Embedded Files
The Mission
The Mission
The FDA holds a trove regulatory data and valuable scientific knowledge from thousands of failed biotech companies which could accelerate drug development if made accessible. The CTD Commons leverages bankruptcy law to create an open-source library of these "lost" regulatory filings, eventually powering AI tools that will help level the playing field for small biotechs and accelerate the path from lab to patient. Read the original proposal from experts at the Institute for Progress.
the fund
the fund
The CTD Commons Fund is dedicated to acquiring the regulatory dossiers of the biotech companies that have entered bankruptcy. The Fund will assemble a small team of legal experts and data engineers to monitor bankruptcy cases involving biotechnology sponsors and submit calibrated offers to secure non-exclusive rights to this information.
How it works:
How it works:
Step 1: Monitor Bankruptcy Proceedings
A small team of legal experts tracks bankruptcy cases involving biotech companies with valuable regulatory submissions, including INDs, NDAs, and BLAs.
Step 2: Acquire Through Bankruptcy Court
The Fund submits offers to acquire non-exclusive rights to regulatory dossiers under 11 U.S.C. § 363, which authorizes bankruptcy courts to transfer both tangible and intangible assets. This approach requires no involvement from the FDA as a disclosing party, avoiding conflicts with FOIA and trade secret protections.
Step 3: Digitize and Anonymize
Each dossier is digitized in its entirety, with personal identifiers removed while preserving scientific reasoning and regulatory correspondence.
Step 4: Create Public Repository
Files are ingested into a secure, cloud-based repository with full-text search and chronological indexing modeled on the SEC's EDGAR system.
Step 5: Train AI Models
Developers use this corpus to train specialized language models that understand FDA decision criteria and can provide context-sensitive guidance.
making regulatory data accessible
making regulatory data accessible
Common Technical Documents (CTDs) contain invaluable regulatory and scientific data that could accelerate drug development, yet they remain largely inaccessible to the researchers and small biotech startups who need them most.
Understanding the CTD Landscape
Understanding the CTD Landscape
The Common Technical Document is the internationally accepted format for submitting drug applications to regulatory authorities. These comprehensive dossiers contain detailed information about drug chemistry, manufacturing, preclinical studies, and clinical trial results. While CTDs represent decades of accumulated knowledge and billions of dollars in research investment, access to this crucial information remains severely limited.
Why Accessibility Matters
Why Accessibility Matters
Accelerating Scientific Progress
When researchers and small biotechs can access regulatory submissions, they avoid duplicatting failed experiments and can build upon proven approaches. This transparency enables the scientific community to learn from both successes and failures, dramatically reducing the time and cost required to bring new therapies to patients. Knowledge sharing through accessible CTDs can transform pharmaceutical development from isolated silos into a collaborative ecosystem.
Leveling the Playing Field
Large pharmaceutical companies maintain extensive internal databases of regulatory knowledge, giving them a significant competitive advantage. Small biotech startups and academic researchers, lacking these resources, must often rediscover information that already exists within inaccessible CTDs. By democratizing access to regulatory data, we enable innovative small companies to compete more effectively and bring novel therapies to market.
Call to Action
Call to Action
The market won't solve this coordination problem on its own. No individual company has an incentive to release data, but the collective value of shared access would be transformative.
The AI Regulatory Transparency Fund represents an ambitious yet practical undertaking. This strategy requires modest resources compared to its potential impact, bypasses the complexity of changing laws, and could catalyze an AI-driven renaissance in regulatory science.
By democratizing access to regulatory knowledge, we can ensure that the small innovators who will bring tomorrow's therapies to patients have the tools they need to compete and succeed.
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