title: [Evaluation of the safety of innovative drugs against viruses and infectious agents].
abstract: Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.
authors: Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501.
authors: Tetsu
authors: T
authors: Kobayashi
authors: Keisuke
authors: K
authors: Yusa
authors: Nana
authors: N
authors: Kawasaki
mesh_terms: D000818:Animals; D000998:Antiviral Agents; D001685:Biological Factors; D064987:Cell- and Tissue-Based Therapy; D055808:Drug Discovery; D006801:Humans; D011328:Prions; D018570:Risk Assessment; D012308:Risk Management; D014777:Virus Diseases / Q000628:therapy*
chemical_list: D000998:Antiviral Agents; D001685:Biological Factors; D011328:Prions