Zero to MVP

Enabling first pharma customer to get FDA approval for commercial scale launch of 72% efficacy leukemia treatment.

2017 May | Vineti

#project, #startup, #MVP, #enterprise, #healthcare


Impact. Delivered ~4,000 patient treatments, while establishing the foundation of Vineti's future platform.

Problem

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.

Process

Solution

Impact

FDA approval and successful commercial launch of Kite Gilead's Yescarta leukemia treatment. FDA approval

This solution ultimately delivered around 4,000 patient treatments over the course of the next 5 years. 4k treatments