ABPI/BIA task force in wake of TGN1412

In the wake of the tragic adverse reactions to German firm TeGenero's monoclonal antibody drug TGN1412, seen in a trial being conducted by contract research firm Paraxel at the UK's Northwick Park Hospital (Marketletters March 27), the Association of the British Pharmaceutical Industry and the BioIndustry Association have set up a joint taskforce to provide industry input to the expert working group set up to try to learn from the event.

During this Phase I trial, six of the men given TGN1412 suffered severe multiple organ failure, while the two on placebo did not. This raised grave concerns, resulting in the UK government setting up a criminal investigation into the incident and the Medicines and Healthcare products Regulation Agency (MHRA) an expert committee to advise on testing of monoclonal antibodies, under Gordon Duff, Florey Professor of Molecular Medicine, and Director of the Division of Genomic Medicine at the University of Sheffield.

The BIA/ABPI industry taskforce is co-chaired by David Chiswell, a non-executive director of several drugmakers, and Sir Colin Dollery, a former consultant on R&D to GlaxoSmithKline, with its membership consisting of bioscience and pharmaceutical industry experts in fields such as immunology, biopharmaceutical development and clinical trials.