miRNA Biomarkers for Toxicology

Online Material

Abstracts

Abstract for Poster and Invited Speaker Presentations

Program

miRNA Biomarkers for Toxicology Program

Program Agenda

miRNA Biomarkers for Toxicology Program Agenda

Registrant List

miRNA Biomarkers for Toxicology Attendee List

Continuing Education

Sunday, March 13, 2016

Meeting attendees have the opportunity to attend the AM05: Discovery and Validation of miRNA Biomarkers Bridging Preclinical and Clinical Toxicity: Lessons Learned from Hepatotoxicity on Sunday morning.

If you have already registered for this CE Course, you will have received a ticket for the course with your SOT Annual Meeting Badge. If you would like to register for the course or need assistance, please go to the Annual Meeting On-Site Registration counter.

Vision and Background

Vision

Long-term strategies are needed to coordinate future activities across different consortia, with an understanding of the efforts needed to progress a miRNA biomarker from discovery toward routine use in nonclinical and/or clinical safety assessment. Particular attention must be focused on the guidelines established by regulatory agencies for assessing new biomarkers, which have evolved along with the scientific efforts in this area. This conference will bring together scientists from the various consortia along with colleagues in academia and industry who are working independently with the goal of coordinating efforts toward identification and validation of miRNA biomarkers of toxicologic pathology.

Background

MicroRNAs (miRNAs) are small, regulatory RNAs that control gene expression posttranscriptionally, thus acting as epigenetic regulators within cells. Recent data demonstrate that some miRNAs are specific to or enriched in certain cell types and/or organs and that they are released upon cellular damage, supporting their potential as non-invasive biomarkers of injury. Ease of detection and high stability at room temperature in biofluids contribute to enthusiasm of miRNAs as non-invasive biomarkers. miRNA detection is relatively straightforward with low inputs of material by quantitative real-time-PCR, microarray, or next-generation sequencing.

Several consortia efforts have been established to discover and validate miRNA biomarkers that

• provide insight into injury mode of action;
• distinguish the specific injury location and affected cell type; and/or
• are more sensitive for detection than “gold standard” protein biomarkers.

Critically, several of these biomarkers, particularly for liver injury, have progressed to clinical validation. Communication of recent discovery efforts and discussion of miRNA biomarker research efforts between consortia partners and independent researchers is a critical step toward the streamlined utilization of promising biomarkers for nonclinical and clinical safety assessment.

Speaker Presentations

Program: Saturday, March 12, 2016