David Kelly

Management of assigned External Manufacturing relationships including ongoing contractual oversight. Collaborate on forecasting, production planning and supply chain business process activities. Lead efforts to manage and execute risk mitigation plans. Collaborate with Global Procurement and Legal in negotiation of applicable contracts with TPMs. Establish and managing the technical transfer start-up and spend budgets for assigned TPMs and the associated variances.

• Co-ordination of a portfolio of new launch products, transfers and switches for the EMEA region across global internal and external manufacturing networks. • Creation and communication of accurate overview of project activities and timelines to affiliate markets, regional and global launch management.. • Alignment and monitoring of all concerned specialist functions. Co-ordination of forecasting, demand and supply analysis activities to mitigate stock outs and ensure sucessful launch / transfer.

Developed generic and NDA solid dose products for EU and US markets. Supported regulatory submission and CMC activities. Planned and executed development strategies through pre-clinical, scale up and Phase I to Phase III clinical supplies. Evaluated and collaborated with 3rd Parties. Execution of technology transfer.

Developed a patentable oral formulation for the treatment of MS in partnership with Merck-Serono. Key role in establishing and executing pre-clinical, scale up, Phase I to Phase III development strategy for this NDA. Technical point of contact for project sponsors to support CMC activities. Facilitated the outsourcing of process to contract manufacturing organisations during development and commercialisation. Developed generic products for US and EU markets.

Pharmaceutical Industrial Advanced Training (PIAT) Module: Pre-formulation studies

Pharmaceutical Industrial Advanced Training (PIAT) Module: Solid Dosage Forms