Partner at Consilium, Salmonson and Hemmings
Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the development, authorisation and life-cycle management of medicines.
Previously Rob worked at AstraZeneca and then for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists. Rob is a statistician by background and was co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology. Over 11 years at CHMP, Rob served as was Rapporteur for multiple products and was widely engaged across both scientific and policy aspects of the committee’s work. Rob also chaired the CHMP’s Scientific Advice Working Party for 8 years (4,229 procedures!) and also chaired EMA expert groups on Biostatistics, Modelling and Simulation and Extrapolation.
Rob has co-authored multiple regulatory guidance documents, including those related to estimands, subgroups, use of conditional marketing authorisation, development of fixed-dose combinations, extrapolation, missing data and adaptive designs. Rob has a particular interest in when and how to use data generated in clinical practice to support drug development.