Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials-D2-AM

This workshop assisted the FDA in identifying current knowledge gaps for using NITs as diagnostic biomarkers and reasonably likely surrogates, as well as provided a framework for additional data that are needed to fill these knowledge gaps. The primary focus of this workshop was “non-cirrhotic NASH/MASH population with advanced (i.e., Stage 2 or Stage 3) liver fibrosis.”

-Session One: Considerations for Surrogate Endpoint Development.
-Session Two: Imaging Based Biomarkers for Noncirrhotic NASH Clinical Trial.

Timestamps

00:11 – Welcome Remarks, Recap, and Introduction

06:28 – Biomarkers and Surrogate Endpoints in the Regulatory Framework

11:37 – Session Two Introductions

13:54 – Ultrasound Based Liver Stiffness

29:08 – Magnetic Resonance Elastography (MRE)

49:28 – Corrected T1 (cT1) MRI and MRI-PDFF

01:09:14 – Session Two Q&A Discussion Panel

Speakers:

Insook Kim, PhD
Master Scientist
Division of Inflammation and Immune Pharmacology (DIIP)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER) | FDA

Rebecca Hager, PhD
Lead Mathematical Statistician
Division of Biometrics III (DBIII)
Office of Biostatistics (OB)
OTS | CDER | FDA

Abbas Bandukwala, MS
Commander
United States Public Health Service (USPHS)
Science Policy Analyst
Biomarker Qualification Program
Office of New Drugs (OND) | CDER | FDA

Philip Newsome MD, PhD, FRCPE
Director, Centre for Liver & GI Research
University of Birmingham

Claude Sirlin, MD
Professor of Radiology
Liver Imaging Group
University of California, San Diego

Scott B. Reeder, MD, PhD
Professor and Senior Vice Chair (Research)
Chief of Magnetic Resonance Imaging
Departments of Radiology, Medical Physics, Biomedical Engineering, Medicine, and Emergency Medicine University of Wisconsin-Madison

Panelists:

Abbas Bandukwala, Phillip Newsome, Claude Sirlin, Scott Reeder

and

Daniel Krainak, PhD
Assistant Director
Division of Radiological Imaging & Radiation Therapy Devices
Office of Radiological Health (OHT8)
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH) | FDA

Rajarshi Banerjee
DPhil, MPH, MA, BM BCh, MRCP
CEO, Perspectum Ltd
Honorary Consultant Physician, Oxford University Hospitals NHS Trust


Richard L. Ehman, MD
Professor of Radiology
Blanche & Richard Erlanger Endowed Professor of Medical Research
Mayo Clinic

David T. Fetzer, MD
Assistant Professor, Abdominal Imaging Division
Medical Director, Ultrasound
Department of Radiology
UT Southwestern Medical Center (UTSW)

Céline Fournier, PhD
Chief Medical Officer
Echosens

Lori E Dodd, PhD
Mathematical Statistician
Clinical Trials Research Section
Biostatistics Research Branch
Division of Clinical Research
NIAID | National Institutes of Health (NIH)

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Phone - [phone] I [phone]