EPISODE · Sep 19, 2022 · 19 MIN
S3 E45.1 - Paris Review: Regulator Response and "Dynamic Tension”
from Surfing the MASH Tsunami · host HEP Dynamics LLC
Send us Fan MailThe 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 meeting.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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Send us Fan Mail 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 meeting. 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 “dyn...
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S3 E45.1 - Paris Review: Regulator Response and "Dynamic Tension”
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