Manal Abdelmalek - Podcast Details

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$What\'s it Worth? A Journal Club Podcast$ What's it Worth? A Journal Club PodcastS3E5 (#21) Empagliflozin Meets MASLD: Hope, Hype, or Hypothesis?Welcome back to What’s it Worth! Join your hosts, Dr. Diana Langworthy and Dr. Peyton Braun (PGY1 Pharmacy Resident), as we sift through strengths and limitations of at trial assessing the effects of empagliflozin on nonalcoholic fatty liver disease. The authors sought to quantify the impact of Sodium Glucose Cotransporter 2 - inhibitors (SGLT2i's) on Metabolic Dysfunction Associated Liver Disease (MASLD). This episode is full of EBP detective moments - dissecting trial language to get a clear picture of the story. Let's dive in and see what its worth! Key Points MASLD is a condition marked...2025-06-0350 min

Surfing the MASH TsunamiS5 E14.2 - Remembering Stephen Harrison: Professional AccomplishmentsManal Abdelmalek and Naim Alkhouri join co-hosts Jörn Schattenberg, Louise Campbell and Roger Green to reflect on the greatest professional accomplishments of co-founder and former co-host Dr. Stephen Harrison.Naim Alkhouri starts this conversation by describing the two prospective epidemiology papers Stephen co-authored at San Antonio Military Medical Center in 2011 and 2021, an innovative design that provided early estimates of the breadth of MASLD and MASH in an asymptomatic population. He goes on to discuss Stephen's work on FAST and other NITs and finishes by remembering Stephen's exceptional work in drug development, culminating in the recent FDA a...2024-05-1208 min

Surfing the MASH TsunamiS5 E14.1 - Remembering Stephen Harrison: Personal MemoriesManal Abdelmalek and Naim Alkhouri join co-hosts Jörn Schattenberg, Louise Campbell and Roger Green to share personal memories of co-founder and former co-host Dr. Stephen Harrison. Naim Alkhouri starts the conversation by describing how he met his "friend and mentor," Stephen. He recalls coming to San Antonio in 2017 to work with a different research group and contacting Stephen. Stephen told Naim he had "made the wrong decision" by not joining his team instead. Nonetheless, Naim persisted, and the two began a rich, rewarding friendship and research experience, which Naim describes in greater detail.Jörn...2024-05-1215 min

Surfing the MASH TsunamiS5 - E14.3 - Remembering Stephen Harrison: "Harrisonisms"Manal Abdelmalek and Naim Alkhouri join co-hosts Jörn Schattenberg, Louise Campbell and Roger Green to rshare some of their favorite "Harrisonisms" - words, phrases and verbal memes associated with co-founder and former co-host Dr. Stephen Harrison.Naim Alkhouri starts by stating two of his favorite Harrisonisms, two that SurfingMASH listeners know well: "is the juice worth the squeeze?" and "Keep It Simple, Stupid." He goes on to add one that never appeared on the podcast, "FAIL stands for First Attempt In Learning," which he u...2024-05-1110 min

Surfing the MASH TsunamiS5 - E14 - Remembering Stephen Harrison - colleagues share memories and impressions of an SLD masterThe sudden passing on April 23 of our co-founder and colleague Stephen Harrison sent shock waves throughout the global SLD community. This week, Manal Abdelmalek and Naim Alkhouri join Jörn Schattenberg, Louise Campbell and Roger Green to remember and pay tribute to an exceptional leader, role model and human being.00:00:00 - Surf's Up: Season 5 Episode 14Episode introduction, including brief quotes taken directly from panelists. 00:03:11 - IntroductionRoger introduces the podcast. The three key opinion leaders, Jörn Schattenberg, Manal Abdelmalek and Naim Alkhouri, discuss their fast-paced, high intensity travel schedules.00:04:41 - Gr...2024-05-0837 min

GLI LIVEFighting NASH around the World #StepUpforNASHIn this episode of GLI LIVE, our VP of Liver Health Programs, Jeff McIntyre, is joined by guests from around the world to hear about how they elevate liver health year-round – and to hear what they have planned for International #NASHDay. Guests include William J. Ocran (Ghana), Dr. Manal F. Abdelmalek (USA), Michael Betel (Canada), Dr. Shahinul Alam (Bangladesh), and Tarja Teitto-Tuckett (Finland).2023-06-0755 min

