The race is on for non-alcoholic steatohepatitis (NASH) drug development as the disease—which has no approved treatments—is rapidly growing in prevalence and is the fastest rising cause of liver transplantation in the United States. This untapped market and pathophysiology of NASH, which lends itself to pharmacological manipulation at multiple pathways, have prompted many pharmaceutical and biotechnology companies to pursue novel treatments to address this unmet medical need.
NASH drug development presents distinct challenges. For progress to be made, companies need to understand, formulate and improve strategies to overcome these challenges including limited education and awareness in both physicians and patients, differences in Western and Eastern populations, the presence of comorbidities, diagnostics for patient selection, and selection of appropriate endpoints throughout development.
In this webinar, medical and operations experts from Medpace will facilitate a Q&A session with Dr. Stephen A. Harrison, an experienced Key Opinion Leader (KOL) in NASH. The presenters will participate in an in-depth discussion on selected topics associated with NASH development as well as strategies and opportunities for researchers. Key questions that will be addressed include:
- What are the current trends in successful NASH trial recruitment?
- How can differences in epidemiology and patient management paradigms in the US vs Europe be leveraged to improve recruitment?
- How can differences in NASH between Western and Eastern population reflect on patients’ suitability in early/late NASH trials?
- Imaging and Liquid Biomarkers
- What are the most successful current biomarkers in NASH clinical trials?
- What endpoints should be considered at different stages of development in Phase 2-4 trials?
Dr. Harrison and the Medpace team will also be taking questions during the live presentation.
Stephen A. Harrison, MD, Gastroenterologist/Hepatologist and Medical Director, Pinnacle Clinical Research
Dr. Harrison earned his medical degree from the University of Mississippi School of Medicine. He completed his internal medicine residency and gastroenterology fellowship at Brooke Army Medical Center and a 4th year advanced liver disease fellowship at Saint Louis University. He is board certified in both Internal Medicine and Gastroenterology. Dr. Harrison served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is a peer-reviewer for over 20 medical journals and internationally known for studies in hepatitis C and non-alcoholic fatty liver disease with over 170 peer-reviewed publications in these fields. Dr. Harrison most recently served as a Colonel in the United States Army. Retiring in 2016, he concluded 20 years of dedicated service to his country.
Piotr Krzeski, MD, PhD, FFPM, Senior Medical Director, Medical Affairs, Medpace
Dr. Piotr Krzeski is an internist with a broad background in pharmaceutical research. He has over 19 years of experience in clinical drug development, with global expertise in the design and medical oversight of clinical trials in the area of gastroenterology and hepatology including NAFLD and NASH. Dr. Krzeski completed his internal medicine training at the Gastroenterology Department at the Warsaw Postgraduate Centre in Poland. He earned his PhD in Hepatology. Dr. Krzeski is recognized in the field for his contribution to the pioneering work on standardization of central imaging in drug development.
Jen Harness, BS, RD, Director, Clinical Trial Management, Medpace
Ms. Harness is a Registered Dietitian with significant global project management experience, as well as clinical experience specializing in medical nutrition therapy for patients with cardiovascular and metabolic diseases. She has a strong clinical research background, with over 13 years in Clinical Operations at Medpace, including 10 years of trial management experience. Ms. Harness’ primary focus during her tenure at Medpace, as well as her time in dietetics, has been metabolic diseases, including diabetes, lipid disorders, obesity, and NASH, where she has established a proven track record of success in trial management.
Who Should Attend?
VPs, Directors, Managers and Department Heads working within:
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries.
Pinnacle Clinical Research
Pinnacle Clinical Research is dedicated to conducting late phase clinical trials in the areas of Hepatology and Gastroenterology, with a special focus on fatty liver disease. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Pinnacle has highly skilled board-certified investigators involved with the daily oversight of clinical trials. Our coordinating team consists of Clinical Research Coordinators and Research Assistants with extensive experience in conducting all phases of clinical trials. Our quality control, and regulatory team work with sponsors to ensure the highest quality of data collection and documentation, according the good clinical practices and the FDA regulations for every trial.