Academic Development of Cell and Gene Therapies: Three Different Perspectives, Including EMA and Academia

Academic developers are major contributors to the research and development of cell and gene therapies, however, experience shows that navigating through the regulatory framework surrounding ATMPs can be challenging. In this session, the audience will be provided with an overview of the main challenges faced by an academic developer and learn about initiatives intended to accelerate development for advanced therapies. The audience will also hear about the EU Medicines Agency (EMA)’s support mechanisms to academia and about the recent launch of a pilot program, open to non-profit organizations developing promising cell/gene therapies, during which the EMA will offer enhanced support to navigate through the regulatory framework and optimize the development of a promising product. By the end of this session, the audience will have a better understanding of some of the challenges associated with academic development, but also will learn about ongoing initiatives and possible solutions.