OnCo
ideasIdea

Fund regulator-ready evidence dossiers for the 20 best-supported off-patent drugs

The evidence for old drugs against cancer is scattered across hundreds of papers. Assembling it into the format regulators and funders need is cheap and would speed decisions.

The Anticancer Fund's ReDO_DB and similar efforts catalogue candidates but stop short of the structured, regulator-grade dossiers (preclinical summary, pharmacology, safety in the target population, systematic review of clinical signals, proposed trial design) that a funder or a third-party label filing needs. The proposal is a funded programme, with methodologists and regulatory writers, that produces and publishes open dossiers for the 20 candidates with the strongest evidence, updated annually, each ending with a prioritised trial proposal and a regulatory strategy.

Hypothesis
Within three years, at least half of the dossiers lead to a funded trial or a regulatory or guideline submission, compared with a small minority of candidates in the current catalogue.
Rationale
Funders and regulators act on well-organised evidence; the marginal cost of a dossier is trivial against the cost of the trial it enables, and public dossiers prevent duplicated effort across countries.
What would test it
Produce the first ten dossiers, circulate to funders and regulators, and track downstream trial funding and submissions against ten matched candidates without dossiers.
Maturity
early clinical
Who has to act
philanthropy
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

Connected

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