Surfing the MASH TsunamiS4-E16.2 - #NASHDay 2023 Theme: Step Up to NASH!As International #NASHDay 2023 approaches on June 8th, Surfing NASH dedicates a session to explore what makes this year’s occasion incredibly important for patient advocacy and what we all can consider in preparation. Founder, President and Chief Executive Officer of the Global Liver Institute (GLI), Donna Cryer, shares her anticipations alongside Pamela Danagher (Terns Pharmaceuticals) and co-hosts Jörn Schattenberg and Roger Green.Roger turns to Jörn and Pamela for their first impressions on what #NASHDay 2023 means to them. Jörn recalls his participation in the inaugural launch of #NASHDay in 2018, highlighting the unique and intimate quali...2023-04-1512 min

Surfing the MASH TsunamiS4-E15.2 - Liver Forum 14: Panelists Select Sessions of InterestThis week on Surfing NASH, co-hosts Jörn Schattenberg and Roger Green review the recently concluded Liver Forum. Joining discussion are Liver Forum Executive Director Veronica Miller and speakers Mazen Noureddin (Houston Research Institute), Michelle Long (Novo Nordisk) and Jeff McIntyre (Global Liver Institute).Roger leads this conversation by asking the panelists to pick a particular session that captured their attention in a way that could not have been predicted. Michelle first mentions how the agenda as a whole illuminated the depth of the issues surrounding drug development for the fatty liver field. Veronica points t...2023-04-0811 min

Surfing the MASH TsunamiS4-E15 - Review of Liver Forum 14This week on Surfing NASH, co-hosts Jörn Schattenberg and Roger Green review the recently concluded Liver Forum. Joining discussion are Liver Forum Executive Director Veronica Miller and speakers Mazen Noureddin (Houston Research Institute), Michelle Long (Novo Nordisk) and Jeff McIntyre (Global Liver Institute). This integrative meeting aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing an independent and neutral venue for ongoing multi-stakeholder dialogue. The resulting conversations facilitate making the best science-based decisions on how to study efficacy and safety in real time as collective knowledge and experience w...2023-04-0653 min

EndoDirect - Endocrinologia e MetabologiaEndoDirect 47 - Doença Hepática Gordurosa Metabólica com Dr. Álvaro DelgadoNeste episódio vamos discutir sobre Doença Hepática Gordurosa Metabólica ou Doença Hepática Gordura Não Alcoólica e para isso convidamos o Dr Álvaro Delgado, gastroenterologista pela USP, para uma discussão breve sobre os principais aspectos dessa doença que não especialistas não podem deixar de saber! Apresentação do convidado e roteiro Caso clínico (02:30) Definição da doença e história natural (05:50) Diagnóstico (11:50) quando pedir transaminases? (12:00) quando pedir USG? elastografia? (19:00) Escores de fibrose? (23:30) quando indicar biópsia? (28:00) Tratamento - Não far...2023-02-2850 min

Surfing the MASH TsunamiS3-E57.4 - Discussing Critical Success Factors for Placebo CohortsThe Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. In this final conversation, Executive Director Veronica Miller joins guest Manal Abdelmalek and co-host Jörn Schattenberg (both Steering Committee members) to discuss the Liver Forum, its unique processes and valuable work. Roger Green starts this conversation suggesting that the findings of...2022-12-0411 min

Surfing the MASH TsunamiS3-E57.3 - A Priori Placebo Response Rates and Challenges in Managing Samples Through TrialsThe Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. Previously, Executive Director Veronica Miller had introduced ongoing work with the Placebo Arm Database Project, co-chaired by Manal Abdelmalek.Jörn Schattenberg leads this conversation with the observation that in Manal's past appearances on the podcast, she has discussed the value o...2022-12-0311 min

Surfing the MASH TsunamiS3-E57.2 - Origins of the Liver Forum and Capturing the Richness of Data Emerging from NASH StudiesPreviously, Executive Director Veronica Miller explained how she arrived to the field of NAFLD and the history of the Liver Forum. This conversation begins with recollections from Manal Abdelmalek and Jörn Schattenberg on their respective introductions to the Liver Forum. Before the collaborative space existed, Manal points out that when industry first began to ponder NASH drugs there were no road maps for trial design or endpoints. Jörn then describes his first attendance of a Liver Forum meeting. He found the experience to be uniquely valuable for its welcoming diversity of stakeholder inclusion and participation. Today, he is...2022-12-0313 min

