EMA To Hold Workshop on Manufacturing of T-Cell Immunotherapies

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-16-2016 14:40


The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) is organizing a workshop on November 15 and 16, 2016 to discuss scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that normally fight off viruses and bacteria).

Immunotherapy is a type of cancer treatment that mobilizes the body's own defense mechanisms to fight cancer. Immunotherapy medicines have significantly changed the therapeutic landscape, particularly for the treatment of patients with certain cancers, such as lung cancer or melanoma. T-cell based immunotherapy is an innovative approach where T cells from a patient’s blood are genetically engineered in a laboratory in order to allow them to recognize cancer cells through specific receptor proteins. In the body of a patient, the modified T-cells can then identify and destroy cancer cells.

T-cell immunotherapy medicines are being developed and are currently being tested in clinical trials in a variety of cancers. However, there are still many scientific and regulatory challenges to be overcome before these innovative products can be brought to the market. Therefore, the open workshop aims to facilitate dialogue between the CAT and medicine developers from industry and academia on: current scientific developments; regulatory requirements for product manufacture and testing; and non-clinical studies and clinical development.

Source: European Medicines Agency


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