7-8 Maggio 2024 – San Sebastián, Spagna
Si terrà a San Sebastian (Spagna), il secondo Workshop Internationale sulle Terapie Avanzate con focus sulla produzione on-site di Terapie Cellulari e Terapie Geniche. L’evento coorganizzato dalla Cell Factory BioGipuzkoa (Opsedale Universitario Donostia) e BioAir vuole rappresentare un forum per direttori di facility GMP degli ospedali pubblici spagnoli con l’obiettivo di incoraggiare il rafforzamente della rete e la condivisione del Know-how tra le cell factory spagnole.
Scientific Program:
Day 1 – Tue, May 7
10:00 – 10:30 REGISTRATION & COFFEE
10:30 – 10:40 Welcome & Workshop introduction: Itziar Vergara (Scientific Director,
BioGipuzkoa HRI) + Sara Arévalo (Medical Director, Donostia University Hospital) + Ander Izeta
10:40 – 10:55 Ander Izeta, BioGipuzkoa HRI & Donostia University Hospital. “Introduction to the Advanced Therapies Unit: design & activity”
10:55 – 11:15 Franco Severina, Senior Engineer, BioAir. “ATMP production in Closed systems: sustainability, CO2 footprint and cost savings compared to Open systems manufacturing. An overview based on two real cases”
11:15 – 11:45 Jean-Francois Brunet, Lausanne University Hospital. “GMP cell production center at CHUV: Implementation and long experience of
bioconfinement concept”
11:45-12:15 Andoni Garitano, Universitätsklinikum Würzburg, Würzburg, Germany
“Virus-free Novel CAR-T cells targeting Acute Myeloid Leukemia”
12:15 – 12:30 Paula Solana Aguilar & Yann Peytour, Field Application
Specialists, ScaleReady. “How to increase production capacity with existing space and no additional capital”
12:30 – 13:30 LUNCH BREAK
13:30-14:00 Martina Kropp, University of Geneva, Switzerland “From Bench to Bedside: GMP-grade manufacturing & Quality Control – challenges by developing a non-viral gene therapy to treat age-related macular degeneration”
14:00 – 14:30 Cecilia Sendresen, S. Raffaele Hospital. “Design of a new GMP facility for academic ATMP clinical trials: the role of isolators”
14:30 – 16:30 COFFEE BREAK & Visit to the Advanced Therapies Unit Visits to the Unit will be organized in groups. Meanwhile, other groups will have coffee break and will have the opportunity to watch a video of equipment in use.
16:30 – 18:30 Presentations of Spanish facilities that are involved in point-of-care ATMP production at the National Health Service.
Each facility will have 10 min presentation + 5 min discussion to present their facility,
personnel, ATMPs being produced/developed and target indications.
19:00 Guided Historic Tour of downtown San Sebastian
20:30 Gala Dinner at La Perla Restaurant
Day 2 – Wed, May 8
08:00 – 08:30 TBD, Position, Carlos III Health Institute (ISCIII). “Research support to Advanced Therapies in Spain by the ISCIII”
08:30 – 08:45 Rosario Sanchez Pernaute, BioBizkaia HRI. “Advanced Therapy activities in the public health system of the Basque Country”
08:45 – 09:30 KEYNOTE LECTURE. Manel Juan, Clinic Hospital. “Academic CAR-T cell development from HE to marketing authorization”
09:30 – 11:30 Presentations of hospital-based ATMP Facilities.
11:30-11:45 Workshop wrap up and conclusions. Cristina Zanini + Ander Izeta
11:45-12:00 Workshop closure & farewell. Nekane Murga, Coordinator of Personalized Precision Medicine and Advanced Therapies at Osakidetza.
12:00 – 13:00 LUNCH BREAK