Keith Purdy is a graduate of Leicester School of Pharmacy and registered as a Pharmacist after Pre-Registration training at Addenbrookes Hospital, Cambridge and MSD, Hoddesdon. Following this he completed a PhD in Pharmaceutics at the University of Bath (stability of chlorhexidine). Keith then began his career in the pharmaceutical industry with Boots Pharmaceuticals where he undertook pre-formulation studies on all NCEs and provided formulation research support to Boots development and marketed products. He then moved to Fisons as Team Leader for tablet development projects where he had accountability for the formulation development and manufacture of clinical supplies for remacemide. As this compound progressed to Phase III clinical studies, he also led the technology transfer in to an Operations facility.
Following the acquisition of Fisons by Astra, he continued as Team Leader then Section Manager to lead formulation development programmes for a range of product types across multiple therapy areas. Keith’s responsibility included both early and late stage projects, the manufacture and packaging of clinical trial supplies and Regulatory Authority submissions and he line managed a group of 15-20 scientists.
Following the merger between Astra and Zeneca he then moved into a Project Management role having accountability for the CMC development of early and late stage NCEs. He led cross-functional teams delivering the pharmaceutical development contribution to AZ global projects and sat on numerous global development teams. One of these was the AZ compound ticagrelor (Brilinta/Brilique), where Keith has been Project Manager since the first study in man, through large complex clinical studies and to regulatory submissions and market approval in over 100 territories. As a consequence, he has extensive experience in all aspects of the end-to-end development process including scale-up and technology transfer, clinical trial supplies (including comparators), working with CROs, Regulatory Authority submissions / interactions and life-cycle management. Additionally, as Project Manager, he has expertise in project planning and control, budget forecasting and reporting, stakeholder management / communication and managing complex project across geographical and cultural boundaries. From the many development projects he has led, he also has significant experience in forming and leading new teams, defining objectives and milestones and then closing down or transferring teams / projects.
Keith’s expertise and skills, acquired over 30 years working with hundreds of development projects, is a valuable resource for any project or technical issue regardless of stage of development or product type.
CMC, Formulation, UK