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If you have any questions or you are interested in the services/assays showcased in our poster and talks please contact us and come meet us at booth #710 !

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Posters and slides

Poster 349: Development of protein-based assay methods for authentication of insects in food and feed

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Poster 392: Assay validation and quantification of novel protein safety biomarker candidates for the detection of glomerular injury in clinical specimens

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Poster 413: Development and validation of assay methods for novel mechanistic protein biomarkers of drug-induced liver injury (DILI)

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Poster 432: In vitro models to determine the pre-systemic metabolism of the human intestine following oral administration

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Poster 725: Assessing Hepatotoxic and Nephrotoxic Compounds in HepaRG and RPTEC Cells by Key Signaling Events Using Multiplexed Microsphere-Based Sandwich Immunoassays

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Sessions & Talks

Advances in cardiotoxicity assessment (12-Mar, 1:00 pm, Room 250D): Development and validation of assay methods for novel mechanistic protein biomarkers of drug-induced vascular injury (DIVI)

This presentation will address the detection and monitoring challenges of drug-induced vascular injury (DIVI), underscoring the urgency of identifying reliable biomarkers for patient safety. Despite advancements, no clinical biomarkers for DIVI have been established. The TransBioLine project, an EU initiative, aims to qualify biomarkers for drug induced organ injury.

We will showcase a protein assay panel designed for signaling endothelial activation and smooth muscle damage, consisting of vascular-cell adhesion molecule 1 (VCAM1), angiopoietin 2 (ANG2), P-selectin (SELP), smoothelin B (SMTNB), and matrix metalloproteinase 3 (MMP3). This panel was validated in line with FDA guidelines. A key achievement includes the precise measurement of smoothelin B, highlighting its potential as a vascular injury biomarker.

Future steps involve testing these biomarkers in clinical samples from patients with vasculitides and mechanical vascular injuries, aiming to validate and qualify them within the scope of the TransBioLine project to enhance the detection and monitoring of DIVI.

Session (12-Mar, 3:00 pm, Room 155 B): Advances in Drug-Induced Organ Injury Biomarker Development

There is an unmet need for reliable tests to detect drug-induced organ injury, as organ toxicity remains a major cause of drug development failure. During the drug development process, mandatory testing must be performed on various animal species such as rodents, dogs, and non-human primates and humans to rule out organ toxicity. To date, such studies have been dominated by time-consuming and non-quantitative histological analyses. Therefore, potential biomarkers from body fluids to detect drug-induced kidney (DIKI), liver (DILI), pancreas (DIPI), vascular (DIVI), and central nervous system injury (DINI) have been investigated by academic-industrial consortia like the Safer and Faster Evidence-based Translation Consortium (SAFE-T) and the Predictive Safety Testing Consortium (PSTC).Here, potential protein and microRNA biomarkers were analyzed in retrospective and prospective studies. The results were recognized by the FDA and EMA and resulted in letters of support recommending selections of these biomarkers for further investigation. The qualification process is currently continuing under the Translational Safety Biomarker Pipeline (TransBioline) project, which is supported by the EU Innovative Medicine Initiative program. The TransBioLine consortium has established work streams for biomarker research and development in a comprehensive network of industry, academic institutions, and small and medium-sized enterprises. The research plans for each work package have been recognized and accepted by the FDA’s Biomarker Qualification Program. In this symposium, the individual work groups will provide an overview of the status of research in the five different indications and the results of the exploratory phase. Finally, an overview of the qualification plans will be given.