Alacrity Pharma Associates ® is an allegiance between Keith Purdy, PhD and Alan R Harris, PhD. Between us we have more than 60 years of experience working in the Pharmaceutical Industry in a wide variety of roles associated with all CMC activities. Our combined experience spans all phases of development and includes working in both drug substance and drug product areas where we have managed and resolved many issues arising from drug discovery, drug substance and product manufacture and scale-up, clinical trial supplies, Regulatory Authority submissions and interactions, working with CRO / CMOs and performing due-diligence.

Keith Purdy started his career at Boots Pharmaceuticals where he performed pre-formulation studies on NCEs, supported drug delivery research and line-extension activities. He then moved to Fisons as Section Head in product formulation leading teams across a range of formulation types. Following the acquisition of Fisons by Astra, Keith oversaw a significant expansion in product development activities supporting all clinical phases and technology transfer into manufacturing sites. After Astra and Zeneca merged, he moved into a Project Management role where he was responsible for the drug product delivery in numerous early and late stage development projects. Keith managed AstraZeneca’s latest NCE, Brilinta/Brilique, from Phase I through to regulatory approval and launch. As a result he has considerable experience in understanding and resolving the complexities associated with each stage of development. He is particularly aware of the challenges in clinical trial supplies, regulatory authority submissions / meetings and technology transfer between sites and into Operations facilities.

Alan Harris began his career as a medicinal chemist at Allen and Hanburys (now GSK) before moving into process R&D with Fisons, which was later absorbed into Astra. He held a number of positions, including team manager roles in process research and process development, project manager and pilot plant operations manager. Following the Astra and Zeneca merger he moved into the newly formed Business Development group within process R&D where he was responsible for building the early development outsourcing group within AZ working with a large range of CROs in Europe, the US and India to deliver materials for development studies. He is an experience auditor for Quality, EHS and corporate responsibility and has a particular interest in risk assessments and risk mitigation. He has published a number of scientific papers as well as contributing to three chapters of a book on Technology Transfer published by the PDA. He has also published and presented on outsourcing theory and practice.

Alan and Keith have worked together on many development projects whilst they were at Fisons, Astra and AstraZeneca. Their skills combine and complement each other to form the complete CMC consultancy solution.