Will the project "Reforming regulations for pandemic countermeasures" receive receive any funding from the Clearer Thinking Regranting program run by ClearerThinking.org?

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Below, you can find some selected quotes from the public copy of the application. The text beneath each heading was written by the applicant. Alternatively, you can click here to see the entire public portion of their application.

Why the applicant thinks we should fund this project

In order to prevent future pandemics, including those with an existential risk to humanity, we need to improve our defenses faster than the risk of dangerous pathogens increases. While there is broad agreement that prototype countermeasures against pathogen families with pandemic potential need to be developed and tested in humans ahead of time, how that data will be used for regulatory authorization decisions is currently undefined. The FDA should develop clear standards outlining what data is needed for authorization of pan-sarbecovirus vaccines and prototype vaccines against pandemic pathogens more generally, and develop an accelerated pathway for review and approval, but it is unlikely to do this without external pressure.

Project Activities

Our project involves advocating for clear standards for, and an accelerated pathway for, regulatory approval of pan-sarbecovirus vaccines and prototype vaccines against pandemic pathogens more generally. Specifically, we propose a “Warp 2 Pathway” for these products that includes faster entry into and exit out of Phase 1 and multiple options for proof of surrogate biomarkers to establish relatively narrow emergency use authorization designed to allow for rapid confirmatory trials before broader authorization and licensure.

How much funding are they requesting?

$255,000

What would they do with the amount specified?

$125,000: Recruit and hire a regulatory science director

$50,000 polling (likely Blue Rose or Data for Progress)

$50,000 contract expert lobbyists to review and draft policy proposals and make introductions to other former FDA officials

$20,000: run two workshops with pan-sarbecovirus vaccine developers

$10,000: cover portion of salaries for (1) Strategic Projects Lead and (2) Regulatory Policy and Research Coordinator

Here you can review the entire public portion of the application (which contains a lot more information about the applicant and their project):

https://docs.google.com/document/d/1JGAmWkEXjWQ_feV4TVm1iuEQPO0SI2y0CjHuot5d7Ws/edit

Sep 20, 3:33pm:

Sep 20, 3:47pm: