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- General Strategies in Biomarker Research
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1. The proteomic revolution
- Dr. Larry Gold
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2. Lipid biomarkers: lipidomics of the macrophage and plasma lipidomes
- Prof. Edward A. Dennis
- New Tools for Biomarker Research
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5. Development of glyco-biomarkers using glycoproteomics technologies
- Dr. Hisashi Narimatsu
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6. Circulating nucleic acids as biomarkers in cancer patients
- Prof. Klaus Pantel
- Specific Disease Applications
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7. Biomarkers in breast cancer
- Prof. Joe Duffy
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8. Bacterial biomarkers
- Dr. Christiane Honisch
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9. Diabetes biomarkers
- Prof. Naveed Sattar
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10. Gene networks, brain networks: understanding schizophrenia
- Dr. Daniel Weinberger
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11. Biomarkers for Huntington's disease - promises and challenges
- Prof. Sarah Tabrizi
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12. Update on fluid biomarkers for neurodegenerative diseases
- Prof. Henrik Zetterberg
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13. Biomarkers in osteoarthritis
- Dr. Ali Mobasheri
- Biomarkers in Drug Discovery and Delivery
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14. Pharmacogenomics: emphasis on clinical drug development
- Dr. Amelia Warner
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15. Biomarkers in drug development: potential use and challenges
- Dr. Abdel-Bassett Halim
- Biomarkers in development, nutrition, and health
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18. Ethnic differences in nutrition
- Prof. Jose Ordovas
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19. Non-invasive prenatal diagnostics
- Prof. Y. M. Dennis Lo
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20. Epigenetic biomarkers in cancer
- Prof. Bob Brown
- Archived Lectures *These may not cover the latest advances in the field
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21. Biomarkers for Alzheimer's disease
- Prof. Henrik Zetterberg
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
Talk Citation
Halim, A. (2022, February 24). Biomarkers in drug development: potential use and challenges [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 31, 2024, from https://doi.org/10.69645/IGAK6703.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Abdel-Bassett Halim has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello. This is Abdel Halim,
Director and Function Lead of
Clinical Biomarkers at
Daiichi-Sankyo Global
Pharmaceutical Company.
I'm a doctor of pharmacy,
and hold the master
degree in biochemistry,
and other master in
biochemical analysis,
and PhD in clinical biochemistry
and cancer molecular biology.
I'm triple board certified
in molecular diagnostics,
clinical chemistry,
and toxicology.
I'm a fellow of
the American Academy of
Clinical Biochemistry.
I'll be speaking today on
the potential utility,
and the challenges or biomarkers
in drug discovery
and development.
0:47
On this presentation, I'm going
to cover the main topics.
Why we need biomarkers
in drug development,
potential applications
of biomarkers
in drug discovery
and development,
and the challenges around that.
I will not be able to
cover all the challenges,
but we'll focus on major ones.
We'll provide some insight on
possible tools for
their mitigations.
1:14
Drug development
is a long process,
encompasses multiple stages from
discovery to final approval.
The entire process may
take up to 15 years,
where from every 5,000 to
10,000 chemical compounds,
only about 250 can be
good candidates for
animal experimentation.
Out to this 250,
only about five compounds
may reach the clinic
with a possibility of only
one final approved drug.
As you can see, rate of
success can be only
one in 10,000.