Prof. Dr. Marietta Kaszkin-Bettag: Biologist, Pharmacologist (Director, Head of Development Consulting & Scientific Affairs) is responsible for the management and execution of scientific and regulatory writing projects and providing advice on regulatory strategy. Her experience comprises the coordination and preparation of gap analyses of dossiers, preparation and conduct of scientific advices, preparation of all nonclinical and clinical documents for CTDs, paediatric plans, Orphan Designations, Toxicology Expert Statements and others. She has gained profound experience across a wide range of therapeutic areas for a broad spectrum of medicinal products, particularly for innovative drugs (e.g. ATMP, monoclonal antibodies), food supplements, veterinary drugs and medical devices for more than 13 years. Since at PharmaLex Marietta has closely worked together with Zaklina on ATMPs and provided clinical and strategic input. Marietta holds a PhD from the University of Heidelberg. She is Associate Professor for Molecular Pharmacology at the Medical Faculty of the University of Frankfurt/Main (Germany).