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Printable Handouts
Navigable Slide Index
- Introduction
- Topics
- Stages of drug development
- Attrition in drug development
- Increased drug development cost - Eroom's law
- Drug development strategies are unsustainable
- Number of hits for biomarkers-related publications
- How Pharaohs detected pregnancy
- Biomarkers in drug development
- PG biomarkers in FDA-approved drug labels
- Personalized medicine: potential value & benefits
- Vemurafenib (Zelboraf)/BRAF mutation test
- How can a biomarker be useful?
- Expectations from biomarker results
- Challenges
- LDL-C and HDL-C predict CHD
- Inadequate understanding of biology
- Intra-tumor heterogeneity
- Can we have right tissue quantity and quality?
- The pursuit of traceability
- Blood hemoglobin: standardized assays
- Perceived level of confidence in a laboratory test
- Regulated molecular Dx
- LDH on different platforms
- Within-lab/within-platform reagent lot-to-lot change
- Regulated biomarker assays
- Different platforms: ALP (1)
- Different platforms: ALP (2)
- The case of LDL-C
- LDL-C detection using different methods
- PT as a surrogate for appropriate anticoagulation
- PT results analyzed in different labs
- Conclusion
- How to mitigate analytical challenges?
- 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
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Talk Citation
Halim, A. (2013, September 23). Biomarkers in drug development: potential use and challenges [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 21, 2021, from https://hstalks.com/bs/2646/.Publication History
Financial Disclosures
- Dr. Abdel-Bassett Halim has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.