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Nominated by: Chris James, Director, TS&BA, Amgen (CA, USA)
“After a PhD and post-doc, Omar began his Pharma career in discovery bioanalysis at BMS and subsequently moved to Amgen. Omar has built a unique combination of experience in LC–MS bioanalysis of proteins, LM and SM drugs, biomarkers and regulatory bioanalysis. Omar’s work has included the qualification and bioanalysis of multiplexed biomarker panels, oligonucleotide analysis, development of challenging tissue protein biomarker analyses and more recently application of hybrid LC–MS methods for GLP and clinical studies, as well as development of high-sensitivity HRMS techniques for bioanalysis of intact protein drugs in biofluids. Omar has learned the full rigor required for FDA bioanalytical validations and GLP study support, including leading the first Amgen application of hybrid LC–MS methods to GLP studies as a Principal Investigator, while continuing to investigate novel methods such as HRMS for proteins. Omar has collaborated closely with project team colleagues to develop novel drug and biomarker assays to enable program objectives. In the future, Omar is set to continue to develop novel LC–MS methods for proteins and LM drugs to enable rapid progress of drug development candidates while meeting the high standards for fully validated GLP and clinical bioanalytical methods set by the FDA.”
1Describe the main highlights of your bioanalytical work.
A consistent theme of my scientific career has been to develop solutions for challenging bioanalysis. Examples include the qualification of highly multiplexed LC–MS/MS assays for the bioanalysis of polyunsaturated fatty acids and sterols, hybrid immunocapture LC–MS/MS approaches for the quantification of target proteins in tissue for receptor occupancy modeling, validation and application of sensitive (50 ng/mL) intact protein HRMS methods with SIL-protein internal standards for bioanalysis, leading the application of a hybrid immunocapture LC–MS/MS method for a GLP study, and serving as principal investigator for small molecule GLP studies. In addition, I have recently led several collaborations to drive LC–MS/MS technology at Amgen, including a cross-site collaboration to train colleagues in oligonucleotide bioanalysis by high resolution mass spectrometry (HRMS), leading an effort to cross-train all LC–MS staff in surrogate peptide identification with subsequent hybrid immunocapture LC–MS bioanalysis, and mentoring both a graduate intern and LBA-focused staff member in validating hybrid immunocapture HRMS methods for the bioanalysis of intact mAB based drugs. Further, I have continually collaborated with other functions to characterize large molecule (LM) reagents and quantify cell culture contaminants by LC–MS/MS.