Commercialization of Investigational Cell Therapy Products

Over the last several decades, cellular therapies have emerged as novel forms of treatment with potential to benefit patients who currently have limited to no treatment options. Cell therapies have been developed for a wide variety of maladies, including heart disease, neurodegenerative diseases, immunodeficiencies, as well as hematologic and solid cancers. However, due to their substantial complexity compared to small molecules or other biologic drugs, developing and commercializing cell therapies remains difficult. Some commonly identified challenges include maintaining stable funding through lengthy developmental timelines, rigorous regulatory hurdles, scalability and manufacturing concerns, distribution, and unclear reimbursement processes. However, limited commercial successes have not dampened enthusiasm or expectations for the field. Here, we describe examples of cellular therapy products that have been successfully commercialized, as well as the components necessary to achieve commercialization.