Expediting NASH Clinical Trials and Biomarker Research: NASH PASS®, a Growing Patient Registry Platform

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 non-invasive 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 to be discussed during this webinar:

• NASH pre-screening 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

Speakers

Marcus Hompesch, MD, Chief Executive Officer, ProSciento, Inc., Editor-in-Chief, Endocrinology, Diabetes & Metabolism

Dr. Marcus Hompesch is Chief Executive Officer at ProSciento and has led the company since its inception in 2003. He is also a licensed physician, as well as editor-in-chief of the journal Endocrinology, Diabetes & Metabolism, a Wiley publication. His career and track record in metabolism-focused clinical R&D, spanning more than 25 years in academic and industry settings, includes contributions to clinical development strategies and early phase research studies for many of the diabetes and related metabolic drugs and devices on the market globally. Dr. Hompesch has been the principal investigator on more than 80 clinical research studies for metabolic small and large molecule therapies, biologics, biosimilars and devices. He is an author on more than 100 peer-reviewed publications in the field of endocrinology and metabolism.

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Michael Grimm, MD, PhD, 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).

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Heidi Guthrie, Director of Clinical Strategies and Logistics, ProSciento, Inc.

Heidi Guthrie is the Director of Clinical Strategies & Logistics at ProSciento, Inc. Her career in the CRO industry and clinical trial management of metabolic diseases spans more than 20 years and includes contributions to many diabetes and related metabolic drugs and devices on the market globally today. Her operational and therapeutic experience has led to a robust expertise is building strategic business processes for increased efficiencies as well as operational planning to secure quality outcomes.  She is a member of ProSciento’s Senior Leadership Team and manages clinical operations governance and strategic vendor management for ProSciento projects, including as a founding member of the oversight committee for ProSciento’s NASH PASS program.

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