The FDA has endorsed a new approach where an IND can be supported solely by human vascularized organoid-based combination studies, without traditional animal efficacy proof-of-concept testing. The example highlighted involves SillaJen’s IND enabling a Phase I clinical trial of tislelizumab or paclitaxel with BAL0891, a dual TTK/PLK inhibitor, with preclinical support from Qureator’s vTIME platform. The development is positioned as part of the broader “new approach methodologies” push, accelerated by FDA Modernization Act 2.0, which removed the animal testing requirement that had been imposed via the 1938 FD&C Act. For biopharma teams, the operational takeaway is that organoid-based models can now be used earlier as an evidentiary pillar for clinical entry—at least for certain programs. The report also notes market momentum for organoids, reinforcing that regulatory acceptance is starting to translate into commercial scaling plans, not just academic validation.