Zero to MVPEnabling first pharma customer to get FDA approval for commercial scale launch of 72% efficacy leukemia treatment.
2016 Jun | Vineti
Impact. Delivered ~4,000 patient treatments, while establishing the foundation of Vineti's future platform.
Two pharmaceutical manufacturers are competing to get FDA approval for the first cell therapy for leukemia, a blood cancer. The larger pharma company opts to build their own software solution. The smaller company partners with Vineti. At a small clinical trial scale, the logistical complexity of a cell therapy treatment can be managed with heavy manual coordination. In order to scale commercially, that logistical complexity requires automation and tracking in order to safely scale (and therefore be FDA approved) as a commercial product.
stakeholder interviews & process capture primary persona & scenario synthesis on-site observational research prototyping testing iteration & polish
Bite-sized guided hospital workflows for nurse attending patient. Planning & scheduling manufacturing capacity & calculated logistics. A patient treatment overview for case managers of the calculated schedule.
FDA approval and successful commercial launch of Kite Gilead’s Yescarta leukemia treatment FDA commercial approval 4k patient treatments delivered This solution ultimately delivered ~4,000 patient treatments over the course of the next 5 years.