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Velocity Clinical Research, Inc.

23,954 followers

6mo Edited

“When things start to go wrong for patients with liver disease, it can go wrong very, very quickly.” The global prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is rising. In light of the stark unmet needs in liver disease treatment — particularly for metabolic dysfunction-associated steatohepatitis (MASH) — there’s a pressing need for more sites equipped to effectively support advanced liver disease research. As Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, highlights in this video, there’s reason to be optimistic if we can carry momentum from recent hepatology breakthroughs further into MASH treatment. With the expertise of leaders Dr. Kowdley, Nadege Gunn, MD, CPI, J. Scott Overcash, M.D., and Lauri Befus, Velocity’s MASH Council to Accelerate Research Excellence (CARE) will deliver world-class operational, recruitment, and trial conduct oversight to all Velocity sites conducting MASH trials. #MASH #MASLD #Hepatology #CARECouncil

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We have a huge unmet need in terms of patients with liver disease. Liver disease has a very long natural history, but when things start to go wrong for patients with liver disease, it can go wrong very, very quickly. Liver transplantation is a therapy of last resort, but access to liver transplantation is not easy. There are way more patients requiring transplantation than organs available. We've seen the proof of what clinical research can do in hepatology and liver disease. During my own professional career, in a period of 30 years, we went from hepatitis C being a untreatable, deadly disease to a disease that can now be cured with one tablet once a day for as little as eight weeks. I can't imagine a time when therapeutic advances were translated into clinical advances more quickly than at the present time. So despite huge advances in therapeutic trials that have brought medicines to patients, we now have another growing problem of unmet need for patients who have MASLD, which is metabolic dysfunction-associated steatotic liver disease, and also metabolic associated steatohepatitis, which are now called MASLD and MASH respectively. 90 million Americans are estimated to have fatty liver disease, which is what MASLD is, and millions of them have a more serious form of fatty liver disease called MASH, which may progress to end stage cirrhosis and liver cancer. So obviously liver transplantation is not going to be a therapeutic option for these patients. And not only in the U.S., but worldwide, it's estimated that anywhere from one out of four to one out of three people may suffer from this condition. So there's never been a greater need to develop new therapies in this area, and without new medications being developed, and patients participating in clinical trials, and our ability to reach those patients, particularly those that are underserved and historically have not participated in clinical trials, remains an urgent and important research and clinical need. The challenges that we face in MASH trials is the need for specific technology. MRI technology is required frequently to evaluate liver fat content. Liver biopsies remain necessary for many if not most clinical trials as a therapeutic endpoint readout. Availability of liver biopsy, standardization of the technique, making sure that adequate samples are collected, making sure the procedure can be done safely, are all different types of aspects of clinical trials and MASH where CARE Councils can standardize education, standardize our approach to educating patients about these various procedures, and to transfer the information and knowledge that someone like myself has accumulated over 30 years of doing research to sites that are capable, interested, and have the patient population. We can really bring all of our sites that are interested in and selected to be potential sites for MASH trials up to a standard that will ensure safety, ensure adequate enrollment so the studies can be completed on time, and to be able to generate quality data and do it with the best interest of the patient in mind.

Nadege Gunn, MD, CPI, DABOM

Nadege Gunn, MD, CPI, DABOM

Former CEO and President of Impact Research Institute , Senior Scientific Advisor, Medical Director at Velocity Clinical Research, Inc.

6mo

Well said, Dr. Kowdley! A true honor to work alongside you as we strive to make a difference in the lives of our patients.

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