Rob Hemmings, MSc is a Partner at Consilium Salmonson & Hemmings. He was the Head of Statistics and Pharmacokinetics, Licensing Division at the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. He sat for 11 years on EMA’s Committee for Medicinal Products for Human Use (CHMP) as the co-opted member with expertise in medical statistics and epidemiology, working as methodological expert across the spectrum of applications reviewed by the committee, as rapporteur for specific applications and more broadly across the policy and procedural aspects of the committee work (e.g. development of the PRIME scheme, scientific guideline on Conditional Marketing Authorisation). For 8 years, Rob was the Chair of the Scientific Advice Working Party handling over 4,000 procedures, and at various times chaired the Biostatistics Working Party, the Modelling & Simulation Working Party, and the Extrapolation Working Parties within the CHMP of the EMA. Mr. Hemmings is an expert in clinical trial design and critical appraisal of clinical trial data with extensive experience across all therapeutic areas, including innovative therapies, rare diseases, and biosimilars.