International Workshop on NASH Biomarkers 2018

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Viral Hepatitis and Liver Disease

Integrating science, logistics and cost in approval of hierarchical testing strategies for NASH - The payer's perspective- Robert LoNigro, MD

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Viral Hepatitis and Liver Disease

Pathways and priorities for biomarker assessment- Peter Stein, MD

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Viral Hepatitis and Liver Disease

Repeatability, reproducibility and analytic standards for biomarker development- Abbas Bandukwala

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Viral Hepatitis and Liver Disease

Linking “intended use” to evidence needed for bringing a biomarker to market- John Sninsky, PhD

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Viral Hepatitis and Liver Disease

Defining the reference standard for biomarker development - Histology versus clinical outcomes- Kathleen Donohue, MD

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Viral Hepatitis and Liver Disease

A Context of Use Framework for Bioanalytical Validation of the CK18 Apoptosis Biomarker for NASH Drug Development- Sumit Kar

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Viral Hepatitis and Liver Disease

Serum markers of collagen formation are associated with the severity of Liver fibrosis and Non-Alcoholic Steatohepatitis (NASH) histological features and to impaired renal function (IRF) in a NAFLD cohort- Samuel Daniels

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Viral Hepatitis and Liver Disease

What is needed to link device approval to clinical application approval?- David Litwack, PhD

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Viral Hepatitis and Liver Disease

Algorithm to identify non-alcoholic steatohepatitis (NASH) patients with a NAS≥4 and F≥2: algorithm derived in an American screening cohort and validation in a British non-alcoholic fatty liver disease (NAFLD) cohort- Celine Fournier

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Viral Hepatitis and Liver Disease

Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH- Brent Tetri, MD

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Viral Hepatitis and Liver Disease

Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH- Detlef Schuppan, MD, PhD

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Viral Hepatitis and Liver Disease

Defining therapeutic response in precirrhotic and cirrhotic NASH- Manal Abdelmalek , MD

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Viral Hepatitis and Liver Disease

The clinical need for integrated assessment of NASH diabetes and heart disease- Arun Sanyal, MD, MBBS

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Viral Hepatitis and Liver Disease

Use of plasma PRO-C3, PRO-C5, and PRO-C6 for the diagnosis and follow-up of fibrosis stage in patients with nonalcoholic fatty liver disease (NAFLD)- iana Leeming

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Viral Hepatitis and Liver Disease

Neoepitope fragments of extracellular matrix as markers of fibrosis in chronic liver disease: Insights into clinical and preclinical utilization for unfolding disease pathogenesis - Diana Leeming, PhD

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Viral Hepatitis and Liver Disease

Feasibility of Using Deep-learning-based Techniques for Liver Couinaud Segmentation and Proton Density Fat Fraction (PDFF) Estimation- Hashem Almahmoud

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Viral Hepatitis and Liver Disease

Repeatability and Reproducibility of Multiparametric Magnetic Resonance Imaging of the Liver- Andrea Dennis

Slideset

Viral Hepatitis and Liver Disease

International Workshop on NASH Biomarkers 2018

Integrating science, logistics and cost in approval of hierarchical testing strategies for NASH - The payer's perspective- Robert LoNigro, MD

Pathways and priorities for biomarker assessment- Peter Stein, MD

Repeatability, reproducibility and analytic standards for biomarker development- Abbas Bandukwala

Linking “intended use” to evidence needed for bringing a biomarker to market- John Sninsky, PhD

Reporting standards: STARD & TRIPOD- Patrick Bossuyt, PhD

Quality standards for imaging studies- Claude Sirlin, MD

Case definitions for use as reference standards- Mohammed Siddiqui, MD

Defining the reference standard for biomarker development - Histology versus clinical outcomes- Kathleen Donohue, MD

A Context of Use Framework for Bioanalytical Validation of the CK18 Apoptosis Biomarker for NASH Drug Development- Sumit Kar

Serum markers of collagen formation are associated with the severity of Liver fibrosis and Non-Alcoholic Steatohepatitis (NASH) histological features and to impaired renal function (IRF) in a NAFLD cohort- Samuel Daniels

What is needed to link device approval to clinical application approval?- David Litwack, PhD

Algorithm to identify non-alcoholic steatohepatitis (NASH) patients with a NAS≥4 and F≥2: algorithm derived in an American screening cohort and validation in a British non-alcoholic fatty liver disease (NAFLD) cohort- Celine Fournier

Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH- Brent Tetri, MD

Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH- Detlef Schuppan, MD, PhD

Defining therapeutic response in precirrhotic and cirrhotic NASH- Manal Abdelmalek , MD

The clinical need for integrated assessment of NASH diabetes and heart disease- Arun Sanyal, MD, MBBS

Use of plasma PRO-C3, PRO-C5, and PRO-C6 for the diagnosis and follow-up of fibrosis stage in patients with nonalcoholic fatty liver disease (NAFLD)- iana Leeming

Neoepitope fragments of extracellular matrix as markers of fibrosis in chronic liver disease: Insights into clinical and preclinical utilization for unfolding disease pathogenesis - Diana Leeming, PhD

Feasibility of Using Deep-learning-based Techniques for Liver Couinaud Segmentation and Proton Density Fat Fraction (PDFF) Estimation- Hashem Almahmoud

Repeatability and Reproducibility of Multiparametric Magnetic Resonance Imaging of the Liver- Andrea Dennis

FDA perspective on parallel review (Not available)- Rochelle Fink, MD, JD