THURSDAY 27 APRIL
10:00-11:00
Registration
11:00-11:30
Opening
Chair: Zoltan Ivics, Paul-Ehrlich-Institut, Langen
11:00-11:10 Zoltan Ivics, Paul-Ehrlich-Institut, Langen
Welcome and opening remarks
11:10-11:30 Martina Schüssler-Lenz, Paul-Ehrlich-Institut, Langen
INV01: The life cycle management of Advanced Therapy Medicinal Products (ATMPs)
11:30-12:45
Session 1: Accelerating innovation in gene and cell therapy
Chair:
11:30-11:50 Christopher Baum, BIH Berlin
INV02: Building an ecosystem for innovation in the field of cell and gene therapy
11:50-12:10 Tobias Helmstorf, Bayer, Berlin
INV03:
12:10-12:30 John Bell, The Ottawa Hospital Research Institute
INV04: The BioCanRx Consortium
12:30-12:45 Q&A
12:45-13:45
Lunch
13:45-15:00
Session 2: Trends in ATMP Manufacturing
Chair:
13:45-14:05 Mario Assenmacher, Miltenyi Biotec GmbH
INV05: Advancing CAR/TCR T cell processing platforms towards decentral manufacturing
14:05-14:25 Qasim Rafiq, University College London
INV06: Automated process intensification and manufacturing strategies for ATMPs
14:25-14:45 Simon Hort, Fraunhofer IPT
INV07: The AIDPATH Consortium: How can digitalisation and automation enable large-scale application of CAR-T cell therapies?
14:45–15:00 Q&A
15:00-16:20
Session 3: Academic Development of ATMPs
Chair:
15:00-15:15 Claire Booth, University College London
INV08: The AGORA Initiative
15:15-15:30 Alessandro Aiuti, San Raffaele Scientific Institute, Milano
INV09: A novel platform approach for the treatment of lysosomal storage diseases with skeletal involvement
15:30-15:50 Özcan Met, National Center for Cancer Immune Therapy, Herlev
INV10: Manufacture of adoptive cell therapies at an academic cancer center
15:50-16:00 Caroline Pothet, EMA, Amsterdam
INV11: EMA’s pilot for academic and non-profit ATMP developers
16:00-16:20 Q&A
16:20-16:40
Coffee Break
16:40-18:00
Roundtable Discussion
T2 EVOLVE Regulatory Focus: Progressing the Parent-Child IND Concept
Chair:
Friday 28 April
08:30-09:00
Registration
9:00–10:40
Session 4: What’s hot: Preclinical and Clinical Developments to Accelerate ATMP
Chair:
9:00-9:20 Emmanuel Donnadieu, INSERM, Paris
INV12: Predicting safety and efficacy of engineered T cells using ex vivo human models
9:20-9:40 Julio Delgado, Hospital Clínic de Barcelona
INV13: ATMPs: from bench to bedside (through the regulator’s desk)
9:40-10:00 Anna Maria Veiga, IDIBELL, Barcelona
INV14: Predicting safety and efficacy of engineered T cells using ex vivo human models
10:00-10:20
INV15:
10:20-10:40 Q&A
10:40-11:00
Coffee
11:00-13:10
Session 5: Improving Awareness and Access to Cell and Gene Therapies
Chair:
11:00-11:20 Clare Blackburn, University of Edinburgh
INV16: The EuroGCT Consortium: Meeting information needs of all stakeholders in cell and gene therapy
11:20-11:40
INV17:
11:40-12:00
INV18:
12:00–12:20 Alexander Natz, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Brussels
INV19: Reimbursement of ATMPs: Current roadblocks and the implications of the EU HTA
12:20-12:40
INV20:
12:40-13:10 Q&A
13:10-13:15
Closing Remarks
Chair: Zoltan Ivics, Paul-Ehrlich-Institut
13:15-14:00
Lunch