Surfing the MASH TsunamiS3-E57 - The Liver Forum: Fighting Fatty Liver Using Collective Knowledge and ExperienceThe Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. In this episode, Executive Director Veronica Miller joins guest Manal Abdelmalek and co-host Jörn Schattenberg (both Steering Committee members) to discuss the Liver Forum and its valuable work. Veronica details her fascinating, well-traveled background and the path she has taken fr...2022-12-0155 min

Surfing the MASH TsunamiS3-E52.6 - From the Vault: AASLD 2021: The Path To Making NITs the “Gold Standard” for Drug TrialsManal Abdelmalek, Jörn Schattenberg and Ian Rowe join Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from TLMdX 2021, the AASLD annual liver meeting. This conversation focuses on crafting the most robust efficient pathway to shift the gold standard of drug development from semi-quantitative biopsy reads to intelligent use on non-invasive techniques.Opinions diverge about everything from how easy it will be to replace biopsy to exactly what that pathway might look like. What is clear is that everyone in this discussion believes with a hot passion that biopsy is a critical i...2022-11-0612 min

Surfing the MASH TsunamiS3-E38.4 - From the Vault: NITs & Advancing NASH Therapy at AASLD 2021Our week of "Greatest Hits" episodes from the vault continues with our second most popular conversation ever, which came from the wrap-up episode for AASLD2021. In this episode, Manal Abdelmalek, Jörn Schattenberg and Ian Rowe joined Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from AASLD2021 TLMdX and specifically to focus on how NITs will help, in the words of Stephen Harrison, "put a big, fat dent in Fatty Liver disease."As I wrote at the time: The conversation starts with the group congratulating Manal Abdelmalek on her wrap-up NAFLD talk a...2022-07-3020 min

Surfing the MASH TsunamiS2-E63.1 - SurfingNASH's 2021 NAFLD year-in-review Covers Cirrhosis Treatment Strategies Today and NASH Drugs in DevelopmentThis conversation is part of SurfingNASH's 2021 NAFLD Year-In-Review. Professor Manal Abdelmalek of Duke University joins Louise Campbell and Roger Green to discuss the use of older drugs to treat cirrhosis patients today and her views on where NASH drug development is heading.Manal begins by discussing the inherent tension between the research world, which reveals several promising modes of action and drugs in development but are unlikely to yield a first approval less than two years from now, compared to patient treatment, where people living with cirrhosis are looking for help today. Her talk focuses...2021-12-2835 min

Surfing the MASH TsunamiS2-E63 - Manal Abdelmalek, Ken Cusi And Jörn Schattenberg Join SurfingNASH's 2021 NAFLD Year-In-ReviewThe last half of December marks our annual NAFLD Year-in-Review. Episodes 62-64 each include ~20 minute segments of longer interviews with Stakeholders who have made a dent in Fatty Liver disease in 2021. In this episode, Louise Campbell and Roger Green are joined by Manal Abdelmalek, Kenneth Cusi and Jörn Schattenberg.Highlights:3:26 – Manal Abdelmalek introduction and discussion: opportunities in the new drug pipeline and ways to treat using older agents until new agent arrive5:06 – Manal: urgent to treat cirrhosis when it appears. Reversal may not be “achievable;” but blunting progression can provide stability 9:51 – We learn more...2021-12-271h 02

Surfing the MASH TsunamiS2-E57.4 - TLMdX 2021 From AASLD: What Does the Future Hold For NAFLD and NASH?Manal Abdelmalek, Jörn Schattenberg and Ian Rowe join regulars Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from the 2021 , the AASLD annual liver meeting. This conversation focuses on complexities and challenges NAFLD drug development and patient treatment will face in the future and ends with predictions about the biggest stories of the 2022 Liver Meeting (hopefully hybrid instead of only digital!).The specific complications include microbiome, which has the potential to add a regional (or even individual) component to our understanding of NAFLD. Stephen Harrison speculates on how the scarcity o...2021-11-2213 min

