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CAR-T Meeting 2021 | Regulatory considerations for CAR-T academic trials

Manel Juan Otero, MD, PhD, Hospital Clínic de Barcelona, Barcelona, Spain, explains how academic CAR-T clinical trials face more limitations regarding regulatory requirements than industry-initiated trials. For innovative technologies such as the CAR T-cell therapy, the current regulatory requirements can represent an enormous burden for academic institutions. To prevent the regulation from acting as an innovation blocker, regulatory and commercial aspects should be improved to promote the success of academic clinical trials in the field of cellular immunotherapies. This interview took place during the 3rd European CAR T-cell Meeting.

Transcript (edited for clarity)

We will try to explain that academical trials has a lot of limitations in relation to regulation because regulation is defining for most of the commercial approaches, like the conventional drugs and cell therapy. It’s an important new aspect that need a more, an easier way to develop. Because if we need to follow all the elements that we have to follow by the regulations, finally, and only those approaches that can be used only for big number of patients will really arrive to these patients...

We will try to explain that academical trials has a lot of limitations in relation to regulation because regulation is defining for most of the commercial approaches, like the conventional drugs and cell therapy. It’s an important new aspect that need a more, an easier way to develop. Because if we need to follow all the elements that we have to follow by the regulations, finally, and only those approaches that can be used only for big number of patients will really arrive to these patients. When we try to develop immunotherapy, we try to find very specific approaches and probably without some kind of changes in regulation. It will be regulatory, those will be very difficult to obtain the final approval for specific targeting or specific patients that have a low level or a very low number of patients.

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