WP3 Regulatory approval of the EURE-CART cell product
Objectives of WP3
- To foster the approval of the harmonised IMPD for the EURE-CART cell product.
- To elaborate on the difficulties found for this type of advanced therapy medicinal products (ATMP) in the regulatory pathways in EU.
- To produce a document (White Paper) containing issues about CAR-T cells and proposals to foster the harmonisation of authorising procedures for multicentre clinical studies with ATMPs
The main project tasks are the following
Task 3.1 Constitution of an EU Regulatory Advisory Committee.
EU-leading experts both in the scientific and regulatory aspects of CAR-T will be officially invited to join an ad hoc Regulatory Advisory Committee (RAC) chaired by ISS. RAC members will be appointed after their documented acceptance. The RAC will also include a representative from each EURE-CART clinical participant (OSR, UKW, OPBG, PAU and UHO). The RAC will be completely independent from the CART developmental work, nevertheless it will work together with the project participants to recognise the regulatory bottlenecks during development of this product type and propose possible common ways of overcoming them. The RAC will organise scientific meetings with the aim at interacting with scientists involved in development. The meeting will address the scientific and regulatory issues of CAR-T cells also in comparison with US experience and regulations.
Task 3.2 Permanent harmonisation activities for EURE-CART.
Under ISS steering, the RAC will interact with EURE-CART clinical participants (OSR, UKW, OPBG, PAU and UHO) and, although recognised as completely independent, will have privileged access to the clinical results from the Phase I/IIa study (see WP4 and WP5) .A measurable output of this activity will be producing a White Paper containing issues about CAR-T cells and proposals to foster the harmonisation of authorising procedures for multicentre clinical studies with ATMPs such as EURE-CART. The white paper will be widely disseminated through the Project website and made available to other potential end-users (e.g. other EU groups investigating CAR-T cells). Moreover, it will be up-dated and therefore constitute an open-access source for the implementation of CAR-T cell immunotherapy in the EU.