Next Generation Biomarkers - 1st Edition - ISBN: 9780128143155

Next Generation Biomarkers

1st Edition

From Omics to Precision Medicine

Editors: Wim Van Criekinge
Paperback ISBN: 9780128143155
Imprint: Academic Press
Published Date: 1st June 2018
Page Count: 400
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Description

Next Generation Biomarkers: From Omics to Precision Medicine offers a clear methodology for successfully discovering and validating biomarkers using next generation sequencing, and provides a comprehensive overview of next generation biomarkers currently used in the clinic. With recent advances in genomics and -omics approaches, elaborative molecular profiling is increasingly employed to gain fundamental insight into disease etiology and progression. However, without proper vetting and validation, few next generation genomic and -omic signatures make for clinically meaningful biomarkers. Through a case-study based approach, Next Generation Biomarkers examines a variety of NGS genomic and omics approaches to biomarker discovery and validation, lessons learned from recent studies and clinical trials, common challenges, regulations, and strategies for more accurate and efficient development of next generation biomarkers for use in precision medicine. Chapters cover NGS approaches ranging from whole exome sequencing to whole genome sequencing, epigenomic profiling, transcriptomics, peptidomics, proteomics, and liquid biopsy in addition to ethical considerations and patient empowerment in biomarker development.

Key Features

  • Establishes a clear methodology for successfully discovering and validating biomarkers using next generation sequencing, with emphasis on achieving meaningful outcomes for clinical diagnostics, drug development, and therapeutics
  • Provides a comprehensive overview of next generation biomarkers currently used clinically
  • Via foundational chapters and detailed case studies, examines a variety of NGS approaches to biomarker identification, lessons learned from recent studies, common challenges, regulations, and strategies for more accurate and efficient identification of next generation biomarkers for use in precision medicine
  • Covers NGS approaches ranging from whole exome sequencing to whole genome sequencing, epigenomic profiling, transcriptomics, peptidomics, proteomics, and liquid biopsy, as well as ethical considerations and patient empowerment in biomarker development
  • Features contributions from leading international researchers working at the forefront of NGS biomarker discovery and validation

Readership

Students, physicians, and researchers in the field of clinical genomics and precision medicine; molecular biologists and life science researchers with a focus in molecular profiling; medical practitioners across medical disciplines as well as systems biology and genomic/-omic epidemiology; pathologists; oncologists; genetic counselors; researchers and those conducting clinical trials in industry and pharma; pharma regulators

Table of Contents

Section 1: Introduction

1. Scope  

2. Biomarker is a biomarker is a biomarker

3. Omics

4. Precision medicine

Section 2: Biomarker Development Path

5. Overview – clinical development path (analogy to Therapeutics) - Fit for purpose

6. Analytical Validation

7. Clinical Validation

8. Clinical Utility

Section 3: Statistical Considerations

9. Introduction

10. Discovery Informatics / Machine Learning

11. Statistical Issues for Biomarker Studies (confounding, statistical tests, multiplicity/overfitting, FDR)

12. Statistical versus clinical significance

13. Biomarker study design (RCT, Biomarker by Treatment Interaction Design, Adaptive Designs)

Section 4: Molecular Profiling

The Sample: Diagnostic Matrices

14. FFPE

15. Liquid Biopsies

16. Extracellular vesicles

The method: Technologies

17. PCR versus Sequencing: The Heisenberg Uncertainty

The test

18. From Central Reference Labs over IVD kids to Sample to Anwers and Mobile Platforms

Section 5: Clinical Biomarkers

Genetic

19. Lessons learned 1

20. Lessons learned 2

21. Lessons learned 3

22. Whole genome-exome diagnostics

Epigenetic

23. Lessons learned 1

24. Lessons learned 2

25. Whole epigenome / Methylation atlas

Expression (RNA, miRNA, lncRNA)

26. Lessons learned 1

27. Lessons learned 2

28. Transcriptomics

Translation (Protein)

29. Lessons learned 1

30. Lessons learned 2

31. Proteomics

32. Peptidomics

Section 6: Clinico-Genomic

33. best of both worlds

Section 7: The Economics of Molecular Diagnostics

34. HTA/Economic evaluation

35. Reimbursement

36. IP – Intellectual Property

37. Commercialization - Business Models - Translating biomarkers successfully to the clinic

Section 8: Biomarkers and ELSI (Ethical, Legal and Social Implication)

38. Legal – Regulations

39. Ethical and Social Implications

Section 9: Biomarkers and Patient Empowerment

40. Risk Management, A Review of Shared Decision-Making and/or Evidence-based advocacy

Section 10: Best Practices

41. Keys to success/lessons learned

Details

No. of pages:
400
Copyright:
© Academic Press 2018
Published:
Imprint:
Academic Press
Paperback ISBN:
9780128143155

About the Editor

Wim Van Criekinge

Dr. Wim Van Criekinge graduated in 1994 as a Chemical Engineer from the University of Ghent, Belgium, where he also earned his PhD in Molecular Biology in 1998. Today he holds a part-time Professorship at the same university, where he is head of the laboratory for computational genomics and bioinformatics (Biobix) within the department of molecular biotechnology. He is a founding partner of NXT-GNT, a next generation sequencing facility and board member of N2N (nucleotides 2 networks), a multidisciplinary platform grouping systems biology expertise at the University of Ghent. In 1997 he was co-founder and director of Devgen, a biotechnology company, which had a successful IPO in June 2005. Dr. Van Criekinge has also worked as a consultant for the government (iHealth) and various biotech companies, and he currently serves as VP of Science & Technology at MDx-Health. Dr. Van Criekinge has published over 130 peer reviewed papers in topics ranging from epigenetics to biotechnology, translational medicine, bioinformatics, ICT, pharmacogenomics, eHealth, biobanking, omics, and biomarker research.

Affiliations and Expertise

Professor Bioinformatics, University of Ghent, Belgium