Clinical Trials Expert Advisory Group of the Commission on Human Medicines

Remit

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 mechanismAny 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.

Meeting dates for 2008

February	April	June	September	November
13	16	18	17	12

Membership

Chair
Professor Robert Lechler MB ChB PhD FRCP FRCPath FMedSci
Vice-Principal (Health), King's College London

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

Professor James K Chipman BSc PhD F I Biol FRCPath
Professor of Cell Toxicology, Birmingham University

*Professor Janet H Darbyshire OBE MB ChB  FRCP FFPH FMedSci
Professor of Epidemiology and Director of the MRC Clinical Trials Unit, Royal Free and University College London Medical School; Co-Director of UK Clinical Research Network

Professor Andrew J T George- PhD FRCPath FRSA
Professor of Molecular Immunology

Professor Andrew P Grieve BSc MSc PhD
Professor of Medical Statistics, School of Medicine, King’s College

Professor John D Issacs- BSc (Hons) MB BS PhD FRCP
Professor of Clinical Rheumatology

*Professor B Kevin Park BSc PhD Hon MRCP FMedSci
Professor of Pharmacology & Head of Department of Pharmacology and Therapeutics, Liverpool University

Mrs Vivienne Parry BSc (Hons)
Lay representative

&*Professor Munir Pirmohamed MC ChB PhD FRCP FRCPE
Professor of Clinical Pharmacology, Liverpool University

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

%Professor Stuart Ralston MD FRCP FMedSci FRSE
Head of School of Molecular and Clinical Medicine & ARC Professor of Rheumatology Molecular Medicine Centre, Western General Hospital, Edinburgh

*Professor Faith M Williams MA PhD
Professor of  Toxicology, Toxicology Unit, The Medical School  & Institute for Research in  Environment & Sustainability, University of Newcastle – upon - Tyne

*= Commission on Human Medicines
+=Biologicals & Vaccines Expert Advisory Group
%=Rheumatology & Immunology Expert Advisory Group
&=Pharmacovigilance Expert Advisory Group