Diagnosing and assessing the progression of nonalcoholic steatohepatitis (NASH) continue to be some of the most challenging aspects of its management. Most patients would opt out of the diagnostic or follow-up liver biopsy. In addition, liver biopsies would not be a front-line test offered by primary care physicians, endocrinologists and diabetologists where a large proportion of undiagnosed patients exist. In addition, recent clinical trial data has shown considerable variability in histopathology readings, making it unreliable for use in clinical trials.
A better approach is needed. Over the last 10 years, there has been increasing interest in the development and validation of non-invasive tests (NITs) that can diagnose NASH, stratify risk, predict clinical outcomes and/or monitor the progression or regression of the disease. These NITs would have greater acceptance amongst patients, broader applicability across physician specialties and offer the potential of improved management of NASH patients. NITs may also help to identify NASH sub-phenotypes with potential distinct natural history and prognosis and eventually, facilitate personalized treatment and better response rate. Finally, available data suggest that NITs can predict clinical outcomes and help accelerate clinical development and bring a safe and efficacious therapy to NASH patients with high unmet need.
Currently, many different imaging and blood-based NITs are being explored in clinical trials. In some trials, pre-biopsy enrichment strategies with NITs are becoming increasingly popular to reduce the number of liver biopsy-related screen failures. These NITs include genetic susceptibility alleles, specific protein biomarkers and multi-analyte algorithms. Sorting through these NITs, their use individually and in combination, admittedly requires some navigational assistance.
While the identification of patients at high risk of progressive NASH remains an on-going challenge, there is a wealth of emerging data from clinical trials which will directly influence future NIT use in NASH clinical care.
Register to learn how non-invasive biomarkers are driving a paradigm shift in NASH clinical trials and clinical care.
Claudia Filozof, MD, PhD, Vice President, Liver Therapeutic Area, Labcorp Drug Development
Claudia Filozof is board-certified in nutrition in metabolism. She has over 20 years of experience in clinical research in the pharma and CRO businesses. Claudia leads development programs on obesity and diabetes and has been fully dedicated to NAFLD/NASH and cholestatic liver diseases since 2011. She is a member of the Liver and PSC Forum, AASLD steatohepatitis working group and EASL NAFLD group. Claudia is the author of multiple manuscripts including six recent review papers about clinical development in NASH and adaptive design studies.
Katherine T. Landschulz, PhD, Senior Director, Therapeutic Area Lead, Biomarker Solution Center, Labcorp Drug Development
Katherine T. Landschulz has over 25 years of industry experience spanning drug discovery through translational medicine. She supports biomarker strategy/implementation for NASH and cardiovascular/metabolic disease/renal and neurodegeneration studies at Labcorp where she has 12 years of experience. Katherine provides consultation for biomarker service placement throughout the Labcorp laboratory network as well as supervises specified biomarker services, preclinical/clinical biomarker selection, assay design, feasibility/validation consultation and biomarker data interpretation.
Lara Dimick-Santos, MD, Executive Medical Director, CVMER, Labcorp Drug Development
Lara Dimick-Santos has 12 years of experience as medical reviewer and team leader at the US Food and Drug Administration (FDA). Lara has primary experience in liver indications — namely, PBC, PSC, NASH, AIH, alcohol-associated hepatitis, etc. In addition, she is experienced in rare and common diseases and regulatory pathways in biomarker development. Lara has experience at the FDA in GI and metabolic diseases.
Margery A. Connelly, PhD, MBA, FAHA, Strategic Director, Diagnostics R&D, Labcorp
Dr. Connelly has more than 25 years of experience in academia and industry, including 18 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 more than 180 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 nine 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), nonalcoholic 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.
Who Should Attend?
- Chief Medical Officers
- Chief Executive Officers
- Senior Medical Directors, Medical Directors
- Senior Director and Directors of:
- Clinical Development
- Clinical Research
- Research and Development
- Project Directors, Project Managers
- Academic Investigators and Researchers
- Government Regulators
- Clinical Outcome Assessment Specialists
What You Will Learn
Attendees will learn:
- How non-invasive tests (NITs) can help overcome the under-diagnosis of nonalcoholic steatohepatitis (NASH)
- The challenges and opportunities with using genetic and non-genetic NITs to minimize screen failure rate in clinical development
- NITs as potential surrogate endpoints that can lead to accelerated/conditional approval
- Emerging NIT for use in both clinical trials and clinical care
Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Learn more about Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.