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Advancing Expansion

The UK has significant experience in first-in-human (FIH) clinical trials and has performed almost a quarter of the total of 2,206 FIH studies in the EU between 2005 and 2017 (Figure 1). Furthermore, the number of FIH trials conducted in the UK continues to increase; 69 out of 143 (48%) Phase 1 trials in 2016 were FIH, whereas, in 2017, this number grew to 105 out of 167 (63%) (1). The collective experience of regulators, clinical Phase 1 units, and FIH principal investigators in the last couple of decades has played a significant role in the development of guidelines for FIH/early phase clinical trials. However, two events come to the forefront of any early clinical developer’s mind in relation to the guidance issued by the EMA in this area.

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Dr Simon Hutchings has over 11 years of experience in the drug development process, including preclinical pharmacology/toxicology, Phase 1 (including first-in-human) pharmacology/ PK studies, and investigator-led Phase 2 and 3 trials. In addition to undergraduate and postgraduate qualifications in pharmacology, he also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine at the Royal College of Physicians, UK. Simon has extensive practical experience and scientific knowledge of the design, management, and reporting of clinical development projects.
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Dr Simon Hutchings
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