There is immense interest in finding new therapies for non-alcoholic steatohepatitis (NASH), which is increasingly being known as metabolic-associated steatohepatitis (MASH), due to the unmet need and race to the market to get the first treatment approved. In parallel, the rates of MASH are increasing, and it is linked to the global obesity epidemic and related metabolic disorders. MASH is now expected to be the leading indication for liver transplant in the next few years, surpassing hepatitis C and Alcoholic Hepatitis. Despite the high rates of MASH, recruitment to clinical trials remains challenging in NASH clinical trials.
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Partnering with patients is particularly important in NASH clinical trials to overcome important barriers to accelerate effective research. Symptoms are often silent or non-specific to MASH, making it difficult to diagnose. As a result, MASH patients can remain unaware of their condition until the late stages of the disease, which poses challenges for engaging patients to participate in early-stage clinical research. Moreover, confirming a diagnosis of MASH requires a liver biopsy which can be a key barrier to recruitment.
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This webinar will bring together a panel of experts representing the patient voice in MASH, and leading expertise in NASH clinical trials and the use of patient-centered research and patient-centric trial strategies. The feature speakers will discuss the patient burden and challenges of this disease, focusing on the need to partner across stakeholder groups in MASH to understand and improve the patient experience and incorporate the patient voice into the design of clinical trials.
The panel will also discuss the way forward for building on the voice of patients to define strategies to improve patient recruitment and retention in NASH clinical trials.
Join this webinar to hear a rich discussion on pioneering ways to innovate and improve the patient experience in MASH clinical trials, optimize protocol design and study delivery based on patient input and to accelerate enrollment and improve retention in clinical trials.
Speakers
Soren Skovlund, Senior Director, Head, Patient Engagement & Insights, Patient-Centered Research, Evidera Patient Advisory Services Division, PPD, part of Thermo Fisher Scientific
Soren Skovlund is the Senior Director of Patient Engagement and Insights at Evidera. He has 17 years of global experience leading patient-centered research and engagement activities across the value chain within the pharmaceutical industry and has published more than 50 scientific articles within the area. He has designed numerous international research studies focused on patient engagement, has been a part of developing EUPATI and co-authored the global PFMD quality guidance for patient engagement.
Michael Betel, President and Founder of the Fatty Liver Alliance, Fatty Liver Alliance
Michael Betel is the President and Founder of the Fatty Liver Alliance and has been a leader in the area of liver disease, in both commercial and not-for-profit organizations for over 30 years. He has held senior leadership roles including a Business Unit Director in Virology and Oncology at Hoffmann-La Roche, Director of Donor Relations at Canadian Blood Services, and as a Sales and Marketing Leader at Schering-Plough. He was a Director on the board of a Canadian liver-focused charity for nine years.
He is currently acting as the Chair for the Global Liver Institute’s Liver Action Network. Michael is a member of the community advisory board (CAB) for the Canadian Association for the Study of the Liver (CASL). Michael was an AASLD collaborator on the fatty liver disease research and action priorities consensus statement, an EASL participant in NASH consensus statement development and an AASLD participant at the Delphi expert panel developing consensus around the nomenclature of NAFLD.
In 2023, he participated as a stakeholder at Mosaic (A multi-stakeholder multi-specialty NASH Trialists Think Tank) and is a member of the Liver Forum.
Message Presenter
Dr. John M. Vierling, Professor of Medicine and Surgery and Chief of Hepatology and Director of Baylor Liver Health at the Baylor College of Medicine in Houston
Dr. John M. Vierling MD, FACP, FAASLD, AGAF is a Professor of medicine and surgery and Chief of Hepatology and Director of Baylor Liver Health at the Baylor College of Medicine in Houston, Texas. He also serves as Director of Advanced Liver Therapies (a clinical research unit) and formerly served as Program Director of the Hepatology and Liver Transplantation Fellowship.
He graduated from Stanford University with a degree in biology with great distinction and received his MD from Stanford University School of Medicine. He was a Clinical Associate in the liver unit at NIH prior to completing a Gastroenterology Fellowship at UC in San Francisco. He was the founding Medical Director of the Liver Transplantation programs at the University of Colorado Health Sciences Center and at Cedars-Sinai/UCLA.
His clinical interests include autoimmune and alloimmune liver diseases, liver transplantation, acute liver failure, viral hepatitis, non-alcoholic fatty liver disease, Wilson disease and drug-induced liver injury (DILI). His translational research interest is immunologic mechanisms of hepatobiliary injury. He has authored over 290 manuscripts and chapters. He is co-editor of Liver Immunology: Principles and Practice, now in its 3rd edition.
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He currently serves on the NIH NIDDK Liver Tissue and Cell Distribution System Coordinating Committee and on the DILI Network’s DSMB. He is a past President of the American Association for the Study of Liver Diseases, Secretary-Treasurer of Digestive Disease Week(r) and Chairman of the National Board of Directors of the American Liver Foundation to advance the science and practice of hepatology.
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Dr. Graham Ellis, Executive Medical Director, Medical Science Strategy, PPD part of Thermo Fisher Scientific
Dr. Graham Ellis, MBChB is a Specialist Physician (endocrinology) based in Cape Town, South Africa. He is currently the Executive Director of Medical Science and Strategies at PPD and is responsible for the diabetes and metabolic disease portfolio. He also serves as a Voting Member of the PPD human safety committee. He joined PPD in 2022 after working as Medical/Snr Director, therapy area strategies for Synexus and Accelerated Enrollment Solutions (AES).
His almost 20 years of experience in clinical research includes being a contributing PI to more than 200 Phase II and III international clinical trials in a wide range of therapy areas including large numbers of studies on T2 diabetes, metabolic disease, diabetic complications and obesity. He was a Founder and Director of HCTC, a large and successful clinical research center until it was acquired by Synexus in 2014.
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Until 2021, Dr. Ellis enjoyed almost 20 years as a Consulting Physician in a large diabetes and metabolic disease practice. He is a founder member of the Centre for Diabetes and Endocrinology (CDE) and a member of SEMDSA (Society for Endocrinology, Metabolism and Diabetes of South Africa), he serves as a Council Member of NOFSA (National Osteoporosis Foundation of South Africa) and as an Advisory Board Member and Honorary Research Associate, Faculty of Science at Stellenbosch University, South Africa.
Dr. Ellis has published in peer-reviewed diabetes and osteoporosis journals and has spoken at numerous local and international meetings.
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Who Should Attend?
This webinar will appeal to:
- Clinical research leaders in the pharma, biotech and healthcare industries
- Liver/MASH patient groups and advocacy board members
What You Will Learn
Attendees will gain insights into:
- The patient perspective on burdens and challenges preventing participation in non-alcoholic steatohepatitis (NASH) clinical trials from a leading NASH key opinion leader (KOL) and patient expert
- How to partner across the industry to improve the patient experience by using patient-centric trial strategies in NASH clinical trials
- The strategies to include the patient voice to aid in NASH patient recruitment and retention for clinical trials
Xtalks Partner
PPD
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, its capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, PPD clinical research serves serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, the business applies cutting-edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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