This conversation revolves around one question: “What lessons should the BioPharma industry take from the launch of Rezdiffra?” Answers revolve largely around clinical trial design and, generally, taking a broad, long-term view of what the trial must accomplish to optimize drug adoption.
More specifically, Roger Green starts this conversation by noting that much of the SurfingMASH audience works in pharma or biotech. He asks what lessons they should take from this experience. Zobair Younossi responds first, commending Madrigal for “doing the right thing” and being persistent for years, even when it appeared that Rezdiffra would come to market years after the anticipated first drug. To Zobair, “the right thing” includes conducting multiple trials at different diseases and targets, including large samples in each trial, and introducing NITs as endpoints.
Jeff McIntyre also feels that using NIT markers to parallel biopsy in clinical trials has created a major bridge to an all-NIT, post-biopsy initial diagnosis plan. Louise Campbell asks what impact the two-day NIT workshop the FDA conducted last autumn had on any of this. Zobair, who works closely with the FDA, suggests that the agency is taking time to process this information collaboratively. He believes the agency is moving in the right direction, if more slowly than we might like.