Alan is a Senior Synthetic Chemist with more than 28 years experience in API Process Research & Development. He has a proven track record of identifying, developing and implementing synthetic processes for the successful manufacture of API from pre-clinical to commercial supplies.
Alan received his BS and PhD in Synthetic Organic Chemistry from Heriot-Watt University, Edinburgh, before moving to the US to carry out a Post-Doctoral assignment with Prof. Sidney M. Hecht at the University of Virginia. Alan started his pharmaceutical career with Parke-Davis Pharmaceutical R&D before joining GlaxoSmithKline, where he held a variety of domestic and international, Scientific and Leadership roles.
Alan’s primary expertise is in identification, development and implementation of synthetic processes for the manufacture of API. His experience covers the breadth of the drug development process, from laboratory based manufacture of early clinical supplies, through validation of processes in commercial manufacturing facilities. Using his knowledge of the regulatory environment and experience with early clinical development, he encourages application of a pragmatic (differentiated-development) approach to supporting early phase clinical development; while applying a systematic (quality-by-design) approach to the later phases of the development process. He has extensive experience in working with the regulatory authorities and is proficient in addressing the evolving requirements associated with the recently issued ICH M7 guidance on “Assessment and Control of Mutagenic Impurities in Pharmaceuticals’. He has a proven track record of leading multi-disciplinary teams, as well as working with international partners and CROs to achieve successful outcomes.
Examples of projects completed: