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Journey of Biomarker from Discovery to Qualification

AAPS | American Association of Pharmacueticals Scientists | Path Course Page

Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum creatinine, and urinary markers, such as urinary volume, specific gravity, or osmolality, protein, fractional electrolyte excretion, or sediment examination). Although many of these measurements are valid indicators of renal function, there is a vast gap to overcome for early detection of kidney damage to identify nephrotoxic biomarkers with high sensitivity and specificity. There is promise in utilizing urinary biomarkers as an indicator of nephron toxicity. This program has taken on work to help qualify by FDA/EMA protein biomarkers like clusterin and Renal Papillary Antigen (RPA-1) in rats, has published work to identify urinary biomarkers, and defined technical best practices for protein biomarker evaluation and interpretation. There have been efforts ongoing to characterize on a multi-laboratory program to investigate kidney region-specificity of microRNA (miRNA) candidates in rodents is in its final phase.

This webinar will also cover the quantification of laser capture microdissection (LCM) of nephron segments (glomerulus, proximal tubule, a loop of Henle, collecting duct). Urinary clusterin and RPA-1 are now qualified biomarkers by the Food and Drug Administration for some context of use. Urinary clusterin is approved for use in detecting acute drug-induced renal tubule alterations, and urinary RPA-1 is a qualified biomarker for voluntary use in detecting acute drug-induced renal tubule alterations. This webinar will cover the utility, promises, and challenges in using biomarkers of nephrotoxicity.

Moderated by

Shraddha Thakkar, FDA and Syril Pettit, HESI e-star

AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

Course Objectives
  • Share the development of the nephrotoxicity biomarker and its utility and promises.
  • Provide developers point of view for biomarker development point of view.
  • Share the essential components required for the biomarker development process and will help attendees with an understanding of criteria they would need to go through the qualification process.