S4-23 – Stephen Harrison on Challenges and Opportunities in NASH Drug Development

S4-23 - Stephen Harrison on Challenges and Opportunities in NASH Drug Development
Stephen Harrison speaks with Louise Campbell and Roger Green about challenges and opportunities in NASH drug development. The group dives deep into a range of topics including drugs with strong metabolic foundations, the state of histopathology, clinical trial design and screen fail rates, FDA ADCOM on obeticholic acid and much more.

This week on Surfing NASH, Stephen Harrison speaks with Louise Campbell and Roger Green about challenges and opportunities in NASH drug development.

00:00 Introduction

04:26 What has Stephen been working on since last being on the podcast?

06:21 Stephen’s take on the outcome of the FDA ADCOM meeting on OCA for NASH

12:52 Discussing drugs with strong metabolic foundations

16:29 2023 Nature article on challenges and opportunities in NASH drug development

21:40 Disease progression in the diabetic population and screen fail rates

32:17 Deeper dive into histopathology

36:55 Closing question on the future of clinical trial design

The conversation comes aptly after the outcome of FDA’s ADCOM meeting for obeticholic acid (OCA) as a treatment for pre-cirrhotic fibrosis due to NASH. The group considers and comments on the safety profile of OCA and what the FDA requires in a first drug approval. However, this session extends much farther to offer a positively stimulating deep dive into the ongoing developments of a range of other therapeutic candidates and research directions for Fatty Liver disease. From the outset, Stephen shares that he is more convinced that we can move the needle in the toughest to treat patient populations prior to them developing decompensating disease. “There is hope that this population is not too far gone and we can be impactful.” Listen on to discover just what is so convincing in this space and what are the elements that give the group hope for the future of Fatty Liver disease.

00:00 Introduction

04:26 What has Stephen been working on since last being on the podcast?

06:21 Stephen’s take on the outcome of the FDA ADCOM meeting on OCA for NASH

12:52 Discussing drugs with strong metabolic foundations

16:29 2023 Nature article on challenges and opportunities in NASH drug development

21:40 Disease progression in the diabetic population and screen fail rates

32:17 Deeper dive into histopathology

36:55 Closing question on the future of clinical trial design

If you enjoy the episode, have questions or interest around NASH therapeutic development, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.

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