Jean Lee
Papers
2
Total Citations
44
H-Index
2
About
Jean Lee is a distinguished bioanalytical scientist whose work bridges the critical gap between biomarker validation and therapeutic development. Her primary research focuses on the rigorous application of ligand-binding assays and electrochemiluminescence platforms for macromolecule quantification in regulated bioanalysis. Lee’s most impactful contribution is her 2009 paper on the “fit-for-purpose” validation of C-terminal telopeptides of Type 1 collagen (CTX-1) as a bone turnover biomarker in denosumab clinical studies. This work, cited 33 times, established a methodological framework that enabled robust pharmacodynamic monitoring of the osteoporosis drug, directly influencing regulatory decision-making. She further advanced the field by critically evaluating planar electrochemiluminescence platforms, detailing their benefits—such as broad dynamic range—and limitations for macromolecule assays. Lee’s achievements include pioneering practical strategies for biomarker implementation in late-stage clinical trials, ensuring that complex bioanalytical data meets stringent regulatory standards. Her research remains essential for scientists developing and validating biomarkers in pharmaceutical development, demonstrating how meticulous method validation can translate laboratory science into real-world therapeutic impact.
Research Focus
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Top Papers
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