A joint taskforce has been set up by the BioIndustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) to provide industry input to the expert working group set up to learn from the TGN1412 clinical trial adverse events at Northwick Park.

 

‚ÄčThe BIA/ABPI industry taskforce is co-chaired by Dr David Chiswell and Sir Colin Dollery, with its membership consisting of bioscience and pharmaceutical industry experts in fields such as immunology, biopharmaceutical development and clinical trials.

The taskforce will offer input in the areas to be considered by Professor Gordon Duff's expert group which is reviewing early stage clinical trial design with specific reference to:

  • Biological medicines with novel molecules of action.
  • New agents with a highly species-specific action.
  • New drugs directed towards immune system targets.

Dr Richard Barker, Director General of the ABPI said: "Safety is at the forefront of all that we do, and it is imperative to examine carefully every aspect of the clinical development of ground-breaking medicines that work in a novel way related to that at the centre of this incident.

"We must do everything possible to prevent such an event ever again occurring without unnecessarily complicating a well-established procedure for testing the broad range of new medicines."

Aisling Burnand, Chief Executive of the BIA, said: "As a responsible industry, we have brought together this group of world-class individuals with significant experience in the clinical development of innovative medicines.

"We look forward to sharing this expertise with Professor Duff and his group to ensure the highest possible standards of patient and volunteer safety."

For further information, please contact: ABPI Press office: 020 7747 1410

 
 
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