Across my 23 years of industrial experience, I have led the development of novel pharmaceutical formulations and their associated analytical methods. In addition, I have designed, delivered, and scaled up over 100 formulations for Phase I clinical studies, primarily novel chemical entities, but I am also experienced in generic development. I have advised over 40 clients on the optimum design of a dose form for their API, navigating them via tailored preformulation studies, small-scale proof-on-concept batches, and robust pilot-scale batches to meet the requirements for regulatory submissions for Phase I and II batches. Many of these were highly challenging projects, including APIs having poor solubility or physical and chemical instability or needing delayed or extended-release profiles.
Before joining SGS Quay Pharma, I was an Associate Principal Scientist for 14 years at MSD (Merck Sharp and Dohme), leading teams to develop new oral solid pharmaceutical products for NCEs. I also hold a PhD (Physical Chemistry) and BA (Natural Sciences) credentials from the University of Cambridge in the UK.