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1. Introduction
2. Topics
3. Stages of drug development
4. Attrition in drug development
5. Increased drug development cost - Eroom's law
6. Drug development strategies are unsustainable
7. Number of hits for biomarkers-related publications
8. How Pharaohs detected pregnancy
9. Biomarkers in drug development
10. PG biomarkers in FDA-approved drug labels
11. Personalized medicine: potential value & benefits
12. Vemurafenib (Zelboraf)/BRAF mutation test
13. How can a biomarker be useful?
14. Expectations from biomarker results
15. Challenges
16. LDL-C and HDL-C predict CHD
17. Inadequate understanding of biology
18. Intra-tumor heterogeneity
19. Can we have right tissue quantity and quality?
20. The pursuit of traceability
21. Blood hemoglobin: standardized assays
22. Perceived level of confidence in a laboratory test
23. Regulated molecular Dx
24. LDH on different platforms
25. Within-lab/within-platform reagent lot-to-lot change
26. Regulated biomarker assays
27. Different platforms: ALP (1)
28. Different platforms: ALP (2)
29. The case of LDL-C
30. LDL-C detection using different methods
31. PT as a surrogate for appropriate anticoagulation
32. PT results analyzed in different labs
33. Conclusion
34. How to mitigate analytical challenges?
35. Concluding remarks

Topics Covered

• Biomarkers in drug development
• Classes of biomarkers
• Crisis in pharmaceutical development
• Potential value of biomarkers and personalized medicine to enhance probability of success
• Challenges (biology, pre-analytical, analytical)
• Possible mitigation

Links

Series:

• Biomarkers
• Small Molecule Drug Discovery

Categories:

• Biochemistry
• Cell Biology
• Pharmaceutical Sciences

Therapeutic Areas:

• Oncology

Talk Citation

Publication History

• Published on September 23, 2013

Financial Disclosures

• Dr. Abdel-Bassett Halim has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.