Navigating the clinical to commercial transition for autologous therapies

An Expert View providing best practices on developing a sound commercial strategy, building out secure logistics platforms, and creating a connected ecosystem through technology from Andrea Zobel, senior director of Personalized Supply Chain at World Courier (a part of AmerisourceBergen), Melissa Lattanzi, senior director of Channel Strategy at AmerisourceBergen, and Jason Ramseth, chief product officer at TrakCel.

Autologous cell therapies are some of the most innovative products being developed today, offering life-extending and potentially curative treatments for patients. Driven by increased investments and new regulatory guidance, officials anticipate a wave of new cell therapies by 2024. In fact, there are more than 1,300 active cell therapy trials - which has grown significantly in recent years due, in part, to a dramatic increase in CAR-T cell clinical trials. Cell therapies - most of which are of autologous origin - offer tremendous promise for patients worldwide, including those who have conditions with few treatment options and no cures. However, the potential of these products could remain largely unrealized if innovators and their partners don’t develop a sound commercial strategy - one that accounts for the unique logistics considerations and end-to-end solutions needed to support providers, payers and patients throughout the product journey.

As the number of cell therapy agents in the global pipeline continues to increase, it’s critical that therapy innovators take the necessary steps, including identifying the right partners, to navigate the challenges of moving from clinical to commercial development. In order to expand patient access and maximize the potential of these therapies, innovators should consider the following strategies in planning for a successful product launch.