Surfing the MASH TsunamiS2-E57.3 - 2021 TLMdX From AASLD: Non-conventional efficacy Metrics, Genomics of NAFLD and an Exciting FutureManal Abdelmalek, Jörn Schattenberg and Ian Rowe join regulars Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from the 2021 TLMdX, the AASLD annual liver meeting. This conversation focuses how to make NITs the "gold standard" of drug development instead of biopsy.The guests is Antaros Medical Chief Scientific Officer and recent SurfingNASH (S2 E50) panelist Lars Johansson, who joins the discussion from the audience to ask about use of spleen volume as a surrogate measure in F2 and F3, the value using AI models to re-evaluate old imaging data a...2021-11-2112 min

Surfing the MASH TsunamiS2-E57.2 - 2021 TLMdX From AASLD: The Path To Making NITs the "Gold Standard" for Drug TrialsManal Abdelmalek, Jörn Schattenberg and Ian Rowe join regulars Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from the 2021 TLMdX, the AASLD annual liver meeting. This conversation focuses on crafting the most robust efficient pathway to shift the gold standard of drug development from semi-quantitative biopsy reads to intelligent use on non-invasive techniques.Opinions diverge about everything from how easy it will be to replace biopsy to exactly what that pathway might look like. What is clear is that everyone in this discussion believes with a hot passion that biopsy is a...2021-11-2112 min

Surfing the MASH TsunamiS2-E57.1 - 2021 TLMdX from AASLD: Putting a "Big, Fat Dent" in NAFLD and NASHManal Abdelmalek, Jörn Schattenberg and Ian Rowe join regulars Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from the 2021 TLMdX, the AASLD annual liver meeting. This conversation focuses on what we have learned about NITs and clinical development testing that will, in the words of Stephen Harrison, "put a big, fat dent in Fatty Liver disease."The conversation starts with the group congratulating Manal Abdelmalek on her wrap-up NAFLD talk at the 2021 TLMdX. From there, the group focuses on the shortcomings of using biopsy as the clinical trial gold standard and h...2021-11-2118 min

Surfing the MASH TsunamiS2-E57 - AASLD 2021 Wrap-up: Looking Back on an Eventful TLMdXManal Abdelmalek, Jörn Schattenberg and Ian Rowe join regulars Stephen Harrison, Louise Campbell and Roger Green to recap this week's just-concluded TLMdX 2021, the AASLD annual liver meeting. When AASLD announced that the 2021 TLMdX would be held as a purely virtual meeting, attendees and observers feared a loss of focus and the kind of amplifying energy that comes from being with colleagues. That did not happen. Instead, the breadth, quality and novelty of the meeting's presentations generated exceptional positive energy despite the virtual setting. 4:10 - Roger starts by saluting Manal for giving the NAFLD Wrap-up Tal...2021-11-191h 02

Surfing the MASH TsunamiS2-E53.3 - AASLD 2021 Preview: NASH Patient Management Topics Range From Drugs In Development To Applied Day-to-Day Issues In the third conversation from SurfingNASH's AASLD 2021 preview, Manal Abdelmalek, Ken Cusi and Jörn Schattenberg join Louise Campbell and Roger Green to discuss a range of issues in the later days of the conference, all loosely related to NASH Patient Management.Jörn starts this conversation by identifying some of the important presentations on clinical trials of novel therapies. From here, the group focuses on other Sunday and Monday presentations, some with a basic science focus and others that are more patient-oriented. In the end, the group answers Roger's final question, "If there's one imp...2021-11-0714 min

Surfing the MASH TsunamiS2-E53.2 - AASLD 2021 Preview: A Weekend of Broad NASH Disease/Drug Management CoverageIn the second conversation from SurfingNASH's AASLD 2021 preview, Manal Abdelmalek, Ken Cusi and Jörn Schattenberg join Louise Campbell and Roger Green to discuss the breadth of NASH Drug/Disease Management on the weekend agenda.Louise starts this conversation by pointing out Saturday sessions she believes will be important to understanding Fatty Liver care delivery, including sessions addressing women's health, health service and public health. From there, Ken leads into a discussion of Saturday's post-graduate course and Manal Abdelmalek opens a discussion on Sunday's Presidential Plenary session. She and Jörn note the importance of th...2021-11-0612 min

