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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
- Group Head of Statistical Methodology
- Novartis Pharma AG, Switzerland
William Wang, PhD
- Executive Director, Clinical Safety Statistics, BARDS
- Merck Research Laboratories, United States
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
Speaker(s)
Speaker
Paul Michael Imbriano, PhD, MSc
- Mathematical Statistician
- FDA, United States
Estimands in Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Challenges and Complexities
Peter Grant Mesenbrink, PhD
- Executive Director of Biostatistics
- Novartis Pharmaceuticals Corporation, United States
Speaker
Veronica Miller, PhD
- Executive Director
- Forum For Collaborative Research, United States
Panelist
Michael Crutchlow, DrMed, MD
- Distinguished Scientist, Clinical Research
- Merck & Co, Inc, United States
