Legal and Compliance Considerations When Bringing Cellular Therapies to Market

Journal of Commercial Biotechnology

Amy K. Dow, Jennifer E. Michael, and Lauren Sullivan, Members of the Firm in the Health Care & Life Sciences practice, co-authored an article in the Journal of Commercial Biotechnology, titled “Legal and Compliance Considerations When Bringing Cellular Therapies to Market.” (Read the full version – subscription required.)

Following is an excerpt:

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.