Biotech Founders Face Regulatory 'Lost Archive': Expert Calls for Transparency in 10,000-Page Filings

Ruxandra Teslo, a prominent voice in science and innovation, recently highlighted a significant barrier to progress in the biotechnology sector: the lack of public access to regulatory filings. In a recent tweet, Teslo stated, > "Most biotech founders have never seen a regulatory filing before they start their company — because none are available." This absence of transparency, she suggests, contributes to a pervasive "safetyism" cultural issue within the industry.

Regulatory submissions, such as those made to the U.S. Food and Drug Administration (FDA), contain highly detailed information, often spanning over 10,000 pages, covering drug design, manufacturing processes, safety assessments, and clinical trial data. This proprietary nature of these documents grants a significant structural advantage to large, established pharmaceutical companies that possess extensive archives of historical filings. Smaller biotech startups, lacking such resources, are forced to navigate complex regulatory pathways with limited precedent, often relying on expensive consultants.

Teslo, a Genomics PhD student at the Sanger Institute and an advocate for clinical trial abundance, has actively campaigned for greater transparency in this area. She is a key figure behind the "Biotech's Lost Archive" initiative, a proposal aiming to leverage existing U.S. bankruptcy law to create an open-source library of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs) from failed drug sponsors. This approach seeks to unlock a vast amount of "sunk-cost scientific knowledge" that is currently inaccessible.

Making these "orphaned" regulatory dossiers publicly available, potentially with the aid of artificial intelligence (AI) tools, could revolutionize drug development. It would significantly lower compliance costs, accelerate approval timelines, and level the playing field for small biotech firms, academic researchers, and non-profits. This increased access to data could foster a more efficient and innovative environment, ultimately leading to faster and more affordable development of novel therapies for patients.

The push for regulatory modernization comes at a critical time, with the U.S. facing intense global competition in biotech. By addressing the current lack of transparency and democratizing access to crucial regulatory data, initiatives like Teslo's aim to dismantle unnecessary hurdles, promote a culture of open innovation, and ensure the U.S. remains at the forefront of biomedical advancements.