Host: The Japanese Society of Toxicology
The emergence of the highly pathogenic coronavirus SARS-CoV-2 and its rapid spread leading to the coronavirus disease 2019 (COVID 19) pandemic has posed a serious global public-health emergency. The ongoing pandemic has led to the development of several investigational cell and gene therapy (CGT) products as a potential treatment of COVID-19. The conduct of a clinical trial for an investigational (CGT) product is guided by the Code of Federal Regulations (CFR) Title 21, Part 312, to ensure the safety and rights of subjects in all phases of a clinical investigation. According to 21 CFR 312.23(a)(8), the sponsor is responsible for providing adequate pharmacology and toxicology data to support a conclusion that the proposed clinical trial is reasonably safe to conduct. This presentation will provide an overview of the regulatory considerations for preclinical development programs designed to assess the safety and activity of CGT products for COVID-19.
