Next Generation Biomarkers

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.

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