This event introduced technical and regulatory strategies for pre-clinical development, with a focus on biologicals and advanced therapy medicinal products (ATMPs). The sessions are designed to provide attendees with a regulatory scientific approach for successful translation of biologicals and ATMPs into the clinic. We aim to provide an understanding of pre-clinical development pathways and requirements for biologicals and ATMPs leading to the most expedited regulatory strategy in Europe, the US and beyond. Potential challenges in the development and registration of these products will also be discussed, to provide practical advice as well as highlight key aspects determining successful regulatory submissions.