Risk Assessment and Regulation
Working group 4 will bring together expertise in genetic stability and tumorigenicity testing for evaluation of best current scientific practice in cell safety testing and establish a consensus approach to identification and testing for the wider range of acute and emerging infectious diseases beyond the viral infections tested for in transplantation, as well as the regulatory landscape for donation and clinical use of cord blood-derived hiPSC and their derivatives.
Objectives
- Bring together expertise in genetic stability and tumorigenicity testing for evaluation of best current scientific practice in cell safety testing.
- Establishment of a consensus approach to identification and testing for the wider range of acute and emerging infectious diseases beyond the viral infections tested for in transplantation.
- Establishment of the regulatory landscape for donation and clinical use of CB-derived hiPSC and their derivatives.
WG4 Leaders
András Dinnyés
Description of Work
T4.1
Literature review on safety issues (e.g., genetic instability, tumorigenicity, immune rejection) in the production on hiPSC for manufacture of cell therapy products.
T4.2
Expert meeting on safety, regulatory and harmonisation issues.
Deliverables and milestones
D4.1
Regulatory road-map document from donor samples to hiPSC production for the manufacture of cell therapy products (M36).
D4.2
Guidelines for promoting quality and safety of hPSC-based medicines and cell therapy products (M39).
M4.1
Identification of aspects where there is good EU and international harmonisation and remaining challenges for harmonisation.
M4.2
Identify clinical risks and regulatory requirements for minimum best practice.