On Demand Webinar
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in North America, and nonalcoholic steatohepatitis (NASH) is a growing contributor to liver transplantation and liver-related mortality rates. The relatively asymptomatic progression of NAFLD and NASH presents challenges in patient and physician awareness, combined with gaps in knowledge regarding pathogenic drivers, adds to the complexities of NASH clinical drug development. There is an urgent need to develop noninvasive tools for diagnosis and disease tracking, as well as therapeutic strategies, for patients with NASH, from early stages through advanced liver fibrosis. This webinar will address these unique challenges by defining strategies for the design and enrollment of clinical studies, as well as the study of disease progression and biomarker discovery.
Topics discussed in the webinar:
- NASH prescreening and patient registry strategies utilizing real-time and longitudinal data to aid in the design and enrollment of clinical research studies, including predictive insights into inclusion/exclusion criteria
- Expediting study start-up and front-loading patient enrollment: Case studies from recent NAFLD and NASH clinical trials
- NASH PASS: A growing NASH patient registry platform to support biomarker discovery and validation to aid in the diagnosis, treatment, and disease monitoring for NAFLD and NASH
- Collaborative initiatives to utilize the NASH PASS biobank, bridging academic and industry biomarker research efforts
Chief Executive Officer, ProSciento, Inc.
Editor-in-Chief, Endocrinology, Diabetes & Metabolism
Chief Medical Officer, ProSciento, Inc.
Dr. Michael Grimm is Chief Medical Officer at ProSciento and a drug development expert with key contributions to multiple FDA-approved drugs. Prior to joining ProSciento, he served as Executive Director of Clinical Development for AnaptysBio, overseeing the development of etokimab for inflammatory respiratory and skin diseases and, before that, was Executive Director of Clinical Development for MyoKardia, responsible for the clinical development strategy and execution of the company’s lead drug candidate mavacamten. Prior to this role, Dr. Grimm was Senior Director at Receptos and Clinical Development Lead for the early phase drug candidate RPC4046 (anti-IL-13 mAb) and Medical Director at Santarus for FDA-approved Ruconest (recombinant C1 esterase inhibitor) and UCERIS (budesonide). He was also Medical Director at Amylin Pharmaceuticals and the Clinical Development Physician for FDA-approved drugs Exenatide (GLP-1 receptor agonist) and Metreleptin (leptin analog).
Director of Clinical Strategies and Logistics, ProSciento, Inc.
Originally recorded on Sep 15th, 2020