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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

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

  • Executive Director, Clinical Safety Statistics, BARDS
  • Merck Research Laboratories, United States
George  Kordzakhia, PhD

George Kordzakhia, PhD

  • Mathematical Statistician
  • Food and Drug Administration, 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


Paul Michael Imbriano, PhD, MSc


Paul Michael Imbriano, PhD, MSc

  • Mathematical Statistician
  • FDA, United States
Peter Grant Mesenbrink, PhD

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

Peter Grant Mesenbrink, PhD

  • Executive Director of Biostatistics
  • Novartis Pharmaceuticals Corporation, United States
Veronica  Miller, PhD


Veronica Miller, PhD

  • Executive Director
  • Forum For Collaborative Research, United States
Michael  Crutchlow, DrMed, MD


Michael Crutchlow, DrMed, MD

  • Distinguished Scientist, Clinical Research
  • Merck & Co, Inc, United States

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Biostatistics Industry Resource Kit