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The role of biomarkers has been exponentially increasing in guiding decisions in every phase
of drug development, from drug discovery into post-marketing studies. Also, biomarkers
can predict patients? response to compound by identifying certain patient populations that are
more likely to respond to the drug therapy or to avoid specifi c adverse events. Th is shift toward
?personalized medicine is helping the drug industry achieve the goal of cost-eff ective and faster
research, especially in poorly served areas such as neurodegenerative disorders and cancer.
Biomarkers assays range from esoteric type of assays performed on a fi t-for-purpose basis
to rigorously validated assays when a biomarker is used as a surrogate end point, for patient
selection, or for randomization into diff erent arms. Assay validation is essential, but of equal
or even greater importance is the monitoring of assay performance and level of quality during
Despite all of the potential benefi ts of using biomarkers to advance pharmaceutical industry,
discrepant results can pose a threat to development programs by triggering false decisions.
Laboratory errors may be of pre-analytical, analytical, or post-analytical origin. Although clinical
laboratory errors due to analytical problems have been, with momentous eff orts, signifi cantly
reduced over time, the overall quality of clinical laboratory results can be compromised by
the absence of true method-to-method or platform-to-platform standardization, or at least
harmonization of test results.
Th is talk will highlight the following topics;
1. Biomarkers and their potential utility in drug development.
2. Th e major reasons behind discrepant results from biomarker laboratories and how to mitigate
Abdel Halim is a nationally recognized biomarker and clinical laboratory professional with more than 25 years
of experience in all aspects of biomarker discovery, development, validation, and applications in patient
management and pharmaceutical development. He is an expert in all biomarker techniques and platforms
From safety lab POC till whole genome sequencing.
Abdel is leading the biomarker function within Daiichi-Sankyo pharmaceutical company and managing all safety
and specialty biomarker aspects across different therapeutic areas in all phases of drug development.
Abdel holds Pharm D, and PhD in Clinical Biochemistry and Molecular Biology, and one of three lab professionals
in the USA who are triple certifi ed by the American Board in Clinical Chemistry, Molecular Diagnostics, and
Abdel is a member of 14 Clinical Laboratory Standard Institute (CLSI) subcommittees to establish guidelines
promoting quality in clinical laboratories worldwide.
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