Asphalion recently participated in the 25th anniversary meeting of the European Society of Gene and Cell Therapy (ESCGT) in Berlin which covers all aspects of advanced therapy medicinal product (ATMP) development including traditional gene and cell therapies as well as new technologies such as CAR T cells and CRISPR.
The meeting was the biggest in the societies history with more than 1200 delegates from around the world attending. Critically, there was a noticeable presence of industry and regulators reflecting the significant advances the ATMP field has made in the last couple of years with several products already on the market and several more under evaluation. Asphalion used the meeting to meet old and new clients and extend our knowledge base on different vector types and we now boast CMC and regulatory experience with all the major gene therapy vector types including adenoviruses (AdVs), adeno-associated viruses (AAVs), lentiviruses, modified vaccinia Ankara (MVA), plasmids, as well as different cell therapy approaches including mesenchymal stem cells, autologous stem cells, chimeric antigen receptor T cells (CAR Ts) and pancreatic cells and islets.
Asphalion also has in-house experience on medical devices and combined products and has recently participated in the presentation of several projects to the European competent authorities, the EMA and the FDA.
Reflecting the changes and advances in ATMP manufacturing and regulatory issues, the European Medicines Agency (EMA) also recently announced a new action plan to foster development of advanced therapies. In particular, the EMA proposes a host of new initiatives to foster further education about ATMPs and to provide updated guidelines and training to improve the development of these technologies.
In parallel, as part of the Horizon 2020 program the European Commission also published the call “SC1-BHC-09-2018: Innovation platforms for advanced therapies of the future” to fund European ATMP projects. Asphalion is already a regulatory partner in several Horizon 2020 projects for advanced and innovative therapies.