Making full use of early access and regultatory tools available to ATMPs

Description: The session will start with an overview of a sponsor experience with the Innovative Licensing and Access Pathway (ILAP) designed to provide safe, timely and efficient development of medicines to improve patient access to therapies in the UK. This pathway is relatively new and real-world experiences from obtaining the ILAP designation and Target Development Profile (TDP) are not widely available. This session will discuss strategic approaches to determine if a drug in development will benefit from utilizing the ILAP designation. Additionally, this section will provide strategies to address the ILAP criteria and management of the TDP meeting and platform associated tool kits. Finally, the Sponsor will give a brief overview of their experience with obtaining the ILAP designation and preparing and utilizing the TDP. The second presentation will be by a representative of the European Medicines Agency who will provide an overview of the early access tools available to ATMPs to different types of ATMP developers.