Dr Simon Warren is the Research Director at Cardiff Scintigraphics. He studied for a degree in Applied Biology at the University of Wales Institute of Science and Technology and a PhD in Pharmaceutical Science at the Welsh School of Pharmacy (WSP) in Cardiff. Dr Warren subsequently undertook a Post-Doctoral research position, to investigate novel formulation approaches for pressurized metered dose inhalers (pMDIs). Dr Warren joined Scintigraphics in 1994 with responsibility for radiolabelling development and validation programs for oral and inhalation delivery systems. He has extensive experience in small scale GMP manufacture of radiolabelled pMDIs, dry powder inhalers and nebulizer systems for use in clinical trials in both healthy volunteers and patient populations.
Simon is responsible for contributing to regulatory submissions, development of batch records for GMP manufacture, image analysis, and integration of scintigraphy data into clinical study reports. The data from several studies have been used in marketing authorisations for inhalation and orally administered products.
Scintigraphics, trading as i2c Pharm, was part of a consortium that delivered a United Nations Industrial Development Organisation (UNIDO) program to reformulate pMDI products in HFA propellants. Simon was responsible for scale-up from laboratory to commercial batches and technical transfer of re-formulated pMDIs to several pharma companies, undertaking on-site technical transfer of both analytical and manufacturing methods. Four products developed during the project have been marketed.
Dr Warren is also the co-inventor of several patents describing novel formulation and manufacturing methods for pMDIs using propellants with low global warming potential.