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Biotech’s Lost Archive | IFP

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This essay is part of The Launch Sequence, a collection of concrete, ambitious ideas to accelerate AI for science and security. FDA submissions contain unparalleled detail about the design of clinical trials, manufacturing processes, safety assessments, and reviewer correspondence. Yet these documents submitted to the FDA are not publicly available. This gives a structural advantage to large pharmaceutical incumbents who have amassed regulatory filing archives over small biotechs. As private regulatory archives and institutional know-how are costly to replicate, new innovators are effectively boxed out. Meanwhile, AI stands ready to revolutionize drug development by auto-drafting submissions, predicting approval outcomes, and optimizing trial protocols — but only if it can be trained on unredacted, high-quality datasets. This proposal outlines a bold, legally grounded mechanism to democratize FDA filings: leveraging existing US bankruptcy law to create an open-source library of orphane

Download PDF Content Summary Motivation The US can’t afford to lose the biotech race Innovation is increasingly driven by start-ups — but regulation favors large incumbents The FDA sits on a treasure trove of data AI could unlock the value — if we unlock the data This is an opportunity for policy and philanthropy Solution Further resources Appendix Additional context on CTDs The current state of obtaining information under FOIA and the legal landscape How bankruptcy law enables the transfer of intellectual assets This essay is part of The Launch Sequence , a collection of concrete, ambit

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