Christian K Schneider, M.D., is Head of Biopharma Excellence and Chief Medical Officer (Biopharma) at PharmaLex. He was previously interim Chief Scientific Officer at the UK’s MHRA, where he was also Director of the National Institute for Biological Standards and Control (NIBSC) for five years. He has also held leading positions at the Danish Medicines Agency and at the Paul-Ehrlich-Institut, Germany’s Federal Agency for Vaccines and Biomedicines.
At EMA, he has chaired the Committee for Advanced Therapies (CAT) as well as the Biosimilar Medicinal Products Working Party (BMWP), and served as a member of the Committee for Medicinal Products for Human Use (CHMP). He is one of the key architects of EMA’s advanced therapies and biosimilars framework. As a regulatory scientist, Christian has published 50+ articles in international, peer-reviewed journals.
While advanced therapy medicinal products (ATMPs) hold great promise, the path to exploiting the technology has been challenging. Christian K. Schneider outlines the five strategies that must be considered to increase the success rates of development programs, while avoiding some of the common pitfalls.