S2-E7 - The Newer Diabetes Drugs and Patients with NASH
Send us a text Jörn Schattenberg and Fatty Liver Foundation President Wayne Eskridge join Louise and Roger to consider the current and future roles that GLP-1 receptor agonists like semaglutide and SGLT-2 inhibitors like Jardiance in treating NASH patients. Over the next couple of years, we are likely to see improvements in our ability to diagnose and track NASH patients but no new medicines to treat them. On this podcast, Jörn Schattenberg reviews data on the role that two relatively recent...
18 Helmi 202149min
S2 E6.3 - #RealTalk: Trial Recruiting Challenges: Traps to Avoid in designing patient protocols for NASH Trials
Send us a text Three experience NASH trial site execs identify at least 11 specific things to consider when designing your trial protocols. Stephen Harrison challenges colleagues Naim Alkhouri and Rashmee Patil to identify a "Top Ten" of criteria to consider/pressure test in designing protocols...and they come up with at least 11! In the end, Naim Alkhouri advocates for sponsors talking to trial sites, not simply CROs, during the design phase. Rashmee Patil highlights the importance ...
14 Helmi 202124min
S2 E6.2 - #RealTalk: Trial Recruiting Challenges: Educating Physician during the pandemic
Send us a text The panel explores three less obvious ways that the COVID-19 pandemic has affected the ability to recruit the right patients into clinical trials. This week, SurfingNASH discusses why recruiting and maintaining the right patients for NASH clinical trials will require focus, discipline, and perhaps a new way of thinking about trial recruitment. When we think of how COVID-19 has reshaped medicine, we usually think about patient fear and the impact of staff exposure. Throu...
13 Helmi 202112min
S2 E6.1 - #RealTalk: Trial Recruiting Challenges: Daunting Numbers and Challenging Protocols
Send us a text Naim Alkhouri and Dr. Rashmee Patil of the South Texas Research Institute join the Surfers to discuss misconceptions about the ease of recruiting and qualifying patients for NASH clinical trials. Exciting Phase 2b results over the last few months will increase demand for patients to include in NASH clinical trials. So will the recent FDA white paper and webcast, which focused on larger populations for safety evaluation. This week, SurfingNASH discusses why finding these patien...
13 Helmi 202115min
S2 E6 - #RealTalk on Clinical Trial Design and Execution
Send us a text Naim Alkhouri and Dr. Rashmee Patil of the South Texas Research Institute join the Surfers to discuss practical challenges and issues in conducting on-time, on-target NASH clinical trials. The January 29 FDA webcast on NASH Drug Development suggested the need for larger, longer clinical trials with more patients in the overall dataset. This week, Stephen Harrison, Naim Alkhouri, and Rashmee Patil of the South Texas Research Institute (each of whom manages hepatology clinical t...
11 Helmi 202158min
S2 E5.5 - Bonus Interview with Suneil Hosmane: What FDA webcast means for "Wet" Diagnostics
Send us a text NEW CONTENT: Suneil Hosmane joins Roger Green to discuss why he found the FDA Webcast so encouraging for liquid biomarkers. BONUS INTERVIEW: GenFit Global Head of Diagnostics Suneil Hosmane joined Roger Green for a post-FDA Webcast interview. Suneil expressed general optimism about the Webcast. Like the Surfers, he appreciated the agency's request for data to begin answering pivotal questions about diagnostics and proof of benefit. Unlike the Surfers, he extended the conversat...
10 Helmi 202122min
S2 E5.4 - Bonus Interview with Prof. Dr. Jörn M. Schattenberg: What FDA webcast means for researchers and trial sites outside the US
Send us a text NEW CONTENT: Prof. Dr. Jörn M. Schattenberg joins Roger Green to discuss his highly optimistic reaction to the FDA Webcast. BONUS INTERVIEW: Prof. Dr. Jörn M. Schattenberg and Roger Green spend 20 minutes discussing Jörn's reaction to the January 29 FDA Webcast. Joern discusses why digital pathology is such a benefit to trial sites outside the US and some of the new clinical development and sample size considerations emanating from a need to provide more robust safety data. A...
10 Helmi 202121min
S2 E5.3 — After the FDA Webcast: Discussing Drug Development and Clinical Trial Strategies
Send us a text The Surfers and guests Manal Abdelmalek, Naim Alkhouri, and Akero Therapeutics Chief Development Officer Kitty Yale discuss sections of the FDA Webcast that centered on drug development and clinical trial strategies. The panel discussed key takeaways from the FDA webcast on NASH Drug Development on the subjects of clinical trial design and development strategies. Much discussion centered around parallel clinical trials for F2/F3 and controlled cirrhotic patients, both in terms...
9 Helmi 202124min
