Successfully Launching Drugs In Europe On Time And On Budget

By Margarida Duarte

Launching a drug in Europe comes with unique challenges as each country has its own set of regulations ranging from local reimbursement and pricing schemes to country-specific supply chain requirements. I helped launch several drugs in Europe over the course of my career, which has taught me a great deal about what goes into a successful launch in this region. Here, I share insights from my recent experience with launching a new oncology drug, QINLOCK, for adults with gastrointestinal stromal tumor (GIST). It was first approved in the U.S. and now is approved across the EU, Switzerland, and the U.K. Less than 12 months after our first hire in Europe (myself), we were launching.