Alimentiv is a niche GI contract research organization. Leading with science, we provide a complete range of clinical research services to a broad base of academic and industry clients.
Our expert panel provides an overview of nonalcoholic steatohepatitis (NASH) including a review of the drug development landscape, imaging as a non-invasive measure in NASH Clinical Trials, and the role of histopathology and machine learning in NASH Clinical Trials. Our key opinion leaders then answered audience questions.
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Dr. Jairath oversees the global Medical R&D initiatives and services. In conjunction with the executive team and senior medical advisors, he assumes overall responsibility for research strategy, as well as performance of the organization’s Medical R&D services including medical operations, medical imaging, precision medicine, medical writing, medical monitoring, medical/biostatistics advisory collaborations and IBD fellowships. He also provides medical oversight for the design of clinical trials, protocol development and imaging R&D endpoints. Dr. Jairath was previously VP Medical Research & Development (2019-2021) and Director of Academic Research and Development (2016-19).
Dr Jairath obtained his BSc (Pharmacology) and Medical Degree from the University of Leeds (UK), DPhil (PhD) in Clinical Medicine from the University of Oxford and post-graduate diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine. He is Professor of Medicine at the Schulich School of Medicine and Dentistry, and holder of the John and Susan McDonald Endowed Chair in Inflammatory Bowel Disease (IBD) at Western University.
His specialist clinical training in Gastroenterology was completed in London and Oxford, and he holds specialist certification in both Ontario and the UK. Prior to moving to Western in 2016, he was a National Institute for Health Research Clinical Trials Fellow at the Oxford Clinical Trials Research Unit and Consultant Gastroenterologist at Oxford University Hospitals.
He is a practising gastroenterologist and specialist in IBD, and his research interests in clinical therapeutics for IBD include design of clinical trials, development and validation of outcome measures for use in clinical trials, patient reported outcome measures and prediction modelling for response to therapy.
Dr. Jairath has driven the development and validation of several novel indices for use in IBD clinical trials, like the UC-100 and the novel patient reported outcome measures, Symptom and Impacts Questionnaire for Ulcerative Colitis and Symptom and Impacts Questionnaire for Crohn’s Disease. In addition, he was instrumental to the delivery of the REACT2 trial and to the design of the VERDICT trial, both of which are important clinical practice questions for patients with Crohn’s disease and ulcerative colitis, respectively.
Dr. Rohit Loomba is a tenured Professor of Medicine in the Division of Gastroenterology, and Adjunct Professor in the Division of Epidemiology at the University of California, San Diego. He is a leading expert in translational research and innovative clinical trial design in nonalcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH).
Dr. Loomba is the founding director of the UCSD NAFLD Research Center where his team is conducting cutting edge research in all aspects of NAFLD including non-invasive biomarkers, genetics, epidemiology, clinical trial design, imaging end-points, and integrated OMICs using microbiome, metabolome and lipidome. This integrated approach has led to several innovative applications such as establishment of MRI-PDFF as a non-invasive biomarker of treatment response in early phase trials in NASH, which has now been adopted in more than 25 clinical trials conducted worldwide. He holds two patents on non-invasive biomarkers of NAFLD and fibrosis.
His research is funded by the National Institutes of Health as a Principal Investigator currently leading three R01, a P01 and a U01 grant.
He is the Deputy Editor of hepatology, the official journal of the AASLD.
Dr. Loomba has published more than 250 manuscripts and has an H-index of 73. He is among the top 1% of the globally highly cited scientists across all fields in 2019 by Web of Science. He is an elected member of American Society of Clinical Investigation.
Zobair M. Younossi is the President of Inova Medicine as well as Professor and Chairman of the Department of Medicine at Inova Fairfax Medical Campus, Falls Church, Virginia, USA. Dr. Younossi earned his medical degree from the University of Rochester School of Medicine and Dentistry (Alpha Omega Alpha 1989) in Rochester, NY, USA. He then completed his residency in internal medicine with a fellowship in gastroenterology and hepatology at Scripps Clinic and Research Foundation in La Jolla, California, USA, while earning his master of public health degree with multiple honours from San Diego State University School of Public Health, San Diego, California, USA.
He served as Staff Hepatologist and Senior Researcher at the Cleveland Clinic Foundation, Cleveland, Ohio, USA, before establishing the Canter for Liver Diseases at Inova Fairfax Hospital, which is now renowned for research related to outcomes research in liver disease and clinical, health services and translational research in non-alcoholic fatty liver disease (NAFLD). He has served as Vice President and Chairman of Research for Inova Health System. He also serves as the President and Chairman of the Board of Trustees of the Chronic Liver Disease Foundation (2018-Present) and the Board of Inova Health System Foundation (2011-Present). He was appointed by Governors T Kaine and B McDonnell of Virginia to the Board of Directors of Virginia Biotechnology Research Partnership Authority (2008-2014). He also served Virginia Tobacco & Health Research Repository (VTHRR), Board of Directors, American Heart Association, Mid-Atlantic Affiliate (2010-2012) and Board of the American College of Gastroenterology Institute for Clinical Research & Education (2013-2019). Finally, he has served on multiple committees for American Association for the Study of Liver Diseases, American College of Gastroenterology, American Gastrointestinal Association, and George Mason University as well as numerous committees at Inova Fairfax Medical Campus and Inova Health System.
Over the past 3 decades, Dr.Younossi has pioneered research in NAFLD and has been a leader in the field of patient-reported outcomes (PROs), economic assessment and outcomes research in liver disease. He leads several international efforts related to NAFLD and PROs in liver disease through global collaborations, including the Chair of Global NASH Council and the Global Liver and NASH Registries as well as Serving as the President and Chairman of the Board of Trustees of Chronic Liver Foundation. Dr.Younossi specializes in hepatology and gastroenterology, has authored over 600 articles, 3 books, 6 journal supplements, over 25 book chapters and more than 1,000 abstracts presented at international scientific meetings, and has an H-index of 100. He is a highly sought-after speaker and has provided over 470 faculty lectures in national and international meetings. Dr. Younossi has also served as the co-editor of Liver International, Associate Editor of J of Hepatology, and on the editorial board of a number of important medical journals. He has represented the American Association of Liver Disease and American Gastroenterological Association at different congressional meetings.
Cynthia Behling is a liver pathologist in San Diego who has been an active member of the NIDDK NASH Clinical Research Network as part of the University of California at San Diego NASH Group since 2005. She is co-lead of the pathology committee with Dr. David Kleiner. In addition to her collaborations with the NASHCRN and UCSD Liver group, she is part of Pacific Rim Pathology Medical Group and Laboratories which provides medical director services to the Sharp Hospital System in San Diego. Research interests include patterns of pathology in adult and pediatric NASH, clinical and imaging correlates of pathology findings and new methods of image analysis.