The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) is arranging a workshop on 15 and 16 November 2016 to talk about 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 assembles the body’s own resistance mechanism to fight cancer. Immunotherapy medicines have considerably changed the therapeutic landscape, mainly for the treatment of patients with certain cancers, such as lung cancer or melanoma.
T-cell based immunotherapy is a modern 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 definite receptor proteins. In the body of a patient, the modified T-cells can then spot and destroy cancer cells.
T-cell immunotherapy medicines are being developed and are now being tested in clinical trials in a variety of cancers. However, there are still many scientific and regulatory challenges to be prevail over before these modern products can be brought to the market for the assistance of patients.
Therefore the open workshop aspires to smooth the progress of dialogue between the CAT and medicine developers from industry and academia on:
- present scientific growth;
- regulatory requirements for product manufacture and testing;
- Non-clinical studies and clinical expansion.
Date: 16/08/2016