This conversation focuses on how the need for biomarkers will evolve in an era of in-office screening and MASH drugs and ends with answers to Roger Green's closing question.
Hannes Hagstrom starts this conversation by noting that one challenge as MASH drugs become available involves knowing when to discontinue or add to therapy since, as he points out, Rezdiffra will not be efficacious for all patients. This leads Jörn Schattenberg to the need for predictive biomarkers that will be specific to drugs or modes of action. These have not been studied much to date. Jörn is confident these will not be today’s biomarkers, but is unclear about whether they should point to genotype, mode of action or something else. After some byplay about how quickly this can come about (years vs. decades), Roger Green suggests that one key to commercial success will be the identification of this exact type of biomarker.
Louise Campbell broadens the group's focus somewhat by noting that since changes in nutrition and physical activity will be part of any regimen we need to assess the impact of these as compared to the drug itself. Jörn describes this vision as “kind of scary” but notes that diet and exercise labeling is standard for drugs in the US, exactly as it is with Rezdiffra, and these are not monitored closely. From there, we consider the kind of study one might do to assess nutrition and physical activity independently and why that might be extremely hard.
From there, the discussion moves on to Roger's final question, in which he asks what steps each panelist believes will take place in the next two years to support improved triaging and patient management through the system. Four active minds produce more than four answers. Listen to learn.
This conversation focuses on how the need for biomarkers will evolve in an era of in-office screening and MASH drugs and ends with answers to Roger Green's closing question.
Hannes Hagstrom starts this conversation by noting that one challenge as MASH drugs become available involves knowing when to discontinue or add to therapy since, as he points out, Rezdiffra will not be efficacious for all patients. This leads Jörn Schattenberg to the need for predictive biomarkers that will be specific to drugs or modes of action. These have not been studied much to date. Jörn is confident these will not be today’s biomarkers, but is unclear about whether they should point to genotype, mode of action or something else. After some byplay about how quickly this can come about (years vs. decades), Roger Green suggests that one key to commercial success will be the identification of this exact type of biomarker.
Louise Campbell broadens the group's focus somewhat by noting that since changes in nutrition and physical activity will be part of any regimen we need to assess the impact of these as compared to the drug itself. Jörn describes this vision as “kind of scary” but notes that diet and exercise labeling is standard for drugs in the US, exactly as it is with Rezdiffra, and these are not monitored closely. From there, we consider the kind of study one might do to assess nutrition and physical activity independently and why that might be extremely hard.
From there, the discussion moves on to Roger's final question, in which he asks what steps each panelist believes will take place in the next two years to support improved triaging and patient management through the system. Four active minds produce more than four answers. Listen to learn.