ideasIdea
Open-source dossier-building software for academic sponsors and generic makers
Preparing a regulatory filing requires expensive specialist software and consultants. Free, open tools would let universities and small generic firms file in more countries.
Academic groups that run positive trials of repurposed or de-escalated regimens rarely file for label changes because eCTD authoring, publishing and validation tools are commercial and expensive. The proposal is an open-source toolchain (eCTD v4 authoring, CDISC dataset conversion, validation against regional rules, submission gateway clients) maintained by a foundation, plus templated modules for common academic filings such as new-indication supplements for off-patent drugs.
Hypothesis
Within three years of release, at least ten academic or non-profit sponsors file regulatory submissions using the toolchain that they would otherwise not have made, and the cost of a multi-region generic oncology filing falls by half.
Rationale
Open-source infrastructure has repeatedly lowered barriers where the format is standardised and the buyer base is fragmented (statistics, genomics pipelines). eCTD is a fully specified standard.
What would test it
Build the minimum toolchain, use it for two real academic new-indication submissions to FDA and EMA, and publish the time and cost against a consultant-led equivalent.
Maturity
speculative
Who has to act
engineering
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- No incentive to repurpose cheap drugs · Old, cheap drugs with anti-cancer signals never get the trials they need because no one profits from the result.