Non-Invasive Approaches to NAFLD/NASH Drug Development

Margery A. Connelly, PhD, MBA, FAHA, Strategic Director, Diagnostics R&D, Labcorp

Dr. Margery Connelly has more than 25 years of experience in academia and industry, including 19 years in pharmaceutical and diagnostic research and development. She has a PhD in pathology and immunology from Stony Brook University School of Medicine and an MBA in pharmaceutical and healthcare management from LeBow College of Business, Drexel University. She is a Fellow of the American Heart Association (FAHA) and has published >200 publications and patents in her areas of expertise. Before accepting the Vice President of Translational Research position at LipoScience (now part of Labcorp), Dr. Connelly worked at Janssen R&D discovering therapeutics for atherosclerosis, diabetes and obesity.

Dr. Connelly has spent the last 10 and a half years applying her scientific expertise and leadership experience toward the development and clinical validation of new nuclear magnetic resonance (NMR)-based tests for various diseases including cardiovascular disease, chronic inflammatory diseases and metabolic disorders such as metabolic syndrome, diabetes, obesity and liver diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and alcoholic hepatitis. In addition, Dr. Connelly has established and maintained productive research collaborations with both industry and academic partners in several therapeutic and disease areas of interest.

Katherine T. Landschulz, PhD, Senior Director and Therapeutic Area Lead, Cardiovascular/Metabolic/Renal Disease, NAFLD/NASH, Neurodegenerative Diseases, Biomarker Solution Center, Labcorp

As Therapeutic Area Lead for the Labcorp Biomarker Solution Center, Dr. Katherine Landschulz has overarching responsibility for the delivery of biomarker strategies for sponsor programs in cardiovascular, metabolic and renal diseases, nonalcoholic fatty liver diseases including NASH, as well as Alzheimer’s, Parkinson’s and other neurodegenerative disease indications. Kathy serves as a consultant to sponsors and teams, advising on biomarker selection and strategy development, laboratory placement of testing, feasibility designs and overall guidance around translational and exploratory biomarker data in drug development. Additionally, she serves as a liaison, directing questions and connecting sponsors and Labcorp biomarker scientists. Finally, Kathy participates in enterprise-wide assessments, licensing and implementation of new laboratory biomarkers and tests transitioning from clinical trial to clinical care utilization.

Kathy received her doctorate in human genetics/biology from Johns Hopkins University and School of Medicine, where she specialized in erythropoietin receptors on erythroid progenitor cells. Her postdoctoral areas of focus were molecular biology/lipogenesis at Johns Hopkins University School of Medicine and molecular biology/lipoproteins (HDL, VLDL) at The University of Texas Southwestern Medical Center.

Dr. Mohammad Shadab Siddiqui, MD, Associate Professor, Gastroenterology and Hepatology, Virginia Commonwealth University

Dr. Mohammad Shadab Siddiqui is currently Associate Professor of Medicine at Virginia Commonwealth University in the Division of Gastroenterology and Hepatology. His clinical and research interest are largely in nonalcoholic fatty liver disease (NAFLD) as it spans the entire disease spectrum from early disease, compensated cirrhosis, decompensated cirrhosis to post liver transplantation NAFLD. More specifically, he is interested in the liver-heart axis and metabolic complications of NAFLD. Also, he has an interest in biomarker development both in NAFLD and post liver transplant patients. He has over 150 publications in the field and are reflective of his clinical and research interest. He helped co-author the newly released AASLD Practice Guidelines on Management of NAFLD (2023) and was the lead author on the NAFLD case definition for clinical trials published through the Liver Forum.