BioInsights - EMA CAT perspective: the European Union regulatory landscape for ATMPs

EMA CAT perspective: the European Union regulatory landscape for ATMPs

Cell & Gene Therapy Insights 2020; 6(8), 1127–1134


Published: 22 September 2020
Martina Schüssler-Lenz

Dr Martina Schüssler-Lenz In January 2020, was elected on her second mandate as the Chair of the Committee for Advanced Therapies (CAT) of the European Medicines Agency’s (EMA). The CAT is the committee responsible for evaluating the quality, safety and efficacy of marketing authorisations of cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). Dr. Martina Schüssler-Lenz received her medical degree at Mainz University Hospital, Germany. Following this, she was trained in Haematology/Medical Oncology and completed an Internal Medicine Residency and Fellowship at Berlin Moabit Hospital and at Mainz University Hospital. She worked as a research and clinical fellow at Memorial Sloan Kettering Cancer Center and at the Instituto Municipal de Investigacion Medica in Barcelona, Spain, before she joined pharmaceutical industry for clinical drug development projects in haemato-oncology. Since 2005 she is working as M.D. at the Paul-Ehrlich Institute in the Section Advanced Therapies and Tissue Preparations, where she has reviewed Advanced Therapies in clinical trials and marketing authorizations, and has provided advice to ATMP development and life cycle management. She is committed to facilitate the development of Advanced Therapies and has a specific focus in providing guidance to academic developers of ATMPs. Dr. Schüssler-Lenz has been a member of the EMA Committee for Advanced Therapies for many years before she was elected as its chairperson in February 2017 and re-elected for a second term in January 2020.