In this webinar, the leading experts in hepatology discuss metabolic- and alcohol-associated liver disease (MetALD) and alcohol-associated liver disease (ALD) focusing on the drug development pipeline, endpoints and key outcome measures. They will also explore related areas such as metabolic-dysfunction associated steatohepatitis (MASH) and metabolic-dysfunction associated steatotic liver disease (MASLD).
Alcohol is the most widely consumed substance in many countries. According to data from the US Centers for Disease Control, alcohol is responsible for approximately 178,000 deaths annually. Over half of US adults consume alcohol, with about 20 percent engaging in excessive drinking, which can result in severe health consequences.
It is widely known that alcohol consumption leads to liver complications, such as MetALD and ALD, both of which can progress to cirrhosis and its complications, including liver cancer, thus creating a significant unmet medical need for targeted drug development.
The clinical progression of MetALD and ALD typically starts with fat accumulation (steatosis), advancing to scaring (fibrosis) and potentially leading to alcoholic hepatitis, cirrhosis and ultimately liver failure. Each of these stages is associated with other health conditions, prompting drug development programs to focus on mechanistic targets and disease progression.
For instance, several ongoing development programs are targeted at treating MASH, including the 2024 approval of the first drug, Rezdiffra. MASH is defined by progression through various clinical features secondary to metabolic processes. Note that patients with excessive alcohol intake are excluded from MASH trials. Therefore, the medical community, including clinical trial sites, would benefit from conducting parallel studies in MetALD, ALD and MASH to improve screening efficiency while industry partners can de-risk their development strategies.
Despite the attraction for underlying liver histology, MetALD and ALD trials contain unique scientific and operational considerations. This webinar will address the current drug development pipeline for MetALD and ALD, including enrollment and retention challenges, clinical trial endpoints and key outcome measures, which will equip participants with insights that will drive innovation and collaboration in the ongoing fight against liver diseases.
Register for this webinar to advance the understanding of MetALD/ALD and the clinical trial landscape.
Speakers
Dr. Mazen Noureddin, Chief Scientific Officer, Summit Clinical Research
Dr. Mazen Noureddin, MD, MHSc, is the Chief Scientific Officer and Co-Chairman of the board at Summit Clinical Research and Pinnacle Clinical Research. Dr. Noureddin is internationally known for his research in the area of MASLD/MASH and cirrhosis.
He is a Professor of Medicine at the Lynda K. and David M. Underwood Center for Digestive Disorders, J.C. Walter Jr. Transplant Center Sherrie, and Alan Conover Center for Liver Disease and Transplantation at Houston Methodist Hospital (ranked #5 in GI and GI surgery by US News). He has also established the Houston Research Institute, which is the state-of-the-art facility that offers patients with liver disease access to new innovative non-invasive diagnostic tests and breakthrough therapies. Prior to his work in Houston, Dr. Noureddin held roles at Cedars-Sinai, UCSD and NIH.
Dr. Noureddin has been published in over 280 publications and he presents his work at national and international medical conferences.
Message Presenter
Dr. Naim Alkhouri, MD, Chief Academic Officer, Summit Clinical Research
Dr. Naim Alkhouri, MD, is the Chief Academic Officer at Summit Clinical Research. Prior to joining Summit, Dr. Alkhouri was Chief Medical Officer (CMO), Chief of Transplant Hepatology and Director of the Steatotic Liver Program at Arizona Liver Health (ALH) in Phoenix, AZ.
Dr. Alkhouri also previously served as the Director of the Metabolic Health Center at the Texas Liver Institute and Associate Professor of Medicine and Pediatric at the University of Texas (UT) Health in San Antonio, TX. Dr. Alkhouri is a key opinion leader in the field of MASH therapeutics and an advisor/consultant to many pharmaceutical and biomarker development companies.
Dr. Alkhouri has been published in over 250 publications and he presents his work at both national and international medical conferences.
Message Presenter
Dr. Brian Lee, MD, Associate Professor of Clinical Medicine, USC
Dr. Brian Lee, MD, is a transplant hepatologist who treats patients before and after liver transplant. His NIH-funded research program focuses on improving health for patients with alcohol use, metabolic dysfunction and liver disease through: 1) early transplant with alcohol; 2) intersection of alcohol and obesity in the liver; 3) health inequities; 4) public policy and advocacy and 5) novel therapies and translational science.
His research has led to lead-author studies in Lancet Public Health, JAMA Internal Medicine, Annals of Internal Medicine, Gastroenterology and Journal of Hepatology. He has led advocacy initiatives that successfully changed national- and state-wide transplant and insurance policies to improve healthcare access for patients.
His research has incorporated into practice guidelines across North America, Europe, Latin America and Asia. He has interest in clinical trial design and is the first author of international expert task force consensus guidelines to design clinical trials in alcohol use and liver disease.
Message Presenter
Dr. Juan Pablo (JP) Arab, Associate Professor of Medicine, Virginia Commonwealth University
Dr. Juan Pablo Arab is Associate Professor of Medicine at the Division of Gastroenterology, Hepatology, and Nutrition, Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA. He is the Director for Alcohol Sciences at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health.
Dr. Arab is a Transplant Hepatologist and Clinical Researcher with an interest in clinical/translational research and epidemiology in ALD and MASLD. He has published more than 240 peer-reviewed papers and co-authored several book chapters. Dr. Arab is an Associate Editor for Hepatology (flagship AASLD journal).
He is currently the Chair of the Special Interest Group on alcohol-associated liver disease of the AASLD and the Past-Chair of the Education and Scholarship Committee of the International Liver Transplantation Society (ILTS). Additionally, he is spearheading international collaboration groups aiming to study steatotic liver disease (SLD) (Global AlcHep BigData Network, AH-LATIN, and STELLA).
Message PresenterWho Should Attend?
This webinar is for CMO, CSO, CDO, VP Clinical Operations, or other drug development decision-makers in the hepatology field.
What You Will Learn
Attendees will learn about:
- MetALD and ALD, including drug development pipeline
- Key outcome measures and development endpoints
- Adjacent diseases to MetALD and ALD (e.g., MASH) that may offer mechanistic efficiencies for drug development
Xtalks Partner
Summit Clinical Research
Summit Clinical Research is an Integrated Research Organization founded in 2018 to advance clinical trial execution. Launched by Dr. Stephen Harrison and Gail Hinkson, they developed a proven model for overcoming the challenges of MASH research. With a vision to help research sites implement efficient processes and mentor principal investigators (PIs) and research staff on the intricacies of MASH protocols, they established Summit Clinical Research.
Together, Summit and our expanding network of sites operate as an Integrated Research Organization, employing effective research strategies and logistical expertise to conduct high-quality studies – managing large patient volumes in MASH, MetALD, ALD, Cirrhosis, Phase I Hepatic Impairment, and Obesity without compromising data integrity.
We are led by a team of industry experts and fueled by a passion for advancing medical science. Our network of research sites has grown from the initial fifteen locations to over 100 sites across nine countries, and we remain committed to guiding research sites to new levels of efficiency and effectiveness.
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