Towards a better use of Scientific Advice for developers of advanced therapies.

Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency (EMA) in 2018 to advanced therapy medicinal products (ATMPs) originally developed by public bodies, we discuss most commonly raised issues and the complexity and timings of the questions posed. Earlier and more frequent SA could help ATMP developers to pre-empt delays at marketing authorisation stage. Carefully addressing quality and non-clinical issues before entering the pivotal phase of development will clear the path for a smooth clinical development and successful marketing authorisation.