Advanced Therapeutic Medical Products (ATMPs): From the Definition to the Clinical Product
In this BIH Tech-Transfer Seminar Dr. Ralf Sanzenbacher, Deputy Head of Tissue Engineering and Somatic Cell Therapeutics at the Paul-Ehrlich Institut (PEI) in Langen, will talk about Advanced Therapeutic Medical Products (ATMPs). In his talk, Dr. Sanzenbacher will address the regulatory background and news for (ATMPs) and will give an overview of actual product developments.In complementation to Dr. Sanzenbacher, Dr. Mohammed Abou El-Enein, Head of Clinical Development Platform at the Berlin-Brandenburg Centre for Regenerative Therapies (BCRT), will discuss practical difficulties in the application of the ATMP Regulation and provide a case study of an approved ATMP for a phase I/II clinical trial in an academic setting.
About ATMPs and PEI:
"Major progress in biotechnology resulted in the development of advanced therapies such as gene therapy, somatic cell therapy, and tissue engineering. These developments provide new opportunities in treating serious diseases and functional disorders of the human body. Based on their novelty and complexity, special harmonized regulations have been established for so-called Advanced Therapy Medicinal Products (ATMP) at a European level. In Germany, the Paul-Ehrlich-Institut (PEI) is the competent authority for for human and veterinary medicinal products." (Source: www.pei.de) The PEI also holds the Vice Chair of the Committee for Advanced Therapies at the European Medicines Agency (EMA), London, UK