The Genetics Podcast
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