Module 9 2021

Non-clinical development for has ATMPs different endpoints

Interaction with surrounding tissues Defect correction in homolgous model Effective dose Cell differentiation Gene expression and VCN

PoC

Cell persistence Viral shedding Cell homing / migration Vertical transmission

ADME

Repeated dosing?

Repeated dose Tox

Insertional Mutagenesis Cell transformation Clonogenic assays Use of specific tumour prone animals

Carcinogenicity

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