This conference will focus on delving deeper into the main scientific, regulatory, ethical and clinical challenges of the development of Advanced Therapy Medicinal Products (ATMPs), from the preclinical phase to the first clinical trials in humans.

Program

14.30h -14.50h Talk: Vall d’Hebron University Campus as leaders in Clinical Research

14:50h – 15:10h Talk: Vision and Experience of the Pharmaceutical Industry in ATMP Development

15:10h - 15:30h  Talk: From Bench to Trial: Regulatory Requirements for ATMP Development

15:30h – 16:05h Round Table  From Preclinical to First-in-Human: Ethical and Clinical Trial Design Challenges in ATMP Development

16:05 – 16:20h Coffee break

16:20h – 16:40h Talk: Developing Academic CAR-T Therapies: An Academic Development Model

16:40h – 17:15h Round Table: Managing Uncertainty in ATMPs: High-Risk Administration, Uncertain Long-Term Durability, Immunogenicity, and Patient-Specific Biological Barriers

*Online access available: https://gencat.zoom.us/webinar/register/WN_c3QQkblXQYKIb9vSTU_vxA