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Journey of Biomarker from Discovery to Qualification


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.

Learning 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.
Moderated by Shraddha Thakkar, FDA and Syril Pettit, HESI e-star


  • Alison Harrill, Ph.D.

    Alison Harrill is leading efforts toward developing models that incorporate host genetic susceptibility into risk assessment. Genetics plays a key role in metabolism and response to drugs and chemicals, yet the systematic study of population dynamics in toxicity responses is in its infancy and understanding these dynamics may have important implications for human health risk assessment. Her current research includes investigation of population dynamics in response to drugs and chemicals, identification of gene variants that influence toxicity responses, and study of different transcriptional alterations that occur in affected tissues of sensitive versus resistant individuals. These efforts will take aim at reducing uncertainty when extrapolating risk from animal species to human populations.

    Prior to joining the NTP, Harrill was an Assistant Professor at the University of Arkansas for Medical Sciences and, prior to her academic tenure, Head of the Translational Pharmacogenetics Laboratory at the Hamner Institutes for Health Sciences. In these roles, she worked to qualify population-based rodent models, such as Diversity Outbred mice, for pharmaceutical safety testing and identification of pharmacogenetics toxicity risk factors that might enable precision medicine strategies. In addition, she has led safety biomarker discovery and qualification efforts that translated from animal species to clinical populations, with particular emphasis on liver and kidney injury biomarkers.

    Harrill received her Ph.D. in Toxicology from the University of North Carolina at Chapel Hill and her B.S. in Genetic Engineering from Cedar Crest College (Allentown, PA). She currently serves as a co-chair on the Application of Genomics for Risk Assessment Committee of ILSI/HESI, a member of the Contemporary Concepts in Toxicology Committee within the Society of Toxicology, and an executive committee member within the Toxicology Division of the American Society for Pharmacology and Experimental Therapeutics. She has been honored to receive many awards for her research, most recently: The Best Paper Published in Toxicological Sciences Award (2016) and the Burroughs Wellcome Fund Innovation in Regulatory Sciences Award (2013-2016).

February 11, 2021
Thu 12:30 PM EST

Duration 1H 30M

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