The CORE of Innovative and Advanced Therapies at VHIR, together with the Catalan Advanced Therapies Network of BIOCAT and within the framework of the ATMP Catalonia Series, is organizing the initiative “ATMPs: From Preclinical Discovery to First-in-Human Trials”.

This conference will focus on exploring the main scientific, regulatory, ethical, and clinical challenges in the development of Advanced Therapy Medicinal Products (ATMPs), from the preclinical phase to the first clinical trials in humans. The session will bring together a diverse range of public and private partners from both academic and industry sectors to share insights and perspectives, fostering discussion on best practices and innovative approaches in the field of advanced therapies.

14h – 14:15h Registration

14:15h – 14:50h Talk 'Welcome and Vall d’Hebron University Campus as leaders in clinical research '

14:50h – 15:10h Talk  'Kymriah and the CAR-T Revolution: Lessons from the First FDA Approval and the Road Ahead'

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, Regulatory, and Trial Design Challenges in ATMP development'

16:05 – 16:20h Coffee Break

16:20h – 16:40h Talk 'Developing Academic 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'
 

In-person registration: Click here

Online registration: Click here