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Virtual Event

May 27, 2020 10:45 AM - May 29, 2020 3:30 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

DIA/FDA Biostatistics Industry and Regulator Forum

Session 9: Therapeutic Area Focused Session: Diabetes with a Focus on NASH

Session Chair(s)

Mouna  Akacha, PhD

Mouna Akacha, PhD

Group Head of Statistical Methodology

Novartis Pharma AG, Switzerland

William  Wang, PhD

William Wang, PhD

President

Merck & Co, Inc, United States

George  Kordzakhia, PhD

George Kordzakhia, PhD

Statistical Sciences Senior Director

AstraZeneca, United States

Non-alcoholic steatohepatitis (NASH) is a liver inflammation and damage caused by a buildup of fat in the liver. With the growing burden of NASH, and the inherent limitations of transplantation both in terms of cost and number of livers available, it is critical to increase the pace of development of safe and effective therapies to prevent and treat NASH (see Liver Forum Project). In this session, we will discuss the challenges and opportunities that arise when developing drugs in NASH, e.g. what is the estimand of primary interest?

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Recognize the challenges that arise in NASH drug development programs
  • Recognize the main clinical efficacy outcomes in NASH as well as biomarkers/surrogates which are linked to clinical benefit
  • Contrast the various clinically meaningful endpoints and treatment effect measures

Speaker(s)

Paul Michael Imbriano, PhD, MSc

Speaker

Paul Michael Imbriano, PhD, MSc

FDA, United States

Mathematical Statistician

Peter  Mesenbrink, PhD

Estimands in Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Challenges and Complexities

Peter Mesenbrink, PhD

Novartis Pharmaceuticals Corporation, United States

Executive Director of Biostatistics

Veronica  Miller, PhD

Speaker

Veronica Miller, PhD

Forum For Collaborative Research, United States

Executive Director

Michael  Crutchlow, DrMed, MD

Panelist

Michael Crutchlow, DrMed, MD

Merck & Co, Inc, United States

Distinguished Scientist, Clinical Research

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