Industry experts to advise Northwick Park investigation
pharmafile | May 19, 2006 | News story | Research and Development |Â Â Â
Experts from the UK's pharmaceutical and biotech industries are to assist the inquiry into the Northwick Park drug trial, which aims to understand why six volunteers nearly died in the tests in March.
All the volunteers in the trial who suffered side-effects from the phase I trials of TGN-1412 have now recovered, but the cause of the severe reactions remains unclear.
The MHRA is expected to name a group of international experts in the near future, who will form a special committee to investigate the drug, and consider how similar problems could be anticipated in the future.
The pharma and biotech industries will be excluded from the inquiry team, but the UK industry bodies, the ABPI and BIA, have now unveiled their own panel of experts, who will offer technical insight and possible answers as to what went wrong.
The BIA/ABPI industry taskforce is co-chaired by Dr David Chiswell and Sir Colin Dollery, with its membership consisting of bioscience and pharma industry experts in fields such as immunology, biopharmaceutical development and clinical trials.
The taskforce will offer input into the MHRA 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."
Asked about how much real input into the inquiry the taskforce would be given, Dr Barker told Pharmafocus that, in his opinion, there were no particular barriers to industry input. He said he believed industry representatives had been excluded from the inquiry team itself to reassure observers the investigation would be entirely independent and unbiased.The MHRA has yet to name the members of its inquiry team, but the investigation will be led by its leading scientist Prof Gordon Duff.
Dr David Chiswell and Sir Colin Dollery, the co-chairmen of the industry taskforce have many years of experience in drug development.
Dr Chiswell is an expert in virology, immunology and microbiology and founded Cambridge Antibody Technology, one of the UK's leading biotech companies.
Sir Colin Dollery has been a senior R&D consultant to GlaxoSmithKline for nearly 10 years, with particular expertise in the transfer of drugs from the laboratory to early studies in man.
