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NON-CLINICAL TESTING FOR ADVANCED THERAPY
Session Chair(s)
Carla Herberts, PhD
Non-Clinical Assessor
Medicines Evaluation Board, Netherlands
Advanced therapy medicinal products (ATMPs) are a group of medicinal products consisting of gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (CTMPs) and tissue engineered products (TEPs). Non-clinical development of advanced therapy medicinal products are particularly challenging due to their complexity and innovative nature. Presentations in this session will consist of a general overview of possible approaches to tackle the challenges, of experiences gained with the currently only registered cell therapy product, and of a promising gene therapy product earlier in development.
Speaker(s)
Non-Clinical Issues Discussed in Scientific Advice of Advanced Therapy Medicinal Products
Carla Herberts, PhD
Medicines Evaluation Board, Netherlands
Non-Clinical Assessor
The Experiences Gained with ChondroCelect
Gert De Beckker, MS
Galapagos NV, Belgium
Head Regulatory Affairs
Stem Cell Gene Therapy for Pompe's Disease
Merel Stok, MSc
Erasmus Medical Center, Netherlands
PhD candidate
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