I have a PhD from Imperial College (1993) and 28 years’ experience working in the pharmaceutical industry as an organic chemist; with the last 26 years at GSK, working in process research and development in R&D.
I have worked to develop numerous new chemistries and new processes for new drug molecules in development and redeveloped existing manufacturing processes as part of post approval change. I have experience of working in R&D pilot plants and leading the technical transfer of new batch processes from R&D to manufacturing.
A trail blazer in continuous processing
I am best known as a one of the leading innovators in the field of continuous processing for small molecules. Since 2000, I led the development of the lab-based technology and the ways of working for the development of continuous processes for Active Pharmaceutical Ingredients (API) at GSK.
I was heavily involved in the design, construction and commissioning of the first multifunctional pilot plant for continuous flow chemistry, within the pharmaceutical industry. In this facility, I led the teams that developed the processes that produced cGMP API for clinical evaluation and transfer to manufacturing.
The worlds’ first multistage continuous manufacturing platform
The highlight of my GSK career was to sucessfully lead a large multifunctional matrix team of >50 people across R&D and multiple manufacturing sites, to redevelop an existing GSK asset – Fluticasone Propionate (FP) – from a batch process into a continuous process. This was the first multistage continuous process to an API in the GSK manufacturing network and as far as I can tell, the first across the industry. The factory module was installed in Singapore in 2015, commissioned in 2016, validated in 2017 and the new process was filed with regulatory agencies in Europe and USA in 4th quarter 2018. The picture on the title page of this web site is the FP rig.
Regulatory experience
As part of designing, developing and implementing a ground breaking mulitstage continuous process to API, I have worked closely with the emerging technologies team (ETT) at FDA, regarding the registration and implementation of this process. This pre-file engagement culminated in a landmark meeting at the GSK manufacturing site where I led a 5-day pre-operational visit for members of the ETT. This was an important meeting to show case the new manufacturing process for FP, with an up close a personal tour of the facility and detailed explanation of the control strategy ahead of filing the dossier.
My experience with regulatory agencies is not limited to FDA, I have also led engagement with and EDQM, EMA, PMDA and I have hosted a similar 4-day pre-operational visit at the GSK manufacturing site with the PMDA.
I led the team that wrote the files for FDA and EDQM for the registration of FP as a continuous process.
I have also contributed to ICH Q13; guidance on continuous manufacturing.
