Jim Ryan

Background

About Jim Ryan

My primary remit is to provide robust and timely environmental support for all GSK drug filings worldwide, particularly in the United States and European Union. Specifically, I design intelligent fate and effects testing strategies based on the physico-chemical properties of active pharmaceutical ingredients (API) with a view to assessing its environmental impact. Furthermore, I am responsible for the management and review of study protocols and final reports, extrapolation of scientific data and preparation of a comprehensive environmental risk assessment (ERA) expert report in harmony with NDA/MAA regulatory requirements. Additional responsibilities include the following: • Project management in delivering environmental risk profiles and assessments in accordance with NCE milestone progression in compound development. • Provision of risk assessment in support of Swedish classification of Pharmaceuticals (Fass). • Academic liaison and collaboration in support of original scientific projects through PhD CASE awards and EC funded projects. • Modelling the environmental impact of pharmaceuticals using QSARs, EUSES and EPI suite models. • GSK technical expert representative at scientific conferences and workshops. • Representing GSK on Industry and Trade Association activities particularly in relation to environmental risk assessment and pharmaceuticals in the environment (PIE). Active membership of cross-industry ERA expert users network and PhRMA ERA strategic initiative teams. • Management, composition and review of the environmental section of GSK safety data sheets (SDS) in accordance with internal hazard assessment programmes. • Application of environmental ecotoxicological data to underpin responsible aqueous waste disposal strategies at GSK manufacturing sites. • Leverage bioinformatic and cheminformatic platforms to develop more intelligent environmental testing strategies resulting in higher quality risk assessments.