Simon has been with NDA since 2013. He is an expert in biostatistics and clinical trials with over 30 years’ experience, covering drug development, clinical trial design, regulatory procedures, and strategy.
Simon’s extensive knowledge is key when guiding clients through the clinical trial design and the regulatory process associated with drug and biologics development.
Key Areas Of Expertise
- Clinical documentation requirements supporting European regulatory applications
- Experience preparing and reviewing regulatory submission documents, briefing documents for Scientific Advice procedures and responses to regulatory agency questions
- Expertise in the inner workings of the EU & US regulatory systems
- Supporting Sponsors preparing for meetings with European and US regulatory agencies - Advisory Committee meetings and oral explanations.
- Professional presentation skills and extensive teaching experience
- Joint course developer and lead presenter on FDA course on Science of Small Clinical Trials
- Simon has run training programmes on general drug development, clinical trial design, regulatory procedures and strategy, data monitoring committees and interim analysis, equivalence and non-inferiority study designs, and general statistical issues in clinical trials.
Before Joining The NDA Advisory Board
Simon was the Head of the Statistics Unit at the Medicines and Healthcare Regulatory products Agency in the UK; Vice-Chairman of Committee for Human Medicinal Products Scientific Advice Working Party; a Senior Consulting Statistician at Roche and held various professional posts including, Editor-in-Chief of Statistics in Medicine and former President of the International Society for Clinical Biostatistics.
Simon was also the lead author for CHMP Guideline on Clinical Trials in Small Populations.
Simon is a Fellow of the Royal Statistical Society and Society for Clinical Trials
Day S, Jonker AH, Pek Lian Lau L, Hilgers R-D, Irony I, Larsson K, Roes K and Stallard N. Recommendations for the design of small population clinical trials. Orphanet Journal of Rare Diseases, 2018; 13:195.
Jonker AH, Hivert V, Gabaldo, M, Batista L, O’Connor D, Aartsma-Rus A, Day S, Sakushima K and Ardigo D. Boosting delivery of rare disease therapies: IRDiRC’s Orphan Drug Development Guidebook. Nature Reviews Drug Discovery, 2020; 19:495–496.
Dr Simon Day