Legal and Compliance Considerations When Bringing Cellular Therapies to Market

Amy Dow
Jennifer E. Michael
Lauren Sullivan

DOI:https://doi.org/10.5912/jcb958

Abstract:

Cellular therapies treat the underlying cause of disease by removing cells from a patient’s body, modifying the cells by introducing a new gene or correcting a faulty one, and then infusing the modified cells back into the patient.  While cellular therapies raise many regulatory and legal issues that are common to all therapeutic products, this article focuses on the unique legal and compliance challenges cellular therapy manufacturers face when bringing cellular therapies to market, securing reimbursement for their products, and providing financial assistance to the patients who need them.