Surfing the MASH TsunamiS2-E53.1 - AASLD 2021 Preview: Presentations on Basic NASH ScienceIn the first conversation from SurfingNASH's AASLD 2021 preview, Manal Abdelmalek, Ken Cusi and Jörn Schattenberg join Louise Campbell and Roger Green to focus on some of the basic NASH Science presentations during the first two days of the meeting.After some preliminary comments from Roger and others about Saturday's day-long post-graduate course in NAFLD and NASH, Manal kicks this session into high gear by highlighting the Hans Popper Basic Science State-of-the-Art lecture, with its focus on single-cell genomics and its ability to transform our understanding of disease pathogenesis. As Manal points out, this becomes t...2021-11-0615 min

Surfing the MASH TsunamiS2-E53 - SurfingNASH Previews AASLD 2021: the Digital Liver MeetingManal Abdelmalek, Ken Cusi and Jörn Schattenberg join Louise Campbell and Roger Green to discuss key presentations at AASLD 2021 and preview SurfingNASH's coverage of the event. This virtual meeting runs from November 12-15 and is scheduled on East Coast time.Highlights include:9:19 – Roger begins the conversation, by describing the AASLD program elements and what SurfingNASH will cover.10:46 – Manal Abdelmalek kicks us off by focusing on Dr. Neil Henderson’s Hans Popper (Basic State of Science) Lecture and the relevance his talk will have meaning for NAFLD and NASH.12:53 – Ken Cusi links this talk...2021-11-0449 min

Surfing the MASH TsunamiS2-E47.3 - Most Important Story of Summer? Manal Abdelmalek Says, "NIH Funding Liver Cirrhosis Network"Professor Manal Abdelmalek joins Louise Campbell and Roger Green to discuss the important Fatty Liver stories of the last few months. She focuses on NIH's recent decision to stand up and fund the Liver Cirrhosis Network.To Dr Abdelmalek, the NIH action signifies increased focus on the significant long-term consequences of Fatty Liver disease. She discusses a Q&A at a talk she gave this summer where a physician noted that drug development is exciting but three years in the future and asked, "What can I do for my patients NOW?" She cites a recent...2021-09-2627 min

Surfing the MASH TsunamiS2-E47 - Ask Opinion Leaders: The Biggest NAFLD/NASH Stories of SummerIan Rowe, Michelle Long and Manal Abdelmalek reveal what they consider the most important NAFLD/NASH stories of summer.Which NAFLD/NASH stories did they choose? The newly-appointed Professor Rowe discusses the importance of the FDA approval of the ELF test as a prognostic for cirrhosis. True to her epidemiological background, Professor Long reviews the prospective prevalence study that Stephen Harrison, Naim Alkhouri and others conducted in San Antonio. Finally, Professor Abdelmalek uses a comment she received at a presentation this summer as a jumping-off point to discuss potential value currently available generic drugs...2021-09-241h 13

Surfing the MASH TsunamiS2-E34 - #ILC2021 Day Three - Multi-Disciplinary NAFLD Thinking, with Exciting Drugs on the HorizonManal Abdelmalek, Ian Rowe and first-timer Ken Cusi join Louise Campbell and Roger Green to review a thought-provoking, assumption-challenging Day Three of #ILC2021.Most of the presentations the panel covered focused on medications, the core ideas and discussions spoke to changes in thinking. One theme that ran through the discussion was about multi-disciplinary care...and not only because Fatty Liver Endocrinologist Ken Cusi was on the panel. Another was to think about drugs for NASH holistically. In all, this podcast takes the broad view and the long view on treating Fatty Liver diseases, and should...2021-06-251h 13

Surfing the MASH TsunamiS2-E23.1 - From the Fourth Global NASH Congress -- Diagnosing DiagnosticsThe SurfingNASH Team has curated over three hours of recordings from the Fourth Global NASH Congress to highlight pieces that discuss the current and future states of diagnostics in Fatty Liver disease. You will hear Manal Abdelmalek, Naim Alkhouri, Suneil Hosmane, Ian Rowe, Jörn Schattenberg, Louise Campbell and Roger Green sharing opinions and debating issues.Discussions about diagnostics ran through SurfingNASH's entire coverage of the Fourth Global NASH Congress. Listen here for some of the diagnostics highlights. The group discusses exciting new precision diagnostics, urine and breath-based biopsies, realistic expectations for diagnostics in market t...2021-05-0334 min

