S3 E45.1 – Paris Review: Regulator Response and “Dynamic Tension”

S3 E45.1 - Paris Review: Regulator Response and "Dynamic Tension”
In a review of Paris NASH 2022, Surfers Roger Green, Louise Campbell, and Jörn Schattenberg are joined by patient advocate, Jeff McIntyre. In this conversation, the group shares one particularly striking takeaway from the meeting.

The episode begins with the panelists – Jörn, Louise, Jeff McIntyre of GLI and Roger – discussing one thing each found particularly striking at the recent Paris NASH conference.

Most comments centered around three themes:

  1. A general appreciation of the quality and diversity of talks at Paris NASH.
  2. Disappointment with the regulatory response from Frank Anania of FDA on the question of moving beyond biopsy and changing the shape of conditional drug approvals.
  3. The “dynamic tension” between forces pushing for rapid progress vs. forces slowing pace of development.

The group further considers the influence of providers, manufacturers and patients versus that of regulators and payers. Jeff and Roger agree that payers are likely to present the last- and likely highest- barrier to rapid progress on prescription medicines and testing.

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