The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

As EMA explains, “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.”

The subject of the workshop is a specific type of immunotherapy that has received a lot of attention and investment this year and focuses on genetically engineering T cells from a patient’s blood in a laboratory in order to allow them to recognize cancer cells through specific receptor proteins, with the hopes of using the modified T-cells to identify and destroy cancer cells.

Despite some early signs of success in some trials, EMA notes that “there are still many scientific and regulatory challenges to be overcome before these innovative products can be brought to the market for the benefit of patients.”

The workshop aims to facilitate dialogue between the CAT and drug developers from industry and academia on:

• current scientific developments (including next generation t-cell therapies)
• regulatory requirements for product manufacture and testing
• non-clinical studies and clinical challenges and development

Stanley Frankel, head of immuno-oncology clinical research and development at Celgene, will present at the workshop on “Taking CARs/TCRs [chimeric antigen receptor (CAR) T-cells] from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer.”

In addition, Maura O’Leary from the US Food and Drug Administration (FDA) will present on FDA’s pilot project to develop a clinical database to examine safety in trials using CAR T cells. FDA previously presented a couple of slides at the DIA conference last June on that database:

The rest of the program for EMA’s workshop can be found here. The event will be broadcast live and those interested in participating are invited to register using the attached form.