Flagship Pioneering’s Tom Dilenge On Accelerated Approvals

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One of the brightest minds in DC, Tom Dilenge recently joined Flagship Pioneering, the highly respected bio platforms innovation company behind such groundbreaking startups as Moderna. Tom leads Flagship’s public policy, regulatory, and governmental affairs.

Vital Transformation has worked closely with Tom in his previous role as President of the Biotechnology Innovation Organization (BIO), where he was directly responsible for all their policy, advocacy, communications, legal affairs, and Board governance operations – he had the largest desk plaque in DC.

In this podcast, we discuss several DC proposals trying to change the way accelerated approvals are managed by the FDA, and Vital Transformation’s recently released research and analysis of the impact of CMS’ guidance related to Alzheimer’s disease, which was commissioned and funded by Biogen. The podcast highlights the mounting attacks on the accelerated approval pathway, and the negative unintended consequences that would impact the US R&D ecosystem if it were to be regulated out of existence.

This Vital Health Podcast was recorded on April 1st, 2022, before CMS had finalized its National Coverage Determination of Amyloid treatments for Alzheimer’s Disease. However, the now final CMS policy continues what the podcast participants feel is an unfavorable approach towards amyloid products and accelerated approvals. The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, Tom Dilenge. While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.

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