CK18 as a Biomarker in NASH Clinical Trials

C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Scientific Product Manager, DiaPharma Group, Inc.
    Biography
      Dr. Jessica Tuohy is the Scientific Product Manager for Diapharma's biomarker portfolio, which includes assays for studying liver injury in the context of non-alcoholic fatty liver disease, alcoholic hepatitis, metabolic syndrome, and drug-induced liver injury. Jessica received her PhD in Pharmacology from the University of Colorado Health Sciences Center, where she was trained in mass spectrometry of lipids. She contributed to some of the early work in lipidomics in two research positions - first at Cell Therapeutics in Seattle, and subsequently at Vanderbilt University in Nashville, as part of the LIPID-MAPS consortium. Jessica joined Diapharma in 2005. She spent eleven years as the Western Territory Account Manager with a focus on assays for hemostasis, thrombosis and anticoagulation monitoring before she transitioned to her current role as brand ambassador and technical specialist for the company's hepatology and toxicology product lines. When she is not working, Jessica is busy trying to keep up with her three kids - two human and one furry.

    Abstract:

    Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in developed countries, and it affects over 25% of the population worldwide. Within the next five years, the more advanced form of this disease, Non-alcoholic steatohepatitis (NASH), is expected to become the leading cause for liver transplants in the US. There are currently no approved pharmacologic therapies for NAFLD or NASH.  Several drug pipelines with diverse mechanisms of action are in clinical development to address this unmet medical need.  While improvement in liver histology confirmed through biopsy is still a required endpoint for regulatory approval, non-invasive biomarkers may be used in early-stage trials to assess treatment effect. Serum Cytokeratin 18 (CK18) levels are reflective of hepatocyte apoptosis and necrosis, which are thought to be important processes involved in the progression of NAFLD. Monitoring serum CK18 levels, therefore, provides mechanistic information on the effect of drug treatment. Furthermore, changes in Serum Cytokeratin 18 Levels have been shown to correlate with changes in liver histology.

    The aims of this talk are to:
    1. Introduce the audience to the growing epidemic of NAFLD
    2. Elucidate challenges in developing therapies for the treatment of NASH
    3. Present data that support the value of CK18 as a biomarker for assessing the efficacy of drugs in NASH clinical trials.


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