EP 108: Drug Development in Liver Disease: Breakthroughs, Challenges, and Insights with Dimitar Tonev
September 28, 2023
In this episode of The Genetics Podcast, we're joined by Dimitar Tonev, an experienced drug development consultant specialising in Hepatology and Virology. Tune in to discuss the recent reclassification of Non-alcoholic Steatohepatitis (NASH) to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), and the complexities of identifying treatments for this condition.
Dimitar sheds light on the pioneering role of non-invasive biomarkers and comments on the potential impacts of the Maestro study. Join us as we dive into the world of liver disease and drug development, touching upon the breakthroughs, challenges, and ethical considerations of clinical trials.
For anyone interested in liver health innovations and the future of hepatology research, this episode is a must-listen.
In this episode of The Genetics Podcast, we're joined by Dimitar Tonev, an experienced drug development consultant specialising in Hepatology and Virology. Tune in to discuss the recent reclassification of Non-alcoholic Steatohepatitis (NASH) to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), and the complexities of identifying treatments for this condition.
Dimitar sheds light on the pioneering role of non-invasive biomarkers and comments on the potential impacts of the Maestro study. Join us as we dive into the world of liver disease and drug development, touching upon the breakthroughs, challenges, and ethical considerations of clinical trials.
For anyone interested in liver health innovations and the future of hepatology research, this episode is a must-listen.
Timestamps:
0:00 Intro
2:01 Change in the name of Non-alcoholic Steatohepatitis (NASH) to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
8:01 Challenges with clinical trials and drug development for liver diseases
16:10 Discussing the breakthroughs and future of hepatology research
21:30 Ethical dilemmas of placebo-controlled trials
27:46 An overview of FDA's approach and stance on biomarkers and technologies in NASH/MASLD
30:40 Insights into the anticipated Madrigal approval and its significance
35:10 Closing Remarks