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.

Program

14.15- 14.50 h Welcome and Vall d’Hebron University Campus as leaders in clinical research

14.50 - 15.10 h Kymriah and the CAR-T Revolution: Lessons from the First FDA Approval and the Road Ahead

15.10 - 15.30 h From Bench to Trial: Regulatory Requirements for ATMP Development

15.30 - 16.05 h From Preclinical to First-in-Human – Ethical, Regulatory, and Trial Design Challenges in ATMP development

16.05 - 16-20 h Coffee Break

16.20 - 16-40 h Developing Academic Therapies: An Academic Development Model 

16.40 - 17-15 h Managing Uncertainty in ATMPs: High-Risk Administration, Uncertain Long-Term Durability, Immunogenicity, and Patient-Specific Biological Barriers

“To attend the event, registration is required

In-person registration: Click here

Online registration: Click here

“We look forward to seeing you there!”