The conversation starts with Roger asking the group about one thing each found particularly striking from the meeting.
A Review of Paris NASH Meeting 2022 with Jeff McIntyre
Jörn responds first, noting his many appearances across the history of the event. He thinks this year’s dominating theme to be the engagement of regulatory questions that address moving beyond biopsies and conditional drug approval.
Jeff joins to echo this takeaway, adding that he is intrigued by the multinational dynamics of the meeting. Next, Louise recalls a more specific crux. In response to an industry roundtable, she suggests that with the wealth of data provided from clinical trials it is now time to consider changing endpoints.
Lastly, Roger offers his general thoughts on witnessing the shifting tensions between the scientific and patient advocate positions and the regulatory and payer responses. The group then compares the American and European positions on moving the field toward a more metabolic perspective.
They consider where this pressure comes from in terms of regulators, patients, payers, politicians and employers.
Moving on, Roger asks the group for an example of one particular talk or panel that grabbed their imagination and why. Louise returns to the statistics surrounding NASH. She reminds that while the field searches for more data, an expected rise of 110-125% in advanced liver disease and mortality by 2040 is underway. Given the influence of obesity on this rise, Louise highlights the role of allied health professionals in providing lifestyle guidance to mitigate disease progression from an earlier stage.
In the closing session, both Jörn and Jeff reflect on participating in discussions surrounding the role of the patient voice and developing a global strategy for NASH. This leads the group to explore the potential for public advocacy in the field of NAFLD and NASH.
Afterwards, Roger brings focus to educating physicians and other healthcare professionals on the nature of metabolic disease. By developing an understanding of the multifaceted application of many drugs in a metabolic context, the wait for an F1 or NAFLD drug approval can be possibly eliminated altogether.
Louise adds that a pivot is required to move away from organ-centric thinking.
Next, the group provides their thoughts on Session 5, starting with response adaptive trial design to pick the best dose. Roger and Jörn share ideas on clinical trial criteria and the use of Bayesian priors in enrichment strategies. Jeff also revisits the role of patient involvement in this topic.
Roger then suggests the four go through and connect missing dots between sessions covered in the conversation thus far. After that, the final response:
Louise looks toward a bright future with metabolic coordination. She believes patients are key in developing person-centric approaches.
Jörn believes that addressing multiple organ systems is the way forward and that it is necessary to partner with other disciplines.
Jeff feels grateful for his participation as a patient advocate. He says he is looking for the experience of the science, which in the end feels positive to him.
Roger reiterates the importance of investigating these discussions as Paris NASH does. “One thing that became clearer to me in this meeting than it’s ever been before, is that this is all about metabolic disease.” He is hopeful.
Surf on for the full review.