Next Generation Biomarkers

  • ID: 4455029
  • Book
  • 400 Pages
  • Elsevier Science and Technology
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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.

  • 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
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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 Matrices14. FFPE
15. Liquid Biopsies
16. Extracellular vesiclesThe method: Technologies17. PCR versus Sequencing: The Heisenberg UncertaintyThe test18. From Central Reference Labs over IVD kids to Sample to Answers and Mobile Platforms
Section 5: Clinical Biomarkers
Genetic19. Lessons learned 1
20. Lessons learned 2
21. Lessons learned 3
22. Whole genome-exome diagnosticsEpigenetic23. Lessons learned 1
24. Lessons learned 2
25. Whole epigenome / Methylation atlasExpression (RNA, miRNA, lncRNA)26. Lessons learned 1
27. Lessons learned 2
28. TranscriptomicsTranslation (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
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Van Criekinge, Wim
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.
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