Clinical Trials Expert Advisory Group of the Commission on Human Medicines

To advise the Commission on: 

• First Time in Man (FTIM) studies with new compounds acting (directly or indirectly) via the immune system with a novel target or a novel mechanism of action or having a secondary potential effect on the immune system via a mechanism of action which currently is not well characterised
• FTIM studies with novel compounds acting via a possible or likely species specific mechanism
• any FTIM studies which are otherwise seen as requiring expert advice
• other clinical trials involving classes of compound where MHRA may wish to seek external expert advice or CHM may wish to have oversight
• provide expert advice on whether a product’s mechanism of action is novel and comes within the scope of the EAG
• provide MHRA with expert advice on pre-meeting scientific advice documentation for within scope compounds
• other clinical trials where MHRA may wish to seek advice or where there is a difficult risk benefit balance
• other clinical trials involving products where a new class safety issue has been identified.

Members

Dr Susan M Bews BSc MBBS LRCP FFPM FRCPL FRCPE FRCPGlas
Immediate Past President of the Faculty of Pharmaceutical Medicine

*Professor Derek H Calam OBE MA DPhil DScHon CChem FRSC FRSA Hon MRPharmS Hon MTOPRA
Visiting Professor of Pharmaceutical Sciences at the University of Strathclyde

Professor Janet H Darbyshire CBE MB ChB FMedSci FRCP FFPH FRSS (Hon)
Emeritus Professor of Epidemiology, University College London

Professor Andrew J T George BA PhD FRCPath FRSA
Professor of Molecular Immunology, Imperial College, London

Professor John D Isaacs BSc (Hon) MB BS PhD FRCP
Professor of Clinical Rheumatology, Medical School, Newcastle University

*Professor B Kevin Park BSc PhD FMedSci FRCP (Hon) FTBS
Director of MRC Centre for Drug Safety Science, Professor of Pharmacology and Head of Department of Pharmacology and Therapeutics, Liverpool University

Dr Stephen Poole PhD
Head of Parenterals Section, Biotherapeutics Group, National Institute for Biological Standards and Control

Professor Munir Pirmohamed MB ChB (Hons) PhD FRCP(E) FRCP
Professor of Clinical Pharmacology, University of Liverpool, NHS Chair of Pharmacogenetics and Director of the Wolfson Centre for Personalised Medicine

Mrs Madeleine Wang
Lay Member - Patient Advocate

Dr Christopher J Weir BSc (Hons) PhD MSc FRSS CStat CSci
Associate Director (Statistics), MRC Hub for Trials Methodology Research, University of Edinburgh