Dario Trapani, Medical Oncologist at European Institute of Oncology (IEO), Researcher at Department of Oncology and Hemato-Oncology at University of Milan, shared a post on LinkedIn:
“With the incredible Dr Bibek Aryal we provide our point on drug development , when it’s about innovation for no-profit.
Modern oncology excels at fast-tracking patent-protected innovations, but it lacks the equivalent machinery to evaluate and scale promising, off-patent generic therapeutics.
We describe a 3-gate framework currently blocking off-patent generics from entering standard care.
- Gate 1. The Capital Gate.
No intellectual property means no commercial sponsor to fund definitive phase III trials. - Gate 2. The Label Gate.
Regulators may act as passive gatekeepers, waiting for sponsors to seek label expansions rather than updating them proactively. - Gate 3. The Algorithm Gate.
Guideline and payer machinery inherently privilege branded novelty over ‘unowned’ evidence.
We are calling for an open-source oncology framework, a public-interest infrastructure funded by sovereign healthcare budgets and philanthropy. By treating off-patent therapeutics and biomarker data as universal resources, we can decouple clinical value from commercial monopolies and deliver true global health equity.”
Title: Patient value over patent value: the mandate for open-source oncology
Authors: Bibek Aryal, Dario Trapani
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