CLINICAL TRANSFER OF EV-BASED THERAPEUTIC PRODUCTS (a GEIVEX workshop on clinical translation of Extracellular Vesicles)

Organizing Committee:
– Pilar Martin Duque, Universidad de Zaragoza, co-chair
– Marta Monguió-Tortajada, Institut d’Investigació Germans Trias i Pujol, Badalona, co-chair
– Marcel·la Franquesa, Institut d’Investigació Germans Trias i Pujol, Badalona
– Lydia Álvarez-Erviti, Center for Biomedical Research of La Rioja
– María Yáñez-Mó, UAM/IIS-IP, CBM, Madrid; GEIVEX president

ABOUT THE WORKSHOP & REGISTRATION
This event focuses on giving a first grasp of the steps needed for clinical translation for EV-based products to members of GEIVEX. Researchers working on EV therapeutics
may benefit from attending this workshop sessions including GMP basics and requirements to regulatory issues and the industry viewpoint, given by experts in the field
of cell and gene therapy, clinical and regulatory bodies.
The workshop will take place in Badalona & Barcelona, on 26-27 June 2023, at the Germans Trias i Pujol Research Instiute (IGTP, Badalona), and the Blood and Tissue
Bank (BST, Barcelona).
The workshop will be organized in two different days. In day 1, attendees will have lectures and roundtables separated on three different sections: (1) “Cell and gene
therapy development for clinical application”, (2) “Regulatory affairs”, (3) “Academia & Industry focused on EV therapies”. In day 2, we are planning on a fully interactive
workshop, including a visit to clean room facilities and a hands-on discussion of their own TPP design.

This workshop is open only to GEIVEX members. more information and registration in this link

Workshop program (Preliminary Program)

DAY 1: 26th June 2023 – LECTURES AND DISCUSSION.
Location: Germans Trias i Pujol Research Institute, Badalona & online
9:30-10h. Registration
10-10:20h. INAUGURATION
10:20-11:30h. SESSION 1: CELL AND GENE THERAPY DEVELOPMENT FOR CLINICAL APPLICATION

1.1. How to turn a cell production into clinical grade: what does GMP mean and entail?
Luciano Rodríguez (Blood and Tissue Bank, Barcelona) (20 min)
1.2. Manufacturing of cell therapy products and ATMP development.
Joaquim Vives (Blood and Tissue Bank, Barcelona) (20 min)
1.3. Our experience at CliniStem: a gene and cell therapy GMP facility.
Begoña Díez Cabezas (CIEMAT, CliniStem cleanroom facility) (20 min)

11:45-12:15h. COFFEE BREAK
12:15-13:40h. SESSION 2: REGULATORY AFFAIRS

2.1. Regulatory affairs on cell therapy and ATMPs. Generalities.
TBD (20 min)
2.2. Biological therapy: the experience of the Spanish Regulatory Agency.
Pablo de Felipe (AEMPS) (20 min)
2.3. Regulatory affairs on EV therapies: the experience of the Austrian Regulatory Agency.
Silke Dorner (Austrian Medicines and Medical Devices Agency (AGES MEA)) (20 min)
2.4. The French experience.
Jessica Gobbo (EVOLVE group) (20 min)

13:40-14h. Q&A on EV therapies and regulatory issues
14:00-15:30h. LUNCH
15:30-16:30h. SPONSORS TALKS

16:30-18:00h. SESSION 3: ACADEMIA AND INDUSTRY FOCUSED ON EV THERAPIES

1.4. Academic CART19 manufacturing for anti-tumour immunotherapy.
Manel Juan (Clinic Hospital, Barcelona) (30 min)
3.1. A platform for therapeutic engineered EV.
Robert Mamoun (Ciloa) (30 min)
3.2. EV for osteoarthritis.
Maroun Khoury (Center of Interventional Medicine for Precision and Advanced Cellular Therapy (IMPACT), Universidad de los Andes, Chile) (30 min)

DAY 2: 27th June 2023 – CLEANROOM VISIT AND TPP WORKSHOP
Location: Blood and Tissue Bank of Catalonia (BST), Barcelona

9-9:15h. Registration
9:15-10:30h. Get your Target Product Profile (TPP) and product quality attributes (QTPP) canvas ready
10:30h Organize workshop participants into two subgroups (1 & 2) to participate in:

(A) Visit to cleanroom facilities
Joaquim Vives, Cristina Prat-Vidal (BST)
(B) Design and improve your TPP and QTPP canvas
Luciano Rodríguez (BST)

10:40-11:20h 1-A / 2-B
11:20-11:50h BREAK
11:50-12:30h 2-A / 1-B
12:30-13:30h CONCLUSIONS AND FAREWELL