Bundesinstitut fuer Impfstoffe und Biomedizinische Arzneimittel
The Paul-Ehrlich-Institut (PEI) is an agency of the German Federal Ministry of Health. It is internationally recognized as both, an excellent medicines agency regulating biomedical products, and a biomedical research institute. The integration of research and regulatory activities enables chaperonage of biomedicines from development and regulation all the way to pharmacovigilance.
Biomedicines under responsibility of the PEI include human and veterinary vaccines and human biomedicines such as antibodies, allergens, blood and plasma-derived products, tissue preparations and advanced therapy medicinal products (gene therapy, somatic cell therapy and tissue engineered medicinal products). By carrying out research projects, PEI scientists keep track of and contribute to new developments in biomedicine. As a result, the PEI provides health policy decision-makers, clinical research groups, industry and the public with expert advice on biomedicine-related issues.
PEI will contribute to CARAT with its expertise on regulatory issues of gene therapy medicinal products and on the surface engineering of viral vectors combined with the transduction of lymphocytes. Work Package 6 which specifically deals with regulatory issues will be led by PEI. Here, PEI will prepare a status report on current CAR T-cell clinical trial outcomes with a specific focus on the technological solutions and requirements that are addressed by CARAT. PEI will in addition actively contribute to the planned workshops organized by CARAT and will advise all partners on any upcoming regulatory issues. A crucial role will also be adopted in improving CAR gene-delivery and the anti-tumoural activity of CAR T-cells. Here, PEI’s contributions will be based on its world-wide unique technologies for receptor-targeted lentiviral and AAV vectors.