S2 E5.2 — After the FDA Webcast: Discussing Clinical Endpoints
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 clinical and surrogate endpoints. The panel discussed key takeaways from the FDA webcast on NASH Drug Development on the subject of endpoints. The group focused discussion on a few issues: (a) histology, both in terms of its continued primacy as a surrogate for pre-cirrhotics and FDA's willingness to accept digi...
9 Feb 202117min
S2 E5.1 - After the FDA Webcast: Beginning and Ending Perceptions
Send us a text The Surfers and guests Manal Abdelmalek, Naim Alkhouri and Akero Therapeutics Chief Development Officer Kitty Yale share high-level perspectives on the FDA Webcast, both before and after the group's detailed conversation. The panel shared overall impressions and key takeaways from the FDA webcast on NASH Drug Development, both before and after the detailed discussion. Key issues included the agency's continued reliance on histology coupled with a willingness to accept digital ...
8 Feb 202127min
S2 E4.2 - Anticipating The FDA Webcast: Specific Items to Listen For
Send us a text Manal Abdelmalek joins the Surfers to discuss key themes they hope to hear at the January 29 FDA Webcast on NASH Drug Development. In this conversation, Professor Manal Abdelmalek joins the Surfers to explore some of the specific items for which they hope the FDA will provide clear guidance at its January 29 webcast on NASH Drug Development. Key issues included: (a) how to manage sample sizes with both safety issues and the need for patient heterogeneity in mind, and (b) wheth...
4 Feb 202123min
S2 E4.1 - Anticipating the FDA Webcast: Overall Areas for Guidance
Send us a text Manal Abdelmalek joins the Surfers to discuss key themes they hope to hear at the January 29 FDA Webcast on NASH Drug Development. In this conversation, Professor Manal Abdelmalek joins the Surfers to explore some of the major themes they hope the FDA will address at its January 29 webcast on NASH Drug Development. Key issues included: implications of safety: efficacy tradeoffs in the approval process, expanding use of non-invasive testing during Phase 2 trials, and language i...
4 Feb 202124min
S2 E5 - What We Learned at Today's FDA Webcast on NASH Drug Development
Send us a text Manal Abdelmalek, Naim Alkhouri, and Akero Therapeutics Chief Development Officer Kitty Yale join the Surfers to discuss Friday's FDA webcast on NASH Drug Development. Friday's FDA Webcast on NASH drug development provided few concrete answers but several clues and directions to pursue. Listen as Manal Abdelmalek, Naim Alkhouri, and Kitty Yale, Chief Development Officer at Akero Therapeutics, join the Surfers to read the tea leaves and identify fruitful areas for further resea...
1 Feb 20211h 9min
S2 E4 - What to Listen For Friday at the FDA Webcast
Send us a text Manal Abdelmalek joins the Surfers to share expectations in advance of Friday's FDA Webcast on NASH Drug Development. FDA's Friday webcast titled "Regulatory Perspectives for Development of Drugs for Treatment of NASH" is the agency's long-awaited public event to provide better definition on what trial must achieve for a NASH drug to gain approval. In advance of that event, Stephen, Louise, Manal and Roger share expectations for that session. Kitty Yale, Chief Development Offi...
28 Jan 202151min
S2 E3.2 - Call to action: Can We use COVID-19 Vaccine Centers to support Liver health?
Send us a text The Surfers discuss ways that COVID-19 Vaccine Centers might present an opportunity to educate and screen patients on Liver Health Stephen Harrison suggests that COVID-19 Vaccine Centers might be an excellent site for providing screening and education around Liver Health and the conversation explodes with ideas and enthusiasm. In the span of 15 minutes, the group explores ideas for endorsers, volunteer educators and on-site testing, all based on the expectation that patients a...
23 Jan 202124min
S2 E3.1 - Challenges Disadvantaged Minorities Face in Liver Health
Send us a text Donna Cryer and Louise Campbell discuss how governmental action (or inaction) couple with community efforts to shape Liver Health initiatives in the US, UK, and Australia. The Surfers discuss challenges facing Disadvantaged Minorities in the US, UK and Australia related to Liver Health issues. Donna Cryer covers US issues, including structural challenges within the healthcare system and insufficiency of information, and also discusses community and culture-driven solutions. Lo...
23 Jan 202125min
