Cell-Based Therapies, ATMPs and Enabling Technologies
Cell-based therapy is a rapidly growing area, representing the ‘next generation’ of complex treatment solutions. Some of these therapies are regulated as a species of medicinal product, while others fall outside that regulatory framework or into one of a number of specific and technical exemptions. We advise clients across this spectrum.
Advanced Therapy Medicinal Products (ATMPs) are medicines based on genetic intervention, the grafting of somatic cells and the use of engineered tissue. The class not only includes CAR-T cell and other immunotherapeutic products, tissue/device composites and organoids, but in some cases even a patient’s own, un-manipulated cells.
ATMPs present particular legal challenges. Far removed from the established ‘pill paradigm’, regulatory parameters, best practice and legal stipulations are still being shaped and discussed. Legal and regulatory advice on the parameters of ATMP manufacture and use is essential, particularly in the pre-clinical and early clinical phases of product development.
We understand that clients developing ATMPs are focused on the scientific excellence of the treatment solution, and that they are frequently frustrated by the uncertain regulatory situation that still persists with ATMPs.
Advanced therapy projects that fail to plan a regulatory route to implementation bear serious risks, not only of commercial failure, but of liability. We not only understand the ATMP Regulation in detail: we also understand the limits of regulatory authority. We not only understand stem cell patent law in detail, we also understand where the value is, even when there is no patent to be had. By way of example, many (particularly allogeneic) therapies in this sector will depend on so called ‘regulatory IP’ to a greater degree than conventional patents.
We provide EU and UK legal and regulatory advice and assistance with these and other strategic matters.