Cell-Based Therapies and ATMPs
Cell-based therapies a rapidly growing area in translational research, these represent 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 gene therapy, somatic cell therapy, or tissue engineering.
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 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 disintegration, but of liability. Government websites are helpful, but are recognised as inadequate for individual therapies. We not only understand the regulation: we also understand the limits of regulatory power. We not only understand, in detail, stem cell patent law: we also understand where the value is, even when there is no patent to be had.
Denoon Legal provides advice and assistance with these and other strategic matters. 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.