BioInsights - FDA perspective on the preclinical development of cell-based immunotherapies

FDA perspective on the preclinical development of cell-based immunotherapies

Cell & Gene Therapy Insights 2020; 6(9), 1381–1390

10.18609/cgti.2020.148

Published: 23 October 2020
Regulatory Insight
Alyssa Kosmides Galaro, Christopher Saeui

Preclinical studies are conducted to support administration of investigational products in clinical trials. Assessment of the safety profile and product activity for an investigational product are important to inform the clinical trial design and characterize the benefit–risk profile related to the product and target clinical population. However, identifying appropriate animal models and designing informative preclinical studies can be challenging for cell-based immunotherapies. This review discusses the general expectations for preclinical assessment of cell-based immunotherapies, including resources to support transition from bench to bedside.