miRNA Biomarkers for Toxicology

MiRNA Biomarkers for Toxicolog logo

March 12, 2016 | New Orleans, Louisiana

SOT is pleased to provide registrants these conference materials. Download the materials to your computer, smartphone, or tablet. All online meeting information is intended for registered miRNA meeting attendees.

Online Material


Abstract for Poster and Invited Speaker Presentations


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


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.


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

9:00 AM–10:00 AM

Keynote Lecture

About Chomsky, DNA Patterns, non-Coding RNAs and Cancer Patients
George Calin, MD Anderson Cancer Center, Houston, Texas

10:00 AM–1:00 PM

Plenary Session I: MiRNAs as Biomarkers of Tissue Injury or Disease across Organ Systems


Heidrun Ellinger-Ziegelbauer, Bayer Pharma AG, Wuppertal, Germany
Igor Pogribny, US FDA-NCTR, Jefferson, Arkansas

The ILSI/HESI miRNA Rat Atlas Project to Identify Tissue-Specific miRNA Expression
Aaron Smith, Lilly Research Laboratories, Indianapolis, Indiana

Discovery of Glomerular Versus Tubular Injury Specific Urinary miRNA Biomarkers in Rodents
Rounak Nassirpour, Pfizer, Cambridge, Massachusetts

  Session Break

MiRNA-206 As a Useful Biomarker of Skeletal Muscle Injury
Masayuki Kanki, Astellas, Osaka, Japan

Plasma miRNAs as Potential Early Biomarkers for Acute Cardiac Injury
Andre da Costa, UCB BioPharma, Brussels, Belgium

MiRNAs Signatures of Prostate Cancer in Urinary Exosomes
Peter Mouritzen, Exiqon, Denmark

10:00 AM–1:00 PM Lunch and Poster Session – Room 217
All meeting attendees are encouraged to attend the Poster Session and enjoy a free lunch. More than 20 posters on current miRNA research will be presented. Network with your colleagues and enjoy some New Orleans favorites!
10:00 AM–1:00 PM

Plenary Session II – Technical Considerations for Measurement and Analysis of Small Non-Coding RNA in Biofluids

Karol Thompson, US FDA, Silver Spring, Maryland
Michael Lawton, Pfizer, Groton, Connecticut

Measurement Methodology and Experimental Considerations for miRNA Quantification
Jami Elliott, Quantigen Genomics, Indianapolis, Indiana

Extracellular Vesicle Enrichment of miRNA in Biofluids
Kenneth Witwer, Johns Hopkins University, Baltimore, Maryland

Classes of Small Non-Coding RNA in Biofluids
Kendall Van Keuren-Jensen, TGen, Phoenix, Arizona

  Session Break

Reference Samples for miRNA Measurements
Scott Pine, National Institute of Standards and Technology, Gaithersburg, Maryland

Bioinformatics Challenges for Next Generation Sequencing Analysis of miRNA Expression
Weida Tong, US FDA-NCTR, Jefferson, Arkansas

5:30 PM

Closing Remarks
Alison Harrill, University of Arkansas for Medical Sciences, Little Rock, Arkansas
Warren Glaab, Merck, West Point, Pennsylvania

  • Alison Harrill, Chair, University of Arkansas for Medical Sciences, Little Rock, AR
  • Warren Glaab, Co-Chair, Merck Research Laboratories, West Point, PA
  • Brian Chorley, US EPA, Research Triangle Park, NC
  • Heidrun Ellinger-Ziegelbauer, Bayer Pharma AG, Wuppertal, NW, Germany
  • Jean-Charles Gautier, Sanofi, Vitry-sur-Seine, France
  • Michael Lawton, Pfizer, Groton, CT
  • Eric McDuffie, Janssen, San Diego, CA
  • Rounak Nassirpour, Pfizer, Cambridge, MA
  • Igor Pogribny, US FDA-NCTR, Jefferson, AR
  • Karol Thompson, US FDA, Silver Spring, MD