Rethinking early clinical testing: The translation from laboratory to clinic
16-17th April 2007, Surrey, UK
In March 2006, just over a year before this CMR International Institute Workshop took place, pharmaceutical research received an abrupt wake‑up call following the TGN1412 incident, in which six healthy volunteers were admitted to intensive care after a first‑in‑man study of a novel anti‑CD28 monoclonal antibody in the UK. The incident focused attention on safety and best practice at the laboratory‑to‑clinic transition.
Although the TGN1412 incident and its immediate regulatory consequences—including the Duff Report, the Joint ABPI/BIA report and EMEA consultation guidelines—formed an important backdrop to the Workshop discussions, the scope of the programme was broader. The Workshop examined changing paradigms for early clinical testing, the role of translational medicine and strategies for introducing new technologies at the discovery–development interface.