Mastering Commercial Pathways: Conquering Business Hurdles In Personalized Cancer Immunotherapies

By Siddharth Agrawal, Senior Principal; Anne Marie Robertson, Senior Vice President, Strategy & Marketing; and Maneesh Gupta, Managing Director, EVERSANA

Neoantigens – antigens specific to tumor cells and based on the molecular mutation profile of each patient – are paving the way for personalized immunotherapies to lead the fight against cancer. Personalized cancer immunotherapies enable a more patient-centric approach to treatment, and their novel mechanism of action and combinability with immuno-oncology agents hold great promise for the treatment’s efficacy.

However, the complex manufacturing components and individualized nature could create access and affordability issues in underserved communities. Manufacturers will need to recalibrate supply chain and data processing operations to support therapy personalized for each patient. This new technology requires agility and an innovative commercialization model that is nimble and agile enough to respond to the individualized nature of patient populations, competition, changing patient journeys, and evolving interactions with the FDA.