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 September 2019
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, along with 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 insights into disease etiology and progression. Through a case-study based approach, the book examines a variety of NGS genomic and omics approaches to biomarker discovery and validation, along with lessons learned from recent studies and clinical trials.

Chapters explore common challenges, regulations and strategies for more accurate and efficient development of next generation biomarkers, and NGS approaches, ranging from whole exome sequencing, to whole genome sequencing, epigenomic profiling, transcriptomics, peptidomics, proteomics, liquid biopsy, ethical considerations, and patient empowerment in biomarker development.

Key Features

  • Establishes a clear methodology for successfully discovering and validating biomarkers using next generation sequencing
  • Provides a comprehensive overview of next generation biomarkers currently used
  • 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 kits to Sample to Answers 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
Language:
English
Copyright:
© Academic Press 2020
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 of Bioinformatics, University of Ghent, Belgium

Ratings and Reviews