Expert Working Group
This article was originally published in SRA
Executive Summary
Eighteen members added to UK clinical trials expert group
Eighteen members added to UK clinical trials expert group
The membership of the expert group that will review data from the failed trial of the monoclonal antibody, TGN1412, has been announced. The group, headed by Professor Gordon Duff, professor of molecular medicine at Sheffield University, will look at the study data and consider how first-in-man trials involving biological products with a specific action should be conducted in the future.
Among the 18 members are Sir Bob Hepple of Cambridge University and the chair of the Nuffield Council of Bioethics, and Professor Dr Johannes Lower, president of the Paul-Erhlich-Institut in Germany1. The group met for the first time on 23 May 2006, and an interim report, including minutes of meetings and interim findings, is expected in three months.
The group's work will focus on biological molecules with novel mechanisms of action, new agents with a highly species-specific action and new drugs directed towards immune system targets. It will be taking evidence from a range of stakeholders and experts, but it also welcomes submissions from anyone else who may like to make a contribution. Comments should be emailed to the UK Department of Health before the end of June 2006 to [email protected].
The group's work will be observed by representatives of the European Medicines Agency, the UK Department of Health, the UK Department of Trade and Industry's biosciences unit, the US Food and Drug Administration, the Pharmaceutical and Medical Devices Agency of Japan and the UK's Medicines and Healthcare products Regulatory Agency.
References
1. UK Department of Health press release, 25 May 2006, www.dh.gov.uk