Malcolm was the founding Managing and Clinical Director of HMR in 1993. Since then, he’s been principal investigator or co-investigator for over 950 phase 1 and early phase 2 trials. He is accredited by the MHRA as PI for FIH studies, and is a Qualified Person (QP) to release batches of investigational medicinal products (IMP). Also, as Quality Systems Manager, he has responsibility for the quality management system.
Malcolm qualified in physiology and medicine in Bristol, and subsequently became Fellow of the Royal College of Physicians; Fellow of the Faculty of Pharmaceutical Medicine; and Honorary Fellow of the British Pharmacological Society. He’s Honorary Professor of Clinical Pharmacology, Queen Mary University of London, and Visiting Professor of Clinical Pharmacology, King’s College, London. In 2019, Malcolm was awarded the President’s Medal by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.
Malcolm has held various posts in clinical and academic medicine, and has worked for several major pharmaceutical companies. While in the industry, he coordinated numerous clinical trials in Europe and the USA across all phases of drug development, with a wide variety of new compounds. He’s published over 160 papers in journals and books on drug development and research ethics.
Outside of HMR, Malcolm is a member of the HRA Phase 1 Advisory Group; MHRA GCP Consultative Committee; Founding Committee of the Faculty of Medical Leadership and Management; The National Research and Ethics Advisors’ Panel (NREAP); BIA Science and Innovation Advisory Committee (SIAC); and Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI).
He’s Chairman of the Faculty of Pharmaceutical Medicine DHP/CHP Advisory Committee; and Clinical Pharmacology Special Interests Group of the Faculty of Pharmaceutical Medicine.
Malcolm is also CEO of a pharmaceutical company, Trio Medicines, a subsidiary of HMR, that has a portfolio of novel compounds at various stages of development.
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