Alan Harris graduated from Southampton University and began his career as a graduate medicinal chemist with Allen and Hanburys (now part of GSK) at their site in Ware, Hertfordshire. During this time he completed a part time MPhil degree on the synthesis of bicycle [3,2,1] octylamines as potential agents for the relief of pain. He then moved into process development with Fisons where he initially worked on the development of compounds for the treatment of Asthma, first as a process chemist and later as a team leader. During this time he completed a part time PhD at Coventry University on the use of sodium formaldehyde sulphoxylate as a reagent for synthesis. During this period Fisons diversified its portfolio and Alan became responsible for the development of a potential anti epilepsy compound, Remacemide, which was taken through to the end of Phase 3, acting as project manager as well as the chemistry lead and sitting on the global development team. This project involved making some 25 tonnes of API for phase 3 and commercial launch and involved the management of several different CROs .
Fisons R&D was absorbed into the Swedish company Astra in 1995 and Alan moved into a role of Pilot Plant Operations manager where he was responsible for all the chemistry undertaken, as well being responsible for the development of the quality and safety systems, in the newly built plant. Following the Astra and Zeneca merger he became 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 Phase 1/2 development studies. He was also involved in the several focus groups aimed at unifying quality systems across the newly merged organisation and was responsible for the introduction of an electronic SOP system for the Global Process R&D organisation. A further responsibility was leading the User Design Teams for laboratory blocks being constructed in Bangalore, India and in Loughborough. As part of his outsourcing responsibilities he was involved in auditing suppliers from technical, QA and HSE perspectives.
Since 2010, Alan has been advising small and virtual Pharma companies on their outsourcing requirements and small CROs on their strategy and systems development. Recently he has worked with several Chinese companies and can offer an insight into the risks and advantages of low cost outsourcing in this region. He has published a number of scientific papers as well as contributing to the key API chapter of a book on Technology Transfer, published by the PDA, which is currently being revised and updated. He has also published and presented on outsourcing theory and practice.
Alan’s offers over 30 years of broad experience in all aspects of process R&D work (Technical, Quality and HSE) and is ideally qualified to set up and manage outsourcing projects for small pharmacompanies who do not have the required internal expertise.
Regulatory, UK, Process R&D, API drug substance, development, Technology Transfer, Quality, QbD, Audit, Pharmaceutical, R&D, Route, Process, Analytical, Validation, Scale-up, Clinical Supply.