Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412.
Current immunology research is generating many new approaches to immunotherapy. However, the recent disaster surrounding the testing of TGN1412, has unsettled regulators and the pharmaceutical industry regarding new immunotherapies and highlighted the complexities of conducting clinical trials with agents that target the immune system. Here we discuss the critical role for immunologists in ensuring that the development of new immunotherapies continues.
Dayan
C M
CM
Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology, Dorothy Hodgkin Building, University of Bristol, Bristol, UK. colin.dayan@bris.ac.uk
Wraith
D C
DC
D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D035843:Biomedical Research / Q000379:methods / Q000592:standards; D017321:Clinical Trials, Phase I as Topic / Q000379:methods* / Q000592:standards; D006801:Humans; D007167:Immunotherapy; D012107:Research Design; D012308:Risk Management / Q000379:methods
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412