Surfing the MASH TsunamiS2-E21 - Day One At The 4th Global NASH Congress -- Diagnostics, Drugs And Regulatory IssuesManal Abdelmalek, Jörn Schattenberg and GenFit Global Diagnostics Leader Suneil Hosmane join the Surfers to review presentations from Day One at the 4th Global NASH Congress.On April 28, over 175 NASH stakeholders from across the globe will meet virtually to hear 23 presentations from leaders in academia and industry. SurfingNASH has selected 11 presentations to discuss in a session we will record right after the conference concludes. The speakers and their broad topic areas are:Manal Abdelmalek -- innovative non-invasive non-device diagnosticsJörn Schattenberg -- Developmental drugs that address fructose metabolismSuneil Hosmane...2021-04-291h 01

Surfing the MASH TsunamiS2 E11 — NASH-TAG Session 1 summary: Major Drugs in Development and Why Trials FailManal Abdelmalek and Ian Rowe join Roger, Louise and Donna to review the morning that Vlad Ratziu and Michael Charlton both identified as the highlight session of NASH-TAG 2021. The Friday morning session of NASH-TAG 2021 highlights advancing research for five major NASH drugs in development, explores the question why drug trials fail and wraps up with a rapid-fire session on promising data. Surfers were excited about some of the new drugs and found the presentations from Vlad Ratziu and Mary Rinella about why cirrhotic and non-cirrhotic drug trials fail to be particularly powerful and well-presented. Af...2021-03-1250 min

Clinical Liver Disease17-1: Insights Into Metabolic Mechanisms and Their Application in the Treatment of NASHAudible Article by Phillip J. White and Manal F. Abdelmalek 2021-02-1009 min

Surfing the MASH TsunamiS2 E5.3 — After the FDA Webcast: Discussing Drug Development and Clinical Trial StrategiesThe 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 of rethinking endpoints (is it sufficient to "halt" progression?) and designing sets of parallel trials to the sponsor's best benefit. Another key topic involved combination of...2021-02-0924 min

Surfing the MASH TsunamiS2 E5.2 — After the FDA Webcast: Discussing Clinical EndpointsThe 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 digital histology; (b) ratification that "the goalposts" are not moving on the endpoint issue; (c) frank statement that risk: benefit ratio...2021-02-0917 min

Surfing the MASH TsunamiS2 E5.1 - After the FDA Webcast: Beginning and Ending PerceptionsThe 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 pathology results, the importance of risk: benefit ratio in drug evaluation, the importance of a composite fibrosis+steatosis endpoint, and new approaches to clinical trials...2021-02-0827 min

Surfing the MASH TsunamiS2 E4.2 - Anticipating The FDA Webcast: Specific Items to Listen ForManal 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) whether we can seek to reduce screen fail rates by utilizing high-value non-invasive tests like MR...2021-02-0423 min

Surfing the MASH TsunamiS2 E4.1 - Anticipating the FDA Webcast: Overall Areas for GuidanceManal 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 in the agency's white paper suggesting that Phase 3 trials possibly should be two years or longer.2021-02-0424 min

Surfing the MASH TsunamiS2 E5 - What We Learned at Today's FDA Webcast on NASH Drug DevelopmentManal 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 research and pursuit. Issues around diagnostics and the risk: benefit tradeoff received particular attention.2021-02-011h 09

Surfing the MASH TsunamiS2 E4 - What to Listen For Friday at the FDA WebcastManal 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 Officer for Akero Therapeutics and a participant in our post-session podcast, sends in four points to explore. Whether you care about the...2021-01-2851 min

Surfing the MASH TsunamiS2 E2.2 - Economic and Patient Motivation Costs and Value of telemedicine and New Non-Invasive Diagnostic TestingEvaluating 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 critical success factors in making these innovations patient-friendly and motivating patients to take advantage of them.2021-01-1615 min

Surfing the MASH TsunamiS2 E2.1 - Innovations in Telemedicine and Mobile Technology can improve care for NAFLD patientsInnovations 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 and non-invasive blood tests like NIS-4, ELF, and FIB-4, into patient care. Stephen Harrison and Louise Campbell build on Manal’s concept.2021-01-1620 min

Surfing the MASH TsunamiS2 E2 — How COVID-19 is changing patient management and clinical trialsManal 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 patient communication and treatment, including innovations in patient-management and out-of-office diagnostics. Whether discussing "de-livery" vans loaded with complete sets of diagnostic tools or the use of colors, icons, and one-letter code to convey the results of lab tests, the Surfers surface an...2021-01-1450 min