Quantitative Proteomics Techniques in Biomarker Discovery

2.1 Introduction

2.2 2D-Difference Gel Electrophoresis

2.3 Mass Spectrometry-Based Proteomics

2.4 MALDI Mass Spectrometry Imaging

2.5 Conclusion

Chapter 3: Biomarker Qualification: A Company Point of View

3.1 Introduction

3.2 Biomarker Uses

3.3 Biomarker Types

3.4 Validation vs. Qualification

3.5 Strategic Choices in Business Models

3.6 Validation of Analytical Methods

3.7 Clinical Qualification of Candidate Biomarkers

3.8 Biomarker Qualification in the 'omics Era

3.9 An Example of a Biomarker Provider

3.10 Conclusion

Chapter 4: Biomarker Discovery and Medical Diagnostic Imaging

4.1 Introduction

4.2 Factors to Consider in Biomarker Selection for Imaging

4.3 Defining the Insertion Point of the Assay and Its Business Case

4.4 Practical In Vitro Methods Used to Identify Biomarkers

4.5 Preclinical Models

4.6 Preclinical Analysis Techniques

4.7 Translational Considerations and Restrictions

4.8 Other Uses of Preclinical Models

4.9 Nuclear Imaging Infrastructure

4.10 Image Processing

4.11 Concluding Remarks

Chapter 5: Breath: An Often Overlooked Medium in Biomarker Discovery

5.1 Introduction

5.2 Breath Analysis Studies: Targets, Techniques, and Approaches

5.3 Biomarker Confounders

5.4 Biomarkers in Breath

5.5 Outlook for Breath Analysis

Acknowledgments

References.

Chapter 6: HTA in Personalized Medicine Technologies

6.1 Introduction

6.2 Health Technology Assessment (HTA)

6.3 Validation and Evaluation of Biomarker Tests

6.4 Health Technology Assessment of Personalized Medicine Technologies

6.5 Concluding Remarks

Chapter 7: Bone Remodeling Biomarkers: New Actors on the Old Cardiovascular Stage

7.1 Introduction

7.2 Cardiovascular Disease and Osteoporosis: Common Risk Factors and Common Pathophysiological Mechanisms

7.3 Biomarkers of Bone Health in CVD

7.4 Conclusion

Chapter 8: Identification and Validation of Breast Cancer Biomarkers

8.1 Introduction

8.2 Current Detection and Treatment Modalities

8.3 Current Biomarker Limitations

8.4 Future Biomarker Discovery Targets

8.5 Summary

Chapter 9: Evaluation of Proteomic Data: From Profiling to Network Analysis by Way of Biomarker Discovery

9.1 Introduction

9.2 Proteomic Methodologies

9.3 Shotgun Proteomics

9.4 Biomarker Discovery

9.5 Protein-Protein Interaction Network Analysis

9.6 Conclusion

Chapter 10: Biomarkers: From Discovery to Commercialization

10.1 Comparison of Different Platforms

10.2 Mass Spectrometry

10.3 Enzyme-Linked Immunosorbent Assay

10.4 SPR Imaging

10.5 Reverse Phase Protein Microarrays

10.6 Next-Generation Sequencing (NGS)

10.7 Still a Struggle: Achieving Clinical Trial Status

10.8 Commercial Biomarker Assays

10.9 Quo Vadis, Biomarker Assays?

Chapter 11: Clinical Validation

11.1 Introduction

11.2 Classification of Biomarkers

11.3 Translational Use of Biomarkers

11.4 Biomarkers in Clinical Studies

11.5 Safety Markers in Clinical Development

11.6 Statistical Considerations

11.7 Validation.

11.8 Regulatory Considerations for Implementation of Biomarkers in Clinical Studies

11.9 Biorepositories and Ethics

11.10 Conclusion

Chapter 12: Genomics and Proteomics for Biomarker Validation

12.1 Introduction

12.2 Challenges in Biomarker Discovery/Verification Phases

12.3 Verification of Biomarkers

12.4 Role of Biobanking in Biomarkers Validation

12.5 Conclusions

Index

End User License Agreement.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references at the end of each chapters and index.

Description based on online resource; title from PDF title page (ebrary, viewed March 17, 2015).

ISBN:

9783527680672

3527680675

9783527680658

3527680659

9783527680665

3527680667

OCLC:

904046276