Surfing the MASH Tsunami

Send us Fan Mail 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 ,...

Send us Fan Mail 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...

Send us Fan Mail 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...

Send us Fan Mail 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 c...

Send us Fan Mail 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 ter...

Send us Fan Mail 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 iss...

Send us Fan Mail 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...

Send us Fan Mail 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...

Send us Fan Mail 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...

Send us Fan Mail 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 adva...

Send us Fan Mail 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 fo...

Send us Fan Mail 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 syst...

Send us Fan Mail Donna Cryer joins the Surfers to explore efforts to support residents in disadvantaged minority communities in the US, UK, and Australia in improving their Liver Health and awareness. "The Band gets together again" as Donna Cryer joins Stephen, Louise, and Roger to explore the state of Liver Health and Health Education in disadvantaged minority communities. In the first...

Send us Fan Mail The Surfers end this episode by discussing the need for public education to create the awareness necessary for change. This conversation covers a broad range of topics -- public health needs in different parts of the world, non-communicable disease, public awareness -- but ends in a discussion on the need for public and industry sponsorship to support the broad scale of education...

Send us Fan Mail Evaluating the economic and patient-motivating value of enhanced telemedicine and mobile non-invasive testing technologies in improving NAFLD diagnosis and lowering rates of non-communicable disease. The Surfers and our guest Dr. Manal Abdelmalek consider the economic costs and value of enhanced telemedicine and mobile “de-liver” testing technology and then move on to consider cri...

Send us Fan Mail Innovations in Telemedicine and Mobile Technologies are already changing patient care in ways that will remain and expand in the "New Normal" after the COVID-19 pandemic is less urgent. Our guest, Dr. Manal Abdelmalek discusses how a rough week in patient-management led her to envision innovative ways to incorporate telemedicine and mobile technologies such as FibroScan...

Send us Fan Mail Manal Abdelmalek joins the Surfers to describe long-term changes in patient management that improved diagnostic and telecommunication technologies can drive in response to new COVID-19 induced challenges. How must we adapt to the changes in patient management caused by COVID-19? The Surfers, spurred by creative ideas from guest Manal Abdelmalek, think about ways to re-engineer pat...

Send us Fan Mail Question: If NALFD patients have poorer COVID-19 prognoses, how can we use this fact to drive broader population-based screening? This conversation asks a two-part question: How do we motivate primary care treaters and specialists who treat metabolic syndromes to manage NAFLD more aggressively? The conversation considers education and telemedicine in this context and then turns to...

Send us Fan Mail The COVID-19 conversation continues with the group focusing on challenges in clinical trial execution and how innovative logistics and consistent education can lessen or overcome them. In this conversation, the group starts by discussing the significant number of patients who could benefit from NAFLD or NASH therapy centered around defatting the liver through medications and behav...

Send us Fan Mail Manal Abdelmalek joins the Surfers to consider the three most important COVID-19 stories today. The conversation focuses on the British variant, the new vaccines, and the physical and emotional toll the pandemic continues to take on front-line physicians and other healthcare workers. Stephen and Manal each have a sibling who works as an ER physician and they provide heart-wrenchin...

Send us Fan Mail Manal Abdelmalek joins the Surfers to discuss how recent COVID-19 news might affect Fatty Liver patients and what the medical profession and BioPharma companies can do to support patients better during this dangerous phase of the pandemic. Manal Abdelmalek joins the Surfers to discuss the implications of the new British COVID-19 variant, availability of the Pfizer/BioNTech and Mod...

Send us Fan Mail Wayne Eskridge describes how hope fell and then rose as patients did not receive the drug approval they expected but then learned about exciting paths for new agents and non-invasive testing. Wayne Eskridge describes his excitement as 2020 ends, saying "The quality of the work that's being done overall says that this is a far more tractable problem than we thought it was...

Send us Fan Mail Louise Campbell questions the implication of APASL and ALEH endorsing "MAFLD" as Fatty Liver Disease nomenclature and Stephen Harrison discusses behind-the-scenes activities to resolve this issue. Louise Campbell "wonders" where increased support for adopting the term "MAFLD" (Metabolic-Associated Fatty Liver Disease) instead of NAFLD (Non-Alcoholic F...

Send us Fan Mail Joern Schattenberg discusses the public health implications of German newspapers beginning to discuss Fatty Liver Disease For Joern Schattenberg, reading about Non-Alcoholic Fatty Liver Disease in a German newspaper "has two or three very important implications that we have discussed on the podcast in the past year," particularly in terms of educating patients with metab...

Send us Fan Mail Ian Rowe discusses how streamlined use of ELF, FIB-4 and FibroScan improves cost effectiveness and patient satisfaction associated with NASH screening. Ian Rowe comments on data from the landmark work he, Richard Parker and colleagues in Leeds, UK are conducting around the issue of population screening for NASH: "it's quite easy to show that you can identify more liver d...