Non-invasive imaging biomarkers for nonalcoholic steatohepatitis (NASH) clinical drug development are widely used to study the effects of investigational products on the degree of steatosis, inflammation and fibrosis of the liver. It is a rapidly evolving area to measure target engagement and mechanism of action beyond the liver.
In this webinar, Dr. Linda Morrow, an expert in NASH clinical trial design and conduct, and Dr. Lars Johansson, an expert in imaging biomarkers, will discuss the importance of an interdisciplinary approach to implement a successful design and operational framework for the use of non-invasive medical imaging methods in NASH clinical trials.
Topics discussed during the webinar will include:
- Non-invasive imaging techniques for NASH clinical drug development including MRI, MRE, MRS, PET, and ultrasound, including FibroScan
- The use of non-invasive imaging to measure disease activity, disease staging, target engagement and mechanism-of-action in NASH clinical trials
- Combining imaging techniques with functional assessments, such as hyperinsulinemic-euglycemic
clamps and stable isotope methods - Innovations in structural and functional imaging of major metabolically active organs beyond the liver, including adipose tissue, pancreas, skeletal muscle, heart and kidney
- Advantages and limitations of imaging in NASH clinical drug development including cost, availability, pathophysiological relevance, accuracy and suitability for repeat measurements
This webinar is the first in a series in collaboration with the NASH Roundtable, focusing on the advancement and application of scientific methods and strategies for NASH clinical research.
Speakers
Linda Morrow, MD, Chief Medical Officer, ProSciento, Inc.
Dr. Linda Morrow’s career in clinical research and drug development for NASH, diabetes and obesity spans more than 25 years and includes contributions to many diabetes and related metabolic drugs/devices on the market globally today. Prior to her role as Chief Medical Officer, Dr. Morrow was Chief Operating Officer (COO) for ProSciento with oversight of contract research organization (CRO) and scientific services for global multi-site clinical trials and clinical operations for ProSciento’s state-of-the-art early-phase facility in San Diego. During her role as COO, ProSciento gained an industry-wide reputation as the leading organization for early-phase diabetes research and one of only a few CROs with the experience and expertise in designing and conducting NASH first-in-human studies.
Dr. Morrow has been the principal investigator of more than 80 clinical research studies for metabolic small and large molecule therapies, biologics, biosimilars and devices. She is an author on more than 50 peer-reviewed articles and book chapters. Dr. Morrow is also a frequent presenting speaker at medical and industry conferences, including keynote presentations at the NASH Summit.
Message Presenter
Lars Johansson, PhD, Associate Professor of Translational Imaging, Uppsala University, Sweden and Chief Scientific Officer, Antaros Medical AB
Dr Lars Johansson is Chief Scientific Officer and co-founder of Antaros Medical AB, an advanced clinical imaging research and methodology company. Dr. Johansson is recognized as a leading expert in innovative MRI and PET imaging techniques as biomarkers indicative of disease activity and therapeutic responses in cardiometabolic clinical research, including NASH. Dr. Johansson has authored more than 150 peer-reviewed publications in the cardiovascular and metabolism field, with a primary focus on imaging. His experience in drug development includes a 10-year tenure at AstraZeneca, where he was Senior Principal Scientist, involved in projects ranging from preclinical drug development to lifecycle management. Dr. Johansson has led a large number of international multi-center imaging trials, including principal investigator on international grants from the EU, JDRF, NIH and EFSD. Dr. Johansson frequently presents at industry conferences, including keynote presentations at the NASH Roundtable and the NASH Summit.
Message PresenterWho Should Attend?
This webinar is intended for professionals, scientists and educators of all levels interested in learning from leading experts about clinical trial design and current and emerging imaging techniques for NASH/NAFLD drug development.
What You Will Learn
Attendees will learn about:
- Current and emerging non-invasive imaging biomarkers for NASH clinical drug development
- An optimal operational framework for the use of imaging methodologies in NASH clinical trials
- Advances in imaging of organs beyond the liver, including adipose tissue, pancreas, skeletal muscle, heart and kidney
- Advantages and limitations of imaging in NASH clinical trials, including cost, availability, pathophysiological relevance, accuracy and suitability for repeat measurements
Xtalks Partners
ProSciento
ProSciento is a highly specialized clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 280 clinical projects for diabetes, NASH and obesity and supported the development of many approved metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.
NASH Roundtable
The NASH Roundtable was established in 2018 to accelerate the advancement and application of scientific methods and strategies for NASH clinical research. The NASH Roundtable meets twice yearly and is a forum to support the development of effective and safe treatments and build consensus towards validated biomarkers and clinical trial endpoints. Roundtable members represent cross-functional expertise in NASH research, drug development and patient care, and hail from prominent academic and medical centers in North America, Europe and Asia. For more information, please visit www.nashroundtable.com.
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